Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
Phase: NA
Conditions: Breast Cancer Stage 0, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Sponsor: Alliance for Clinical Trials in Oncology

 
 
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1  
A L LI A N C E F O R C LI NI C A L T RI A L S I N O N C O L O G Y  
A L LI A N C E A 2 3 1 7 0 1 C D  
 
IN C R E A SI N G S O CI O E C O N O MI C A L L Y D I S A D V A N T A G E D P A TI E N T S ’ E N G A G E M E N T I N B R E A S T C A N C E R 
S U R G E R Y D E CI SI O N M A KI N G T H R O U G H A S H A R E D D E CI SI O N M A KI N G IN T E R V E N TI O N  
A li mite d access st u dy  
Cli nical Trials. g o v I de ntifier: N C T 0 3 7 6 6 0 0 9   
 
St u d y C hair  
 
 
 
 
 
 
 
 
 
 
C o m m u nit y O nc ol o g y C o -c hair 
Healt h Dis parities C o -C hair  
 
 
 
 
 
 
 
C C D R C o m mittee C o -C hairs  
Healt h Dis parities C o m mittee C hair  
 
 
 
 
  
 
 
 
 
 
Statisticia n  
Statisticia n  
 
 
 
 
 
 
 
Data Ma na ger  
 
 
 
 
Pr ot oc ol C o or di nat or  
 
 
 
 
Li mite d Access I nstit uti o ns  
U ni versit y of Ne w Me xic o M/ U N C O R P  N M 0 0 4  
Str o ger H os pital of C o o k C o u nt y M/ U N C O R P  I L 0 4 2 
V C U Masse y Ca n cer Ce nter M/ U N C O R P  V A 0 1 0  
Wisc o nsi n N C O R P  WI 0 3 1  
Me dical U ni versit y of S o ut h Car oli na M/ U N C O R P  S C 0 0 8  
M o nta na Ca ncer C o ns orti u m N C O R P  M T 0 0 2  
Ge or gia Cares M/ U N C O R P  G A 0 2 0  
Carle Ca ncer Ce nter N C O R P  I L 1 6 8 
Ha waii M/ U N C O R P  HI 0 1 2  
Ba y Area T u m or I nstit ute N C O R P  C A 6 7 1  
 
P artici pa nts: N C O R P c o m p o ne nts of t he Allia nce (lea d), E C O G-A C RI N, N R G, a n d S W O G N C O R P Researc h 
Bases  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
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2  
St u d y Res o urces:  
Me di d at a R a ve  i Me di d at a p ort al 
 
O P E N ( O nc ol o g y P atie nt E nr oll me nt Net w or k)  
 
 
Pr ot oc ol C o nt acts:  
A 2 3 1 7 0 1 C D N ursi n g C o nt act  
 
 
 
  
 
 
 
Pr ot oc ol -rel ate d q uesti o ns m a y be directe d as f oll o ws:  
Q uesti o ns  
C o nt act ( vi a e m ail)  
Q uesti o ns re gar di n g patie nt eli gi bilit y, treat me nt, 
a n d d ose m o dificati o n:  
St u d y C hair, N ursi n g C o ntact, Pr ot oc ol 
C o or di nat or, a n d ( w here a p plica ble) Data 
Ma na ger  
Q uesti o ns relate d t o data s u b missi o n, R A V E or 
patie nt f oll o w -u p:  
Data Ma na ger  
Q uesti o ns re gar di n g t he pr ot oc ol d oc u me nt a n d 
m o del i nf or me d c o nse nt:  
Pr ot oc ol C o or di nat or  
Q uesti o ns relate d t o I R B re vie w 
Allia nce Re g ulat or y I n b o x  
 
Q uesti o ns re gar di n g C T E P -A E R S re p orti n g:  
Allia nce P har mac o vi gila nce I n b o x  
 
  
 
 
 
 

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C A N C E R T RI A L S S U P P O R T U NI T ( C T S U) A D D R E S S A N D C O N T A C T I N F O R M A TI O N 
F or re g ul at or y re q uire me nts:  
F or p atie nt e nr oll me nts:  
F or d at a s u b missi o n:  
Re g ulat or y d oc u me ntati o n m ust 
be s u b mitte d t o t he C T S U via 
t he Re g ulat or y S u b missi o n 
P ortal.  
 ( Si g n i n at 
a n d 
select the Re g ulat or y > 
Re g ulat or y S u b missi o n.)  
 
I nstit uti o ns wit h patie nts 
waiti n g t hat are u na ble t o use 
t he P ortal s h o ul d alert t he 
C T S U Re g ulat or y Office 
i m me diatel y at 
 
t o recei ve f urt her i nstr ucti o n 
a n d s u p p ort. 
 
C o ntact t he C T S U Re g ulat or y 
He l p Des k at 
 
f or re g ulat or y assista nce. 
Refer t o t he patie nt e nr oll me nt 
secti o n of t he pr ot oc ol f or 
i nstr ucti o ns o n usi n g t he 
O nc ol o g y Patie nt E nr oll me nt 
Net w or k ( O P E N). O P E N is 
accesse d at 
 
 
C o ntact t he C T S U Hel p Des k 
wit h a n y O P E N relate d q uesti o ns 
b y p h o ne or e mail  : 
 
 
 
S o me d ata c ollecti o n f or t his 
st u d y will be d o ne t hr o u g h 
Me di data Ra ve  a n d ot her data 
s u b missi o n will be d o ne directl y 
t o t he U ni versit y of Wisc o nsi n. 
Refer t o t he data s u b missi o n 
secti o n of t he pr ot oc ol f or 
f urt her i nstr ucti o ns.  
 
T he m ost c urre nt versi o n of t he st u d y pr ot oc ol a n d all s u p p orti ng d oc u me nts  m ust be d o w nl oa de d 
fr o m t he pr ot oc ol-s pecific pa ge l ocate d o n t he C T S U me m bers’ we bsite 
. Access 
t o t he C T S U me m bers’ we bsite is ma na ge d t hr o u g h t he Ca ncer T hera p y a n d E val uati o n Pr o gram - 
I de ntit y a n d Access Ma na ge me nt ( C T E P-I A M) re gistrati o n s yste m a n d re q uires l o g i n wit h a C T E P-
I A M user na me a n d pass w or d.  
Per missi o n t o vie w a n d d o w nl oa d t his pr ot oc ol a n d its s u p p orti n g d oc u me nts is restricte d a n d is base d 
o n pers o n a n d site r oster as si g n me nt h o use d i n t he C T S U Re g ulat or y S u p p ort S yste m ( R S S).   
F or cli nic al q uesti o ns ( i.e., p atie nt eli gi bilit y or tre at me nt -rel ate d)  see t he Pr ot oc ol C o ntacts, Pa ge 2. 
F or n o n -cli nic al q uesti o ns ( i.e., u nrel ate d t o p atie nt eli gi bilit y, tre at me nt, or cli nic al d at a 
s u b missi o n) C o ntact t he C T S U Hel p Des k b y p h o ne or e mail:   
C T S U Ge neral I nf or mati o n Li ne –  
All calls a n d  
c orres p o n de nce will be tria ge d t o t he a p pr o priate C T S U re prese ntati ve.  
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
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IN C R E A SI N G S O CI O E C O N O MI C A L L Y D I S A D V A N T A G E D P A TI E N T S ’ E N G A G E M E N T I N B R E A S T C A N C E R 
S U R G E R Y D E CI SI O N M A KI N G T H R O U G H A S H A R E D D E CI SI O N M A KI N G IN T E R V E N TI O N  
 
P atie nt Eli gi bilit y Criteri a: ( See Secti o n 3. 2 ) 
Re q uire d I niti al L a b V al ues  
• 
W o me n ne wl y dia g n ose d wit h cli nical sta ge 0-III breast ca ncer. 
N o ne  
• 
Eli gi ble patie nts m ust be pla n ni n g breast s ur ger y as a c o m p o ne nt of t heir defi niti ve treat me nt.  
• 
Patie nts wit h i m paire d decisi o n -ma ki n g ca pacit y are n ot eli gi ble f or t his st u d y.  
• 
Patie nts wit h heari n g i m pair me nt re q uiri n g t he use of a n i nter preter are n ot eli gi ble f or t his st u d y.  
• 
Patie nts m ust be a ble t o s pea k E n glis h (see Secti o n 3. 2 . 5) 
• 
A ge ≥ 1 8 years  
 
P A TI E N T S C H E M A  
 
F or p atie nts e nr olle d pri or t o  I nstit uti o n al Cr oss o ver: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C o nse nt/ Re gistr ati o n  
Baseli ne Patie nt 
S ur ve y  
 
A u di o 
rec or di n g 
of 
c o ns ultati o n 
 
Patie nt P ost -
C o ns ultati o n 
F oll o w -u p 
s ur ve y 
N o Decisi o n Ai d 
Offere d  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
F or p atie nts e nr olle d after  I nstit uti o n al Cr oss o ver: 
 
 
 
 
 
 
 
 
Patie nt 
T ele p h o ne/ vi de o/in -
pers o n I nter vie ws 
(s u bsets) 
 
 
 
 
 
 
 
 
acce pte d 
 
Patie nt  
F oc us 
Gr o u ps 
(s u bset) 
 
 
 
 
 
 
decisi o n 
ai d 
 
 
 
 
 
 
 
 
 
C o nse nt/ Re gistr ati o n  
Baseli ne Patie nt 
S ur ve y  
 
A u di o 
rec or di n g 
of 
c o ns ultati o n 
 
Patie nt P ost -
C o ns ultati o n 
F oll o w -u p 
s ur ve y 
 
 
Decisi o n 
Ai d 
Offere d  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patie nt 
Tele p h o ne / vi de o/i n-
pers o n  I nter vie ws*  
(s u bset) 
 
 
 
 
 
 
 
 
decli ne d  
decisi o n 
ai d 
 
 
 
 
 
 
 
 
 
 
 
*  
A s u bset of patie nts w h o decli ne t he decisi o n ai d a n d di d n ot  partici pate i n t he s ur ve ys a n d a u di o rec or di n g 
of t he c o ns ultati o n ma y als o be a p pr oac he d f or a tele p h o ne / vi de o/i n-pers o n  i nter vie w al o ne. 
 

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5  
Cli nic St a ke h ol der ( S ur ge o ns a n d Cli nic St aff) Eli gi bilit y Criteri a: ( See Secti o n 3. 3 ) 
Breast s ur ge o n(s) a n d n ursi n g staff, me dical assista nt, or mi d -le vel pr o vi der at eac h partici pati n g cli nic w h o 
partici pate i n t he care of patie nts ne wl y dia g n ose d wit h breast ca ncer. 
 
S ur ge o n Sc he m a †  
 
Baseli ne 
s ur ge o n s ur ve y 
 
A u di o rec or di n g of 
c o ns ultati o ns wit h 
e nr olle d patie nts 
 
Cli nic sta ke h ol der f oc us 
gr o u ps (s u bset)  
 
 
 
 
I nstit uti o n al Eli gi bilit y Criteri a: ( See Secti o n 3. 4 ) 
 
Eli gi ble cli nics will ser ve a hi g h pr o p orti o n of s oci oec o n o micall y disa d va nta ge d patie nts, defi ne d usi n g t w o 
data s o urces.  Usi n g t hese data, 1 0 cli nics t hat a n n uall y pr o vi de s ur gical care f or 1 2 0 -3 0 0 patie nts ne wl y 
dia g n ose d wit h breast ca ncer will be selecte d t o partici pate i n t his st u d y.  S ur ge o ns at eli gi ble cli nics m ust 
c o nse nt t o t he st u d y as a re q uire me nt f or site partici pati o n.  
 
All partici p ati n g i nstit uti o ns will be selecte d b y t he st u d y tea m per Secti o n 3. 4 pri or t o st u d y acti vati o n.  
 
 
Cli nic Le vel Sc he m a  
 
Us ual Care data 
c ollecti o n ( wit h 
a u di o rec or di n g 
of c o ns ultati o n  
 
I nitiate 1 0-wee k 
Decisi o n ai d I nter ve nti o n 
i m ple me ntati o n peri o d *†  
 
C o nti n ue data c ollecti o n wit h 
decisi o n ai d i nter ve nti o n 
( wit h a u di o rec or di n g of 
c o ns ultati o n ) * * 
 
Meas ure reac h 
of decisi o n ai d 
at cli nic le vel  
*  
Sites are ra n d o mize d t o ti mi n g of cr oss -o ver fr o m us ual care t o decisi o n ai d i nter ve nti o n.  
* *  Sa me data are c ollecte d bef ore a n d after cr oss -o ver t o decisi o n ai d  
†  
S ur ge o ns will be as ke d t o e n ga ge i n t he decisi o n ai d i m ple me ntati o n pr ocess d uri n g t he cr oss -o ver 
i m ple me ntati o n peri o d. 
 
St u d y Ti meli ne  
 
Ye a r 1  
Ye a r 2  
Ye a r 3  
Ye a r 4  
Deter mi ne a n d ra n d o mize cli nic partici pa nts 
( Acti vati o n) 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseli ne s ur ve y t o s ur ge o ns  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Be gi n q ua ntitati ve data c ollecti o n i n us ual care cli nics  
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cli nic visits t o i nitiate i m ple me ntati o n pr ocesses  
 
X  X  X  X  X  
 
 
 
 
 
 
 
 
 
 
O n g oi n g data c ollecti o n a n d cli nics s witc hi n g fr o m 
us ual care t o i m ple me ntati o n  
 
 
X  X  X  X  X  
 
 
 
 
 
 
 
 
 
C o m plete data c ollecti o n wit h all cli nics  
 
 
 
 
 
 
X  
 
 
 
 
 
 
 
 
 
Patie nt i nter vie ws: Accessi bilit y barriers  
 
 
 
 
 
 
X  X  X  
 
 
 
 
 
 
 
Patie nt i nter vie ws:  pre p arat or y or i nteracti o nal barriers  
 
 
 
 
 
 
 
 
 
 
X  X  X  X  
 
 
Sta ke h ol der f oc us gr o u ps  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  X  

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T A B L E  O F C O N T E N T S  
 
 
1. 0  
B A C K G R O U N D  ............................................................................................................................. 8  
1. 1  
I ntr o d ucti o n ................................................................................................................................... 8  
1. 2  
C o nce pt ual M o del  ......................................................................................................................... 9  
1. 3  
Ga p A d dresse d i n t his St u d y  ......................................................................................................... 9  
1. 4  
St u d y O ver vie w  ............................................................................................................................ 9  
1. 5  
Desi g n C o nsi derati o ns a n d S u p p orti n g Preli mi nar y Data  .......................................................... 1 0  
1. 6  
St u d y Desi g n  ............................................................................................................................... 1 2  
2. 0  
O B J E C TI V E S  ............................................................................................................................... 1 3  
2. 1  
C o -pri mar y o bjecti ves  ................................................................................................................. 1 3  
2. 2  
Sec o n dar y o bjecti ve(s)  ................................................................................................................ 1 3  
3. 0  
P A R TI CI P A N T S E L E C TI O N  ..................................................................................................... 1 3  
3. 1  
Patie nt Selecti o n  .......................................................................................................................... 1 3  
3. 2  
Patie nt Eli gi bilit y Criteria  ........................................................................................................... 1 3  
3. 3  
Cli nic Sta ke h ol der ( S ur ge o ns a n d Cli nic Staff) Eli gi bilit y Criteria  ............................................ 1 4  
3. 4  
I nstit uti o nal Eli gi bilit y ................................................................................................................ 1 4  
4. 0  
P A TI E N T R E GI S T R A TI O N  ....................................................................................................... 1 5  
4. 1  
C T E P/ D C P Re gistrati o n Pr oce d ures  ........................................................................................... 1 5  
4. 2  
C T S U Re gistrati o n Pr oce d ures  ................................................................................................... 1 6  
4. 3  
Patie nt a n d Cli nic Sta ke h ol der Re gistrati o n Re q uire me nts  ........................................................ 1 7  
4. 4  
I nstit uti o nal Ra n d o mizati o n ........................................................................................................ 1 9  
4. 5  
S ur ge o n Re gistrati o n  ................................................................................................................... 1 9  
4. 6  
Patie nt Re gistrati o n Pr oce d ures  .................................................................................................. 1 9  
4. 7  
Stratificati o n Fact ors a n d Treat me nt Ass i g n me nts ..................................................................... 2 0  
5. 0  
S T U D Y C A L E N D A R S  ................................................................................................................. 2 1  
5. 1  
Patie nt -le vel St u d y Cale n dar ....................................................................................................... 2 1  
5. 2  
Site Le vel St u d y Cale n dar ........................................................................................................... 2 2  
6. 0  
D A T A S U B MI S SI O N  ................................................................................................................... 2 3  
6. 1  
O ver vie w of Data C ollecti o n a n d S u b missi o n  ............................................................................ 2 3  
6. 2  
Data S u b missi o n t o t he Allia nce  ................................................................................................. 2 5  
6. 3  
Data S u b missi o n t o t he U n i versit y of Wisc o nsi n ....................................................................... 2 5  
7. 0  
S T U D Y I N T E R V E N TI O N — I N S TI T U TI O N S, S U R G E O N S, A N D C LI NI C S T A F F .......... 2 7  
7. 1  
Cli nic -Le vel I nter ve nti o n  ............................................................................................................ 2 7  
7. 2  
I n di vi d ual-le vel I nter ve nti o n— S ur ge o ns a n d Cli nic Staff  ......................................................... 2 9  
7. 3  
I nce nti ves .................................................................................................................................... 3 0  
8. 0  
S T U D Y I N T E R V E N TI O N — P A TI E N T L E V E L ....................................................................... 3 0  
8. 1  
Scree ni n g ..................................................................................................................................... 3 0  
8. 2  
Patie nts e nr olle d bef ore i nstit uti o nal cr oss o ver  .......................................................................... 3 1  
8. 3  
Patie nts E nr olle d f oll o wi n g I nstit uti o nal Cr oss o ver  ................................................................... 3 2  
8. 4  
I nce nti ves .................................................................................................................................... 3 3  
9. 0  
A D V E R S E E V E N T S  .................................................................................................................... 3 4  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
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7  
1 0. 0  
M E A S U R E S  .................................................................................................................................. 3 4  
1 0. 1  
Defi niti o ns of Data f or Pri mar y O bjecti ve  .................................................................................. 3 4  
1 0. 2  
Defi niti o ns of Data f or Sec o n dar y O utc o mes  ............................................................................. 3 9  
1 1. 0  
E N D O F I N T E R V E N TI O N/ S T U D Y  ........................................................................................... 4 2  
1 1. 1  
D urati o n of St u d y  ........................................................................................................................ 4 2  
1 1. 2  
Criteria f or Disc o nti n uati o n of St u d y  .......................................................................................... 4 2  
1 1. 3  
F oll o w -u p  .................................................................................................................................... 4 2  
1 1. 4  
 Ma na gi n g I neli gi ble Patie nts  ..................................................................................................... 4 2  
1 2. 0  
S T A TI S TI C A L C O N SI D E R A TI O N S  ........................................................................................ 4 3  
1 2. 1  
A nal ysis Pla n f or C o -Pri mar y O bjecti ves  ................................................................................... 4 3  
1 2. 2  
A nal ysis Pla n f or Sec o n dar y O bjecti ves  ..................................................................................... 5 0  
1 2. 3  
St u d y Re p orti n g  .......................................................................................................................... 5 1  
1 2. 4  
I ncl usi o n of W o me n a n d Mi n orities ........................................................................................... 5 1  
1 3. 0  
G E N E R A L R E G U L A T O R Y C O N SI D E R A TI O N S: W AI V E R S O F C O N S E N T  .................. 5 3  
1 3. 1  
Wai vers of d oc u me ntati o n of writte n patie nt c o nse nt  ................................................................. 5 3  
1 3. 2  
Wai ver of ele me nts of i nf or me d c o nse nt — patie nts  .................................................................... 5 5  
1 3. 3  
Wai vers of c o nse nt— s ur ge o ns a n d cli nic staff ........................................................................... 5 5  
1 3. 4  
Wai ver of ele me nts of i nf or me d c o nse nt — s ur ge o ns .................................................................. 5 5  
1 3. 5  
Ot her pe o ple prese nt d uri n g a u di ota pe d visits  ............................................................................ 5 5  
1 4. 0  
R E F E R E N C E S  .............................................................................................................................. 5 7  
1 5. 0  
M O D E L I N F O R M E D C O N S E N T F O R P A TI E N T S  ................................................................ 6 3  
1 6. 0  
M O D E L I N F O R M E D C O N S E N T F O R S U R G E O N S  .............................................................. 7 2  
A P P E N DI X I:  U S U A L C A R E –  P A TI E N T B A S E LI N E S U R V E Y  .................................................... 7 7  
A P P E N DI X II:  I N T E R V E N TI O N –  P A TI E N T B A S E LI N E S U R V E Y  ............................................. 8 4  
A P P E N DI X III:  U S U A L C A R E –  P A TI E N T F O L L O W -U P S U R V E Y  ............................................ 9 1  
A P P E N DI X I V:  I N T E R V E N TI O N –  A C C E P T E D D A –  P A TI E N T F O L L O W -U P S U R V E Y ..... 1 0 2  
A P P E N DI X V:   I N T E R V E N TI O N –  D E C LI N E D D A –  P A TI E N T F O L L O W -U P S U R V E Y  ...... 1 1 4  
A P P E N DI X VI:  S U R G E O N B A S E LI N E S U R V E Y  ........................................................................... 1 2 5  
A P P E N DI X VII:  P A TI E N T A C C E S SI BI LI T Y T E L E P H O N E I N T E R VI E W G UI D E  ................. 1 2 9  
A P P E N DI X VIII:  P A TI E N T P R E P A R A T O R Y/I N T E R A C T I O N A L I N-P E R S O N I N T E R VI E W 
G UI D E  ..................................................................................................................................................... 1 4 0  
A P P E N DI X I X:  P A TI E N T F O C U S G R O U P G UI D E  ....................................................................... 1 4 6  
A P P E N DI X X:  C LI NI C S T A K E H O L D E R F O C U S G R O U P G UI D E ............................................. 1 4 7  
A P P E N DI X XI: S U R V E Y & I N T E R VI E W T H A N K Y O U L E T T E R  .............................................. 1 4 8  
A P P E N DI X XII: E M AI L B O D Y F O R P A TI E N T Q U A L T RI C S S U R V E Y  .................................... 1 4 9  
 
 

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1. 0  B A C K G R O U N D  
1. 1  
I ntr o d ucti o n 
S hare d decisi o n ma ki n g ( S D M) ma y re d uce healt h dis parities b y a d dressi n g barriers t o patie nt 
e n ga ge me nt i n 
decisi o n 
ma ki n g t hat 
dis pr o p orti o natel y i m pact 
s oci oec o n o micall y 
disa d va nta ge d patie nts. 1 ,2 S D M i nter ve nti o ns, e. g. decisi o n ai ds, ha ve t he p ote ntial t o i ncrease 
patie nt i n v ol ve me nt i n decisi o n ma ki n g, i m pr o ve healt h o utc o mes, a n d l o wer c osts. 3 Decisi o n 
ai ds ma y ha ve t he a d de d be nefit of re d uci n g healt h dis parities, si nce disa d va nta ge d patie nts ma y 
be nefit m ost fr o m t heir use. 2 T he g oal of S D M is t o i m part k n o wle d ge w hile als o e m p o weri n g 
patie nts t o e n ga ge i n decisi o n ma ki n g. Decisi o n ai ds i ncrease k n o wle d ge. 2 ,4 -6 H o we ver, barriers 
t o patie nt e m p o wer me nt hi n der e n ga ge me nt, i ncl u di n g lac k of a ware ness a b o ut treat me nt 
c h oices, patie nts’ perce pti o ns t hat t heir pers o nal i n p ut is n ot val ue d, a n d d oct or -patie nt p o wer 
i m bala nces.1 
T here  
is  
li mite d 
u n dersta n di n g a b o ut h o w d ecisi o n ai ds 
ca n o verc o me t hese barriers. T his ga p is 
si g nifica nt  
as  
t hese  
barriers 
dis pr o p orti o natel y affect disa d va nta ge d 
patie nts. 1  
I n re gar ds t o breast ca ncer s ur ger y 
s pecificall y, 
m ulti ple 
cli nical trials 
de m o nstrate e q u i vale nt s ur vi val bet wee n 
breast  
c o nser vati o n  
( B C T)  
a n d 
mastect o m y  
( wit h  
or  
wit h o ut 
rec o nstr ucti o n) f or 
w o me n dia g n ose d 
wit h 
earl y 
sta ge 
breast 
ca ncer. 7 ,8 
H o we ver, 
patie nt -ce ntere d 
o utc o mes 
differ greatl y, wit h a hi g her ris k of l ocal 
rec urre nce after 
B C T a n d a greater 
i m pact o n b o d y i ma ge wit h mastect o m y. 
As m ost w o me n are g o o d ca n di dates f or 
b ot h pr oce d ures, patie nts’ val ues a n d 
prefere nces 
s h o ul d 
dri ve 
de cisi o n 
ma ki n g. I ncrease d patie nt e n ga ge me nt i n 
decisi o n ma ki n g ma y miti gate e xisti n g 
dis parities i n breast ca ncer s ur gical 
care. 9 -1 5 M ost p o p ulati o n -base d st u dies 
de m o nstrate t hat disa d va nta ge d w o me n 
are less li kel y t o u n der g o B C T or recei ve 
p ost -mastect o m y rec o nstr ucti o n ( Fi g ure 
1). 1 6 -2 0  T his dis parit y is si g nifica nt, as it ca n ne gati vel y i m pact l o n g -ter m o utc o mes s uc h as 
treat me nt re gret, b o d y i ma ge, a n d q ualit y of life.2 1 -2 6  T he eti ol o g y of t hese dis parities is li kel y 
m ultifact orial. 1 7 ,1 8 ,2 7 ,2 8 H o we ver, patie nt e n ga ge me nt d uri n g t he s ur gical c o ns ult is critical f or 
t his prefere nce-se nsiti ve c h oice. 9 -1 5 Pri or st u dies de m o nstrate t hat s oci oec o n o micall y 
disa d va nta ge d w o me n ha ve less u n dersta n di n g of treat me nt o pti o ns, 2 9 -3 1 are less li kel y t o recall 
disc ussi n g a c h oice wit h t heir s ur ge o n, 3 2 ,3 3 a n d partici pate less acti vel y i n decisi o n ma ki n g. 3 4 
Breast ca ncer s ur ger y decisi o n ai ds ha ve alrea d y bee n de vel o pe d t hat c o ul d  a d dress t hese 
barriers, ma ki n g breast ca ncer s ur ger y a n es peciall y a p pr o priate m o del f or o ur w or k.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9  
1. 2  
C o nce pt u al M o del  
O ur st u d y is base d o n t he t he or y descri be d b y El w y n a n d c ollea g ues t hat i n or der t o e n ga ge i n 
S D M, patie nts m ust ha ve b ot h ( 1) k n o wle d ge of t he treat me nt o pti o ns, a n d ( 2) p o wer — t he self-
percei ve d nee d a n d ca pacit y —  t o i nfl ue nce decisi o n ma ki n g ( Fi g ure 2).1 Decisi o n ai ds i m pr o ve 
patie nts’ k n o wle d ge a b o ut treat me nt o pti o ns. 2 ,4 -6 Decisi o n ai ds ma y als o pre pare patie nts f or t he 
s ur gical c o ns ult b y esta blis hi n g e x pectati o ns of t heir r ole d uri n g t he c o ns ult, s pecific all y t hat 
t heir i n p ut (i.e. t heir val ues a n d prefere nces) is welc o me a n d esse ntial. B y pre pari n g patie nts f or 
s ur gical c o ns ultati o n, decisi o n ai ds ca n i ncrease patie nts’ c o nfi de nce i n t heir a bilit y t o i nteract 
wit h t heir s ur ge o n, e m p o weri n g t he m t o e n ga ge i n S D M d uri n g t he s ur gical c o ns ult. H o we ver, 
barriers t o patie nt e n ga ge me nt ma y persist des pite recei pt of a decisi o n ai d a n d ma y decrease 
t he effecti ve ness of a decisi o n ai d. T hese i ncl u de accessi bilit y barriers, pre parat or y barriers (e. g. 
patie nts feeli n g i nf or me d a b o ut treat me nt o pti o ns, a n d bei n g a ware t heir i n p ut is necessar y), a n d 
i nteracti o nal barriers (e. g. percei vi n g a s ur ge o n-patie nt p o wer i m bala nce). I m p orta ntl y, t hese 
persiste nt barriers ma y dis pr o p orti o natel y i m pact s oci oec o n o micall y disa d va nta ge d patie nts. 1 
1. 3  
G a p A d dresse d i n t his St u d y  
O ur st u d y is f o u n de d o n t he scie ntific pre mise t hat breast ca ncer s ur ger y decisi o n ai ds i m pr o ve 
k n o wle d ge f or m ost patie nts ( necessar y b ut i ns ufficie nt al o ne t o e ns ure e n ga ge me nt i n S D M). 2 ,4 -
6 ,3 5 ,3 6 Base d o n o ur c o nce pt ual m o del , we p osit t hat recei pt of a decisi o n ai d pri or t o t he s ur gical 
c o ns ult will als o e m p o wer s o me patie nts, res ulti n g i n i ncrease d e n ga ge me nt i n S D M. H o we ver, 
ot her patie nts will e x perie nce persiste nt pre parat or y or i nteracti o nal barriers t hat ca n n ot be 
a d dresse d b y t he decisi o n ai d al o ne.  
1. 4  
St u d y O ver vie w  
We pr o p ose a m ulti -site cl uster ra n d o mize d trial usi n g a ste p pe d we d ge desi g n t o e xa mi ne t he 
i m pact of a decisi o n ai d o n patie nt e n ga ge me nt i n decisi o n ma ki n g, f oc usi n g o n cli nics t hat 
ser ve a hi g h pr o p orti o n of s oci oec o n o micall y disa d va nta ge d patie nts. We will assess patie nt 
e n ga ge me nt —  meas ur e d b y k n o wle d ge a n d p o wer —  after recei pt of t he decisi o n ai d t hr o u g h 
a u di o-rec or di n gs of t he s ur ge o n c o ns ultati o n a n d patie nt s ur veys . We will test t he e xte nt t o 
w hic h t he effect of a decisi o n ai d o n e n ga ge me nt is me diate d t hr o u g h t he miti gati o n of barrier s, 
a n d deter mi ne if disa d va nta ge d patie nts dis pr o p orti o natel y e x peri e nce persiste nt barriers . 
Fi nall y, we will c o n d uct i nter vie ws a n d f oc us gr o u ps t o u n dersta n d h o w persiste nt barriers 
Fi g ur e 2.  O ur c o n c e pt u al m o d el i s b a s e d o n t h e t h e or y t h at i n or d er t o e n g a g e i n S D M, p ati e nt s m u st h a v e b ot h t h e p o w er t o i nfl u e n c e d e ci si o n-m a ki n g a n d k n o wl e d g e  a b o ut t h e 
o pti o n s.  Pr e -c o n s ult ati o n r e vi e w of a d e ci si o n ai d c a n a d dr e s s t h e s e k e y c o n diti o n s b y pr e p a ri n g p ati e nt s f or t h e s ur gi c al c o n s ult ati o n a n d i n cr e a si n g t h eir c o nfi d e n c e i n i nt er a cti n g 
wit h t h e s ur g e o n.  H o w e v er, b arri er s t o e n g a g e m e nt m a y li mit t h e eff e ct of t h e d e ci si o n ai d.  T h e s e b arri er s di s pr o p orti o n at e l y i m p a ct s o ci o e c o n o mi c all y di s a d v a nt a g ed p ati e nt s 
( a d a pt e d fr o m J o s e p h-Willi a m s, et al.
1 ).  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0  
i nfl ue nce patie nt e n ga ge me nt, i n or der t o i de ntif y tar gets for a dj u nct i nter ve nti o ns. T he o bjecti ve 
of t his st u d y is t o test t he effecti ve ness of a decisi o n ai d i n i ncreasi n g patie nt e n ga ge me nt i n 
S D M, a n d i de ntif y barriers t o e n ga ge me nt n ot miti gate d b y t he decisi o n ai d t hat c o ul d be tar gets 
f or a dj u nct S D M i nter ve nti o ns. 
1. 5  
Desi g n C o nsi der ati o ns a n d S u p p orti n g Preli mi n ar y D at a  
1. 5. 1  
Selecti o n of a we b -b ase d pl atf or m f or i m ple me nt ati o n  
T he p ote ntial be nefits ass ociate d wit h decisi o n ai d use ca n o nl y be realize d if decisi o n ai ds 
reac h t he “ri g ht patie nt at t he ri g ht ti me”.3 7 Beca use of e xisti n g barriers t o br o a d 
i m ple me ntati o n a n d s ustai ne d use of decisi o n ai ds, fe w patie nts e ver recei ve o ne.3 8 ,3 9 
O nli ne deli ver y, s u p p orte d b y t he orie s i n i m ple me ntati o n scie nce, c o m m u nicati o n, 
e d ucati o n, a n d ps yc h ol o g y, effecti vel y a d dresses str uct ural barriers t o decisi o n ai d use b y 
e na bli n g real -ti me i de ntificati o n of patie nts a n d deli ver y of t he decisi o n ai d pri or t o t he 
i nitial c o ns ult.3 7 ,4 0 -4 9 H o we ver, pri or w or k de m o nstrates t hat it is i ns ufficie nt t o si m pl y 
ma ke a decisi o n ai d a vaila ble o nli ne.
5 0  I nstea d, it is necessar y t o acti vel y c o nsi der a n d 
a d dress c halle n ges t o i nc or p orati n g we b -base d d ecisi o n ai d deli ver y i nt o r o uti ne cli nic 
fl o w.5 1  Alt h o u g h s o me c o ncer n e xists t hat a we b -base d a p pr oac h ma y selecti vel y e xcl u de 
at-ris k patie nt p o p ulati o ns, i nter net use has i ncrease d stea dil y o ver t he past deca de; t h ose 
wit h less e d ucati o n a n d l o wer i nc o me ha ve t he fastest i ncreases i n a d o pti o n ( Fi g ure 3). 5 2 ,5 3  
A critical c o m p o ne nt of t his st u d y is t o e val uate a ccessi bilit y barriers ass ociate d wit h a 
we b -base d decisi o n ai d.  
Preli mi n ar y d at a: G ui de d b y t he Re plicati n g 
Effecti ve 
Pr o gra ms fra me w or k, 
w e 
ha ve 
de vel o pe d a pac ka ge of acti ve i m ple me ntati o n 
strate gies t hat facilitates t he i nc or p orati o n of a 
we b -base d decisi o n ai d i nt o r o uti ne care. 5 4 ,5 5 
T his strate g y will g ui de i m ple me ntati o n i n t his 
st u d y.  We elicite d fee d bac k fr o m patie nts, 
n urses, a n d s ur ge o ns.   T hese sta ke h ol ders 
e n d orse d t he n oti o n t hat deli ver y of a decisi o n 
ai d pri or t o t he s ur ge o n c o ns ult w o ul d best 
m atc h patie nts’ i nf or mati o nal nee ds, a n d 
pre pare t he m t o partici pate acti vel y i n t he c o ns ult; t his is c o nsiste nt wit h t he literat ure. 5 6 ,5 7 
Beca use o ur breast ce nter (si milar t o ot her ce nters) stri ves f or a narr o w wi n d o w bet wee n 
dia g n osis a n d i nitial s ur ge o n c o ns ult t o mi ni mize a n xiet y a n d dela y, a we b -base d decisi o n 
ai d was t he o nl y feasi ble o pti o n. We als o deter mi ne d t hat e mail deli ver y was preferre d, as 
ma n y of o ur patie nts ha ve n ot ha d t he o p p ort u nit y t o esta blis h a patie nt p ortal. A d diti o nal 
i m ple me ntati o n strate gies i ncl u de d i de ntificati o n of a s ur ge o n-c ha m pi o n t o elicit “ b u y -i n” 
a n d perf or ma nce of earl y a u dit -fee d bac k.5 4 ,5 8  
Usi n g t his strate g y, we t he n deli vere d we b -base d i nf or mati o n t o 3 0 9 w o me n i n a n 
aca de mic a n d c o m m u nit y cli nic. 5 4 I n t his pil ot, patie nts were ra n d o mize d t o recei ve eit her 
a we b -base d decisi o n ai d or a li n k t o a sta n dar d we bsite. Pil ot partici pa nts were a me dia n 
a ge of 5 9 years a n d 3 4 % ha d less t ha n a c olle ge de gree. M ost patie nt s re vie we d t he 
we bsites ( 8 3 %) a n d f o u n d t his pre -c o ns ultati o n i nf or mati o n hi g hl y be neficial ( me dia n 
sc ore 8/ 1 0); res ults were si milar f or mi n orit y a n d s oci oec o n o micall y disa d va nta ge d patie nt 
s u b gr o u ps.  
We re vise d o ur i m ple me ntati o n strate g y i n res p o nse t o  c o ncer ns fr o m patie nts w h o 
decli ne d pil ot partici pati o n ( n = 6 8, 1 8 % of patie nts a p pr oac he d). T he m ost c o m m o n reas o n 
was li mite d i nter net c o mf ort or access ( n = 3 6). I n res p o nse, we re vise d o ur i m ple me ntati o n 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1  
strate g y t o i ncl u de alter nati ve wa ys patie nts c o uld re vie w we b -base d material, i ncl u di n g 
e maili n g it t o fa mil y me m bers t o re vie w wit h patie nts a n d i Pa d access i n t he cli nic. Se veral 
patie nts decli ne d d ue t o e m oti o nal distress ( n = 7) or prefere nce t o recei ve i nf or mati o n 
directl y fr o m t he s ur ge o n ( n = 1 4). I n res p o nse, we a d de d scri pts f or use b y cli nic staff 
o utli ni n g t he be nefits of t he decisi o n ai d i n hel pi n g patie nts c o pe wit h t heir dia g n osis, a n d 
i ncl u di n g str o n g s ur ge o n e n d orse me nt of t he decisi o n ai d.  
1 . 5. 2 
Use of Are a De pri v ati o n I n de x ( A DI) t o defi ne s oci oec o n o mic dis a d v a nt a ge   
S oci oec o n o mic disa d va nta ge descri bes t he “state of bei n g c halle n ge d b y l o w i nc o me, 
li mite d e d ucati o n, a n d s u bsta n dar d li vi n g c o n diti o ns f or b ot h t he pers o n a n d his or her 
nei g h b or h o o d or s ocial net w or k”. 5 9 A g oal of t his researc h is t o re d uce s oci oec o n o mic 
dis parities i n healt hcare t hr o u g h t he tail ore d deli ver y  of tar gete d S D M i nter ve nti o ns t o 
t h ose patie nts wit h t he greatest decisi o nal s u p p ort nee ds. O perati o nalizi n g t his a p pr oac h 
re q uires earl y i de ntificati o n of t hese patie nts b y cli nic staff–  wit h o ut re q uiri n g a detaile d 
patie nt assess me nt — t o e ns ure rea d y i nte grati o n i nt o cli nical w or kfl o w. I n t his st u d y, we 
use t he A DI. T he A DI is a n e xisti n g c o m p osite meas ure of nei g h b or h o o d s oci oec o n o mic 
disa d va nta ge, calc ulate d base d o n a n i n di vi d ual zi p c o de + 4. 5 9 ,6 0 It has bee n ass ociate d wit h 
ca ncer o utc o mes. 6 1 -6 3 Zi p + 4 -le vel A DI f or t he U nite d States is p u blicl y a vaila ble fr o m t he 
PI i nstit uti o n. 6 4  
Preli mi n ar y d at a:  We ha ve s uccessf ull y li n ke d 9 9 % of pil ot st u d y patie nts t o t he A DI, 
de m o nstrati n g feasi bili t y i n i de ntif yi n g v ul nera ble patie nts at t he p oi nt of e ntr y i nt o t he 
cli nic. T he fi ve pil ot patie nts w h o met criteria f or s oci oec o n o mic disa d va nta ge re vie we d 
t he decisi o n ai d a n d f o u n d it hel pf ul ( me dia n sc ore 9/ 1 0). 
1 . 5. 3  Use of a ge ner al -use decisi o n ai d   
Beca use we are c o n d ucti n g t his researc h i n cli nics t hat ser ve a hi g h pr o p orti o n of 
s oci oec o n o micall y disa d va nta ge d patie nts b ut t hat als o care f or patie nts i n ot her 
s oci oec o n o mic strata, we are usi n g a ge neral-use decisi o n ai d. Usi n g t he sa me decisi o n ai d 
f or t he e ntire cli nic p o p ulati o n i ncreases t he feasi bilit y a n d s ustai na bilit y of t he 
i nter ve nti o n. H o we ver, a critical part of t he st u d y is t o e val uate t he effecti ve ness of t his 
decisi o n ai d f or patie nts fr o m differe nt bac k gr o u n ds.  
T he t o ol we selecte d was de vel o pe d c olla b orati vel y b y t he I nf or me d Me dical Decisi o ns 
F o u n dati o n  a n d Healt h Dial o g. 3 5, 5 5 Ori gi nal l y create d as a D V D, it was c o n verte d t o a we b-
base d platf or m base d o n user fee d bac k re q uesti n g fle xi bilit y i n m o de of deli ver y. T he we b -
base d decisi o n ai d utilizes static, di dactic i nf or mati o n writte n f or a n 8t h gra de rea di n g 
le vel, a n d vi de o cli nical vi gnettes t o pr o m ote c o nsi derati o n of pers o nal val ues a n d 
prefere nces. It i ncl u des 
m o d ules f or i n vasi ve ca ncer, n o n -i n vasi ve ca ncer, a n d 
rec o nstr ucti o n. It has bee n use d s uccessf ull y i n aca de mic a n d c o m m u nit y setti n gs t o 
i ncrease k n o wle d ge a n d decrease decisio nal c o nflict. 3 5 ,4 3 ,4 4 ,4 8 T he greatest gai ns i n 
k n o wle d ge were see n i n patie nts wit h l o wer e d ucati o nal bac k gr o u n ds. 3 5  
Preli mi n ar y d at a:  I n o ur pil ot st u d y, we ra n d o mize d patie nts t o recei ve eit her t he Healt h 
Dial o g we b -base d decisi o n ai d, or li n ks t o sta n dar d we bsites, pri or t o t he s ur gical c o ns ult; 
pre -c o ns ult k n o wle d ge was assesse d. K n o wle d ge was hi g her i n patie nts w h o recei ve d t he 
decisi o n ai d vers us t he sta n dar d we bsites ( 7 0 % vs. 6 0 %, p = 0. 0 0 4). T hese fi n di n gs were 
u nc ha n ge d after a dj usti n g f or s oci o de m o gra p hic c haracteristics.   

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 2  
1 . 5. 4 
Use of t w o me as ures f or p atie nt e m p o wer me nt   
Perce pti o ns of a patie nt’s r ole d uri n g a d ecisi o n -ma ki n g e nc o u nter de pe n d  o n t he met h o d 
of meas ure me nt. 6 5 Beca use of t his, we will assess o ur pri mar y o utc o me of p o wer b y b ot h 
( 1) a u di o-rec or di n gs of t he s ur gical c o ns ult, a n d ( 2) patie nt s ur ve ys.  
Preli mi n ar y d at a:  O ur researc h tea m uses a d ual a p pr oac h of a u di o rec or di n gs a n d patie nt 
s ur ve ys t o st u d y decisi o n ma ki n g. We ha ve e x perie nce d fe w barriers t o patie nt recr uit me nt 
f or a u di o-rec or di n gs. 
 has s uccessf ull y e nr olle d o ver 2 0 0 patie nts a n d 
a u di o-rec or de d pre-o perati ve c o m m u nicati o ns. 6 6 -6 8 We ha ve als o c o n d ucte d a pil ot st u d y 
wit hi n o ur breast ce nter of a u di o -rec or di n g s ur gical c o ns ultati o ns.  
1. 5. 5  
F oc us o n cli nics re prese nt ati ve of w here m ost s o ci oec o n o mic all y dis a d v a nt a ge d 
p atie nts recei ve c are.  
We ha ve c h ose n t o e nr oll cli nics t hat ser ve a hi g h pr o p orti o n of s oci oec o n o micall y 
disa d va nta ge d patie nts b ut als o care f or patie nts fr o m ot her s oci oec o n o mic strata.  O ur 
o verall g oal is t o re d uce s oci oec o n o mic dis parities i n healt h care t hr o u g h s hare d decisi o n 
ma ki n g.  O ur preli mi nar y data s u g gests t hat, nati o n wi de, 
m ost s oci oec o n o micall y 
disa d va nta ge d patie nts recei ve t heir care i n cli nics t hat ser ve s oci oec o n o micall y di verse 
patie nt p o p ulati o ns.  A n a p pr oac h t o s hare d decisi o n ma ki n g t hat will w or k i n t hese 
s oci oec o n o micall y di verse cli nics will be m ost ge neraliza ble, a n d will ha ve t he greatest 
c ha nce t o re d uce dis parities i n ca ncer care.   
Preli mi n ar y d at a:  Usi n g t he Nati o nal Ca ncer Data base ( 2 0 0 4 -2 0 1 3), we i de ntifie d 
patie nts dia g n ose d 
wit h sta ge 0 -3 breast ca ncer 
w h o 
were s oci oec o n o micall y 
disa d va nta ge d ( me dia n h o use h ol d i nc o me < $ 3 0, 0 0 0, n = 2 5 8, 0 0 7). Patie nts recei ve d care 
at 1, 2 8 2 facilities. We i de ntifie d 6 1 facilities t hat care d f or t he greatest a bs ol ute n u m ber of 
disa d va nta ge d patie nts ( ~ 2 5 % of t he c o h ort). At t hese facilities, disa d va nta ge d patie nts 
c o m prise d a me dia n 3 0 % of t he t otal p o p ulati o n. T hese data s u p p ort o ur pla n ne d 
recr uit me nt strate g y. 
1. 6  
St u d y Desi g n  
We pla n  a m ulti -site cl uster ra n d o mize d trial usi n g a ste p pe d we d ge desi g n  wit h 7 wa ves . We 
will recr uit 1 0 cli nics f or partici pati o n.  All cli nics will be gi n i n t he us ual care ar m.  Cli nics will 
be ra n d o mize d t o t he ti mi n g wit h w hic h t he y cr oss -o ver t o t he decisi o n ai d i nter ve nti o n, w it h 
ne w cli nics cr ossi n g o ver  at eac h wa ve starti n g fr o m wa ve t w o .  Ma xi mizi n g reac h of t he 
decisi o n ai d wit hi n eac h cli nic is critical f or t his i nter ve nti o n. We will use t he strate g y de vel o pe d 
i n o ur pil ot w or k t o g ui de i m ple me ntati o n;5 4 t he pr ocess of i m ple me ntati o n of t he decisi o n ai d  
will occ ur o ver a 1 0 -wee k peri o d d uri n g w hic h t he cli nic d oes n ot c ollect patie nt -le vel data. T he 
researc h tea m will c ollect t he cli nic-le vel d oc u me nts t hat s u p p ort cli nic’s i m ple me ntati o n eff orts 
f or researc h a n d ta ke fiel d n otes d uri n g t he i m ple me ntati o n pr ocess.  Data c ollecti o n wit hi n eac h 
cli nic bef ore a n d after i m ple me ntati o n of t he decisi o n ai d i nter ve nti o n will be t he sa me; t his 
i ncl u des patie nt s ur ve ys a n d a u di o rec or di n g of t he c o ns ult. The pri mar y a nal ysis  will c o m pare 
patie nts i n us ual care vers us t he decisi o n ai d i nter ve nti o n ar ms.  We will f oll o w t he i nter ve nti o n 
c o m p o ne nt wit h patie nt  i nter vie ws a n d f oc us gr o u ps as well as cli nic sta ke h ol der f oc us gr o u ps. 
I n t his c o m p o ne nt of t he st u d y, we will i de ntif y persiste nt barriers t o patie nt e n ga ge me nt i n 
decisi o n ma ki n g t hat c o ul d be tar gete d i n f ut ure i nter ve nti o ns . 
We ha ve e x perie nce d u n der -recr uit me nt, i n part d ue to t he C O VI D -1 9 pa n de mic.   T o 
c o m pe nsate f or t he sl o wer accr ual, we will e xte n d t he peri o d of e nr oll me nt f or sites t hat are still 
recr uiti n g wit hi n t he ste p pe d we d ge desi g n as of 8/ 3 0/ 2 0 2 1. T he e xte n de d recr uit me nt be y o n d 
Wa ve 7 w o ul d c o nti n ue f or si x sites u ntil 1 2/ 3 1/ 2 0 2 1.  Please see S ecti o n 1 2. 1. 3  f or details. 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3  
2 . 0 O B J E C TI V E S  
2. 1  
C o -p ri m ar y o bjecti ve s 
Test t he effecti ve ness of a breast ca ncer s ur ger y decisi o n ai d i n i ncreasi n g patie nt e n ga ge me nt 
i n decisi o n ma ki n g ( meas ure d b y k n o wle d ge a n d p o wer) i n cli nics ser vi n g a hi g h pr o p orti o n of 
s oci oec o n omicall y disa d va nta ge d patie nts  
Test t he e xte nt t o w hic h t he effect of a decisi o n ai d o n patie nt e n ga ge me nt is me diate d t hr o u g h 
t he miti gati o n of barriers, a n d deter mi ne if persiste nt barriers are dis pr o p orti o natel y e x perie nce d 
b y s oci oec o n o micall y disa d va nta ge d patie nts  
2. 2  
Sec o n d ar y o bjecti ve(s)  
C haracterize h o w persiste nt barriers i nfl ue nce patie nt e n ga ge me nt i n decisi o n ma ki n g i n or der 
t o i de ntif y tar gets f or a dj u nct i nter ve nti o ns t hat c o ul d be im ple me nte d i n cli nics ser vi n g a hi g h 
pr o p orti o n of s oci oec o n o micall y disa d va nta ge d patie nts  
3. 0  P A R TI CI P A N T  S E L E C TI O N  
3. 1  
P atie nt Selecti o n  
F or q uesti o ns re gar di n g eli gi bilit y criteria, see t he St u d y Res o urces pa ge. Please n ote t hat t he 
St u d y C hair ca n n ot gra nt wai vers t o eli gi bilit y re q uire me nts.  
O n -St u d y G ui deli nes  
T his cli nical trial ca n f ulfill its o bjecti ves o nl y if patie nts a p pr o priate f or t his trial are e nr olle d. 
All rele va nt me dical a n d ot her c o nsi derati o ns s h o ul d be ta ke n i nt o acc o u nt w he n deci di n g 
w het her t his pr ot oc ol is a p pr o priate f or a partic ular patie nt.  
St u d y staff s h o ul d c o nsi der w het her t he f oll o wi n g ma y re n der t he patie nt i na p pr o priate f or t his 
pr ot oc ol:  
• 
Ps yc hiatric ill ness w hic h w o ul d  pre ve nt t he patie nt fr o m gi vi n g i nf or me d c o nse nt.  
3. 2  
P atie nt Eli gi bilit y Criteri a   
_ _ _  
3. 2 . 1 
W o me n ne wl y di a g n ose d wit h cli nic al st a ge 0-III bre ast c a ncer.  Alt h o u g h me n 
are rec o m me n de d s ur ger y t o treat breast ca ncer, male breast ca ncer is relati vel y rare a n d 
decisi o n ma ki n g f or breast ca ncer s ur ger y is q uite differe nt bet wee n me n a n d w o me n.   
I n o ur pil ot w or k, we ha ve r o uti nel y i ncl u de d patie nts wit h cli nical sta ge 0 ca ncer i n t he 
i nter ve nti o n. Alt h o u g h t he pr o g n osis differs bet wee n D CI S a n d i n vasi ve ca ncer, t he c ore 
s ur gical decisi o ns re gar di n g mastect o m y vers us breast c o nser vati o n re mai ns t he sa me.   
_ _ _  
3. 2 . 2 
Eli gi ble p atie nts m ust be p l a n ni n g bre ast s ur ger y as a c o m p o ne nt of t heir 
defi niti ve tre at me nt.  
_ _ _  
3. 2 . 3 
P atie nts wit h i m p aire d decisi o n -m a ki n g c a p acit y (s uc h as wit h a di a g n osis of 
de me nti a or me m or y l oss) are n ot eli gi ble f or t his st u d y.  
_ _ _  
3. 2. 4  
P atie nts wit h he ari n g i m p air me nt re q uiri n g t he use of a n i nter preter are n ot 
eli gi ble  f or t his st u d y. 
_ _ _  
3. 2 .5  
P atie nts m ust be a ble t o s pe a k E n glis h wit h t he fl ue nc y re q uire d t o ha ve a direct 
disc ussi o n ar o u n d treat me nt decisi o n -ma ki n g (i.e. wit h o ut i nter preter) .  
_ _ _  
3. 2 .6  
A ge ≥ 1 8 ye ars  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4  
3. 3  
Cli nic St a ke h ol der  ( S ur ge o ns a n d Cli nic St aff) Eli gi bilit y Criteri a  
3. 3. 1  
Breast s ur ge o n (s) a n d n ursi n g staff, me dical assista nt, or mi d -le vel pr o vi der at eac h 
partici pati n g cli nic w h o  partici pates i n t he care of patie nts ne wl y dia g n ose d wit h breast 
ca ncer . 
 
3. 4  
I nstit uti o n al Eli gi bilit y 
T he st u d y will utilize t he Nati o nal Ca ncer 
I nstit ute 
O nc ol o g y 
Researc h 
Pr o gra m 
( N C O R P).1 9 Eli gi ble cli nics will ser ve a 
hi g h 
pr o p orti o n 
of s oci oec o n o micall y 
disa d va nta ge d patie nts, defi ne d usi n g t w o 
data s o urces.  Fi g ure 5 de m o ns trates t he 
o verla p bet wee n N C O R P sites (re prese nte d 
as 
circles 
o n t he 
ma p) 
a n d 
U. S. 
nei g h b or h o o ds desi g nate d as t he 
m ost 
disa d va nta ge d acc or di n g t o t he 
A DI. 5 9 
Usi n g t he 
2 0 1 5 
N C O R P 
La n dsca pe 
Assess me nt, we ha ve als o i de ntifie d 2 5 
sites t hat re p ort a hi g h pro p orti o n of 
patie nts 
wit h 
Me dicai d i ns ura nce ( 2 5 -
5 0 %).  
3. 4. 1  
Usi n g t hese data, 1 0 cli nics t hat a n n uall y pr o vi de s ur gical care f or 1 2 0 -3 0 0 patie nts 
ne wl y dia g n ose d wit h breast ca ncer  will be selecte d t o partici pate i n t his st u d y .  
3. 4. 2  
S ur ge o ns at eli gi ble cli nics m ust  c o nse nt t o t he st u d y as a re q uire me nt f or site 
partici pati o n.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 5  
4. 0  P A TI E N T R E GI S T R A TI O N  
4. 1  
C T E P/ D C P Re gistr ati o n Pr oce d ures  
F o o d a n d Dr u g A d mi nistrati o n ( F D A) re g ulati o ns a n d Nati o nal Ca ncer I nstit ute ( N CI) p olic y 
re q uire all i n di vi d uals c o ntri b uti n g t o N CI-s p o ns ore d trials t o re gister a n d re ne w t heir 
re gistrati o n a n n uall y. T o re gister, all i n di vi d uals m ust o btai n a Ca ncer T hera p y E val uati o n 
Pr o gra m  
( C T E P)  
I de ntit y  
a n d  
Access  
Ma na ge me nt  
(I A M)  
acc o u nt  
at 
 I n a d diti o n, pers o ns wit h a re gistrati o n t y pe of I n vesti gat or 
(I V R), N o n-P h ysicia n I n vesti gat or ( N PI V R), or Ass ociate Pl us ( A P) m ust c o m plete t heir a n n ual 
re gistrati o n usi n g C T E P’s we b-base d Re gistrati o n a n d Cre de ntial Re p osit or y ( R C R) at 
 
R C R utilizes fi ve pers o n re gistrati o n t y pes.  
•  
I V R —  M D, D O, or i nter nati o nal e q ui vale nt;  
•  
N PI V R —  a d va nce d practice pr o vi ders (e. g., N P or P A) or gra d uate le vel researc hers 
(e. g., P h D); 
•  
A P —  cli nical site staff (e. g., R N or C R A) wit h data  e ntr y access t o C T S U a p plicati o ns 
s uc h as t he R oster U p date Ma na ge me nt S yste m [ R U M S], O P E N, Ra ve, acti n g as a 
pri mar y site c o ntact, or wit h c o nse nti n g pri vile ges;  
•  
Ass ociate ( A) —  ot her cli nical site staff i n v ol ve d i n t he c o n d uct of N CI -s p o ns ore d trials; 
an d  
•  
Ass ociate Basic ( A B) —  i n di vi d uals (e. g., p har mace utical c o m pa n y e m pl o yees) wit h 
li mite d access t o N CI-s u p p orte d s yste ms. 
 
R C R re q uires t he f oll o wi n g re gistrati o n d oc u me nts:  
D oc u m e nt ati o n R e q uir e d  
I V R N PI V R  
A P  
A  
A B  
F D A F or m 1 5 7 2  
✔ 
✔ 
 
 
 
Fi na ncial Discl os ure F or m  
✔ 
✔ 
✔ 
 
 
N CI Bi os ketc h (e d ucati o n, trai ni n g, e m pl o y me nt, lice nse, a n d 
certificati o n) 
✔ 
✔ 
✔ 
 
 
G C P trai ni n g  
✔ 
✔ 
✔ 
 
 
A ge nt S hi p me nt F or m (if a p plica ble)  
✔ 
 
 
 
 
C V ( o pti o nal)  
✔ 
✔ 
✔ 
 
 
 
A n acti ve C T E P -I A M user acc o u nt a n d a p pr o priate R C R re gistrati o n is re q uire d t o access all 
C T E P a n d Ca ncer Trials S u p p ort U nit ( C T S U) we bsites a n d a p plicati o ns. I n a d diti o n, I V Rs a n d 
N PI V Rs m ust list all cli nical practice sites a n d I nstit uti o nal Re vie w B oar ds (I R Bs) c o veri n g 
t heir practice sites o n t he F D A F or m 1 5 7 2 i n R C R t o all o w t he f oll o wi n g: 
•  
A d diti o n t o a site r oster;  
•  
Assi g n t he treati n g, cre dit, c o nse nti n g, or dr u g s hi p me nt (I V R o nl y) tas ks i n O P E N;  
•  
Act as t he site -pr ot oc ol Pri nci pal I n vesti gat or ( PI) o n t he I R B a p pr o val  
A d diti o nal  
i nf or mati o n  
is  
l ocate d  
o n  
t he  
C T E P  
we bsite  
at 
 F or q uesti o ns, please c o ntact t he 
R C R  Hel p Des k  b y e mail at 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 6  
4. 2  
C T S U  Re gistr ati o n Pr oce d ures  
T his st u d y is s u p p orte d b y t he N CI Ca ncer Trials S u p p ort U nit ( C T S U).  
I R B A p pr o v al   
F or C T E P a n d Di visi o n of Ca ncer Pre ve nti o n ( D C P) st u dies o pe n t o t he Nati o nal Cli nical Trials 
Net w or k ( N C T N) a n d N CI C o m m u nit y O nc ol o g y Researc h Pr o gra m ( N C O R P) Researc h Bases 
after Marc h 1, 2 0 1 9, all U. S. -base d sites m ust be me m bers of t he N CI Ce ntral I ns tit uti o nal 
Re vie w B oar d ( N CI CI R B). I n a d diti o n, U. S. -base d sites m ust acce pt t he N CI CI R B re vie w t o 
acti vate ne w st u dies at t he site after Marc h 1, 2 0 1 9. L ocal I R B re vie w will c o nti n ue t o be 
acce pte d f or st u dies t hat are n ot re vie we d b y t he CI R B, or if t h e st u d y was pre vi o usl y o pe n at 
t he site u n der t he l ocal I R B. I nter nati o nal sites s h o ul d c o nti n ue t o s u b mit Researc h Et hics B oar d 
( R E B) a p pr o val t o t he C T S U Re g ulat or y Office f oll o wi n g c o u ntr y-s pecific re g ulati o ns.  
Sit es partici pati n g wit h t he N CI CI R B m us t s u b mit t he St u d y S pecific W or ks heet f or L ocal 
C o nte xt ( S S W) t o t he CI R B usi n g I R B Ma na ger t o i n dicate t heir i nte nt t o o pe n t he st u d y l ocall y. 
T he N CI CI R B’s a p pr o val of t he S S W is a ut o maticall y c o m m u nicate d t o t he C T S U Re g ulat or y 
Office, 
b ut 
sites 
are 
re q uire d 
t o 
c o ntact 
t he 
C T S U 
Re g ulat or y 
Office 
at 
t o esta blis h site prefere nces f or a p pl yi n g N CI CI R B a p pr o vals 
acr oss t heir Si g nat or y Net w or k. Site prefere nces ca n be set at t he net w or k or pr ot oc ol le vel. 
Q uesti o ns a b o ut esta blis hi n g site prefere nces ca n be a d dresse d t o t he C T S U Re g ulat or y Office 
b y e mail or calli n g 
 
I n a d diti o n, t he Site-Pr ot oc ol Pri nci pal I n vesti gat or ( PI) (i.e. t he i n vesti gat or o n t he I R B/ R E B  
a p pr o val) m ust meet t he f oll o wi n g criteria i n or der f or t he pr ocessi n g of t he I R B/ R E B a p pr o val 
rec or d t o be c o m plete d: 
•  
H ol ds a n acti ve C T E P stat us;  
•  
R ostere d at t he site o n t he I R B/ R E B a p pr o val (a p plies t o U S a n d Ca na dia n sites o nl y) 
a n d o n at least o ne pa rtici pati n g r oster; 
•  
If usi n g N CI CI R B, r ostere d o n t he N CI CI R B Si g nat or y rec or d; 
•  
I ncl u des t he I R B n u m ber of t he I R B pr o vi di n g a p pr o val i n t he F or m F D A 1 5 7 2 i n t he 
R C R pr ofile; a n d  
•  
H ol ds t he a p pr o priate C T E P re gistrati o n t y pe f or t he pr ot oc ol.  
 
A d diti o n al Re q uire me nts  
A d diti o nal re q uire me nts t o o btai n a n a p pr o ve d site re gistrati o n stat us i ncl u de:  
•  
A n acti ve Fe deral Wi de Ass ura nce ( F W A) n u m ber;  
•  
A n acti ve r oster affiliati o n wit h t he Lea d Pr ot oc ol Or ga nizati o n ( L P O) or a Partici pati n g 
Or ga nizati o n ( P O); a n d  
•  
C o m plia nce wit h all pr ot oc ol -s pecific re q uire me nts ( P S Rs).  
 
4. 2 . 1 
D o w nl o a di n g Site Re gistr ati o n D oc u me nts  
D o w nl oa d t he site re gistrati o n f or ms fr o m t he pr ot oc ol -s pecific pa ge l ocate d o n t he C T S U 
me m bers’ we bsite. Per missi o n t o vie w a n d d o w nl oa d t his pr ot oc ol a n d its s u p p orti n g 
d oc u me nts is restricte d base d o n pers o n a n d site r oster assi g n me nt. T o partici pate, t he 
i nstit uti o n a n d its ass ociate d i n vesti gat ors a n d staff m ust be ass ociate d wit h t he L P O or a 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 7  
P r ot oc ol O r ga nizati o n ( P O) o n t he pr ot oc ol.  O ne wa y t o searc h f or a pr ot oc ol is liste d 
bel o w.   
•  
L o g i n t o t he C T S U me m bers’ we bsite (
) usi n g y o ur C T E P -
I A M user na me a n d pass w or d; 
•  
Clic k o n Pr ot oc ols i n t he u p per left of t he scree n 
o  E nter t he pr ot oc ol n u m ber i n t he searc h fiel d at t he t o p of t he pr ot oc ol 
tree; or 
o  Clic k o n t he B y Lea d Or ga nizati o n f ol der t o e x pa n d, t he n select Alli a nce , 
a n d pr ot oc ol n u m ber A 2 3 1 7 0 1 C D . 
•  
Clic k o n D oc u me nts , select Site Re gistr ati o n , a n d d o w nl oa d a n d c o m plete t he 
f orms pr o vi de d. ( N ote: F or sites u n der t he CI R B, I R B data will l oa d a ut o maticall y 
t o t he C T S U.) 
4. 2. 2  
S u b mitti n g Re g ul at or y Re q uire me nts  
S u b mit re q uire d f or ms a n d d oc u me nts t o t he C T S U Re g ulat or y Office usi n g t he Re g ulat or y 
S u b missi o n P ortal o n t he C T S U we bs ite.  
T o access t he Re g ulat or y S u b missi o n P ortal l o g i n t o t he C T S U me m bers’ we bsite, g o t o 
t he Re g ulat or y secti o n a n d select Re g ulat or y S u b missi o n. 
I nstit uti o ns wit h patie nts waiti n g t hat are u na ble t o use t he Re g ulat or y S u b missi o n P ortal 
s h o ul d alert t he C T S U Re g ulat or y Office i m me diatel y at 
 i n or der t o 
recei ve f urt her i nstr ucti o n a n d s u p p ort. 
4. 2. 3  
C hec ki n g Site’s Re gistr ati o n St at us  
Sit e re gistrati o n stat us ma y be verifie d o n t he C T S U me m bers’ we bsite.  
•  
Clic k o n Re g ulat or y at t h e t o p of t he scree n;  
•  
Clic k o n Site Re gistrati o n; a n d  
•  
E nter t he sites 5 -c haracter C T E P I nstit uti o n C o de a n d clic k o n G o.  
o  A d diti o nal filters are a vaila ble t o s ort b y Pr ot oc ol, Re gistrati o n Stat us, 
Pr ot oc ol Stat us, a n d/ or I R B T y pe.  
N ote: T he stat us s h o w n o nl y  reflects i nstit uti o nal c o m plia nce wit h site re gistrati o n 
re q uire me nts as o utli ne d wit hi n t he pr ot oc ol. It d oes n ot reflect c o m plia nce wit h pr ot oc ol 
re q uire me nts f or i n di vi d uals partici pati n g o n t he pr ot oc ol or t he e nr olli n g i n vesti gat or’s 
stat us wit h N CI or t heir affiliate d net w or ks.  
4. 2. 4  
Li mite d access i nf or m ati o n  
T his is a li mite d access st u d y.  All partici pati n g i nstit uti o ns will be selecte d b y t he st u d y 
tea m per Secti o n 3. 4  pri or t o st u d y acti vati o n.  
4. 3  
P atie nt a n d Cli nic St a ke h ol der Re gistr ati o n Re q uire me nts  
• 
P atie nt i nf or me d c o nse nt:  Patie nts  m ust willi n gl y c o nse nt after bei n g i nf or me d of t he 
st u d y acti vities: alter nati ves, p ote ntial be nefits, p ote ntial ris ks, a n d disc o mf orts. C urre nt 
h u ma n pr otecti o n c o m mittee a p pr o val of t his pr ot oc ol a n d a c o nse nt f or m is re q uire d pri or 
t o patie nt c o nse nt a n d re gistrati o n. Writte n c o nse nt is f or t w o s ur ve ys a n d t he a u di o 
rec ordi n g of t he s ur gical c o ns ult.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 8  
• 
S ur ge o n i nf or me d c o nse nt: Partici pati n g s ur ge o ns  m ust willi n gl y c o nse nt after bei n g 
i nf or me d of t he st u d y acti vities: alter nati ves, p ote ntial be nefits, p ote ntial ris ks, a n d 
disc o mf orts. C urre nt h u ma n pr otecti o n c o m mittee a p p r o val of t his pr ot oc ol a n d a c o nse nt 
f or m is re q uire d pri or t o s ur ge o n c o nse nt a n d re gistrati o n . Writte n c o nse nt is f or 
partici pati o n i n site i m ple me ntati o n acti vities, all o wi n g t heir patie nts t o recei ve t he decisi o n 
ai d, baseli ne s ur ve y, a n d a u di o -rec or din g of t he s ur gical c o ns ult.  
• 
W ai vers of c o nse nt : F or all patie nt i nter vie ws a n d patie nt a n d cli n ic sta ke h ol der f oc us 
gr o u ps, we re q uest a wai ver of d oc u me ntati o n of i nf or me d c o nse nt  f or partici pati o n gi ve n 
t he l o w ris k nat ure of t he st u d y acti vit y. Partici pa nts i n eac h of t hese acti vities will be 
pr o vi de d wit h writte n i nf or mati o n descri bi n g t he researc h, t heir partici pati o n, t he ris ks, 
p ossi ble be nefits, a n d all ot her re q uire d ele me n ts of i nf or me d c o nse nt. See Secti o n 1 3 . 0. 
• 
P atie nt - a n d s ur ge o n -c o m plete d b o o klets:  Patie nt a n d s ur ge o n q uesti o n naire b o o klets are 
t o be or dere d pri or t o t he re gistrati o n of a n y patie nts or s ur ge o ns . B o o klets ca n be or dere d 
b y d o w nl oa di n g a n d c o m pleti n g t he C T S U S u p pl y Re q uest F or m, l ocate d o n t he C T S U 
F or ms we b pa ge u n der t he Res o urces ta b. T he f or m m ust be s u b mitte d via t he Re g ulat or y 
S u b missi o n P ortal o n t he C T S U we bsite, l ocate d u n der t he Re g ulat or y ta b . Sa m pl es of t he 
b o o klets are f o u n d i n A p pe n dices I -VI , w hic h are t o be use d f or refere nce a n d I R B 
s u b missi o n o nl y. T he y are n ot t o be use d f or patie nt c o m pleti o n. 
Pr otecte d He alt h I nf or m ati o n:   
•  
A u di o -rec or di n g of t he c o ns ultati o n, i nter vie ws, a n d f oc us gr o u ps will be s hare d wit h 
t he U ni versit y of Wisc o nsi n ( U W). Alt h o u g h P HI will n ot be i nte nti o nall y se nt t o U W, 
it is p ossi ble t hat P HI will be s hare d t hr o u g h t he a u di o-rec or di n gs. All a u di o -rec or di n gs 
will be tra nscri be d i n f ull.  St u d y staff me m bers or o utsi de c o ntract ors wit h a b usi ness 
ass ociate a gree me nt w h o ha ve bee n a p pr o ve d b y U W Le gal Ser vices/ Pri vac y Officer 
f or HI P A A c o m plia nce will be use d f or tra nscri pti o n. Alt h o u g h i de n tif yi n g i nf or mati o n 
ma y e xist o n t he a u di o files, tra nscri pti o nists will stri p all i de ntif yi n g i nf or mati o n o nce 
tra nscri be d a n d will o nl y ha ve access t o t he s u bject I D t hat is assi g ne d b y st u d y staff 
( n o access t o t he patie nt-s u bject l o g or ot her i de ntif yin g i nf or mati o n). T he de -i de ntifie d 
tra nscri pts will be use d i n data a nal ysis b y t he researc h tea m. After data a nal ysis is 
c o m plete a n d ma n uscri pts ha ve bee n acce pte d f or p u blicati o n, t he a u di o rec or di n gs will 
be destr o ye d a n d t he de -i de ntifie d tra nscri pts will be st ore d i n defi nitel y o n a sec ure 
ser ver. 
•  
I n or der t o facilitate c o m pleti o n of t he F oll o w-u p S ur ve y, patie nts’ e mail a d dres ses will 
be e ntere d i nt o t he Allia nce data base. T his i nf or mati o n will be use d o nl y b y a we b 
ser vice t o se n d t he li n k f or t he f oll o w-u p s ur ve y. I n a d diti o n, patie nts’ zi p + 4 will be 
e ntere d i nt o t he Allia nce data base (see Secti o n 1 0. 1. 4. 4 ). 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 9  
4. 4  
I nstit uti o n al R a n d o miz ati o n  
Pri or t o st u d y acti vati o n , eac h of t he 1 0 partici pati n g s ur ger y cli nics will be ra n d o ml y assi g ne d 
t o a ti me w he n t he cli nic cr osses o ver fr o m us ual care t o i nter ve nti o n. T o a v oi d a ntici pat or y 
effects, cli nics will be bli n de d t o cr oss o ver ti me u ntil t he p oi nt of i m ple me ntati o n.   See Secti o n 
4. 7  f or a descri pti o n of t he stratificati o n fact ors f or t his st u d y. 
4. 5  
S ur ge o n Re gistr ati o n  
S ur ge o ns will be i de ntifie d d uri n g t he site selecti o n pr ocess. F oll o wi n g l ocal I R B a p pr o val of 
t his st u d y, s ur ge o ns will be c o nse nte d t o partici pate i n site i m ple me ntati o n acti vities, baseli ne 
s ur ve y, a n d a u di o rec or di n g of t he s ur gical c o ns ult.  
T he S ur ge o n E nr oll me nt F or m s h o ul d t he n be c o m plete d a n d s u b mitte d t o Allia nce 
Re gistrati o n Office via fa x 
 or e mail 
T he re gistrati o n 
office will re gister t he s ur ge o n(s) t o t he st u d y a n d se n d c o nfir mati o n t o t he site via e mail 
wit hi n 1 b usi ness da y. ( N ote: S ur ge o n(s) will n ot  be re gistere d t o t his st u d y usi n g O P E N.)  
4. 6  
P atie nt Re gistr ati o n Pr oce d ures  
T he O nc ol o g y Patie nt E nr oll me nt Net w or k ( O P E N) is a we b -base d re gistrati o n s yste m a vaila ble 
o n a 2 4/ 7 basis. O P E N is i nte grate d wit h C T S U re g ulat or y a n d r oster data a n d wit h t he L P Os 
re gistrati o n/ra n d o mizati o n s yste ms or t he T hera de x I nteracti ve We b Res p o nse S yste m (I W R S) 
f or retrie val of patie nt re gistrati o n/ra n d o mizati o n assi g n me nt. O P E N will p o p ulate t he patie nt 
e nr ol l me nt data i n N CI’s cli nical data ma na ge me nt s yste m, Me di data Ra ve. 
Re q uire me nts f or O P E N access:  
•  
A vali d C T E P -I A M acc o u nt; 
•  
T o perf or m e nr oll me nts or re q uest sl ot reser vati o ns: M ust be o n a n L P O r oster, E T C T N 
c orres p o n di n g r oster, or partici pati n g or ga niza ti o n r oster wit h t he r ole of Re gistrar. 
Re gistrars m ust h ol d a mi ni m u m of a n Ass ociate Pl us ( A P) re gistrati o n t y pe;  a n d 
•  
Ha ve a n a p pr o ve d site re gistrati o n f or t he pr ot oc ol pri or t o patie nt e nr oll me nt.  
T o assi g n a n I n vesti gat or (I V R) or N o n -P h ysicia n I n vest i gat or ( N PI V R) as t he treati n g, 
cre diti n g, c o nse nti n g, dr u g s hi p me nt (I V R o nl y), or recei vi n g i n vesti gat or f or a patie nt tra nsfer 
i n O P E N, t he I V R or N PI V R m ust list t he I R B n u m ber use d o n t he site’s I R B a p pr o val o n t heir 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 0  
F or m F D A 1 5 7 2 i n R C R. If a D T L is re q uire d f or t he st u d y, t he I V R or N PI V R m ust be assi g ne d 
t he a p pr o priate O P E N-relate d tas ks o n t he D T L. 
Pri or t o accessi n g O P E N, site staff s h o ul d verif y t he f oll o wi n g:  
•  
Patie nt has met all eli gi bilit y criteria wit hi n t he pr ot oc ol state d ti mefra mes; a n d  
•  
A ll patie nts ha ve si g ne d a n a p pr o priate c o nse nt f or m a n d HI P A A a ut h orizati o n f or m (if 
a p plica ble).   
N ote:  T he O P E N s yste m will pr o vi de t he site wit h a pri nta ble c o nfir mati o n of re gistrati o n a n d 
treat me nt i nf or mati o n. Y o u ma y pri nt t his c o nfir mati o n f or y o ur rec or ds.  
Access O P E N at 
 or fr o m t he O P E N li n k o n t he C T S U me m bers’ we bsite. 
F urt her i nstr ucti o nal i nf or mati o n is i n t he 
O P E N secti o n of t he 
C T S U 
we bsite at 
 F or a n y a d diti o nal q uesti o ns, c o ntact t he C T S U 
Hel p Des k at 
 
 
4. 7  
Str atific ati o n  F act ors a n d Tre at me nt Assi g n me nts  
4. 7. 1  
Str atific ati o n  
T he ra n d o mizati o n r o uti ne is f o u n d i n 
Secti o n 1 2. 0  ( Statistical 
C o nsi derati o ns). 
Ra n d o mizati o n occ urs at t he cli nic practice site le vel o nl y. Patie nt le vel stratificati o n is n ot 
c o nsi dere d i n t his st u d y.  
T here is o ne pla n ne d c o m p osite stratificati o n fact or wit h t w o le vels ( gr o u p 1; gr o u p 2). 
W he n assi g ni n g sit es t o a gr o u p, t he pri mar y fact or c o nsi dere d was w het her t he site was a 
mi n orit y/ u n derser ve d N C O R P site. Sites will be stratifie d as f oll o ws:  
Gr o u p 1: Wisc o nsi n N C O R P, M o nta na Ca ncer C o ns orti u m N C O R P, Ba y Area T u m or 
I nstit ute N C O R P, Carle Ca ncer Ce nter N C O R P, Ha waii M/ U N C O R P  
Gr o u p 2: U ni versit y of Ne w Me xic o M/ U N C O R P, Me dical U ni versit y of S o ut h Car oli na 
M/ U N C O R P, Vir gi nia C o m m o n wealt h U ni versit y Masse y Ca ncer Ce nter M/ U N C O R P, 
Str o ger H os pital of C o o k C o u nt y M/ U N C O R P, Ge or gia Cares M/ U N C O R P  
 
 
4. 7. 2  
Gr o u pi n g F act ors  
T he gr o u pi n g fact ors are as f oll o ws: a.) Sta n dar d of care, N o decisi o n ai d, a n d b.) Sta n dar d 
of care, Wit h decisi o n ai d  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 1  
5. 0  S T U D Y C A L E N D A R S  
5. 1  
P atie nt -le vel St u d y C ale n d ar 
 
Pri or t o 
Re gistr ati o n  
S ur gic al 
C o ns ult ati o n †  
P ost -
C o ns ult ati o n  
P ost -S ur ger y  
 
Pri or t o I nstit uti o n al Cr oss over  
Baseli ne S ur ve y *  
 
X  
 
 
A u di o Rec or di n g  
 
X  
 
 
F oll o w u p S ur ve y * *  
 
 
X  
 
C hart Re vie w  
 
 
 
X  
 
Be gi n ni n g 1 0 Wee ks after I nstit uti o n al Cr oss over * * *  
Decisi o n Ai d e mail  
X  
 
 
 
De m o gra p hics a n d ‘ Reas o n(s) W h y’  
X ( 3)  
 
 
 
Baseli ne S ur ve y *  
 
X  
 
 
A u di o Rec or di n g  
 
X  
 
 
F oll o w u p S ur ve y * *  
 
 
X  
 
C hart Re vie w  
 
 
 
X  
I n-Pers o n, Tele p h o ne , or Vi de o 
I ntervie w s ( Accessi bilit y Barriers) 
 
 
 
X  (1 ) 
I n-Pers o n , Tele p h o ne or Vi de o 
I nter vie ws 
( Pre parat or y/I nteracti o nal Barriers) 
 
 
 
X ( 2 ) 
F oc us Gr o u p  
 
 
 
X  ( 2) 
†  
Re gistrati o n ca n occ ur bef ore or after s ur gical c o ns ultati o n, as l o n g as patie nt is c o nse nte d pri or t o 
a n y s ur ve ys a n d/ or a u di o -rec or di n gs ta ke place. 
*  
B o o klet; see A p pe n di x I  or II.  
* *  
We b -Base d or B o o klet : see A p pe n di x III, I V, or V.  T he f oll o w -u p s ur ve y m ust be c o m plete d after 
t he patie nt lea ves t he s ur ge o n’s office. 
* * *  After i nstit uti o nal cr oss o ver, patie nts ma y partici pate i n t he s ur ve ys a n d a u di o-rec or di n gs 
re gar dless of w het her t he y were offere d t he decisi o n ai d, or w het her t he y di d or di d n ot acce pt it.  
Acce pti n g or n ot acce pti n g t he decisi o n ai d o nl y i nfl ue nces o p p ort u nit y f or partici pati o n i n patie nt 
i nter vie ws a n d f oc us gr o u ps. 
 
1)  S u bs et of patie nts w h o eit her decli ne d decisi o n ai d w he n offere d (fr o m cli nic l o g), acce pte d it b ut ha d 
diffic ult y accessi n g it ( baseli ne s ur ve y), or acce pte d it b ut di d n ot use it after recei vi n g it ( baseli ne 
s ur ve y). 
2 ) S u bset of patie nts  w h o use d t he decisi o n ai d.  
3)  P atie nts w h o decli ne t he decisi o n ai d  
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 2  
5. 2  
Site Le vel St u d y C ale n d ar  
 
Pri or t o 1 st 
P atie nt  
Us u al C are  
I nstit uti o n al Cr oss o ver 
I m ple me nt ati o n ( 1 0 
Wee ks ) 
Cr oss o ver 
C o m plete  
S ur ge o n a n d Cli nic  S taff 
recr uit me nt 
S, C S  (2)  
 
 
 
Baseli ne  s ur ge o n s ur ve y *  
S  ( 2) 
 
 
 
Site c ollects patie nt -le vel data 
 
( 2) 
 
( 2) 
A u di o rec or di n gs  d uri n g 
c o ns ultati o ns 
 
S  ( 2) 
 
S  ( 2) 
I m ple me ntati o n pac ka ge: 
 
 
 
 
Cli nic Self -Assess me nt 
W or ks heet  
 
 
S, C S  ( 1) 
 
Fiel d n otes  
 
 
S, C S  ( 1) 
 
A u dit -Fee d bac k  
 
 
S, C S  ( 1, 3) 
 
Meas ure reac h of Decisi o n Ai d  
 
 
 
C S  (2 ) 
Cli nic c haracteristics  
 
 
 
C S ( 2)  
Cli nic f oc us g r o u ps 
 
 
 
S, C S  ( 1) 
S -S ur ge o ns  
C S -Cli nic Staff  
*  
B o o klet; see A p pe n di x VI . 
1)  A d mi nistere d/c ollecte d b y U ni versit y of Wisc o nsi n  researc h tea m. 
2)  A d mi nistere d/c ollecte d b y site researc h tea m.  
3)  A u dit -Fee d bac k will occ ur at a b o ut 3 a n d 6 wee ks f oll o wi n g t he cr oss o ver date  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 3  
6. 0  D A T A  S U B MI S SI O N  
6. 1  
O ver vie w of D at a C ollecti o n a n d S u b missi o n   
All d at a are t o be s u b mitte d wit hi n o ne wee k of c ollecti o n. 
T he f oll o wi n g data will be c ollecte d b y eac h site’s researc h c o or di nat or:  
• 
S ur ge o n baseli ne s ur ve y  
• 
Patie nt pre -c o ns ultati o n baseli ne s ur ve y 
• 
A u d i o file of s ur gical c o ns ult 
• 
Patie nt f oll o w -u p s ur ve y  
• 
Patie nt c hart re vie w –  a bstracti n g cli nical data p oi nts  
• 
Patie nt tele p h o ne , vi de o, or i n-pers o n  i nter vie ws f or accessi bilit y barriers (s u bset of 
patie nts  w h o eit her decli ne d decisi o n ai d w he n offere d, acce pte d it b ut ha d diffic ult y 
accessi n g it, or acce pte d it b ut di d n ot use it aft er recei vi n g it , a u di o-files) 
• 
Reac h after c ha n ge t o i nter ve nti o n ar m  
• 
Cli nic  w or ki n g 
d oc u me nts 
ass ociate d 
wit h 
i m ple me ntati o n 
acti vities (cli nic 
i m ple me ntati o n w or ks heet , a u dit-fee d bac k d oc u me ntati o n) 
T he f oll o wi n g data will be c ollecte d b y t he U W resea rc h tea m: 
• 
Fiel d n otes fr o m o bser vati o ns of cli nic  i m ple me ntati o n acti vities 
• 
Patie nt tele p h o ne, vi de o or i n-pers o n i nter vie ws f or pre parat or y/i nteracti o nal barriers 
(s u bset of patie nts w h o use d t he decisi o n ai d a n d partici pate d i n t he s ur ve ys/a u di o 
rec or di n gs, a u di o-files) 
• 
Patie nt f oc us gr o u ps (s u bset of patie nts  w h o use d t he decisi o n ai d a n d partici pate d i n t he 
s ur ve ys/a u di o rec or di n g, a u di o-files) 
• 
Cli nic sta ke h ol der f oc us gr o u ps ( s u bset of sta ke h ol ders, a u di o-files)   
D at a c ollecti o n t y pe  
W h o C ollecti n g  
W here t o s u b mit  
S ur ge o n baseli ne s ur ve y res p o nses  
Sit e c o or di nat or  
E nter i nt o i Me di data/ Ra ve  
Patie n t baseli ne s ur ve y res p o nses 
Sit e c o or di nat or  
E nter i nt o i Me di data/ Ra ve 
A u di o files of s ur gical c o ns ult  
Sit e c o or di nat or  
U pl oa d a n d se n d t hr o u g h U W Sec ure B o x site 
or sec ure  file tra nsfer ser vice 
F oll o w -u p p ost -c o ns ultati o n s ur ve y res p o nses  
Sit e c o or di nat or  
E nter i nt o i Me di data/ Ra ve  
Patie nt c hart re vie w –  a bstracti n g cli nical data 
p oi nts  
Sit e c o or di nat or  
E nter i nt o i Me di data/ Ra ve  
De -i de ntifie d c o pies of cli nic i m ple me ntati o n 
w or ks heet  
Sit e c o or di nat or  
U pl oa d a n d se n d t hr o u g h U W Sec ure B o x site 
or sec ure  file tra nsfer ser vice 
Fiel d n otes of i m ple me ntati o n eff orts 
U W researc h tea m  
U pl oa d b y researc h tea m t o U W Sec ure B o x 
site or sec ure file tra nsfer ser vice 
A u di o files of q ualitati ve tele p h o ne , vi de o, or 
i n-pers o n  i nter vie ws (s u bset of patie nts) 
Sit e c o or di nat or  
U pl oa d a n d se n d t hr o u g h U W Sec ure B o x site 
or sec ure file tra nsfer ser vice  
Reac h  
Sit e c o or di nat or  
U pl oa d a n d se n d t hr o u g h U W Sec ure B o x site 
or sec ure file tra nsfer ser vice  
A u di o files of o ne -o n -o ne tele p h o ne, vi de o or 
i n pers o n i nter vie ws (s u bset of patie nts) 
U W researc h tea m  
U pl oa d b y researc h tea m t o U W Sec ure B o x 
site or sec ure file tra nsfer ser vice 
Patie nt a n d Sta ke h ol der f oc us gr o u ps  
U W researc h tea m  
U pl oa d b y researc h tea m t o U W Sec ure B o x 
site or sec ure file tra nsfer ser vice 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 4  
Patie nt Scree ni n g L o g ( de-i de ntifie d) 
Sit e c o or di nat or  
U pl oa d a n d se n d t hr o u g h U W Sec ure B o x site 
or sec ure file tra nsfer ser vice  
List of patie nts w h o decli ne decisi o n ai d wit h 
li mite d de m o gra p hics ( de-i de ntifie d) 
Sit e cli nic staff  
U pl oa d a n d se n d t hr o u g h U W Sec ure B o x site 
or sec ure file tra nsfer ser vice 
 
6. 1. 1  
D at a Q u alit y P ort al  
T he Data Q ualit y P ortal ( D Q P) pr o vi des a ce ntral l ocati o n f or site staff t o ma na ge 
u na ns were d q ueries a n d f or m deli n q ue ncies, m o nit or data q ualit y a n d ti meli ness, ge nerate 
re p orts, a n d re vie w metrics.  
T he D Q P is l ocate d o n t he C T S U me m bers’ we bsite u n der Data Ma na ge me nt. T he Ra ve 
H o me secti o n dis pla ys a ta ble pr o vi di n g s u m mar y c o u nts of T otal Deli n q ue ncies a n d T otal 
Q ueries. D Q P Q ueries, D Q P Deli n q ue nt F or ms a n d t he D Q P Re p orts m o d ules are a vaila ble 
t o access details a n d re p orts of u na ns were d q ueries, delin q ue nt f or ms, a n d ti meli ness 
re p orts. Re vie w t he D Q P m o d ules o n a re g ular basis t o ma na ge s pecifie d q ueries a n d 
deli n q ue nt f or ms.  
T he D Q P is accessi ble b y site staff t hat are r ostere d t o a site a n d ha ve access t o t he C T S U 
we bsite. Staff t hat ha ve Ra ve st u d y access ca n access t he Ra ve st u d y data usi n g a direct 
li n k o n t he D Q P. 
T o lear n m ore a b o ut D Q P use a n d access, clic k o n t he Hel p ic o n dis pla ye d o n t he Ra ve 
H o me, D Q P Q ueries, a n d D Q P Deli n q ue nt F or ms m o d ules.  
N ote: S o me Ra ve pr ot oc ols ma y n ot ha ve deli n q u e nt f or m details or re p orts s pecifie d o n 
t he D Q P. A pr ot oc ol m ust ha ve t he Cale n dar f u ncti o nalit y i m ple me nte d i n Ra ve b y t he 
Lea d Pr ot oc ol Or ga nizati o n f or deli n q ue nt f or m details a n d re p orts t o be a vaila ble o n t he 
D Q P. Sit e staff s h o ul d c o ntact t he L P O Da ta 
Ma na ger f or t heir pr ot oc ol re gar di n g 
q uesti o ns a b o ut Ra ve Cale n dari n g f u ncti o nalit y.  
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 5  
6. 2  
D at a S u b missi o n  t o t he Alli a nce 
Me di data Ra ve is a cli nical data ma na ge me nt s yste m bei n g use d f or data c ollecti o n f or t his 
trial/st u d y. Access t o t he trial i n Ra ve is c o ntr olle d t hr o u g h t he C T E P -I A M s yste m a n d r ole 
assi g n me nts.  
Re q uire me nts t o access Ra ve via i Me di data: 
•  
A vali d C T E P -I A M acc o u nt; a n d  
•  
Assi g ne d a Ra ve r ole o n t he L P O or P O r oster at t he e nr olli n g site of: Ra ve C R A, Ra ve 
Rea d O nl y, Ra ve C R A ( La b A d mi n), Ra ve S L A, or Ra ve I n vesti gat or.  
Ra ve r ole re q uire me nts:  
o  
Ra ve C R A or Ra ve C R A ( La b A d mi n) r ole m ust ha ve a mi ni m u m of a n 
Ass ociate Pl us ( A P) re gistrati o n t y pe;  
o  
Ra ve I n vesti gat or r ole m ust be re gistere d as a n N o n -P h ysicia n I n vesti gat or 
( N PI V R) or I n vesti gat or (I V R); a n d 
o  
Ra ve Rea d O nl y r ole m ust ha ve at a mi ni m u m a n Ass ociates ( A) re gistrati o n 
t y pe. 
Refer t o 
 f or re gistrati o n t y pes a n d 
d oc u me ntati o n re q uire d.  
U p o n i nitial site re gistrati o n a p pr o val f or t he st u d y i n Re g ulat or y S u p p ort S yste m ( R S S), all 
pers o ns wit h Ra ve r oles assi g ne d o n t he a p pr o priate r oster will be se nt a st u d y i n vitati o n e -mail 
fr o m i Me di data. T o acce pt t he i n vitati o n, site staff 
m ust l o g i n t o t he Select L o gi n 
usi n g t heir C T E P -I A M user na me a n d pass w or d a n d 
clic k o n t he acce pt  li n k i n t he u p per ri g ht-c or ner of t he i Me di data pa ge.  Site staff will n ot be 
a ble t o access t he st u d y i n Ra ve u ntil all re q uire d Me di data a n d st u d y s pecific tra i ni n gs are 
c o m plete d.  Trai ni n gs will be i n t he f or m of electr o nic lear ni n gs (e Lear ni n gs) a n d ca n be 
accesse d b y clic ki n g o n t he li n k i n t he u p per ri g ht pa ne of t he i Me di data scree n. If a n e Lear ni n g 
is re q uire d a n d has n ot yet bee n ta ke n, t he li n k t o t he e Lear ni n g will a p pear u n der t he st u d y 
na me i n i Me di data i nstea d of t he R ave E D C  li n k; o nce t he s uccessf ul c o m pleti o n of t he 
e Lear ni n g has bee n rec or de d, access t o t he st u d y i n Ra ve will be gra nte d, a n d a R ave E D C  li n k 
will dis pla y u n der t he st u d y na me.  
Sit e  staff t hat ha ve n ot pre vi o usl y acti vate d t heir i Me di data/ Ra ve acc o u nt at t he ti me of i nitial 
site re gistrati o n a p pr o val f or t he st u d y i n R S S will recei ve a se parate i n vitati o n fr o m i Me di data 
t o acti vate t heir acc o u nt. Acc o u nt acti vati o n i nstr ucti o ns are l ocate d o n t he C T S U we bsite i n t he 
Data Ma na ge me nt secti o n u n der t he Ra ve res o urce materials ( Me di data Acc o u nt Acti vati o n a n d 
St u d y I n vitati o n Acce pta nce). A d diti o nal i nf or mati o n o n i Me di data/ Ra ve is a vaila ble o n t he 
C T S U me m bers’ we bsite i n t he Data Ma na ge me nt >  Ra ve secti o n at 
 
  
6. 3  
D at a S u b missi o n t o t he U ni versit y of Wisc o nsi n  
All data tra nsferre d t o U W will be se nt usi n g t he U W Sec ure B o x site or S ur ger y a n d Ur ol o g y 
Fil e Tra nsfer s yst e m.   
F oll o wi n g a u di o -file data c ollecti o n fr o m eit her a T 1 s ur gical c o ns ult or patie nt i nter vie w, site 
researc h c o or di nat ors will se n d t he a u di o -file of t he c o n versati o n t o U W f or tra nscri pti o n. Site 
c o or di nat ors will e ns ure t hat t he a u di o -file’s title i ncl u des t he patie nt’s st u d y I D n u m ber ( n o 
i de ntifiers). D ue t o data sec urit y c o ncer ns, a u di o-files will o nl y be s hare d usi n g eit her t he U W 
Sec ure B o x site or S ur ger y a n d Ur ol o g y File Tra nsfer s yste m. T he y are b ot h a sec ure, pass w or d-

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 6  
pr otecte d s yste m . T hese a u di o -files will be d o w nl oa de d t o t he sec ure U W De part me nt of 
S ur ger y ser ver. O nce U W recei ves t he file a n d re vie ws it, t he y will gi ve i nstr ucti o ns t o t he site 
researc h c o or di nat or t o delete t heir c o p y of t he a u di o file.  
T he a u di o -files will t he n be tra nscri be d i n t heir e ntiret y. Alt h o u g h i de ntif yi n g i nf or mati o n ma y 
e xist o n t he a u di o files, tra nscri pti o nists will stri p all i de ntif yi n g i nf or mati o n o nce tra nscri be d 
a n d will o nl y ha ve access t o t he s u bject I D t hat is assi g ne d b y st u d y staff ( n o access  t o t he 
patie nt -s u bject l o g or ot her i de ntif yi n g i nf or mati o n). St u d y staff me m bers or o utsi de c o ntract ors 
wit h a b usi ness ass ociate a gree me nt w h o ha ve bee n a p pr o ve d b y U W Le gal Ser vices/ Pri vac y 
Officer f or HI P A A c o m plia nce will be use d f or tra nscri pti o n. A fter data a nal ysis is c o m plete 
a n d ma n uscri pts ha ve bee n acce pte d f or p u blicati o n, t he a u di o rec or di n gs will be destr o ye d a n d 
t he de-i de ntifie d tra nscri pts will be st ore d i n defi nitel y o n a sec ure ser ver. 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 7  
7 . 0  S T U D Y IN T E R V E N TI O N — IN S TI T U TI O N S , S U R G E O N S , A N D C LI NI C S T A F F  
7. 1  
Cli nic -Le vel  I nter ve nti o n 
7. 1. 1  
Pri or t o I nstit uti o n al Cr oss o ver — Us u al C are  
After st u d y acti vati o n, sites will c o nti n ue t o pr o vi de breast ca ncer s ur gical care per t heir 
us ual care.  Sit e researc h c o or di nat ors will a u di o -rec or d s ur ge o n’s visit c o n versati o n wit h 
e nr olle d patie nts.  
7 . 1. 2 
I nstit uti o n al Cr oss o ver t o I nter ve nti o n ( Decisi o n Ai d) 
Eac h site will start i n t he us ual care ar m. At t he start of eac h wa ve, starti n g fr o m wa ve t w o , 
t w o sites will cr oss o ver i nt o t he i nter ve nti o n ar m (see Secti o n 4. 4  f or a d diti o nal details). 
Eac h site will be n otifie d f o ur wee ks pri or t o t heir cr oss o ver date.  
After t he date of cr oss o ver  t o t he i nter ve nti o n, all patie nts wit hi n t he cli nic will be  as ke d 
w het her t he y w o ul d li ke t o recei ve t he decisi o n ai d b y e mail as acce pte d practice i n t he 
cli nic. T his desi g n, w here recei pt of t he decisi o n ai d is n ot li n ke d t o st u d y c o nse nt, 
ma xi mizes reac h of t he decisi o n ai d i nter ve nti o n itself, es peciall y i m p or ta nt w he n w or ki n g 
wit h disa d va nta ge d patie nt p o p ulati o ns t hat are less li kel y t o partici pate i n researc h. 6 9   
Staff will offer t he decisi o n ai d w he n a s ur ger y c o ns ult is sc he d ule d a n d mai ntai n  a l o g of 
all patie nts w h o are offere d t he decisi o n ai d. If a patie nt e x presses i nterest i n recei vi n g t he 
decisi o n ai d, cli nic staff will o btai n a n d rec or d t heir preferre d e mail a d dress, a n d t he y will 
se n d t he patie nt t he decisi o n ai d.  Beca use of pri vac y c o ncer ns, t he e mail b o d y d oes n ot 
i ncl u de t he w or d “ca ncer”. T he e mail will be se nt b y a staff me m ber t o a n e mail a d dress 
s u p plie d b y t he patie nt t he msel ves. 
Patie nts w h o re p ort diffic ult y wit h i nter net access  will be offere d t w o o pti o ns: ( 1) ha ve t he 
decisi o n ai d se nt t o a fa mil y me m ber, a n d ( 2)  vie w  t he decisi o n ai d i n cli nic o n a n i Pa d .  
Alt h o u g h t he decisi o n ai d is c urre ntl y o nl y a vaila ble i n E n glis h, we will offer it t o all 
patie nts re gar dless of pri mar y la n g ua g e, ass u mi n g patie nts ma y i de ntif y wa ys it c o ul d be 
be neficial (e. g. re vie w wit h E n glis h s pea ki n g fa mil y me m ber).  F or patie nts wit h vis ual 
i m pair me nt, t he decisi o n ai d will be offere d usi n g a n alter nati ve strate g y, s uc h as ( b ut n ot 
li mite d t o) e maili n g it to fa mil y me m bers t o re vie w.  
7 . 1. 3 
Te n -wee k I m ple me nt ati o n of Decisi o n Ai d  
Starti n g o n t he date of cr oss o ver , t here will be a 1 0-wee k i m ple me ntati o n peri o d w he n 
patie nt -le vel data are n ot c ollecte d i n or der t o all o w t he decisi o n ai d t o be f ull y 
i m ple me nte d at eac h cli nic. T he U W researc h tea m  will pr o vi de cli nic ma na ge me nt  wit h 
t he i m ple me ntati o n pac ka ge. Eac h site will ha ve a desi g nate d s ur ge o n c ha m pi o n w h o will 
hel p facilitate i m ple me ntati o n; t his i n di vi d ual will ha ve bee n i de ntifie d at t he ti me of site 
selecti o n f or t he st u d y a n d is n ot necessaril y t he site st u d y PI. T he pri mar y ste ps i n 
i m ple me ntati o n i ncl u de creati n g a n i m ple me ntati o n c ha n ge tea m at eac h cli nic c o m prise d 
of ke y cli nic sta ke h ol ders, c o m pleti o n of a cli nic self -assess me nt w or ks heet t hat i ncl u des 
pr ocess ma p pi n g of patie nts’ fl o w t hr o u g h cli nic, a n d brief a u dit -fee d bac k l o o ps. T hese 
data fr o m t he cli nic self-assess m e nt w or ks heet a n d t he a u dit -fee d bac k, al o n g wit h fiel d 
n otes fr o m a n y i nteracti o ns bet wee n t he U W researc h tea m a n d t he cli nic, will be ke pt as 
data re gar di n g t he i m ple me ntati o n pr ocess.  
• 
Cli nic self -assess me nt w or ks heet  is a self -assess me nt w or ks heet t ha t g ui des t he tea m 
t hr o u g h c o nsi derati o n of percei ve d barriers a n d facilitat ors t o i m ple me nti n g t he 
decisi o n ai d, a n d t hr o u g h pr ocess ma p pi n g of patie nts’ fl o w t hr o u g h cli nic t o e ns ure 
all eli gi ble patie nts will be offere d t he decisi o n ai d. 7 0, 7 1   

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 8  
• 
Fiel d n otes  of all i nteracti o ns bet wee n t he U W researc h tea m a n d t he cli nic will be 
ke pt.  Trai ne d me m bers of t he U W researc h tea m will directl y o bser ve t he meeti n g 
w here t he cli nic self-assess me nt w or ks heet is c o m plete d; t he U W researc h tea m will 
ta ke struct ure d fiel d n otes.  We will e x plicitl y rec or d o bser vati o ns a b o ut t he  cli nic 
i nf or mati o nal tec h n ol o g y i nfrastr uct ure w hic h ma y facilitate or hi n der i m ple me ntati o n.  
I n a d diti o n t o o bser vi n g t he pr ocesses b y w hic h s ol uti o ns t o barriers are i de ntifie d, 
ot he r di me nsi o ns rele va nt t o i m ple me ntati o n s uc h as tea m lea ders hi p b y t he s ur ge o n 
c ha m pi o n a n d c o nflict a m o n gst t he tea m will be rec or de d i n t he fiel d n otes.  F oll o wi n g 
t he assess me nt, eac h site researc h c o or di nat or will c o de t he c o m plete d cli nic self -
assess m e nt w or ks heets t o re m o ve all patie nt a n d tea m me m ber na mes.  T he c o de d 
dataset ( wit h o ut i de ntifiers) will be s hare d wit h t he U W researc h tea m via t he sec ure 
U W Sec ure B o x or S ur ger y & Ur ol o g y File Tra nsfer ser vice . 
• 
A u dit -Fee d b ac k  will occ ur at a b o ut  3 a n d  6 wee ks  f oll o wi n g t he cr oss o ver date as a 
t o ol t o i m pr o ve t he i m ple me ntati o n of t he decisi o n ai d.  D uri n g t he 1 0-wee k 
i m ple me ntati o n p hase, n o patie nt -le vel data are c ollecte d.   T he U W a n d site researc h 
tea m will w or k t o get her t o calc ulate t he pr o p orti o n of eli gi ble patie nts w h o are se nt t he 
decisi o n ai d o ut of t he t otal eli gi ble d uri n g t he 3-wee k peri o d a n d w h o access t he 
decisi o n ai d.  T he U W researc h tea m will s u p p ort t he cli nic tea m i n i de ntif yi n g t he best 
met h o d f or c ollecti n g data o n reac h (e. g. usi n g billi n g data or direct re vie w of cli nic 
sc he d ules). 5 8 ,7 2, 7 3 T he data i n t he a u dit fee d bac k t o ol will be c o de d b y t he site researc h 
c o or di nat or t o re m o ve all patie nt a n d tea m me m ber na mes. T he c o de d ( wit h o ut 
i de ntifiers) dataset will be pr o vi de d t o t he U W researc h tea m. T he U W researc h tea m 
a n d t he site will w or k t o get her t o i de ntif y o p p ort u nities t o i ncrease t he reac h of t he 
decisi o n ai d i n t heir cli nic.  
Alt h o u g h t he materials fr o m i m ple me ntati o n are part of t he i m ple me ntati o n pr ocess, t he y 
are als o c o nsi dere d researc h materials , as t he y will b e use d t o e n ha nce t he o verall 
i nter ve nti o n. Partici pa nts will n ot be i nte nti o nall y as ke d a n y q uesti o ns t hat pertai n t o 
pri vate healt h i nf or mati o n a b o ut s pecific cli nic staff or patie nts d uri n g t hese sessi o ns.  
H o we ver, it is a p ossi bilit y t hat a partici pa n t c o ul d c h o ose t o a ns wer a n o pe n-e n de d 
q uesti o n wit h i de ntifia ble pri vate i nf or mati o n. F or t his reas o n, all ite ms o btai ne d d uri n g 
t he sessi o ns will be c o de d. 
7. 1. 4  
F oll o wi n g t he 1 0 -wee k i m ple me nt ati o n peri o d  
Cli nic staff will c o nti n ue t o offer t he decisi o n ai d w he n a s ur ger y c o ns ult is sc he d ule d (as 
descri be d i n t he prece di n g secti o n) a n d mai ntai n  a l o g of all patie nts w h o are offere d t he 
decisi o n ai d, i ncl u di n g w h o acce pts , w h o decli nes  a n d reas o n(s) w h y . T his data is c ollecte d 
as part of sta n dar d of care t o g ui de o n g oi n g i m ple me ntati o n acti vities i n or der t o ma xi mize 
cli nic-wi de use of t he decisi o n ai d.  
Si milar t o t he us ual care peri o d, d uri n g t he i nter ve nti o n peri o d, site researc h c o or di nat ors 
will a u di o -recor d s ur ge o n’s c o n versati o n wit h e nr olle d patie nts.  
F or all patie nts w h o decli ne t he decisi o n ai d, site c o or di nat ors will c ollect li mite d 
a d diti o nal i nf or mati o n a b o ut t he m ( me dical rec or d n u m ber, a ge, race, et h nicit y, i ns ura nce 
stat us, ZI P c o de + 4, a n d reas o n(s) w h y decli ne d) t o e ns ure we are n ot s yste maticall y 
e xcl u di n g certai n p o p ulati o ns fr o m o ur st u d y.  
 
At t he e n d of t he st u d y peri o d, t he site c o or di n at ors will c ollect t he t ot al n u m ber of 
p atie nts w h o were offere d t he decisi o n ai d, t he t ot al n u m ber of p atie nts w h o were se nt 
t he decisi o n ai d , a n d t he t ot al n u m ber of p atie nts see n i n t he cli nic d uri n g t he 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
2 9  
i nter ve nti o n ar m wi n d o w.  T hese n u m bers will be u pl o a de d t o U W t o c alc ul ate re ac h 
of t he i nter ve nti o n.  
 
7. 2  
I n di vi d u al-le vel I nter ve nti o n— S ur ge o ns a n d Cl i nic St aff 
7. 2. 1  
S ur ge o ns  
Recr uit me nt: Lists of s ur gical pers o n nel will be use d t o i n vite s ur ge o ns t o partici pate i n 
t he st u d y. Pri or t o patie nt e nr oll me nt, all s ur ge o ns will be c o ntacte d b y t he site Pri nci pal 
I n vesti gat or or desi g nee re gar di n g partici pati o n. S ur ge o ns will be pr o vi de d  i nf or mati o n 
a b o ut t he st u d y a n d as k e d if s/ he w o ul d be i ntereste d i n meeti n g i n -pers o n wit h  t he site’s 
researc h c o or di nat or t o disc uss t he st u d y.   
C o nse nt:  S ur ge o n c o nse nt is f or partici pati o n i n site i m ple me ntati o n acti vities, all o wi n g 
t heir patie nts t o recei ve t he decisi o n ai d, a baseli ne s ur ve y, a n d a u di o-rec or di n g of t heir 
patie nt c o ns ultat i o ns.  S ur ge o ns will ha ve a n i n -pers o n meeti n g wit h st u d y staff t o e x plai n 
t he c o m p o ne nts of t he st u d y (i ncl u di n g ris ks, etc.), i n q uire of w het her t he s ur ge o n w o ul d 
li ke t o partici pate, a n d st u d y staff will o btai n writte n i nf or me d c o nse nt i n a pri vate a n d 
q uiet r o o m.   
S ur ge o n B aseli ne S ur ve y:  Pri or t o be gi n ni n g patie nt e nr oll me nt, t he site researc h 
c o or di nat or will a d mi nister  baseli ne s ur ve y t o all c o nse nti n g  s ur ge o ns at t he site.   T he 
s ur ve y b o o klets s h o ul d ta ke a b o ut 1 0 mi n utes t o c o m plete. If t he s ur ve y is n ot c o m plete d, 
t he site researc h c o or di nat or will se n d re mi n ders, eit her b y e mail or b y tele p h o ne calls. 
S ur ge o ns will be c o ntacte d u p t o 6 ti mes t o c o m plete t he s ur ve y.  
F oc us Gr o u ps:  Cli nic sta ke h ol der f oc us gr o u p will ta ke place at a nati o nal  meeti n g  d uri n g 
years 4/ 5 . We will p oll p ossi ble f oc us gr o u p partici pa nts t o i de ntif y t he nati o nal meeti n g 
wit h t he greatest pla n ne d atte n da nce; e xa m ples c o ul d i ncl u de t he Allia nce f or Cli nical 
Trials i n O nc ol o g y bia n n ual meeti n g, t he A merica n C olle ge of S ur ge o ns a n n ual meeti n g, 
or A merica n S ociet y of Breast S ur ge o n s a n n ual meeti n g. We will pla n t o h ol d o ur f oc us 
gr o u p meeti n gs at t his meeti n g.  We will a d diti o nall y ha ve a n o n -li ne o pti o n f or s ur ge o n 
sta ke h ol ders n ot atte n d t he meeti n g as well as ot her cli nic sta ke hol ders less li kel y t o atte n d 
t hese nati o nal meeti n gs. We will c o n d uct o ne f oc us gr o u p at t he be gi n ni n g a n d o ne near 
t he e n d of t he meeti n g; t his will all o w ti me t o re vie w t he f oc us gr o u p a n d re vise t he f oc us 
gr o u p scri pt i n or der t o e x pl ore critical t he mes . We will i n vite s ur ge o ns fr o m eac h cli nic 
t o partici pate i n t he f oc us gr o u ps. 
7. 2 . 2 
Cli nic St aff  
Recr uit me nt:  T he site Pri nci pal I n vesti gat or a n d site researc h c o or di nat or will use staff 
lists t o i de ntif y cli nic staff. Pri or t o i m ple me ntati o n a n d patie nt e nr oll me nt, all cli nic staff 
will be c o ntacte d a b o ut t he st u d y a n d t heir a ntici pate d r ole . T he recr uit me nt mat erials will 
i ncl u de i nf or mati o n a b o ut t he i m ple me ntati o n acti vities a n d f oc us gr o u ps. I n a d diti o n, t he 
e mail will as k if t he y w o ul d be i ntereste d i n meeti n g i n -pers o n wit h st u d y staff t o disc uss 
t he st u d y. Cli nic staff me m bers ha ve t he p ossi bilit y t o o pt out of meeti n g i n -pers o n t o lear n 
m ore a b o ut t he st u d y b y res p o n di n g t o t he e mail stati n g t he y are n ot i ntereste d. Cli nic 
sta ke h ol ders will be c o ntacte d a ma xi m u m of t hree ti mes t o ga u ge i nterest i n t he st u d y.  
All cli nic staff w ill be eli gi ble t o partici pate  i n t he i m ple me ntati o n acti vates (cli nic self-
assess me nt w or ki n g sessi o n) at t heir site.  
F oc us Gr o u ps : Cli nic sta ke h ol der f oc us gr o u p will ta ke place at t he Allia nce f or Cli nical 
Trials i n O nc ol o g y bia n n ual meeti n g  d uri n g years 4/ 5 . We will c o n duct o ne f oc us gr o u p at 
t he be gi n ni n g a n d o ne near t he e n d of t he meeti n g; t his will all o w ti me t o re vie w t he f oc us 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 0  
gr o u p a n d re vise t he f oc us gr o u p scri pt i n or der t o e x pl ore critical t he mes. Alter nati vel y , 
d ue t o t he i m pact of t he n o vel c or o na vir us (C O VI D -1 9 ) s ur ge o n a n d cli nic staff f oc us 
gr o u ps ma y occ ur virt uall y via tele p h o ne or vi de o . Select staff will be i n vite d t o partici pate 
i n t he fi nal f oc us gr o u p after disc ussi o ns wit h t he s ur ge o n c ha m pi o n at eac h cli nic a n d t he 
cli nic ma na ger base d o n t heir le v el of i n v ol ve me nt i n t he decisi o n ai d i m ple me ntati o n a n d 
t heir c o ntact wit h patie nts.  
7. 3  
I nce nti ves 
7. 3. 1  
S ur ge o ns  
S ur ge o ns will n ot recei ve c o m pe nsati o n f or t heir partici pati o n i n t he i m ple me ntati o n 
acti vities, baseli ne s ur ve y a n d a u di o rec or di n gs of t h eir s ur gical c o ns ultati o ns.  
S ur ge o ns will be pr o vi de d a n i nce nti ve of $ 1 0 0 f or cli nic sta ke h ol der f oc us gr o u p 
partici pati o n.  T he U W researc h tea m w o ul d pr o vi de t he i nce nti ve directl y t o t hese 
partici pa nts at c o m pleti o n of t he f oc us gr o u p or mail t he i nce nt i ve, de pe n di n g o n w het her 
t he partici pa nt atte n ds t he f oc us gr o u p i n-pers o n or n ot.  
7. 3. 2  
Cli nic St aff  
Staff will n ot recei ve c o m pe nsati o n f or t heir partici pati o n i n t he i m ple me ntati o n acti vities.  
Staff will be pr o vi de d a n i nce nti ve of $ 1 0 0 f or cli nic sta k e h ol der f oc us gr o u p partici pati o n.  
T he U W researc h tea m w o ul d pr o vi de t he i nce nti ve directl y t o partici pa nts at c o m pleti o n 
of t he f oc us gr o u p or mail t he i nce nti ve, de pe n di n g o n w het her t he partici pa nt atte n ds t he 
f oc us gr o u p i n-pers o n or n ot.  
8. 0  S T U D Y IN T E R V E N TI O N — P A TI E N T L E V E L  
8. 1  
Scree ni n g  
Patie nt eli gi bilit y i n researc h be gi ns at t he ti me of t heir first s ur gical c o ns ultati o n , re gar dless of 
w het her t he y are i n t he us ual care o r decisi o n ai d i nter ve nti o n ar m  a n d w het her t he y di d or di d 
n ot acce pt t he decisi o n ai d.   Eac h wee k, s ur ge o ns , cli nical pers o n nel , a n d t he site’s researc h 
c o or di nat or, will pre-scree n patie nts c o mi n g t o see cli nic s ur ge o ns w h o ma y meet eli gi bilit y 
criteria. Scree ni n g will occ ur t hr o u g h c o ntact wit h ser vice tea ms as well as t hr o u g h me dical 
c hart re vie w. I n or der t o c o n d uct t hese pre -scree ni n gs, t he researc h tea m will o btai n a wai ver of 
c o nse nt as it will be i m practical t o o btai n c o nse nt t o scree n f or all eli gi ble patie nts.  
Sit e c o or di nat ors will be as ke d t o distri b ute t heir recr uit me nt t o all of t he partici pati n g s ur ge o ns 
practici n g at t hat cli nic.  I n ge neral, e nr oll me nt s h o ul d be pr o p orti o nal t o t he v ol u me of breast 
ca ncer patie nts eac h s ur ge o n sees.  Site c o or di nat ors will be pr o vi de d wit h tar get e nr oll me nt 
g oals f or eac h partici pati n g s ur ge o n i n t he cli nic pri or t o t he start of t he st u d y.  
O ur g oal f or t his st u d y is t o e nr oll ~ 3 0 % s oci oec o n o mic disa d va nta ge d patie nts; t o acc o m plis h 
t his, we ha ve selecte d cli nics e nric he d f or t his p o p ulati o n.  We will als o pr o vi de site c o or di nat ors 
wit h e x plicit trai ni n g re gar di n g e nr oll me nt of patie nts fr o m differe nt s oci oec o n o mic strata.  I n 
t his st u d y, we are defi ni n g s oci oec o n o mic disa d va nta ge base d o n t he Area De pri vati o n I n de x, 
w hic h is deter mi ne d b y t he zi p c o de + 4.  T o hel p site c o or di nat ors e nr oll patie nts fr o m eac h 
s oci oec o n o mic strata, we will pr o vi de eac h site c o or di nat or wit h a list of zi p c o de + 4 t hat 
re prese nt s oci oec o n o mic disa d va nta ge i n t heir cli nic catc h me nt area f or refere nce.  We will 
p r o vi de m o nt hl y re p orts t o cli nics s o t hat t he y ca n trac k t heir pr o gress.  We als o pla n a Lea d -i n 
Peri o d  pri or t o wa ve 1, t o e ns ure cli nics ca n s uccessf ull y e nr oll patie nts a n d ma ke a n y necessar y 
u pfr o nt c ha n ges t o site c o or di nat ors recr uit me nt strate gies.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 1  
8. 2  
P atie nts  e nr olle d bef ore i nstit uti o n al cr oss o ver   
8. 2. 1  
C o nse nt pr ocess:  Patie nts w h o meet eli gi bilit y criteria a n d are i de ntifie d as p ote ntial 
partici pa nts b y t he site researc h c o or di nat or f or t he pri mar y o bjecti ve will be q uerie d b y 
cli nic staff d uri n g t he r o o mi n g pr ocess re gar di n g st u d y partici pati o n. If t he patie nt 
e x presses i nterest i n partici pati o n, a p pr o priate site pers o n nel  will meet wit h t he patie nt 
pri or t o her  visit wit h t he s ur ge o n t o e x plai n t he st u d y ; recei ve i nf or me d c o nse nt, (f or t he 
a u di o rec or di n g of t he c o ns ultati o n, t w o s ur ve ys, a n d c o ntacti n g f or f ut ure partici pati o n 
i n eit her a n i nter vie w or f oc us gr o u p); a n d re gister t he patie nt.   
If patie nts decli ne t o partici pate i n a researc h acti vit y, t he researc h c o or di nat or will rec or d 
a ge, race, et h nicit y, i ns ura nce, a n d reas o n f or decli ni n g.  T hese data p oi nts will be c ollecte d 
s o t hat we ma y assess w het her partici pa nts ( b ot h i n t he us ual care a n d i nter ve nti o n gr o u p) 
are cate g oricall y differe nt t ha n n o n -partici pa nts.  T his data  is c o m pletel y de-i de ntifie d. As 
t hese patie nts ha ve decli ne d researc h, t he y will n ot be a p pr oac he d f or f ut ure researc h 
acti vities.  T his decli ne a p plies o nl y t o t hat s pecific researc h acti vit y a n d a n y s u bse q ue nt 
researc h acti vities.  T he decli ne d oes n ot a p pl y t o a n y pri or data c ollecti o n u nless s pecifie d 
b y t he patie nt.  
S o me sites ma y mail or e mail a letter i ntr o d uci n g t he st u d y t o patie nts i n a d va nce of t heir 
arri val t o cli nic. S ite pers o n nel ma y d o w nl oa d t he Patie nt I ntr o d ucti o n E mail or Letter fr o m 
t he S u p ple me ntal M aterials ta b o n t he Allia nce a n d C T S U we bsites.  T his w o ul d li kel y be 
f or l o gistical reas o ns a n d pla n ni n g of cli nic fl o w. T his letter w o ul d i n vite patie nts t o c o ntact 
t he site researc h c o or di nat or i n a d va nce of t he cli nic a p p oi nt me nt t o learn m ore a b o ut t he 
st u d y. T his letter w o ul d all o w c o ntact wit h t he patie nt pri or t o t heir prese ntati o n i n cli nic. 
I n a d diti o n, t he letter als o pr o vi des a n o p p ort u nit y f or patie nts t o o pt o ut of t he st u d y 
alt o get her.  
8. 2. 2  
S ur gic al c o ns ult ati o n:  After patie n t c o nse nt, t he site researc h c o or di nat or will a d mi nister 
t he baseli ne s ur ve y t o t he patie nt. T he prefere nce is f or t he s ur ve y t o be a d mi nistere d orall y, 
alt h o u g h it ma y be c o m plete d o n a pa per b o o klet as well. T he s ur ge o n c o ns ul tati o n will be 
a u di o-rec or ded. T he site researc h c o or di nat or will t ur n o n t he a u di o -rec or der pri or t o 
lea vi n g t he r o o m a n d t he a u di o -rec or der will be c ollecte d f oll o wi n g t he c o ns ultati o n. 
I n di vi d uals ot her t ha n t he patie nt a n d atte n di n g s ur ge o n ma y be prese nt d uri n g t he 
a u di ota pe d cli nic visit. T his i ncl u des fa mil y me m bers, resi de nts, n urses a n d me dical 
st u de nts. Alt h o u g h t he y are n ot st u d y partici pa nts, t he y will recei ve writte n n otificati o n 
t hat t he visit will be or is c urre ntl y bei n g rec or de d. We will all o w i n di vi d uals w h o d o n ot 
ver ball y a gree t o be a u di ota pe d t o ste p o ut of t he r o o m d uri n g t he ti me t he a u di o rec or der 
is o n. T his a p pr oac h has bee n pre vi o usl y use d wit h patie nts c o nsi deri n g hi g h ris k 
o perati o ns a n d it has bee n t olerate d well b y t heir c o m pa ni o ns a n d ot her  cli nic staff. 
H o we ver, if i n di vi d uals w h o d o n ot ver ball y a gree t o be a u di ota pe d d o n ot wis h t o lea ve 
t he r o o m, we will n ot a u di o rec or d t he visit, o ut of se nsiti vit y t o t he patie nt's nee ds. 
8. 2. 3  
P atie nt S ur ve ys:  I m me diatel y after t he s ur gical c o ns ult, the site researc h c o or di nat or will 
se n d t he patie nt a n e mail i n viti n g t he m t o partici pate i n t he p ost -c o ns ultati o n f oll o w-u p 
s ur ve y. N ote: t he f oll o w -u p s ur ve y m ust be c o m plete d after t he patie nt lea ves t he s ur ge o n’s 
office.  
Patie nts will be se nt a li n k f o r a s ur ve y usi n g a sec ure Q ualtrics s ur ve y site a n d t he y will 
be re mi n de d n ot t o i ncl u de a n y i de ntif yi n g i nf or mati o n i n t heir s ur ve y res p o nses. T he 
s ur ve y s h o ul d ta ke a b o ut 1 0 mi n utes t o c o m plete. If n o res p o nse is recei ve d, t he site 
researc h c o or di nat or will se n d re mi n der e mails, f oll o we d b y tele p h o ne calls. A n a d diti o nal 
strate g y will be f or t he site researc h c o or di nat or t o a p pr oac h patie nts at a f oll o w -u p visit t o 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 2  
c o m plete t he s ur ve y eit her orall y or o n pa per . If t he patie nt d oes n ot ha ve a n e mail a d dress 
or if s he prefers s he ma y c o m plete t he s ur ve y orall y or o n a pa per b o o klet, t he y will be 
as ke d w het her t he y w o ul d li ke t o c o m plete t he s ur ve y wit h a pa per b o o klet or b y tele p h o ne. 
Patie nts will be c o ntacte d u p t o 6 ti mes t o c o m plete t he s ur ve y. T he g oal is t o c o m plete t he 
s ur ve y wit hi n 3 wee ks of t he s ur ge o n c o ns ult. 
8. 3  
P atie nts E nr olle d f oll o wi n g I nstit uti o n al Cr oss o ver  
T he o nl y differe nce bet wee n patie nts e nr olle d bef ore  i nstit uti o nal cr oss o ver a n d patie nts 
e nr olle d after i nstit uti o nal cr oss o ver is t h ose w h o are e nr olle d after i nstit uti o nal cr oss o ver will 
ha ve bee n offere d t he decisi o n ai d as acce pte d practice i n t he cli nic . Patie nts will be a p pr oac he d 
f or partici pati o n in t he s ur ve ys a n d a u di o -rec or di n g re gar dless of w het her or n ot t he y acce pte d 
t he decisi o n ai d. 
T he c o nse nt pr ocess, s ur gical c o ns ultati o n, a n d patie nt s ur ve ys f or t hese patie nts will be 
i de ntical t o t h ose descri be d a b o ve.  
8. 3. 1  
Decisi o n ai d:  T he decisi o n ai d use d i n t his st u d y was de vel o pe d c olla b orati vel y b y t he 
I nf or me d Me dical Decisi o ns F o u n dati o n a n d Healt h Dial o g.3 5, 5 5 Ori gi nall y create d as a 
D V D, it was c o n verte d t o a we b -base d platf or m base d o n user fee d bac k re q uesti n g 
fle xi bilit y i n m o de of deli very. T he we b -base d decisi o n ai d utilizes static, di dactic 
i nf or mati o n writte n f or a n 8t h gra de rea di n g le vel, a n d vi de o cli nical vi g nettes t o pr o m ote 
c o nsi derati o n of pers o nal val ues a n d prefere nces. It i ncl u des m o d ules f or i n vasi ve ca ncer, 
n o n -i n vasi ve ca ncer, a n d rec o nstr ucti o n. It has bee n use d s uccessf ull y i n aca de mic a n d 
c o m m u nit y setti n gs t o i ncrease k n o wle d ge a n d decrease decisi o nal c o nflict. 3 5, 4 3, 4 4, 4 8 T he 
greatest gai ns i n k n o wle d ge were see n i n patie nts wit h l o wer e d ucati o nal bac k gr o u n ds. 3 5 
8. 3. 2  
I nter vie ws a n d F oc us Gr o u ps: After t he cli nic cr osses  o ver t o t he decisi o n ai d ar m,  
cli nic staff will trac k patie nts w h o decli ne t he decisi o n ai d . 
Patie nts see n i n cli nics t hat ha ve cr osse d o ver t o use of t he  decisi o n ai d ma y be eli gi ble f or 
partici pati o n i n i nter vie ws a n d f oc us gr o u ps a d dressi n g t he sec o n dar y o bjecti ves.   
P atie nts w h o di d n ot acce pt  t he decisi o n ai d:  
Patie nts will be eli gi ble t o partici pate i n tele p h o ne, vi de o, or i n-pers o n  i nter vie ws 
a d dressi n g Accessi bilit y Barriers if t he y decli ne d t he decisi o n ai d (fr o m cli nic l o g) .  We 
will p ur p osef ull y sa m ple patie nts w h o e x perie nce d access barriers (i de ntifie d t hr o u g h 
s ur ve y res p o nses). If we fi n d t here is a str o n g ass ociati o n bet wee n accessi bilit y ba rriers 
a n d s oci oec o n o mic disa d va nta ge, or t hat accessi bilit y barriers cl uster wit hi n certai n cli nics, 
we will o versa m ple base d o n t h ose fact ors.  
If patie nts decli ne t o partici pate t he i nter vie w, t he researc h c o or di nat or will rec or d a ge, 
race, et h nicit y, i ns ura nce, a n d reas o n f or decli ni n g.  T hese data p oi nts will be c ollecte d s o 
t hat we ma y assess w het her partici pa nts are cate g oricall y differe nt t ha n n o n-partici pa nts.  
T his data is c o m pletel y de -i de ntifie d. As t hese patie nts ha ve decli ne d researc h, t he y will 
n ot be a p pr oac he d f or f ut ure researc h acti vities.  T his decli ne a p plies o nl y t o t hat s pecific 
researc h acti vit y a n d a n y s u bse q ue nt researc h acti vities.  T he decli ne d oes n ot a p pl y t o a n y 
pri or data c ollecti o n u nless s pecifie d b y t he patie nt.  
P atie nts w h o  di d acce pt  t he decisi o n ai d:  
Patie nts will be eli gi ble t o partici pate i n tele p h o ne, vi de o, or i n-pers o n  i nter vie ws 
a d dressi n g Accessi bilit y Barriers if t he y re p orte d diffic ult y accessi n g t he decisi o n ai d 
(fr o m baseli ne s ur ve y) or di d n ot use t he decisi o n ai d (fr o m baseli ne s ur ve y).  We will 
p ur p osef ull y sa m ple patie nts w h o e x perie nce d access barriers (i de ntifie d t hr o u g h s ur ve y 
res p o nses). If we fi n d t here is a str o n g ass ociati o n bet wee n accessi bilit y barriers a n d 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 3  
s oci oec o n o mic disa d va nta ge, or t hat accessi bilit y barriers cl uster wit hi n certai n cli nics, we 
will o versa m ple base d o n t h ose fact ors.  
Patie nts will be eli gi bl e t o partici pate i n a tele p h o ne, vi de o or i n-pers o n i nter vie w  
a d dressi n g Pre parat or y/I nteracti o nal Barriers if t he y acce pte d t he decisi o n ai d. We will 
f oc us o ur sa m pli n g o n patie nts wit h l o w e n ga ge me nt i n decisi o n-ma ki n g, defi ne d as t he 
l o west tertile f or eit her t he P E P PI sc ore or t he Street Acti vati o n meas ure. 
We will 
p ur p osef ull y sa m ple patie nts wit h l o w e n ga ge me nt w h o e x perie nce d o ne or m ore of t he 
pre parat or y or i nteracti o nal barriers o utli ne d i n t he pri mar y o bjecti ve ( q ua ntitati ve data 
c ollecti o n). We will use ot her rele va nt data s uc h as patie nt a ge, race, a n d A DI t o e ns ure a 
ra n ge of partici pa nts. We will c o nsi der s ur ge o n a n d cli nical site t o mi ni mize cl usteri n g of 
i nter vie w partici pa nts at t he pr o vi der or site le vel. 
Patie nts will als o be eli gi ble t o partici pate i n a f oc us gr o u p if t he y acce pte d t he decisi o n 
ai d. We pla n t o c o n d uct t hree patie nt f oc us gr o u ps at t hree se parate cli nics. A gai n, f oc us 
gr o u ps m a y occ ur virt u all y vi a tele p h o ne or vi de o , if i n-pers o n i nteracti o ns are n ot 
p ossi ble d ue t o C O VI D -1 9 or at t he prefere nce of t he site. We will select cli nics wit h a 
relati vel y hi g h pre vale nce of patie nts e x perie nci n g t he barriers o n o ur list of p ote ntial 
tar gets (fr o m q ua ntitati ve data c ollecti o n). T he s pecific c haracteristics of patie nt 
partici pa nts wit hi n eac h cli nic will be deter mi ne d fr o m t he q ua ntitati ve a nal yses  t hat 
c o m prise t he pri mar y o bjecti ve .  
If patie nts decli ne t o partici pate t he i nter vie ws or f oc us gr o u ps, t he researc h c o or di nat or 
will rec or d a ge, race, et h nicit y, i ns ura nce, a n d reas o n f or decli ni n g.  T hese data p oi nts will 
be c ollecte d s o t hat we ma y assess w het her partici pa nts are cate g oricall y differe nt t ha n 
n o n -partici pa nts.  T his data is c o m pletel y de -i de ntifie d. As t hese patie nts ha ve decli ne d 
researc h, t he y will n ot be a p pr oac he d for f ut ure researc h acti vities.  T his decli ne a p plies 
o nl y t o t hat s pecific researc h acti vit y a n d a n y s u bse q ue nt researc h acti vities.  T he decli ne 
d oes n ot a p pl y t o a n y pri or data c ollecti o n u nless s pecifie d b y t he patie nt.  
8. 4  
I nce nti ves 
We will pr o vi de pa tie nts $ 1 0 f or t he a u di o rec or di n g a n d baseli ne s ur ve y.  We will pr o vi de a n 
a d diti o nal $ 1 0 t o patie nts w h o c o m plete t he p ost -c o ns ultati o n f oll o w-u p s ur ve y. We will pr o vi de 
patie nts a n a d diti o nal i nce nti ve of $ 2 0 f or i nter vie w partici pati o n. Lastl y, we will pr o vi de 
patie nts a n a d diti o nal i nce nti ve of $ 2 0 f or f oc us gr o u p partici pati o n. 
I nce nti ves will be deli vere d t o patie nts t hr o u g h a variet y of mea ns, base d o n t he s pecific 
researc h acti vit y.  T he U W researc h tea m will pr o vi de site c o or di nat ors wit h gift car ds o n a 
q uarterl y basis.  Site c o or di nat ors  a n d t he U W researc h tea m will l o g t he patie nt st u d y I D a n d 
gift car d n u m ber f or trac ki n g p ur p oses.  
 
P atie nt Rese arc h A cti vit y 
A m o u nt  
I nce nti ve deli ver y  
Baseli ne s ur ve y a n d a u di o -rec or d 
c o ns ult 
$ 1 0  
Pr o vi de d b y site c o or di nat or directl y t o 
patie nt after c o m pleti o n of c o ns ult  
F oll o w -u p s ur ve y (e mail)  
$ 1 0  
Maile d t o patie nt b y site c o or di nat or 
O ne -o n -o ne i nter vie ws (tele p h o ne , 
vi de o, or i n-pers o n  b y site c o or di nat or)  
$ 2 0  
Maile d t o patie nt b y  site c o or di nat or 
O ne -o n -o ne i nter vie ws ( tele p h o ne, 
vi de o, or i n- pers o n b y U W researc h 
tea m) 
$ 2 0  
Pr o vi de d b y U W researc h tea m directl y t o 
patie nt  
F oc us gr o u ps  
$ 2 0  
Pr o vi de d b y U W researc h tea m directl y t o 
partici pa nts  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 4  
 
9 . 0 A D V E R S E E V E N T S  
We d o n ot a ntici pate a n y a d diti o nal a d verse e ve nts relate d t o partici pati o n i n t his st u d y be y o n d us ual 
care. 
If a partici pa nt re p orts feeli n g distresse d as a res ult of st u d y partici pati o n, eit her as a res ult of bei n g 
a u di o-rec or de d or c o m pleti n g a st u d y s ur ve y, t he y ma y c h o ose n ot t o c o nti n ue or t o c o m plete t he m 
a n d/ or s pea k wit h t he site staff. Partici pa nts e x perie nci n g a n y p h ysical or ps yc h ol o gical c o m plicati o ns 
relate d t o t heir treat me nt s h o ul d disc uss t his wit h t heir treati n g p h ysicia n. 
 
1 0 . 0 M E A S U R E S  
All data is bei n g c ollecte d f or p ur p oses of researc h.  Data will n ot be a vaila ble t o cli nic staff a n d will 
n ot be use d t o g ui de cli nical decisi o n ma ki n g.  
1 0 . 1 Defi niti o ns of D at a f or  Pri m ar y O bjecti ve  
1 0 . 1. 1 Pri m ar y O utc o me  
O ur pri mar y o utc o me is patie nt p o wer . 
Meas ures of P o wer : P o wer is defi ne d as “ patie nts' self-percei ve d ca pacit y t o   i nfl ue nce t he 
decisi o n -ma ki n g e nc o u nter” 1. We o perati o nalize t his c o nstr uct i n t w o wa ys: 
• 
P atie nt’s Self -Effic ac y i n P atie nt -P h ysici a n  I nter acti o ns ( P E P PI): T his is a 
vali date d patie nt s ur ve y  i nitiall y de vel o pe d t o meas ure t he a bilit y of patie nts t o gat her 
me dical i nf or mati o n a n d tal k t o d oct ors a b o ut t heir me dical c o ncer ns.
7 4 , 7 8 F or t his 
st u d y, we are usi n g t he vali date d P E P PI-5 p oi nt scale.  
• 
Acti ve P atie nt P artici p ati o n Be h a vi ors : T his is a vali date d s yste m t o assess acti ve 
patie nt partici pati o n d uri n g t he s ur ge o n c o ns ultati o n de vel o pe d b y Street, et al. a n d is 
meas ure d off t he a u di o -rec or di n g of t he c o ns ultati o n.6 5, 7 5, 7 6 
1 0. 1. 2. Sec o n d ar y O utc o me  
O ur sec o n dar y o utc o me is patie nt k n o wle d ge.  
Meas ures of K n o wle d ge :  We meas ure patie nt k n o wle d ge   a n d pers o nal val ues rele va nt 
f or breast ca ncer s ur ger y usi n g t he Decisi o n Q u alit y I nstr u me nt -Bre ast S ur ger y .7 8  T his 
is a vali date d scale de vel o pe d wit h t he i nte nt of assessi n g t he e xte nt t o w hic h patie nts were 
i nf or me d a b o ut breast ca ncer s ur ger y a n d recei ve d treat me nt i n-li ne wit h t heir pers o nal 
val ues. As we meas ure k n o wle d ge after t he s ur gical c o ns ult, o ur c o m paris o n is bet wee n 
t he decisi o n ai d a n d s ur ge o n c o ns ult vers us t he c o ns ult al o ne.  It is i m p orta nt t o i ncl u de 
t his sec o n dar y o utc o me si nce pri or st u dies 
w hic h e val uate d t he m i ncl u de d fe w 
s oci oec o n o micall y disa d va nta ge d patie nts. 
1 0 . 1.3  Pre dict or V ari a bles  
T he pri mar y e x pla nat or y varia ble is i nter ve nti o n gr o u p assi g n me nt ( decisi o n ai d yes/ n o).  
We defi ne s oci oec o n o mic disa d va nta ge t o be t h ose patie nts 
li vi n g i n t he 2 0 % m ost 
disa d va nta ge d nei g h b or h o o ds acc or di n g t o t he Area De pri vati o n I n de x, c o nsiste nt wit h 
pri or researc h i n ca ncer. 6 0 -6 3  
1 0 . 1.4  A d diti o n al Me as ures    
We c ollect a d diti o nal meas ures  w hic h we defi ne as Pre parat or y/I nteracti o nal barriers a n d 
A ccessi bilit y  barriers (see c o nce pt ual m o del, fi g ure 2 ) f or o ur a nal ysis.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 5  
1 0 . 1.4 . 1 
 
Pre p ar at or y B arriers  
• 
Patie nts E x pectati o ns f or T heir R ole i n a S D M E nc o u nter  
C o ntr ol Prefere nces Sc ale  (b aseli ne  p atie nt s ur ve y) : T he C o ntr ol Prefere nces 
Scale ( C P S) is vali date d s ur ve y i nstr u me nt t hat was de vel o pe d t o meas u re patie nt’s 
preferre d a n d/ or percei ve d r oles i n t heir healt h -care decisi o n -ma ki n g ; it c o nsists of 
a si n gle ite m . T he r oles ra n ge fr o m t he i n di vi d ual ma ki n g t he treat me nt decisi o n, 
t hr o u g h t he i n di vi d ual ma ki n g t he decisi o n j oi ntl y wit h t he p h ysicia n, t o t he 
p h ysicia n ma ki n g t he decisi o n. 7 7 
Pre p ar ati o n f or Decisi o n M a ki n g Sc ale  (f oll o w-u p  p atie nt s ur ve y) : T he te n-ite m 
Pre parati o n f or Decisi o n Ma ki n g ( Pre p D M) scale was de vel o pe d t o e val uate de cisi o n 
pr ocesses relati n g t o t he pre parati o n of patie nts f or decisi o n ma ki n g a n d dial o g ui n g 
wit h t heir practiti o ners. 7 8  It has bee n de m o nstrate d t o be relia ble a n d vali d, a n d 
discri mi nates base d o n perc ei ve d usef ul ness of decisi o n s u p p ort t o ols.  
• 
Patie nts’ K n o wle d ge a b o ut t he Decisi o n Face d : 
“ H o w i nf or me d d o y o u feel ? ” ( b aseli ne  p atie nt s ur ve y):  We will as k h o w 
i nf or me d patie nts feel a b o ut t he s ur gical o pti o ns f or breast ca ncer bef ore t heir 
c o ns ultati o n  wit h t he s ur ge o n.  
S U R E Decisi o n al C o nflict Sc ale  (f oll o w-u p  p atie nt s ur ve y):  T he 4 -ite m S U R E 
( S ure of 
m yself; U n dersta n d i nf or mati o n; Ris k-be nefit rati o; E nc o ura ge me nt) 
scree ni n g test was de vel o pe d t o hel p healt h pr ofessi o nals i de ntif y patie nts wit h 
cli nicall y si g nifica nt decisi o nal c o nflict as q uic kl y as p ossi ble. 8 1 
1 0 . 1.4 . 2 
I nter acti o n al B arriers 
• 
P o wer I m bala nce  
S ur ge o n F acilit ati ve  Be h a vi ors  ( a u di o-rec or di n g of c o ns ult) : I n a d diti o n t o 
assessi n g acti ve patie nt partici pati o n, t he vali date d s yste m de vel o pe d b y Street, et 
al., als o meas ures t he de gree t o w hic h p h ysicia ns use d part ners hi p -b uil di n g a n d  
s u p p orti ve tal k. 6 5, 7 5, 7 6 
He alt h C are Cli m ate Q uesti o n n aire  (f oll o w-u p  p atie nt s ur ve y) : T he Healt h Care 
Cli mate Q uesti o n naire  ( H C C Q) is a vali date d patie nt s ur ve y t hat was de vel o pe d t o  
assess patie nt’s perce pti o ns of t he de gree t o w hic h t heir s pecific d oct or is a ut o n o m y 
s u p p orti ve. It c o nsists of 1 5 ite ms. We will use t his i nstr u me nt t o assess Patie nt Self 
A ut o n o m y  a n d Tr ust i n Pr o vi de r. 
• 
Cli nicia ns’ I nter pers o nal C haracteristics  
S ur ge o n rec o m me n d ati o n  (a u di o -rec or di n g of c o ns ult ):  We will c ollect w het her 
t he s ur ge o n pr o vi de d a rec o m me n dati o n, a n d w he n i n t he c o ns ultati o n t his occ urre d.  
We will classif y t his as earl y rec o m me n dati o n v ers us late/ n o rec o m me n dati o n base d 
o n w het her it occ urs i n t he fi rst q uarter of t he c o ns ultati o n. 
F a mil y me m ber prese nce  ( a u di o-rec or di n g of c o ns ult) : We will o bser ve if  a 
fa mil y me m ber is prese nt d uri n g t he visit wit h t he s ur ge o n. 
Pr actiti o ner  Orie nt ati o n Sc ale (s ur ge o n  b aseli ne  s ur ve y): T he Practiti o ner 
Orie ntati o n Scale meas ures t he r oles t hat d oct ors belie ve t he y s h o ul d pla y i n t he 
c o urse of t heir i nteracti o n  wit h patie nts . T he t otal sc ore f or t his 1 8 -ite m scale, 
ra n gi n g fr o m patie nt-ce ntere d t o d oct or -ce ntere d, ca n be calc ulate d i n a d diti o n t o 
t w o s u b-sc ores. T he first ni ne-ite m s u b-scale, S hari n g, reflects t he e xte nt t o w hic h 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 6  
t he res p o n de nt belie ves t hat patie nts desire i nf or mati o n a n d s h o ul d be part of t he 
decisi o n ma ki n g pr ocess. T he sec o n d ni ne -ite m s u b-scale, Cari n g, reflects t he e xte nt 
t o 
w hic h t he res p o n de nt sees t he patie nt’s e x pectati o ns, feeli n gs, a n d life 
circ u msta nces as critical ele me nts i n t he treat me nt pr ocess. 8 0 
1 0 . 1.4 . 3 
Accessi bilit y B arriers  
• 
Reac h  
Pr o p orti o n of patie nts s e nt t he decisi o n/t otal n u m ber of patie nts see n i n cli nic after 
cr oss -o ver t o i nter ve nti o n ar m.  T his will be calc ulate d usi n g t he n u m bers of patie nts 
w h o were offere d t he decisi o n ai d a n d w h o were  se nt t he decisi o n ai d, a n d eit her 
billi n g rec or ds  or cli nic sc he d ules (site prefere nce as best wa y t o deter mi ne n u m ber 
of patie nts see n d uri n g ti me peri o d t hat w o ul d ha ve be eli gi ble t o recei ve t he decisi o n 
ai d). 
• 
Reas o n f or decli ne of decisi o n ai d  
• 
Accessi bilit y  
W e use a da ptati o ns of t he f o ur pri nci pl es of accessi bilit y o utli ne d b y i n t he We b 
C o nte nt 
Accessi bilit y 
G ui deli nes ( percei va ble, o pera ble, u n dersta n da ble, a n d 
r o b ust), c o m bi ne d wit h ot her ke y c o nce pts rele va nt t o o ur st u d y.8 1 We will c ollect 
data o n acce pta bilit y of e mail deli ver y, h o w patie nts w h o acce pte d t he decisi o n ai d 
use d it, a n d t he acce pta bilit y of t he decisi o n ai d itself via s ur ve y. We will rec or d t he 
n u m ber of ti mes t he site was accesse d b y eac h patie nt vi a t he Healt h Dial o g 
c o m pa n y.  
• 
Healt h Literac y  
We use t he Brief Healt h Literac y Scree n ( B H L S) t o e val uate healt h literac y i n 
cli nical practice. 8 2  T he B H L S is a vali date d meas ure t hat has bee n e val uate d i n b ot h 
t he researc h a n d cli nical setti n g. It c o nsists of t hree ite ms a n d ta kes a p pr o xi matel y 1 
mi n ute t o c o m plete . 
1 0 . 1.4 . 4 
P atie nt, S ur g e o n a n d Cli nic C h ar acteristics  
• 
Patie nt  c haracteristics  
We will a bstract patie nt de m o gra p hic (a ge, race, zi pc o de + 4 t o calc ulate A DI, pa yer), 
cli nical ( AJ C C sta ge, estr o ge n/ pr o gester o ne rece pt or a n d H E R 2 ne u) a n d treat me nt 
fact ors (s ur ger y, ra diati o n, s yste mic t hera p y, h or m o nal t hera p y) fr o m me dical 
rec or ds.  
T he zi pc o de + 4 will be use d t o calc ulate t he Area De pri vati o n I n de x ( A DI) sc ore.  
T he A DI re prese nts a n area -base d meas ure of s oc i oec o n o mic de pri vati o n base d o n 
1 7 Ce ns us -base d mar kers of s oci oec o n o mic stat us.  A p u blicall y a vaila ble dataset 
pr o vi des a n A DI sc ore f or eac h zi pc o de + 4 i n t he U nite d States.  T he ra w A DI sc ore 
will be tra nsf or me d i nt o a 2 0 cate g or y q ua ntile -base d meas ure  (e ver y 5t h perce ntile) 
usi n g nati o nal A DI t hres h ol ds.  After t he tra nsf or mati o n i nt o t he cate g orical 
varia bles, t he ra w zi pc o de + 4 a n d t he ra w A DI sc ore will be destr o ye d.  
• 
S ur ge o n c haracteristics  
We will o btai n ge n der,  race, et h nicit y , fell o ws hi p trai ni n g, perce nt of practice t hat is 
breast, a n d years i n practice. T his will be i ncl u de d i n t he baseli ne s ur ve y.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 7  
• 
Cli nic c haracteristics  
We will o btai n n u m ber of staff, prese nce of a na vi gat or, a n n ual breast ca ncer v ol u me , 
a n d pa yer mi x .  T his will be c ollecte d b y eac h site’s c o or di nat or. 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 8  
1 0 . 1.5   O ver vie w of Me as ures C ollecte d fr o m P atie nts  
Meas ure  
S ur ve y pri or t o 
c o ns ult 
A u di o -
rec or di n g of 
c o ns ult 
S ur ve y 
f oll o wi n g 
c o ns ult 
After 
c o m pleti o n of 
treat me nt*  
Patie nt’s Self -Efficac y i n t he Patie nt -
P h ysicia n ( P E P PI)  
 
 
X  
 
Acti ve Patie nt Partici pati o n Be ha vi ors  
 
X  
 
 
Decisi o n Q ualit y I nstr u me nt -Breast 
S ur ger y  
X  
 
X  
 
C o ntr ol Prefere nces Scale  
X  
 
 
 
Pre parati o n f or Decisi o n Ma ki n g Scale  
 
 
X  
 
H o w I nf or me d D o Y o u Feel?  
 
 
X  
 
S U R E Decisi o nal C o nflict Scale  
 
 
X  
 
Healt h Care Cli mate Q uesti o n naire  
 
 
X  
 
Fa mil y Me m ber Prese nce  
 
X  
 
 
Accessi bilit y  
X  
 
X  
 
Brief Healt h Literac y Scree n  
X  
 
 
 
Patie nt C haracteristics  
 
 
 
X  
*  
Defi ne d as after c o m pleti o n of first c o urse treat me nt (s ur ger y, c he m ot hera p y, ra diati o n). E n d ocri ne 
t hera p y a n d her 2 ne u tar gete d t hera p y ma y be o n g oi n g. 
1 0 . 1.6   O ver vie w of Me as ures C ollecte d fr o m S ur ge o n  
Meas ure  
S ur ve y Pri or t o Start of 
Data c ollecti o n  
A u di o -rec or di n g 
Practiti o ner Orie ntati o n Scale  
X  
 
S ur ge o n Facilitati ve Be ha vi ors  
 
X  
S ur ge o n Rec o m me n dati o n ( yes/ n o a n d 
ti mi n g wit hi n c o ns ultati o n) 
 
X  
S ur ge o n C haracteristics  
X  
 
1 0 . 1.7  O ver vie w of Me as ures C ollecte d fr o m Cli nic 
Meas ure  
Baseli ne  
E n d of Decisi o n Ai d 
I nter ve nti o n 
Cli nic c haracteristics  
X  
 
Reac h of I nter ve nti o n  
 
X  
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
3 9  
1 0 . 2 Defi niti o ns of D at a f or Sec o n d ar y O utc o mes  
1 0 . 2. 1 P atie nt I nter vie ws  
We use fi n di n gs fr o m Ai m 2 t o i nf or m stratifie d p ur p osef ul sa m pli n g a n d i nter vie w 
c o nte nt. 8 3  T w o sets of i nter vie ws will be c o n d ucte d: One a d dressi n g Accessi bilit y Barriers 
a n d o ne a d dressi n g Pre pa rat or y/I nteracti o nal Barriers. 
1 0 . 2. 1. 1 
Accessi bilit y B ar riers 
Tele p h o ne , vi de o, or i n-pers o n  i nter vie ws will be c o n d ucte d b y t he site researc h 
c o or di nat or. We t hi n k a n y m o dalit y  is acce pta ble gi ve n t he n o n -se nsiti ve nat ure of 
t hese i nter vie ws.8 4, 8 5   A d o m ai ne d i nter vie w scri pt is i ncl u de d i n t he A p pe n di x  VII . 
Sa m ple i nter vie w q uesti o ns i ncl u de:  
• 
Tell me a b o ut t he t y pe of c o m m u nicati o n y o u ha d wit h t he s ur ge o n’s office pri or 
t o t he first c o ns ult 
• 
Please descri be h o w t he decisi o n ai d was offere d t o y o u, a n d s hare y o ur i nitial 
i m pressi o ns. 
We will use t he c ollecte d q ua ntitati ve data t o g ui de t he i nter vie ws. F or patie nts w h o 
decli ne d t he decisi o n ai d, we will use t he d oc u me nte d reas o n f or decli ni n g as a pr o be 
a n d will as k a b o ut alter nati ve f or ms of i nf or mati o n t he y ma y ha ve use d. F or patie nts 
w h o acce pte d b ut re p orte d diffic ult y accessi n g or usi n g t he decisi o n  ai d, we will as k 
t he m t o wal k us t hr o u g h t heir e x perie nce recei vi n g t he decisi o n ai d, pr o bi n g o n 
re p orte d c halle n ges. A fi nal q uesti o n will as k patie nts a b o ut percei ve d o p p ort u nities 
t o i m pr o ve e x perie nces i n accessi n g t he decisi o n ai d.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 0  
1 0 . 2. 1. 2 
Pre p ar at or y/I nter acti o n al B arriers  
Tele p h o ne, vi de o or i n -pers o n i nter vie ws will be c o n d ucte d at a pri vate l ocati o n 
c o n ve nie nt t o t he patie nt.  I n -pers o n i nter vie ws are o pti mal  f or t his m ore se nsiti ve 
t o pic area; h o we ver, tele p h o ne or vi de o ma y be necessar y i n so me circ u msta nces (i.e 
C O VI D -1 9 pa n de mic) . We esti mate i nter vie ws will occ ur a n a vera ge 1 8 m o nt hs after 
t he s ur ge o n c o ns ult. Alt h o u g h t his creates t he p ote ntial f or recall bias, t his se q ue ntial 
a p pr oac h is necessar y as t he preli mi nar y fi n di n gs fr o m t he q ua ntitati ve data ( pri mar y 
o bjecti ves) are critical f or b ot h o ur sa m pli n g strate g y a n d i nter vie w c o nte nt. We will 
use tec h ni q ues effecti ve i n ot her st u dies t o mi ni mize recall bias, i ncl u di n g pr o m pts 
fr o m patie nts o w n s ur ve y res p o nses,8 6 a n d will prefere ntiall y sa m ple patie nts 
e nr olle d later i n t he st u d y peri o d t o mi ni mize ti me bet wee n c o ns ult a n d i nter vie w. 
Pri or researc h de m o nstrates t hat breast ca ncer patie nts’ percei ve d r ole i n decisi o n 
ma ki n g has a lasti n g  i m pact o n q ualit y of life, e ve n > 5 years fr o m dia g n osis.8 7, 8 8 T his 
data s u g gests t hat t he decisi o n ma ki n g pr ocess is si g nifica nt e n o u g h t hat patie nts –
es peciall y t h ose e x perie nci n g barriers t o e n ga ge me nt —  will be a ble t o descri be t heir 
e x perie nce e ve n aft er dela y. We a ntici pate t hat 4 0 -5 0 patie nts will be nee de d t o 
ac hie ve i nf or mati o nal re d u n da nc y, 8 9 -9 1 wit h half t he i nter vie ws f oc use d o n 
pre parat or y a n d half o n i nteracti o nal barriers.  
Eac h i nter vie w wi ll be gi n b y as ki n g patie nts: “ Wal k me t hr o u g h h o w y o u a n d y o ur 
s ur geo n  ma de t he d ecisi o n f or t y pe of s ur ger y”. We will s pecificall y pr o be w het her 
patie nts percei ve d t hat t he y were a ble t o partici pate i n decisi o n ma ki n g a n d e x press 
t heir treat me nt g oals, a n d w het her t he y felt t hat t he s ur ge o n u n derst o o d w hat was 
i m p orta nt t o t he m. We will t he n as k o pe n-e n de d q uesti o ns t hat f oc us s pecificall y o n 
barriers t hat patie nts e x perie nce d. Usi n g o ur e xa m ple of “ p o wer i m bala nce” as a 
pri oritize d i nteracti o nal barrier, a sa m ple q uesti o n w o ul d be, “ Tell me h o w y o u felt 
s hari n g w hat was i m p orta nt t o y o u wit h y o ur s ur ge o n.”  We will als o as k patie nts, 
“ Base d o n y o ur e x perie nce, w hat d o y o u t hi n k c o ul d be d o ne t o hel p patie nts li ke 
y o urself?”  
1 0 . 2. 2 P atie nt a n d Cli n ic St a ke h ol der F oc us Gr o u ps 
We will be gi n eac h f oc us gr o u p wit h a re vie w of t he pri oritize d barriers t o e n ga ge me nt 
( pri mar y o bjecti ve) a n d tar gets f or p ote ntial a dj u nct i nter ve nti o ns  (i nter vie ws fr o m 
sec o n dar y o bjecti ve). T o e ns ure t hat t his disc ussi o n is as salie nt as p ossi ble t o sta ke h ol ders, 
we will prese nt eac h barrier usi n g q u otes fr o m patie nts w h o e x perie nce d t he barrier. We 
will briefl y elicit partici pa nts’ perce pti o ns of h o w t hese barriers i m pe de e n ga ge me nt as we 
a ntici pate t hat t he gr o u p disc ussi o n will pr o vi de a d diti o nal i nsi g ht. We will t he n prese nt 
partici pa nts wit h p ote ntial a dj u nct i nter ve nti o ns t o tar get t hese barriers ( Ta ble 7), i de ntifie d 
t hr o u g h t he e xisti n g literat ure. We will elicit fee d bac k fr o m sta ke h ol ders re gar di n g t he 
a ntici pate d ef fecti ve ness a n d feasi bilit y of t hese i nter ve nti o ns i n t heir cli nical setti n gs, a n d 
nee de d a da ptati o ns. 
We a ntici pate t hat a da ptati o n will be necessar y, as i de ntifie d 
i nter ve nti o ns are n ot li kel y t o ha ve bee n de vel o pe d wit hi n cli nics cari n g f or a hi g h 
pr o p o rti o n of disa d va nta ge d patie nts. We will t he n pr o m pt partici pa nts t o brai nst or m ot her 
s ol uti o ns t o a d dress pri oritize d 
barriers. At t he c o m pleti o n of t he 
f oc us gr o u p, we will use n o mi nal 
gr o u p tec h ni q ue t o i de ntif y t hree 
i nter ve nti o ns percei ve d t o ha ve t he 
greatest p ote ntial. 9 2, 9 3 We will as k 
sta ke h ol ders t o 
e val uate 
eac h 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 1  
i nter ve nti o n usi n g a m o difie d Otta wa Acce pta bilit y t o ol.9 4  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 2  
1 1 . 0 E N D O F IN T E R V E N TI O N /S T U D Y  
1 1 . 1 D ur ati o n of St u d y   
Site le vel p artici p ati o n  will e n d w he n t he last patie nt e nr olle d c o m pletes t heir breast ca ncer 
treat me nt.  A s u bset of sites will ha ve a f oc us gr o u p c o n d ucte d usi n g t heir patie nts.  F or t h ose 
sites, partici pati o n will e n d w he n t hat f oc us gr o u p is c o m plete d. 
Cli nic st a ke h ol der p artici p ati o n e n ds w he n t he last patie nt e nr olle d c o m pletes her s ur gical 
c o ns ultati o n.  F or t he s u bset of cli nic sta ke h ol ders t hat will partici pate i n t he f oc us gr o u ps, st u d y 
partici pati o n c o ncl u des at t he e n d of t hat f oc us gr o u p.    
P atie nt -level p artici p ati o n s ur ve ys a n d a u di o-rec or di n g will e n d after t he y c o m plete t he 
f oll o w-u p s ur ve y. C hart re vie ws f or t he m will be c o m plete d after t heir breast ca ncer treat me nt 
is c o m plete t o acc uratel y reflect care recei ve d. F or t he s u bset of patie nts w h o pa rtici pate i n t he 
i nter vie w a n d/ or f oc us gr o u p, st u d y partici pati o n c o ncl u des at t he e n d of t hat i nter vie w/f oc us 
gr o u p.   
Please see t he st u d y cale n dar ( Secti o n 5 . 0) f or f oll o w u p ti me peri o ds.  
1 1 . 2 Criteri a f or Disc o nti n u ati o n of St u d y  
I n t he a bse nce of stu d y pr oce d ures  d ue t o a d verse e ve nt(s), patie nt partici pati o n ma y c o nti n ue 
u ntil o ne of t he f oll o wi n g criteria a p plies:  
• 
Patie nt e x plicitl y deci des t o wit h dra w fr o m t he st u d y  
• 
Ter mi nati o n of t he st u d y b y s p o ns or  
If a patie nt has a s u bse q ue nt decli ne (s uch as o pt -o ut fr o m a n i nter vie w), t he decli ne a p plies 
o nl y t o t hat s pecific researc h acti vit y a n d d oes n ot a p pl y t o a n y pri or data c ollecti o n u nless 
s pecifie d b y t he patie nt.     
1 1 . 3 F oll o w -u p  
1 1 . 3. 1  D ur ati o n of F oll o w -u p  
F oll o wi n g t he s ur gical c o ns ult w here i nf or me d c o nse nt was o btai ne d, t he baseli ne s ur ve y 
( T 0) c o m plete d, a n d c o ns ult a u di o -rec or de d ( T 1), a f oll o w-u p s ur ve y  ( T 2) will be e maile d 
t o patie nts wit hi n 2 4 h o urs of t he c o ns ultati o n. If n o res p o nse is recei ve d, stu d y staff will 
se n d re mi n ders t o t he patie nt via e mail  a n d t ele p h o ne call s ( ma xi m u m of si x atte m pts), 
wit h t he g oal of c o m pleti n g t he s ur ve y wit hi n 3 wee ks. T o a v oi d missi n g data, st u d y staff 
will als o a p pr oac h patie nts f or s ur ve y c o m pleti o n at a f oll o w -u p  visit if t his is sc he d ule d 
wit hi n t he 3 -wee k peri o d.   Patie nts will ha ve c hart re vie w perf or me d after c o m pleti o n of 
t heir breast ca ncer is treat me nt. 
1 1 . 3. 2 L ost t o f oll o w u p  
Patie nts  will be  c o nsi dere d l ost t o f oll o w u p if atte m pts t o reac h t he m f or t he f oll o w-u p  
s ur ve y ( T 2) is u ns uccessf ul. H o we ver, patie nts will still ha ve t heir c hart re vie w perf or me d, 
u nless t he patie nt e x plicitl y deci des t o wit h dra w fr o m t he st u d y  a n d wit h dra ws c o nse nt . 
1 1. 4   M a n a gi n g I neli gi ble P atie nts  
Baseli ne data a n d all p ost -baseli ne data u p u ntil t he p oi nt t he patie nt was f o u n d t o be i neli gi ble 
m ust be s u b mitte d; h o we ver, n o data is re q uire d f oll o wi n g t he p oi nt t hat t he patie nt was f o u n d 
t o be i neli gi ble. T he patie nt s h o ul d c o m plete t he c o nse nt wit h dra wal f or m a n d i n dicate “c o nse nt 
wit h dra wal f or all f oll o w u p.”  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 3  
1 2 . 0 S T A TI S TI C A L C O N SI D E R A TI O N S  
As part of U p date # 0 6, t he statistical c o nsi derati o ns a n d a nal ysis pla n f or t he c o -pri mar y o bjecti ves 
ha ve bee n a me n de d.  T he rati o nale f or t hese re visi o ns was t w of ol d.  First, we  nee de d t o re vise t he 
pri mar y a nal ysis pla n t o a d dress t he c urre nt c halle n ges, w hic h were relate d t o t he C O VI D pa n de mic.  
Sec o n d, we nee de d t o e ns ure t hat t he re vise d pri mar y a nal ysis pla n was c o m pati ble wit h t he p o wer 
calc ulati o ns a n d t hat t he p o wer calc u lati o ns reflecte d w hat realistic effect sizes t he st u d y w o ul d n o w 
be a ble t o detect gi ve n t hese c halle n ges. T he a me n de d statistical c o nsi derati o ns a n d a nal ysis pla n f or 
t he c o-pri mar y o bjecti ves are detaile d bel o w.      
1 2 .1  A n al ysis Pl a n f or C o -Pri m ar y O b jecti ves 
1 2 .1 . 1 Pri m ar y A n al ysis  
C o -Pri mar y O bjecti ve # 1 : T he g oal is t o e val uate t he effecti ve ness of a decisi o n ai d i n 
i ncreasi n g patie nt e n ga ge me nt i n decisi o n ma ki n g i n cli nics ser vi n g a hi g h pr o p orti o n of 
s oci oec o n o micall y disa d va nta ge d patie nts. We will f oll o w a n i nte nti o n t o treat a p pr oac h, 
usi n g all a vaila ble data, re gar dless of gr o u p assi g n me nt or w het her patie nts vie we d t he 
decisi o n ai d. T he data as c ollecte d will ha ve a neste d str uct ure: patie nts neste d wit hi n 
s ur ge o ns wit hi n s ur gical cli nics , t his last le vel bei n g t he f or mal le vel of i nter ve nti o n . 
Descri pti ve a nal yses will s u m marize patie nt, s ur ge o n, a n d cli nic c haracteristics.  W he n 
re p orti n g t hese s u m mar y data, we will re p ort as “ N R-N ot re p orte d” a n y cell w here t he 
n u m ber of patie n ts is less t ha n fi ve t o a v oi d i na d verte nt patie nt i de ntificati o n. We will test 
i nter ve nti o n effects i n t he fra me w or k of ge neralize d li near mi xe d effects m o dels wit h a n 
“i nter ve nti o n vers us us ual care” d u m m y varia ble ( w hic h varies o ver patie nts wit hi n eac h 
s ur ge o n a n d cli nic), a s ur ge o n ra n d o m effect, a n d a cli nic ra n d o m effect. A nal ysis m o dels 
will i ncl u de t w o a d diti o nal para meters, f or wa ve a n d wa ve -s q uare d, res pecti vel y t o fle xi bl y 
c o ntr ol f or p ote ntial ti me effects a n d t o all o w f or a n o n -li near relati o nshi p wit h o utc o me 
meas ures. 
We will i ncl u de a p ost -C O VI D restart dic h ot o m o us varia ble t hat reflects 
w het her a patie nt is e nr olle d d uri n g t he p ost -C O VI D restart ti me peri o d f or a gi ve n site 
( yes/ n o). We als o will i ncl u de ti me (i n u nits of wa ve) p ost-C O VI D i n  all m o dels. T hese 
i n dicat or a n d ti me para meters all o w f or t he c o ntr ol of sites restarti n g t he trial p ost-C O VI D 
s h ut d o w n at differe nt ti mes. T his lea ds t o t he f oll o wi n g pla n ne d li near mi xe d effects m o del 
f or t he t w o pri mar y o utc o mes ( y) i n Ai m 1, na mel y, P E P PI -5 self -efficac y a n d Acti ve 
Patie nt Partici pati o n Be ha vi ors:   
𝑦𝑖𝑗𝑘= 𝛽0 + 𝜃𝑥𝑖𝑗𝑘+ 𝛽1 𝑡1 𝑖𝑗𝑘+ 𝛽2 𝑡1 𝑖𝑗𝑘
2
+ 𝛽3 𝑧𝑖𝑗𝑘+ 𝛽4 𝑡2 𝑖𝑗𝑘+ 𝑢𝑘+ 𝑢𝑗(𝑘) + 𝑒𝑖(𝑗(𝑘)) 
Here, 𝑦𝑖𝑗𝑘 de n otes t he res p o nse of t he 𝑖𝑡ℎ le vel-1 u nit ( patie nt) of t he 𝑗𝑡ℎ level -2 u nit 
(s ur ge o n) of t he 𝑘𝑡ℎ le vel-3 u nit (cli nic).  T he varia ble 𝑥𝑖𝑗𝑘 ( = 0, 1) de n otes t he i nter ve nti o n 
stat us of patie nt 𝑖 fr o m s ur ge o n 𝑗 wit hi n cli nic 𝑘.  T he varia bles 𝑡1  ( = 1, 2, 3, 4, 5, 6, 7) a n d 
𝑡1
2  ( = 1, 4, 9, 1 6, 2 5, 3 6, 4 9) are t he linear a n d q ua dratic ter ms f or wa ve wit h t he 
c orres p o n di n g c oefficie nts 𝛽1  a n d 𝛽2  re prese nti n g t he fi xe d li near a n d q ua dratic effects t o 
m o del t he u n derl yi n g sec ular tre n d.  T he varia ble 𝑧 ( = 0, 1) de n otes if patie nt 𝑖 was e nr olle d 
d uri n g t he p ost -C O VI D restart ti me peri o d f or a gi ve n cli nic wit h t he c orres p o n di n g fi xe d 
effect c oefficie nt 𝛽3 .  T he varia ble 𝑡2  ( = 0, 1, 2, 3, 4, 5, 6) de n otes if patie nt 𝑖 was e nr olle d 
wit hi n t he first wa ve p ost -C O VI D restart ti me peri o d  (𝑡2 = 1 ); wit hi n t he sec o n d wa ve 
p ost -C O VI D restart ti me peri o d ( 𝑡2 = 2 ); a n d s o o n t hr o u g h t he si xt h wa ve p ost-C O VI D 
restart ti me peri o d (𝑡2 = 6 ).  T he ma xi m u m val ue is 𝑡2 = 6  beca use w he n t he ste p pe d -
we d ge desi g n was s us pe n de d all cli nics were at least e nr o lli n g part wa y i n wa ve 2 of t he 
p ossi ble 7 wa ves.  F or patie nts e nr olle d pri or t o t he p ost -C O VI D restart ti me peri o d t he 
val ue of 𝑡2 = 0 .  T he ra n d o m effect 𝑢𝑘 is t he le vel-3 (cli nic) ra n d o m i nterce pt effect 
(ra n d o m cli nic varia nce); t he ra n d o m effect 𝑢𝑗(𝑘) is t he le vel-2 ra n d o m i nterce pt effect f or 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 4  
t he 𝑦(𝑖) 𝑗ℎ le vel-2 u nit (ra n d o m s ur ge o n varia nce neste d i n cli nics); t he ra n d o m effect 
𝑘𝛽(𝜃(𝑥)) is t he ra n d o m i n di vi d ual varia nce wit hi n s ur ge o ns neste d i n cli nics.   T he ter m 𝑖0  
is t he i nterce pt.  T he ter m 𝑗 re prese nts t he i nter ve nti o n effect of t he decisi o n ai d a n d is t he 
pri mar y effect of i nterest.  
M o dels  will a dj ust f or t he a pri ori s pecifie d patie nt c haracteristics descri be d a b o ve t hat are 
li kel y t o be str o n gl y pre dicti ve of t he e n d p oi nts. I n t he e ve nt t hat t he a p pr o xi matel y 
c o nti n u o us o utc o mes P E P PI -5 self -efficac y a n d Acti ve Patie nt Partici pati o n Be ha vi ors are 
n ot a p pr o xi matel y s y m metricall y distri b ute d, varia ble tra nsf or mati o n will be c o nsi dere d 
(e. g., s q uare-r o ot tra nsf or mati o n).  F urt her, as part of t he pla n ne d efficac y a nal ysis we will 
f ull y test t he varia nce-c o varia nce str uct ure of t he m o del, w hile bli n de d t o a n y treat me nt 
effects, w hic h ma y lea d t o a m ore parsi m o ni o us m o del.  
We 
will use li near 
mi xe d effects 
m o dels f or t he a p pr o xi matel y c o nti n u o us a n d 
s y m metricall y distri b ute d o utc o mes ( Acti ve Patie nt Partici pati o n Be ha vi ors, P E P PI -5, 
breast ca ncer k n o wle d ge, percei ve d k n o wle d ge) a n d l o gistic ra n d o m effects m o dels f or 
bi nar y o utc o mes ( Decisi o n Q ualit y I nstr u me nt - Breast S ur ger y). S h o ul d c o u nt varia ble 
e n d p oi nts (e. g., Acti ve Patie nt Partici pati o n Be ha vi ors) e x hi bit fl o or effects, w hic h we d o 
n ot a ntici pate, 9 5 l o g-li near ra n d o m effect m o dels will be use d t o esti mate t he relati o ns hi p 
of t hese e n d p oi nts t o i nter ve nti o n gr o u p. I n a d diti o n t o acc o u nti n g f or ass ociati o n i n t he 
data at vari o us le vels of cl usteri n g, t he mi xe d m o dels will all o w f or esti mati o n of t he 
perce nta ge of varia nce i n o utc o mes acc o u nte d f or b y differe nces at t he s ur ge o n, a n d clinic 
le vel. T his is critical as it will s u g gest at w hat le vel a dj u nct i nter ve nti o ns ma y be m ost 
effecti ve. M o dels will be esti mate d a n d teste d usi n g S A S v 9. 3 ( P R O C MI X E D a n d P R O C 
N L MI X). 9 6 
C o -Pri mar y O bjecti ve # 2 : T he g oal is t o test t he e xte nt t o w hic h t he effect of a decisi o n ai d 
o n patie nt e n ga ge me nt is me diate d t hr o u g h t he miti gati o n of pre parat or y a n d i nteracti o nal 
barriers, a n d deter mi ne if persiste nt barriers are dis pr o p orti o natel y e x perie nce d b y 
s oci oec o n o micall y disa d va nta ge d patie nts. As a decisi o n ai d ca n o nl y be effecti ve if 
patie nts are a ble t o access/re vie w it, we first assess f or accessi bilit y barriers t o decisi o n ai d 
use. 
We will t he n e xa mi ne t he i m pact of pre parat or y a n d i nteracti o nal b arriers o n 
e n ga ge me nt.  
Accessi bilit y Barriers : We will e xa mi ne barriers t o accessi n g t he we b -base d decisi o n ai d 
se paratel y, as o nl y patie nts w h o recei ve t he i nter ve nti o n ca n e x perie nce t hese barriers. 
U n dersta n di n g accessi bilit y barriers is critical t o e n s ure t he i nter ve nti o n will n ot w orse n 
dis parities. T his is a lar gel y descri pti ve a nal ysis t hat will g ui de sa m pli n g a n d i nter vie w 
c o nte nt f or t he patie nt i nter vie ws i n Ai m 3. We will calc ulate reac h of t he decisi o n ai d 
i nter ve nti o n f or t he st u d y c o h ort, a n d f or s oci oec o n o micall y disa d va nta ge d patie nts. We 
will s u m marize reas o ns w h y patie nts decli ne d t he decisi o n ai d. We will s u m marize ot her 
s ur ve y res p o nses re gar di n g decisi o n ai d accessi bilit y ( Ta ble 5) a n d perf or m e x pl orat or y 
a nal yses e val uati n g t he ass ocia ti o n wit h s oci oec o n o mic disa d va nta ge, usi n g c hi-s q uare 
tests a n d o d ds rati os f or cate g orical varia bles a n d A N O V A mea n differe nces  f or c o nti n u o us 
varia bles, res pecti vel y. D ue t o t he e x pl orat or y nat ure of t he a nal ysis, sa m ple size a n d 
p o wer are n ot calc ulate d.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 5  
Pre p ar at or y a n d I nter acti o n al  B arriers t o P atie nt E n g a ge me nt:   
Decisi o n Ai d I m pact o n E n ga ge me nt t hr o u g h Miti gati o n of Barriers  
We will first perf or m a nal yses t o test a n d q ua ntif y t he e xte nt t o w hic h t he effect of t he 
decisi o n ai d i nter ve nti o n o n patie nt e n ga ge me nt e n d p oi nts is me diate d t hr o u g h t he 
miti gati o n of ca n di date pre parat or y a n d i nteracti o nal barriers. We will q ua ntif y t he i n direct 
effect relati ve t o t he t otal effect of t he decisi o n ai d i n j oi nt li near str uct ural e q uati o n m o dels 
( S E M) f or t he en d p oi nt a n d t he ca n di date me diat ors, i ncl u di n g ra n d o m s ur ge o n effects a n d 
ra n d o m re gi o n effects f or eac h of t he me diat or a n d e n d p oi nt parts of t he m o dels. Eac h of 
t he pre parat or y a n d i nteracti o nal Barriers will be re prese nte d b y a c o nti n u o us late nt 
c o nstr u ct i n t he S E M, wit h 3 a n d 5 o bser ve d ite ms f or Pre parat or y a n d I nteracti o nal 
Barriers, res pecti vel y. Bi nar y or c o u nt varia bles will be m o dele d via late nt c o nti n u o us 
c o nstr uct i n t he S E M. Str uct ural e q uati o n m o dels will be s pecifie d, esti mate d a n d teste d 
us i n g M pl us v 7. 3.9 7 T he use of u ni di me nsi o nal late nt c o nstr ucts i ncreases p o wer a n d 
re d uces t he n u m ber of tests, relati ve t o testi n g eac h o bser ve d ite m se paratel y. Sta n dar dize d 
c oefficie nt esti mates fr o m t he S E M, re prese nti n g t otal, direct, a n d i n direct effects, will 
all o w f or t he deter mi nati o n of w het her t he mec ha nis m b y w hic h t he decisi o n ai d lea ds t o 
i ncrease d patie nt e n ga ge me nt is t hr o u g h t he miti gati o n of pre parat or y a n d/ or i nteracti o nal 
barriers ( see Fi g ure 7 f or si m plifie d e xa m ple). F or e xa m ple, if c oefficie nt X is i m p orta nt 
b ut Y is n ot, we ca n c o ncl u de t hat 
alt h o u g h t he decisi o n ai d lea ds t o 
statisticall y si g nifica nt c ha n ges i n 
i nteracti o nal barriers, t his is n ot t he 
mec ha nis m 
t hr o u g h 
w hic h 
t he 
decisi o n 
ai d 
i ncreases 
patie nt 
e n ga ge me nt. 
Alter nati vel y, if o nl y 
c oefficie nt Y is i m p orta nt, we ca n 
c o ncl u de  
t hat  
alt h o u g h  
t he 
i nteracti o nal 
fact ors 
re prese nt 
a 
si g nifica nt  
barrier  
t o  
patie nt 
e n ga ge me nt, t he decisi o n ai d d oes n ot 
si g nifica ntl y i m pact t he 
barrier. 
Fi nall y, if we fi n d si g nifica nt i n direct effects (re prese nte d i n t he fi g ure b y t he das he d li ne 
lea di n g fr o m t he decisi o n ai d t o e n ga ge me nt t hat r u ns t hr o u g h i nteracti o nal barriers), we 
ca n c o ncl u de t hat recei pt of t he decisi o n ai d lea ds t o a c ha n g e i n t he i nteracti o nal barrier, 
w hic h lea ds t o i m pr o ve d patie nt e n ga ge me nt. Statisticall y, c oefficie nts X a n d Y will be 
teste d t o get her, wit h t he n ull h y p ot hesis bei n g t hat t he pr o d uct X Y = 0. If eit her late nt 
c o nstr uct f or pre parat or y or i nteracti o nal Barri ers is si g nifica nt, t he n eac h i n di vi d ual 
o bser ve d ite m will be teste d, p ost h oc, as ca n di date barriers. Ca n di date barriers f or t he ne xt 
m o dels will be barriers f or w hic h t he i n direct effect is si g nifica nt a n d/ or barriers ass ociate d 
wit h l o wer le vels of e n g a ge me nt (i.e. c oefficie nt Y). T h ose barriers ass ociate d wit h l o wer 
le vel of e n ga ge me nt will be c o nsi dere d persiste nt a n d pri oritize d f or i ncl usi o n i n t he 
q ualitati ve i nter vie ws ( Ai m 3).  
Persiste nt B arriers E x perie nce d b y S oci oec o n o mic all y Dis a d v a nt a ge d P atie nts  
We will esti mate l o gistic a n d P oiss o n re gressi o n m o dels wit h s oci oec o n o mic de pri vati o n 
as t he e x pla nat or y varia ble, a n d eac h ca n di date persiste nt barrier as descri be d a b o ve as t he 
o utc o mes, i n or der t o assess t he e xte nt t o w hic h s oci oec o n o mic disa d va nta ge is ass ociate d 
wit h persiste nt barriers t o e n ga ge me nt. As wit h Ai m 1, m o dels will i ncl u de s ur ge o n a n d 
cli nic ra n d o m effects t o acc o u nt f or patie nt cl usteri n g. Fi n di n gs will g ui de t he sa m pli n g 
strate g y f or patie nt i nter vie ws ( Ai m 3) a nd will be i nc or p orate d i nt o t he i nter vie w c o nte nt.    

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 6  
1 2 .1 . 2 S a m ple Size a n d P o wer C alc ul ati o ns  
C o -Pri mar y O bjecti ve # 1 : Base d o n c urre nt patie nt e nr oll me nt , we esti mate  a sa m ple size 
of 5 6 3  patie nts.  T his has bee n  re d uce d fr o m o ur ori gi nal esti mate of 1, 0 5 0 patie nts. We 
ass u me 2 3 s ur ge o ns  will partici pate . Ai m 1 has t w o pri mar y e n d p oi nts: P E P PI -5 self -
efficac y a n d Acti ve Patie nt Partici pati o n Be ha vi ors (c o u nt). We desire a fa mil y -wise t w o -
si de d T y pe I err or rate of α = 0. 0 5; u n der a B o nferr o ni c orrecti o n, tests will be c o n d ucte d 
wit h n o mi nal of α = 0. 0 5/ 2 = 0. 0 2 5.  
Usi n g t he re vise d a nal ysis m o del  a n d u p date d accr ual pr ojecti o ns, we esti mate d Fis her’s 
i nf or mati o n f or t he re gressi o n para meters w he n t he st u d y will ha ve c om plete data; 
i n verti n g t hat i nf or mati o n we o btai ne d a n esti mate of t he sta n dar d err or f or t he 
i nter ve nti o n effect para meter, t here b y c o m p uti n g mi ni mall y detecta ble C o he n’s-D effect 
size f or eac h pri mar y e n d p oi nt at 8 0 % a n d at 9 0 % p o wer. As a se nsiti vit y a n al ysis, we 
c o nsi dere d var yi n g esti mates of I C Cs t o e ns ure r o b ust fi n di n gs.  
 
Self -Efficac y: Ass u mi n g P E P PI -5 has a sta n dar d de viati o n ( S D) of 4. 3  a n d b ot h wit hi n -
s ur ge o n a n d wit hi n-site-bet wee n s ur ge o n I C C of 0. 0 7, we will ha ve 8 0 % p o wer t o detect 
effects as s mall as 0. 5 5 * 4. 3 = 2. 4  a n d 9 0 % p o wer t o detect effects as s mall as 0. 6 3 * 4. 3 = 2. 7  
o n a scale of 5 -2 5 . We c o nsi der a differe nce of 2 p oi nts t o be cli nicall y mea ni n gf ul.  
Acti ve Patie nt Partici pati o n  Be ha vi ors : Ass u mi n g t he acti ve patie nt partici pati o n be ha vi or 
c o u nt has a sta n dar d de viati o n of 2 3. 1  a n d a wit hi n -s ur ge o n I C C of 0. 0 1 a n d wit hi n-site-
bet wee n s ur ge o n I C C of 0. 0 0 0 1, we ha ve 8 0 % p o wer t o de tect a differe nce of 
0. 5 0 * 2 3. 1 = 1 1. 6  a n d 9 0 % p o wer t o detect a differe nce as s mall as 0. 5 7 * 2 3. 1 = 1 3. 2  o n a 0 -
1 5 0 scale. We  c o nsi der a differe nce of 1 0 t o be cli nicall y mea ni n gf ul.  
As part of t he pr ocess t o ascertai n w het her we w o ul d ac hie ve o ur st u d y g oals d es pite t he 
l o wer t ha n pla n ne d accr ual a n d t he re q uire d re visi o ns t o t he a nal ytic pla n i n res p o nse t o 
t he C O VI D-1 9 pa n de mic, we als o perf or me d a p o wer calc ulati o n usi n g t he esti mate d 
sta n dar d de viati o n f or eac h of t he t w o c o-pri mar y e n d p oi nts o btai ne d fr o m data c ollecte d 
d uri n g Wa ve 1 data (all patie nts are i n us ual care i n Wa ve 1 a n d all sites ha d c o m plete d 
Wa ve 1). T o mai ntai n t he i nte grit y of t he trial, we le vera ge d t he o n g oi n g c olla b orati o n wit h 
n o n -Allia nce st u d y statisticia n, 
w h o is n ot i nti matel y i n v ol ve d i n t he 
dail y o perati o ns, data m o nit ori n g, a n d st u d y c o n d uct. T he Allia nce st u d y statisticia n,  
 
 pr o vi de d 
wit h t he esti mate d sta n dar d de viati o ns, b ut n o 
gra n ular data. T he esti mate d sta n dar d de viati o ns we re t he n use d b y 
 t o 
calc ulate t he re vise d p o wer t o detect o ur a pri ori pr ot oc ol -defi ne d st u d y h y p ot hes es. 
Wit h t he ne w a nal ytic pla n, t he ne w 
pr ojecte d  sa m ple size, a n d t he re vise d sta n dar d 
de viati o ns, we ha ve t he f oll o wi n g u p date d statistical p o wer f or eac h of t he t w o c o -pri mar y 
e n d p oi nts ass ociate d wit h C o -Pri mar y O bjecti ve # 1:  
Self -Efficac y: Ass u mi n g P E P PI -5 has a sta n dar d de viati o n ( S D) of 3. 4 a n d b ot h wit hi n -
s ur ge o n a n d wit hi n-site-bet wee n s ur ge o n I C C of 0. 0 7, we will ha ve 8 0 % p o wer t o detec t 
effects as s mall as 0. 5 5 * 3. 4 = 1. 8 7 a n d 9 0 % p o wer t o detect effects as s mall as 
0. 6 3 * 3. 4 = 2. 1 4 o n a scale of 5 -2 5. We c o nsi der a differe nce of 2 p oi nts t o be cli nicall y 
mea ni n gf ul.  
Acti ve Patie nt Partici pati o n Be ha vi ors: Ass u mi n g t he acti ve patie nt partici p ati o n be ha vi or 
c o u nt has a sta n dar d de viati o n of 1 9. 1 a n d a wit hi n -s ur ge o n I C C of 0. 0 1 a n d wit hi n-site-
bet wee n s ur ge o n I C C of 0. 0 0 0 1, we ha ve 8 0 % p o wer t o detect a differe nce of 
0. 5 0 * 1 9. 1 = 9. 6 a n d 9 0 % p o wer t o detect a differe nce as s mall as 0. 5 7 * 1 9. 1 = 1 0. 9 o n a 0 -
1 5 0 scale. We c o nsi der a differe nce of 1 0 t o be cli nicall y mea ni n gf ul.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 7  
C o -Pri mar y O bjecti ve # 2 : Mac ki n n o n et al. ha ve s h o w n t hat o ne of t he m ost acc urate  tests 
f or me diati o n or i n direct effect is t he “as y m metric distri b uti o n of pr o d ucts” test
1 0 0 a n d ha ve 
pr o vi de d e xte nsi ve si m ulati o n st u dies f or esti mati n g p o wer f or a variet y of me diati o n 
tests.1 0 1, 1 0 2 P o w Me d R s oft ware 1 0 3 was de vel o pe d base d o n t hat w or k, w hic h we e x pl oit 
here. We ass u me a sa m ple size of 5 6 3  a n d t he n de d uc t 23  df f or s ur ge o n effects a n d 7 df 
f or n u m ber of wa ves; we  esti mate  a n effecti ve sa m ple size of 5 3 3 . I n a d diti o n, beca use we 
are testi n g t w o me diat ors, we set α = 0. 0 5/ 2 = 0. 0 2 5 f or t hese t w o tests. S u p p ose we ha ve 
s mall me diati o n effects wit h R 2= 2 % f or t h e effect of t he i nter ve nti o n o n t he l ate nt barrier 
me diat or ( Fi g ure 7) a n d f or t he effect of t he late nt me diat or o n P E P PI -5  sc ore or o n acti ve 
p atie nt partici pati o n be ha vi or  co u nt. S u p p ose a d diti o nall y t hat t he t hree o bser ve d ite ms 
ha ve c orrelati o n of at least r = 0. 6 0. T he n, t he a vera ge of t h ose t hree ite ms will ha ve 
relia bilit y of = {r + (1 / 3 )(1 −r)},, yiel di n g net R2 val ues bet wee n t he i nter ve nti o n a n d 
t he o bserve d  me diat or a n d b et wee n t he o bser ve d me diat or a n d P E P PI -5  sc ore or acti ve 
patie nt partici pati o n be ha vi or c o u nt of R 2= 0. 8 2 *. 0 2 = 1. 6 %. 
Usi n g 
t he P o w Me d R  
s oft ware, we will ha ve 6 0 % p o wer t o detect me diati o n  wit h s mall effect size a n d > 9 9 % 
p o wer t o detect me diati o n wit h me di u m  effect  size R 2= 0. 8 2 *. 1 5 = 1 2 .3 %.  P o wer will be 
hi g her wit h fi ve ite ms.  
We will e xte n d t he peri o d of e nr oll me nt f or sites t hat are still recr uiti n g wit hi n t he ste p pe d 
we d ge desi g n as of 8/ 3 0/ 2 0 2 1. T he e xte n de d recr uit me nt be y o n d Wa ve 7 will c o nti n ue f or 
si x sites u ntil 1 2/ 3 1/ 2 0 2 1 (see Secti o n 1 2. 1. 3).  W hile t hese a d diti o nal patie nts will n ot 
c o ntri b ute t o t he first c o -pri mar y o bjecti ve, t he y will be i ncl u de d i n t he a nal ysis f or t his 2 n d 
c o-pri mar y o bjecti ve; all of t hese a d diti o nal patie nts will be e x p ose d t o t he st u d y 
i nter ve nti o n.  We a ntici pate, at a mi ni m u m, t hat t here will be 5 0 s uc h patie nts e x p ose d t o 
t he i nter ve nti o n acr oss t hese si x sites.  We re -esti mate d p o wer ass u mi n g s uc h a n i ncrease, 
w hic h lea ds t o a n  i ncrease i n t he p o wer f or detecti n g s mall effects fr o m 6 0 % t o 6 5 %. 
O nce me diati n g barriers are detecte d, we use a m o del si milar t o t hat i n Ai m 1 t o test f or a n 
ass ociati o n of eac h barrier t o a baseli ne i n dicat or of s oci oec o n o mic disa d va nta ge. W e 
ass u me 3 0 % of t he sa m ple will be disa d va nta ge d, e ve nl y distri b ute d a m o n g cli nics a n d 
s ur ge o ns. Ass u me we will be testi n g u p t o f o ur barriers; as we desire a fa mil y -wise t w o -
si de d T y pe I err or rate of α = 0. 0 5, u n der a B o nferr o ni c orrecti o n, tests will be c o n d ucte d 
wit h n o mi nal of α = 0. 0 5/ 4 = 0. 0 1 2 5. E xte n di n g t he sa me met h o d of c o m p uti n g p o wer as i n 
Ai m 1, we will ha ve p o wer of 8 0 % f or a n effect size of 0. 3 1 a n d 9 0 % p o wer t o detect a n 
effect size of 0. 3 5.   
We t he n re -esti mate d p o wer ass u mi n g a n a d diti o nal 5 0 i nter ve nti o n patie nts  e nr olle d 
be y o n d Wa ve 7 acr oss si x sites . As a res ult,  t he st u d y will ha ve 8 0 % p o wer t o detect a n 
effect size of 0. 3 0 a n d 9 0 % f or a n effect size of 0. 3 4.  
1 2 . 1. 3 Accr u al Ti me a n d St u d y D ur ati o n  
T he sa m ple size t o ac hie ve o ur c o -pri mar y o bjecti ves is 5 6 3  pa tie nts.  O ur pla n ne d ste p pe d 
we d ge desi g n i ncl u des 7 wa ves of a p pr o xi matel y 1 0 wee ks (t otal 7 0 wee ks, ~ 1 8 m o nt hs). 
We als o i ncl u de a Lea d -i n Peri o d pri or t o starti n g t o o pti mize recr uit me nt strate gies.  F or 
eac h cli nic, o ne wa ve is use d f or i m ple me ntati o n o f t he decisi o n ai d at t he ti me of cr oss 
o ver , yiel di n g 6 wa ves  f or data c ollecti o n.  T o ac hie ve o ur st u d y g oal, we a ntici pate  sites 
will nee d t o a p pr oac h a n a vera ge of 9 patie nts per m o nt h a n d e nr oll a n a vera ge of 7 patie nts 
per m o nt h.  H o we ver, as variati o n i n patie nt v ol u me bet wee n cli nics is e x pecte d, we will 
as k cli nics t o o ver -e nr oll eac h m o nt h t o e ns ure s uccessf ul sa m ple size accr ual.  
Ste p we d ge accr u al r ules:  Eac h wa ve wit hi n o ur ste p pe d we d ge desi g n is set t o last 1 0 
wee ks. H o we ver, u n der -recr uit me nt ma y occ ur d uri n g a n y gi ve n wa ve at a n y gi ve n site. 
U n der -recr uit me nt c o ul d a d versel y i m pact sa m ple size a n d st u d y c o ncl usi o ns. We ha ve 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 8  
u p date d o ur accr ual r ules t o ac k n o wle d ge u n der -recr uit me nt. T his decisi o n was ma de at a 
relati vel y earl y sta ge i n t he st u d y (less t ha n half of t he sites ha d starte d accr ual a n d s o me 
f or o nl y a fe w wee ks). F urt her, decisi o n-ma kers were bli n de d t o t he i nter ve nti o n stat us or 
ti me of cr oss-o ver i n ma ki n g t he decisi o n. T he u p date d accr ual r ules state t hat:  
I n a wa ve, if t he c urre nt accr ual f or a gi ve n site is < 2/ 3 of t he state d accr ual g oal f or t hat 
site at t he e n d of t he wa ve, t he n t he wa ve will be e xte n de d b y t hree wee ks f or t hat site. T his 
r ule is t o be a p plie d at t he wa ve-b y -site le vel, i n de pe n de nt of t he pre vi o us hist or y at t hat  
( or a n y ot her) site a n d tra nsiti o n ti me t o t he i nter ve nti o n. O nl y o ne e xte nsi o n is p ossi ble at 
t he wa ve-b y -site le vel, s o t hat t he ma xi m u m wa ve le n gt h is 1 3 wee ks. A si n gle site c o ul d 
be e xte n de d i n m ulti ple differe nt wa ves, as t he r ule is a p plie d i n de pe n de nt of hist or y.  
A critical c o m p o ne nt of t his r ule is t hat t he accr ual pr ocess will be s u p p orte d b y o n g oi n g, 
u nif or ml y a p plie d recr uit me nt m o nit ori n g a n d s u p p ort fr o m t he Allia nce a n d t he U W tea m. 
T his will ser ve t o e nc o ura ge a st ea d y rate of accr ual acr oss ti me.  
T his r ule was selecte d as it best bala nce d statistical vali dit y wit h nee d t o meet accr ual g oals 
a n d c o m plete st u d y i n a ti mel y fas hi o n. It als o was a ble t o a d dress b ot h sit uati o nal a n d 
c hr o nic l o w accr ual at ti mes.  
E xte n de d recr uit me nt be y o n d 
W a ve 7 :  We ha ve e x perie nce d u n der -recr uit me nt 
t hr o u g h o ut t he st u d y as a res ult of a n u m ber of fact ors, i ncl u di n g a n d es peciall y t he 
C O VI D -1 9 pa n de mic.   T o c o m pe nsate f or t he sl o wer t ha n a ntici pate d accr ual rate, we will 
e xte n d t he per i o d of e nr oll me nt f or t he sites t hat are still recr uiti n g wit hi n t he ste p pe d 
we d ge desi g n as of 8/ 3 0/ 2 0 2 1. Patie nts e nr olle d after Wa ve 7 is c o m plete d at eac h of t he 
sites will n ot c o ntri b ute t o t he first c o-pri mar y o bjecti ve.  T he a d diti o nal patie nts recr uite d 
be y o n d Wa ve 7 will be i ncl u de d i n t he a nal ysis f or t he 2 n d c o-pri mar y o bjecti ve a n d t he 
sa m pli n g p o ol f or t he sec o n dar y o bjecti ve. As of 8/ 3 0/ 2 0 2 1, si x of t he ori gi nal te n sites 
were acti vel y recr uiti n g wit hi n t he ste p pe d we d ge desi g n.   T he e xte n de d recr uit me nt 
be y o n d Wa ve 7 w o ul d c o nti n ue f or t he si x sites u ntil 1 2/ 3 1/ 2 0 2 1.  We a ntici pate e nr olli n g 
5 0 a d diti o nal patie nts, at a mi ni m u m; h o we ver, base d o n t he m ost rece nt accr ual rates it is 
li kel y t hat we ma y e nr oll u p t o 6 2 patie nts f or a t otal tar gete d sa m ple size 5 6 3 + 6 2 = 6 2 5 
patie nts.  
1 2 .1 . 4 Missi n g D at a  
We meas ure o ur pri mar y o utc o me b y t w o met h o ds: a nal ysis of t he a u di o -rec or di n g a n d t he 
a nal ysis of t he f oll o w -u p s ur ve y.  As patie nts c o nse nt i m me diatel y pri or t o t he c o ns ultati o n, 
we a ntici pate t hat we will ha ve mi ni mal missi n g -ness of t hat c o m p o ne nt of t he pri mar y 
o utc o me. T o decrease missi n g data fr o m o ur f oll o w -u p s ur ve y, assess me nt b ur de n a n d 
dr o p -o ut, we ha ve li mite d t he n u m ber of s ur ve y q uesti o ns a n d pr o vi de d i nce nti ves. We 
ha ve i ncl u de d fle xi ble mea ns of c o ntacti n g patie nts f or t he p ost -c o ns ultati o n s ur ve y, 
i ncl u di n g e mail ( pri mar y m o dalit y), tele p h o ne, or i n-pers o n at a cli nic visit.  If data are 
missi n g o n pre dict or varia bles of i nterest, data will be i m p ute d usi n g m ulti ple i m p utati o n 
( MI) tec h ni q ues ( MI usi n g c hai ne d e q uati o ns).1 0 4, 1 0 5 MI pr o d uces vali d statistical esti mates 
u n der missi n g ness at ra n d o m ( M A R), w hile als o acc o u nti n g f or a d diti o nal u ncertai nt y 
arisi n g fr o m missi n g data. We will perf or m se nsiti vit y a nal yses t o deter mi ne t he de gree t o 
w hic h res ults are se nsiti ve t o t he M A R ass u m pti o n. We will als o acc o u nt f or s ur ve y n o n -
res p o nse usi n g a n i n verse pr o ba bilit y wei g hti n g a p pr oac h if we s h o ul d fi n d t hat t here is 
differe ntial s ur ve y n o n -res p o nse bet wee n t he i nter ve nti o n a n d us ual care gr o u ps acc or di n g 
t o patie nt c haracteristics t hat als o i nfl ue nce t he o utc o mes of i nterest.  
We will c o nsi der patie nts as partici pa nts if t he y c o m plete t he a u di o -rec or di n g a n d o nl y 
c o nsi der t he m t o ha ve dr o p pe d o ut if t he y wit h dra w c o nse nt.  If a partici pa nt wit h dra ws 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
4 9  
c o nse nt , we will d oc u me nt: 1) t he reas o n f or dr o p o ut; 2) w h o deci de d t he partici pa nt w o ul d 
dr o p o ut; a n d 3) w het her t he dr o p o ut i n v ol ves s o me or all t y pes of partici pati o n.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 0  
1 2 .2  A n al ysis Pl a n f or Sec o n d ar y O bjecti ves  
1 2 . 2. 1 I nter vie ws 
All i nter vie ws will be a u di o rec or de d a n d tra nscri be d ver bati m. Earl y i nter vie ws will be 
re vie we d i n de pe n de ntl y b y at least t hree i n vesti gat ors t o ge nerate a preli mi nar y list of 
c o nce pt ual c o des t hat will be use d t o re d uce t he data. We will i ncl u de tea m me m bers wit h 
u ni q ue cli nical bac k gr o u n ds t o e nric h t he c o di n g pr ocess. T he i de ntifie d c o di n g sc he mes 
will be c o m pare d a n d disc usse d t o reac h c o nse ns us f or a preli mi nar y c o di n g ta x o n o m y, 
w hic h will g ui de pri mar y c o di n g of s u bse q ue nt i nter vie ws. If ne w c o nce pts e mer ge d uri n g 
s u bse q ue nt i nter vie ws, t his c o di n g ta x o n o m y will u n der g o iterati ve re visi o ns a n d earlier 
i nter vie ws will be rec o de d t o i ncl u de t he e mer gi n g c o nstr ucts. We will use vis ual dis pla ys 
t o br oa dl y cate g orize t he data a n d or ga nize it i nt o o verarc hi n g t he mes, facilitati n g 
c o m paris o ns  bet wee n o ur patie nt c o h orts. 1 0 6 We will use 
N Viv o basic pr o gra m ( Q S R 
I nter nati o nal-Mel b o ur ne) t o ma na ge data a n d facilitate a nal ysis.  
We will ta ke t w o a p pr oac hes t o data a nal ysis. First, we will perf or m  directe d c o nte nt 
a nal ysis t o i de ntif y a n d cate g orize barriers de d ucti vel y. 1 0 7, 1 0 8 Alt h o u g h we meas ure d 
discrete c o nce pts relate d t o accessi bilit y, pre parat or y, a n d i nteracti o nal barriers i n o ur 
q ua ntitati ve data c ollecti o n, it is li kel y t hat n ot all rele va nt c o nce pts will ha ve bee n 
ca pt ure d. T heref ore, we will als o perf or m i n d ucti ve c o di n g t o i de ntif y pre vi o usl y 
u nrec o g nize d barriers. T he g oal of t his first a nal ytic ste p is t o c o nfir m a n d e n ha nce o ur 
c o nce pt ual m o del. As a sec o n d ste p, we will perf or m i n d ucti ve c o nte nt a nal ysis t o 
c haracterize t he mec ha nis ms b y w hic h t he i de ntifie d barr iers li mite d patie nt e n ga ge me nt 
des pite a decisi o n ai d. We will als o e x pl ore h o w patie nts were a ble t o o verc o me, or n ot 
o verc o me, i de ntifie d barriers. T his i nf or mati o n will pr o vi de f urt her i nsi g ht of t he 
mec ha nis ms s u p p orti n g a n d i m pe di n g e n ga ge me nt. 
We wi ll c o m pare a n d c o ntrast t he 
e x perie nces re p orte d b y patie nts base d o n t heir c haracteristics t o el uci date t he i nteracti o n 
bet wee n s oci oec o n o mic disa d va nta ge a n d patie nt e n ga ge me nt.  
We use a n e x pla nat or y mi xe d met h o ds a p pr oac h t o i nte grate t he q ua ntitati ve 
( pri mar y 
o bjecti ves) a n d q ualitati ve (sec o n dar y o bjecti ve) fi n di n gs i n or der t o i de ntif y p ote ntial 
tar gets f or a dj u nct i nter ve nti o ns.9 1 T he q ua ntitati ve a nal ysis will i de ntif y a n d pri oritize 
persiste nt barriers t o e n ga ge me nt  t hat e xist wit h a n d wit h o ut a decisi o n ai d. B y 
u n dersta n di n g patie nts’ e x perie nces wit h t hese barriers, we ca n o btai n i nsi g ht i nt o p ote ntial 
wa ys t o a meli orate t he m. Fr o m t his i nte grati o n, we will i de ntif y a list of p ote ntial tar gets 
f or a dj u nct i nter ve nti o ns, pri oritize d b y t he pr o p orti o n of patie nts w h o e x perie nce t he 
barrier a n d percei ve d i m pact of t he barrier o n e n ga ge me nt.  
1 2 . 2. 3  I nter vie w S a m ple Size  
We 
will c o n d uct tele p h o ne , vi de o, or i n-pers o n  i nter vie ws 
wit h 3 0 patie nts 
w h o 
e x pe rie nce d accessi bilit y barriers; we a ntici pate t hat t his will be a de q uate t o o btai n 
i nf or mati o nal re d u n da nc y.8 9 -9 1 
I n a d diti o n, we will c o n d uct tele p h o ne, vi de o or i n-pers o n i nter vie ws wit h 5 0 patie nts w h o 
e x perie nce d pre parat or y or i nteracti o nal barriers t o patie nt e n ga ge me nt.  
1 2 .2 . 4  F oc us G r o u ps 
We will f ull y a u di o -rec or d a n d tra nscri be f oc us gr o u ps, a n d ta ke fiel d n otes t o a u g me nt 
t hese o bser vati o ns. We will perf or m directe d c o nte nt a nal ysis t o i de ntif y t h ose c o m p o ne nts 
of t he disc ussi o n directl y rele va nt t o o ur g oal of i de ntif yi n g a dj u nct i nter ve nti o ns t o tar get 
i de ntifie d barriers. T he deli vera ble fr o m t he f oc us gr o u ps will be a list of p ote ntial a dj u nct 
i nter ve nti o ns t o tar get pri oritize d barriers.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 1  
1 2 . 2. 5 F oc us Gr o u p S a m ple Size  
We pla n t o c o n d uct t hree patie nt f oc us gr o u ps at t hree se parate cli nics. We a ntici pate 
i n viti n g 1 0-1 2 w o me n t o eac h f oc us gr o u p, wit h a n a ntici pate d f oc us gr o u p size of 8 (t otal 
2 4 pati e nts).  
We will als o pla n t o c o n d uct t w o f oc us gr o u ps wit h cli nic sta ke h ol ders fr o m o ur 
partici pati n g cli nics, i ncl u di n g b ot h s ur ge o ns a n d n urses. 
We a ntici pate i n viti n g 1 5 
sta ke h ol ders t o eac h f oc us gr o u p, t o o btai n a fi nal size of 8-1 0 partici pa nts; we w ill ai m f or 
a n e ve n distri b uti o n of s ur ge o n a n d n urses.  
1 2 .3  St u d y Re p orti n g  
1 2. 3. 1  T his st u d y will be m o nit ore d b y t he Alli a nce D at a S afet y M o nit ori n g B o ar d 
( D S M B), a n N CI-a p pr o ve d f u ncti o ni n g b o d y. Re p orts c o ntai ni n g efficac y, a d verse e ve nt, 
a n d a d mi ni strati ve i nf or mati o n will be pr o vi de d t o t he D S M B e ver y 6 m o nt hs as per N CI 
g ui deli nes.  
1 2. 3. 2  Res ults Re p orti n g o n Cli nic al Tri als. g o v: At st u d y acti vati o n, t his st u d y will ha ve bee n 
re gistere d wit hi n t he “ Cli ncial Trials. g o v” we b site. T he Pri mar y a n d Seco n dar y 
E n d p oi nts (i.e., “ O utc o me Meas ures”) al o n g wit h ot her re q uire d i nf or mati o n f or t his 
st u d y will be re p orte d o n Cli nical Trials. g o v. 
1 2 .4  I ncl usi o n of W o me n a n d Mi n orities 
F or cli nic sta ke h ol ders, t here are n o s pecific e xcl usi o n criteria base d o n se x/ ge n der, race or 
et h nicit y as o ur sa m pli n g will be a n y c urre nt cli nic staff me m ber t hat is i n v ol ve d i n t he care of 
ne wl y dia g n ose d breast ca ncer patie nts a n d t he i m ple me ntati o n of t he decisi o n ai d.  
F or patie nts, all ne wl y dia g n ose d fe male breast ca ncer patie nts, re gar dless of a ge, race, or 
et h nicit y, will be offere d t he decisi o n ai d a n d eli gi ble t o partici pate i n t he researc h c o m p o ne nts 
of t he st u d y. We will i ncl u de mi n orit y patie nts i n n u m bers pr o p orti o nate t o t he de m o gra p hics 
of t he te n s ur gical practi ces t hat we recr uit f or t his st u d y.  
We will e xcl u de me n dia g n ose d wit h breast ca ncer fr o m o ur st u d y. Alt h o u g h me n are 
rec o m me n de d s ur ger y t o treat breast ca ncer, male breast ca ncer is relati vel y rare.  A d diti o nall y, 
t he decisi o n f or t y pe of breast ca ncer s ur ger y is si m pler f or me n c o m pare d wit h w o me n.  
Practicall y s pea ki n g, breast c o nser vati o n is ofte n n ot a n o pti o n gi ve n t he lesser a m o u nt of breast 
tiss ue.  A d diti o nall y, mastect o m y d oes n ot ha ve t he sa me i m plicati o ns wit h re gar ds t o b o d y 
i ma ge, se xualit y, etc. as it d oes i n w o me n.  Beca use of t his, t he decisi o n ai d use d i n o ur st u d y is 
a p plica ble o nl y f or a fe male p o p ulati o n.  
Esti mate d e nr oll me nt f or b ot h patie nts ( 6 2 5 ) a n d cli nic sta ke h ol ders (1 0 cli nic staff, a n d 3 0 
s ur ge o ns). Beca use we ha ve n ot selecte d partici pati n g cli nics, o ur esti mates are base d o n a lar ge 
nati o nal ca ncer re gistr y data base, t he Nati o nal Ca ncer Data Base ( N C D B).  T he N C D B is a 
pr o gra m of t he A merica n C olle ge of S ur ge o ns C o missi o n o n Ca ncer a n d t he A merica n Ca ncer 
S ociet y a n d c a pt ures a p pr o xi matel y 7 0 % of all ne wl y dia g n ose d ca ncers i n t he U. S., wit h > 6 0 % 
of t hese cli nics bei n g c o m m u nit y ca ncer pr o gra ms.  T his gi ves us t he best esti mate of o ur 
e nr oll me nt. 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 2  
D O M E S TI C  P L A N N E D E N R O L L M E N T R E P O R T  F O R P A TI E N T S  
R aci al C ate g ories  
Et h nic  C ate g ories  
T ot al  
N ot His p a nic or L ati n o  
His p a nic o r L ati n o  
Fe m ale  
M ale  
Fe m ale  
M ale  
A merica n I n dia n/ 
Alas ka Nati ve  
1  
0  
0  
0  
1  
Asia n  
5 0   
0  
0  
0  
5 0   
Nati ve Ha waiia n 
or Ot her Pacific 
Isla n der 
8  
0  
0  
0  
8  
Blac k or Africa n 
A merica n  
1 3 6   
0  
2   
0  
1 3 8   
W hite  
3 9 3   
0  
2 5   
0  
4 1 8   
M ore T h a n O ne 
Race  
1 0  
0  
0  
0  
1 0  
T ot al  
5 9 8   
0  
2 7   
0  
6 2 5   
 
D O M E S TI C  P L A N N E D E N R O L L M E N T R E P O R T F O R N O N -P A TI E N T S ( C LI NI C S T A K E H O L D E R S)  
R aci al C ate g ories  
Et h nic C ate g ories  
T ot al  
N ot His p a nic or L ati n o  
His p a nic or L ati n o  
Fe m ale  
M ale  
Fe m ale  
M ale  
A merica n 
I n dia n/ Alas ka Nati ve 
0  
0  
0  
0  
0  
Asia n  
2  
0  
0  
0  
2  
Nati ve Ha waiia n or 
Ot her Pacific Isla n der  
1  
0  
0  
0  
1  
Blac k or Africa n 
A merica n  
7  
4  
1  
0  
1 2  
W hite  
9  
1 2  
4  
0  
2 5  
M ore T ha n O ne Race  
0  
0  
0  
0  
0  
T otal  
1 9  
1 6  
5  
0  
4 0  
Et h nic C ate g ories:   
His pa nic or Lati n o –  a pers o n of C u ba n, Me xica n, P uert o Rica n, S o ut h or Ce ntral A merica n, or ot her S pa nis h 
c ult ure or ori gi n, re g ar dless of race. T he ter m “ S pa nis h ori gi n” ca n als o be use d i n a d diti o n t o “ His pa nic or 
Lati n o.”  
N ot His pa nic or L ati n o 
R aci al C ate g ories  
 
A merica n I n dia n or Alas ka n Nati ve –  a pers o n ha vi n g ori gi ns i n a n y of t he ori gi nal pe o ples of N ort h, Ce ntral, or 
S o ut h A merica, a n d w h o mai ntai ns tri bal affiliati o ns or c o m m u nit y attac h me nt.  
Asia n –  a pers o n ha vi n g ori gi ns i n a n y o f t he ori gi nal pe o ples of t he Far East, S o ut heast Asia, or t he I n dia n 
s u bc o nti ne nt i ncl u di n g, f or e x a m ple, Ca m b o dia, C hi na, I n dia, Ja pa n, K orea, 
Mala ysia, Pa kista n, t he 
P hili p pi ne Isla n ds, T haila n d, a n d Viet na m. ( N ote: I n di vi d uals fr o m t he P hili p pi ne Isla n ds ha ve bee n rec or de d 
as Pacific Isla n ders i n pre vi o us data c ollecti o n strate gies.)  
Blac k or Africa n A merica n –  a pers o n ha vi n g ori gi ns i n a n y of t he  blac k racial gr o u ps of Africa.  
Nati ve Ha waiia n or ot her Pacific Isla n der –  a pers o n ha vi n g ori gi ns i n a n y  of t he ori gi nal pe o ples of Ha waii, 
G ua m, Sa m oa, or ot her Pacific Isla n ds.  
W hite –  a pers o n ha vi n g ori gi ns i n a n y of t he ori gi nal pe o ples of E ur o pe, t he Mi d dle East, or N ort h Africa.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 3  
1 3 . 0 G E N E R A L  R E G U L A T O R Y  C O N SI D E R A TI O N S:  W
AI V E R S O F C O N S E N T  
1 3 . 1 W ai vers of d oc u me nt ati o n of writte n p atie nt c o nse nt  
1 3 . 1. 1 Pre -scree ni n g 
Per 4 5 C F R 4 6. 1 1 7c, a wai ver of i nf or me d c o nse nt f or t he prescree ni n g of st u d y eli gi bilit y 
descri be d i n Secti o n 8. 1  is j ustifie d f or t he f oll o wi n g reas o ns:  
• 
Pre -scree ni n g eli gi bilit y re vie w of me dical rec or ds b y cli nical researc h staff d oes n ot 
a d versel y affect t he ri g hts or welfare of s u bjects beca use me dical rec or d i nf or mati o n 
is scree ne d t o esta blis h preli mi nar y eli gi bilit y pri or t o a p pr oac hi n g a p ote ntial s u bject 
a b o ut a st u d y, 
• 
Pre -scree ni n g eli gi bilit y re vie w of me dical rec or ds ca n n ot practica bl y be d o ne wit h o ut 
t he wai ver d ue t o t he n u m ber of ser vices partici pati n g i n w hic h patie nts ma y be 
eli gi ble. Pre -scree ni n g eli gi bilit y decreases t he b urde n o n patie nts of i ntr o d uci n g a 
researc h st u d y t o s u bjects w h o ca n easil y be i de ntifie d t hr o u g h pre-scree ni n g acti vities 
as n ot eli gi ble f or a researc h st u d y,  
• 
Pre -scree ni n g eli gi bilit y re vie w of me dical rec or ds i n v ol ves n o m ore t ha n mi ni mal ris k 
beca use  t he pers o n accessi n g t he i nf or mati o n has u n der g o ne trai ni n g i n c o nfi de ntialit y 
of me dical rec or ds, a n d t he rec or ds are vie we d s olel y t o pre -scree n f or eli gi bilit y 
criteria a n d o nl y mi ni mal i nf or mati o n f o u n d i n t he pre -scree ni n g pr ocess will be 
rec or de d f or researc h p ur p oses. Na mes of patie nts (a n d ot her u ni q ue i de ntifiers) w h o 
are dee me d i neli gi ble will n ot be rec or de d.  
1 3 . 1. 2 Decisi o n ai d  
Decisi o n ai ds ha ve pr o ve n efficac y at s u p p orti n g breast ca ncer s ur ger y decisi o ns a n d ca n 
be c o nsi dere d a n acce pta ble practice . Gi ve n t his, we will n ot o btai n d oc u me ntati o n of 
i nf or me d c o nse nt fr o m patie nts t o se n d t he m t he we b-base d decisi o n ai d after cli n ics cr oss 
o ver t o t he decisi o n ai d i nter ve nti o n.  Bei n g offere d t he decisi o n ai d d oes n ot c o nstit ute 
researc h i n t his st u d y. 
1 3 . 1. 3 P atie nts w h o decli ne t he decisi o n ai d  
C ollecti o n of li mite d de m o gr a p hics: F or all p atie nts w h o decli ne t he decisi o n ai d, site 
c o or di n at ors  will c ollect li mite d a d diti o n al i nf or m ati o n a b o ut t he m  ( me dical rec or d 
n u m ber, a ge, race, et h nicit y, i ns ura nce stat us, ZI P c o de + 4, a n d reas o n(s) w h y decli ne d) 
t o e ns ure we are n ot s yste maticall y e xcl u di n g certai n p o p ulati o ns fr o m o ur st u d y.  As t he 
decisi o n ai d is bei n g i m ple me nte d as a n acce pta ble practice i n t he cli nic, t hese patie nts 
ha ve n ot decli ne d researc h.  H o we ver, u n dersta n di n g de m o gra p hics of patie nts t hat decli ne 
t he decisi o n ai d al o n g wit h reas o ns w h y will greatl y i ncrease o ur u n dersta n di n g of h o w t o 
disse mi nate t his t y pe of i nter ve nti o n i n t he f ut ure a n d e ns ure it is n ot w orse ni n g dis parities. 
I n a d diti o n, t his i nf or mati o n will be use d t o p ur p osef ull y sa m ple f or t he tele p h o ne, vi de o, 
or i n -pers o n  i nter vie ws a d dressi n g Accessi bilit y Barriers. T he ZI P c o de + 4 will be use d 
t o ge nerate t he A DI. After t he tra nsf or mati o n i nt o t he A DI varia ble, t he ra w zi pc o de + 4 will 
be destr o ye d t o e ns ure n o P HI is sa ve d.  Gi ve n t he li mite d a m o u nt of i nf or mati o n t hat is 
c ollecte d, a w aiver of i nf or me d c o nse nt  will be re q ueste d f or t hese s u bjects. A wai ver of 
i nf or me d c o nse nt is re q ueste d beca use: 
•  
C ollecti n g me dical rec or d n u m ber, a ge, race, et h nicit y, ZI P c o de + 4, a n d reas o n(s) f or 
decli ni n g t he decisi o n ai d i n v ol ves n o m ore t ha n mi ni mal ris k beca use  t he pers o n 
accessi n g t he i nf or mati o n has u n der g o ne h u ma n s u bjects trai ni n g, a n d i nf or mati o n t hat 
will be rec or de d f or researc h p ur p oses is mi ni mal. T his data will be trac ke d t o i nf or m 
f ut ure i m ple me ntati o n a n d disse mi nati o n st u dies usi n g t his t o ol.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 4  
• 
C ol lecti n g me dical rec or d n u m ber, a ge, race, et h nicit y, i ns ura nce stat us, ZI P c o de + 4, 
a n d reas o n(s) f or decli ni n g t he decisi o n ai d will n ot a d versel y affect t he ri g hts or 
welfare of s u bjects beca use n o na mes or ot her u ni q ue i de ntifiers will be c ollecte d.  
• 
S pe n di n g t he ti me t o o btai n i nf or me d c o nse nt f or s uc h q uesti o ns w o ul d be a n 
u n necessar y b ur de n f or t he s u bjects at a n alrea d y stressf ul ti me. C ollecti n g t his data o n 
all patie nts w h o decli ne d t he decisi o n ai d is i m p orta nt i n or der f or t he i nf or mati o n t o 
b e mea ni n gf ul. 
P atie nt Tele p h o ne , Vi de o, or I n-pers o n  I nter vie ws: A s u bset of patie nts will be eli gi ble 
t o partici pate i n tele p h o ne i nter vie ws a d dressi n g Accessi bilit y Barriers if t he y eit her 1) 
decli ne d t he decisi o n ai d or 2) e x perie nce d access barriers i d e ntifie d t hr o u g h s ur ve y 
res p o nses.   
F or t he patie nt i nter vie ws assessi n g accessi bilit y barriers, we will re q uest a w aiver of 
d oc u me nt ati o n of i nf or me d c o nse nt  gi ve n t he l o w ris k nat ure of t hese acti vities. 
Partici pa nts i n eac h sessi o n will be pr o vi de d wit h a n i nf or mati o n s heet descri bi n g t he 
researc h, t heir partici pati o n, t he ris ks, p ossi ble be nefits, a n d all ot her re q uire d ele me nts of 
i nf or me d c o nse nt.  T his will be se nt eit her b y mail or e mail pri or t o t he i nter vie w. Beca use 
a si g ne d c o nse nt f or m w o ul d b e t he o nl y d oc u me ntati o n of t he partici pa nts’ i de ntities, we 
feel a wai ver of d oc u me ntati o n of i nf or me d c o nse nt is a p pr o priate. At ti me of t he i nter vie w, 
we will as k ver bal per missi o n t o rec or d pri or t o pr ocee di n g.  If a n i n di vi d ual decli nes t he 
a u di o rec or di n g, t he i nter vie w will pr ocee d wit h e x pa n de d fiel d n otati o n. Partici pa nts ma y 
dr o p o ut at a n y ti me bef ore, d uri n g, or after t he i nter vie w/f oc us gr o u p.  
1 3 . 1. 4 P atie nts w h o acce pt t he decisi o n ai d  
P atie nt Tele p h o ne , Vi de o, or I n-pers o n  I nter vie ws: Patie nts w h o acce pt t he decisi o n ai d 
b ut re p ort diffic ult y accessi n g it or t hat t he y di d n ot use it will be eli gi ble f or t he tele p h o ne 
i nter vie ws assessi n g accessi bilit y barriers.  F or t he patie nt i nter vie ws assessi n g 
accessi bilit y barriers, w e will re q uest a wai ver of d oc u me ntati o n of i nf or me d c o nse nt  gi ve n 
t he l o w ris k nat ure of t hese acti vities. Partici pa nts i n eac h sessi o n will be pr o vi de d wit h a n 
i nf or mati o n s heet descri bi n g t he researc h, t heir partici pati o n, t he ris ks, p ossi ble be nefits, 
a n d all ot her re q uire d ele me nts of i nf or me d c o nse nt; t his will be se nt eit her b y mail or 
email pri or t o t he i nter vie w. 
Beca use a si g ne d c o nse nt f or m w o ul d be t he o nl y 
d oc u me ntati o n of t he partici pa nts’ i de ntities, we feel a wai ver of d oc u me ntati o n of 
i nf orme d c o nse nt  is a p pr o priate. At ti me of t he i nter vie w, we will as k ver bal per missi o n t o 
rec or d pri or t o pr ocee di n g.  If a n i n di vi d ual decli nes t he a u di o rec or di n g, t he 
i nter vie w/f oc us gr o u p will pr ocee d wit h e x pa n de d fiel d n otati o n. Partici pa nts ma y dr o p 
o u t at a n y ti me bef ore, d uri n g, or after t he i nter vie w/f oc us gr o u p. 
P atie nt tele p h o ne, vi de o or i n-pers o n i nter vie ws a n d f oc us gr o u ps: Patie nts w h o 
partici pate i n t he a u di o -rec or di n g ( Secti o n 8. 3 ) ma y be eli gi ble f or patie nt i nter vie ws 
a n d/ or f oc us gr o u ps.   F or t he patie nt i nter vie ws a n d f oc us gr o u ps, we will re q uest a wai ver 
of d oc u me ntati o n of i nf or me d c o nse nt  gi ve n t he l o w ris k nat ure of t hese acti vities. 
Partici pa nts i n eac h of t hese sessi o ns will be pr o vi de d wit h a n i nf or mati o n s heet descri bi n g 
t he researc h, t heir partici pati o n, t he ris ks, p ossi ble be nefits, a n d all ot her re q uire d ele me nts 
of i nf or me d c o nse nt. Beca use a si g ne d c o nse nt f or m w o ul d be t he o nl y d oc u me ntati o n of 
t he partici pa nts’ i de ntities, we feel a wai ver of d oc u me ntati o n of i nf or me d c o nse n t is 
a p pr o priate. At ti me of t he i nter vie w, we will as k ver bal per missi o n t o rec or d pri or t o 
pr ocee di n g.  If a n i n di vi d ual decli nes t he a u di o rec or di n g, t he i nter vie w will pr ocee d wit h 
e x pa n de d fiel d n otati o n. If a n i n di vi d ual decli nes t he a u di o rec or di n g, t he y will n ot be 
eli gi ble f or partici pati o n i n t he f oc us gr o u p. Partici pa nts ma y dr o p o ut at a n y ti me bef ore, 
d uri n g, or after t he i nter vie w/f oc us gr o u p.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 5  
1 3. 2  W ai ver of ele me nts of i nf or me d c o nse nt — p atie nts  
We re q uest a wai ver of t he s pecific ele me nt of c o nse nt re gar di n g me dical i nj ur y t o patie nt.  T his 
st u d y d oes n ot i n v ol ve me dical treat me nt, a n d it is n ot e x pecte d t hat patie nts will s uffer me dical 
i nj ur y d ue t o partici pati o n i n t his trial.  We ha ve t heref ore re m o ve d t he “ W hat ha p pe ns if I a m 
i nj ure d beca use I t o o k part i n t his st u d y” secti o n of t he N CI M o del C o nse nt Te m plate.  O missi o n 
of t his i nf or mati o n d oes n ot c o nstit ute greater t ha n mi ni mal ris k a n d w o ul d n ot a d versel y affect 
t he patie nt. 
I n a d diti o n, patie nts will n ot be i nf or me d t hat the decisi o n ai d is part of t he researc h o bjecti ves 
of t his st u d y at t he ti me of i nf or me d c o nse nt.  O missi o n of t his i nf or mati o n d oes n ot c o nstit ute 
greater t ha n mi ni mal ris k a n d w o ul d n ot a d versel y affect t he patie nt.  Beca use t he st u d y 
meas ures t he effect  of t he decisi o n ai d o n patie nt e n ga ge me nt, it is necessar y t o o mit t he p ur p ose 
of t he st u d y i n t he i nf or me d c o nse nt d oc u me nt.  F oll o wi n g t heir partici pati o n i n t he st u d y, 
patie nts will be n otifie d t hat t he effect of decisi o n ai d use was a n o bjecti ve of t h e st u d y. 
Partici pa nts will be se nt a de briefi n g i nf or mati o n s heet b y mail at c o m pleti o n of t he st u d y.  
Fi nall y, we ha ve pr o vi de d o nl y t he “ St u d y Title f or Partici pa nts” i n t he M o del C o nse nt f or m f or 
t his st u d y.  T he “ Official St u d y Title f or I nter net Searc h o n C T. g o v” will be pr o vi de d u p o n 
patie nt c o m pleti o n of t he st u d y.  T his st u d y will be liste d o n cli nicaltials. g o v.  
1 3 .3  W ai vers of c o nse nt — s ur ge o ns a n d cli nic st aff 
S ur ge o ns : We will re q uest a wai ver of d oc u me ntati o n of i nf or me d c o nse nt  f or partici pati o n i n 
t he sta ke h ol der f oc us gr o u ps gi ve n t he l o w ris k nat ure of t he f oc us gr o u p. Partici pa nts i n eac h 
of t hese sessi o ns will be pr o vi de d wit h writte n i nf or mati o n descri bi n g t he researc h, t heir 
partici pati o n, t he ris ks, p ossi ble be nefits, a n d all ot her re q uire d ele me nts of i nf or me d c o nse nt. 
Beca use a si g ne d c o nse nt f or m w o ul d be t he o nl y d oc u me ntati o n of t he partici pa nts’ i de ntities, 
we feel a wai ver of d oc u me ntati o n of i nf or me d c o nse nt  is a p pr o priate. At ti me of t he f oc us 
gr o u p, we will as k ver bal per missi o n t o rec or d pri or t o pr ocee di n g.  If a n i n di vi d ual decli nes t he 
a u di o rec or di n g,  t he y will n ot be eli gi ble f or partici pati o n i n t he f oc us gr o u p. Partici pa nts ma y 
dr o p o ut at a n y ti me bef ore, d uri n g, or after t he f oc us gr o u p.  
Cli nic St aff : W e will re q uest a wai ver of d oc u me ntati o n of i nf or me d c o nse nt  f or partici pati o n 
i n t he i m ple me ntati o n acti vities (cli nic self-assess me nt w or ki n g sessi o n) a n d t he sta ke h ol der 
f oc us gr o u ps, gi ve n t he l o w ris k nat ure of t hese acti vities. Partici pa nts i n eac h of t hese sessi o ns 
will be pr o vi de d wit h writte n i nf or mati o n descri bi n g t he researc h, t heir partici pati o n, t he ris ks, 
p ossi ble be nefits, a n d all ot her re q uire d ele me nts of i nf or me d c o nse nt. Beca use a si g ne d c o nse nt 
f or m w o ul d be t he o nl y d oc u me ntati o n of t he partici pa nts’ i de ntities, we feel a wai ver of 
d oc u me ntati o n of i nf or me d c o nse nt  is a p pr o priate. At ti me of t he w or ki n g sessi o n a n d/ or f oc us 
gr o u p, we will as k ver bal per missi o n t o rec or d pri or t o pr ocee di n g.  If a n i n di vi d ual decli nes t he 
a u di o rec or di n g,  t he y will n ot be eli gi ble f or partici pati o n i n t he f oc us gr o u p. Partici pa nts ma y 
dr o p o ut at a n y ti me bef ore, d uri n g, or after t he sessi o n.  
1 3. 4  W ai ver of ele me nts of i nf or me d c o nse nt — s ur ge o ns 
We re q uest a wai ver of s pecific ele me nts of c o nse nt re gar di n g me dical treat me nt, me dical ris ks, 
c osts, a n d i nj ur y t o s ur ge o n partici pa nts.  T his st u d y d oes n ot i n v ol ve me dical treat me nt of 
s ur ge o ns, a n d t hese ele me nts of i nf or me d c o nse nt w o ul d n ot a p pl y t o s ur ge o ns partici pati n g i n 
t his st u d y.  We ha ve t heref ore re m ove d t hese secti o ns fr o m t he m o del c o nse nt f or m.  O missi o n 
of t his i nf or mati o n d oes n ot c o nstit ute greater t ha n mi ni mal ris k a n d w o ul d n ot a d versel y affect 
t he s ur ge o n partici pa nt. 
1 3 .5  Ot her pe o ple prese nt d uri n g a u di ot a pe d visits  
I n di vi d uals ot her t ha n t he patie nt a n d atte n di n g s ur ge o n ma y be prese nt d uri n g t he a u di ota pe d 
cli nic visit. T his i ncl u des fa mil y me m bers, resi de nts, n urses a n d me dical st u de nts. Alt h o u g h 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 6  
t he y are n ot st u d y partici pa nts, t he y will recei ve writte n n otificati o n t hat t he visit will be or is 
c urre ntl y bei n g rec or de d. We will all o w i n di vi d uals w h o d o n ot ver ball y a gree t o be a u di ota pe d 
t o ste p o ut of t he r o o m d uri n g t he ti me t he a u di o rec or der is o n. T his a p pr oac h has bee n 
pre vi o usl y use d wit h patie nts c o nsi deri n g hi g h ris k o perati o ns a n d it has bee n t olerate d well b y 
t heir c o m pa ni o ns a n d ot her cli nic staff. H o we ver, if i n di vi d uals w h o d o n ot ver ball y a gree t o be 
a u di ota pe d d o n ot wis h t o lea ve t he r o o m, we will n ot a u di o rec or d t he visit, o ut of se nsiti vit y 
t o t he patie nt's nee ds. 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 7  
1 4 . 0 R E F E R E N C E S  
1 . 
J ose p h-Willia ms N, El w y n G, E d war ds A. K n o wle d ge is n ot p o wer f or patie nts: a s yste matic 
re vie w a n d t he matic s y nt hesis of patie nt-re p orte d barriers a n d facilitat ors t o s hare d decisi o n 
ma ki n g. P atie nt E d uc C o u ns.  2 0 1 4; 9 4( 3): 2 9 1 -3 0 9.  
2 . 
D ura n d M A, Car pe nter L, D ola n H, et al. D o i nter ve nti o ns desi g ne d t o s u p p ort s hare d decisi o n -
ma ki n g re d uce healt h i ne q ualities? A s yste matic re vie w a n d meta -a nal ysis. P L o S O ne.  
2 0 1 4; 9( 4):e 9 4 6 7 0.  
3 . 
Os hi ma Lee E, E ma n uel EJ. S hare d decisi o n ma ki n g t o i m pr o ve care a n d re d uce c osts. N E n gl J 
Me d.  2 0 1 3; 3 6 8( 1): 6 -8.  
4 . 
Stace y D, Le gare F, C ol N F, et al. Decisi o n ai ds f or pe o ple faci n g healt h treat me nt or scree ni n g 
decisi o ns. C oc hr a ne D at a b ase Syst Rev.  2 0 1 4; 1: C D 0 0 1 4 3 1.  
5 . 
Tri kali n os T A, Wiela n d L S, A d a m G P, et al. Decisi o n Ai ds f or C a ncer Scree ni n g a n d Tre at me nt . 
R oc k ville ( M D) 2 0 1 4.  
6 . 
Waljee J F, R o gers M A, Al der ma n A K. Decisi o n ai ds a n d breast ca ncer: d o t he y i nfl ue nce c h oice 
f or s ur ger y a n d k n o wle d ge of treat me nt o pti o ns? J Cli n O nc ol.  2 0 0 7; 2 5( 9): 1 0 6 7 -1 0 7 3.  
7 . 
Fis her B, A n ders o n S, Br ya nt J, et al. T we nt y -year f oll o w -u p of a ra n d o mize d trial c o m pari n g 
t otal mastect o m y, l u m pect o m y, a n d l u m pect o m y pl us irra diati o n f or t he treat me nt of i n vasi ve 
breast ca ncer. N E n gl J Me d.  2 0 0 2; 3 4 7( 1 6): 1 2 3 3 -1 2 4 1.  
8 . 
Ver o nesi U, Casci nelli N, Maria ni L, et al. T we nt y -year f oll o w -u p of a ra n d o mize d st u d y 
c o m pari n g breast -c o nser vi n g s ur ger y wit h ra dical mastect o m y f or earl y breast ca ncer. N E n gl J 
Me d.  2 0 0 2; 3 4 7( 1 6): 1 2 2 7 -1 2 3 2.  
9 . 
Frisell A, La ger gre n J, de B o niface J. Nati o na l st u d y of t he i m pact of patie nt i nf or mati o n a n d 
i n v ol ve me nt i n decisi o n-ma ki n g o n i m me diate breast rec o nstr ucti o n rates. Br J S ur g.  
2 0 1 6; 1 0 3( 1 2): 1 6 4 0 -1 6 4 8.  
1 0 . 
Marti nez K A, Res nic o w K, Willia ms G C, et al. D oes p h ysicia n c o m m u nicati o n st yle i m pact 
patie nt re p ort of decisi o n q ualit y f or breast ca ncer treat me nt? P atie nt E d uc C o u ns.  
2 0 1 6; 9 9( 1 2): 1 9 4 7 -1 9 5 4.  
1 1 . 
Ma n del blatt J, Kreli n g B, Fi ge urie d o M, et al. W hat is t he i m pact of s hare d decisi o n ma ki n g o n 
treat me nt a n d o utc o mes f or ol der w o me n wit h breast ca ncer? J Cli n O nc ol.  2 0 0 6; 2 4( 3 0): 4 9 0 8 -
4 9 1 3.  
1 2 . 
Fr o n gill o M, Fei bel ma n n S, Bel k ora J, et al. Is t here s hare d decisi o n ma ki n g w he n t he pr o vi der 
ma kes a rec o m me n dati o n? P atie nt E d uc C o u ns.  2 0 1 3; 9 0( 1): 6 9 -7 3.  
1 3 . 
Ma n del blatt J S, Ber g C D, Mer o p ol NJ, et al. Meas uri n g a n d pre dicti n g s ur ge o ns' practice st yles 
f or breast ca ncer treat me nt i n ol der w o me n. Me d C are.  2 0 0 1; 3 9 ( 3): 2 2 8-2 4 2.  
1 4 . 
Gree n ber g C C, Sc h nei der E C, Li psitz S R, et al. D o variati o ns i n pr o vi der disc ussi o ns e x plai n 
s oci oec o n o mic dis parities i n p ost mastect o m y breast rec o nstr ucti o n? J A m C oll S ur g.  
2 0 0 8; 2 0 6( 4): 6 0 5 -6 1 5.  
1 5 . 
M orr o w M, Ja gsi R, Al der ma n A K, et al.  S ur ge o n rec o m me n dati o ns a n d recei pt of mastect o m y 
f or treat me nt of breast ca ncer. J A M A. 2 0 0 9; 3 0 2( 1 4): 1 5 5 1 -1 5 5 6.  
1 6 . 
C hristia n C K, Nila n d J, E d ge S B, et al. A m ulti -i nstit uti o nal a nal ysis of t he s oci oec o n o mic 
deter mi na nts of breast rec o nstr ucti o n: a st u d y of t he Nati o nal C o m pre he nsi ve Ca ncer Net w or k. 
A n n S ur g.  2 0 0 6; 2 4 3( 2): 2 4 1 -2 4 9.  
1 7 . 
Jac o bs L K, Kelle y K A, R oss o n G D, et al. Dis parities i n ur ba n a n d r ural mastect o m y p o p ulati o ns : 
t he effects of patie nt- a n d c o u nt y -le vel fact ors o n li keli h o o d of recei pt of mastect o m y. A n n S ur g 
O nc ol.  2 0 0 8; 1 5( 1 0): 2 6 4 4 -2 6 5 2.  
1 8 . 
La ut ner M, Li n H, S he n Y, et al. Dis parities i n t he Use of Breast -C o nser vi n g T hera p y A m o n g 
Patie nts Wit h Earl y -Sta ge Breast Ca ncer. J A M A S ur g. 2 0 1 5; 1 5 0( 8): 7 7 8 -7 8 6.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 8  
1 9 . 
Ja gsi R, Jia n g J, M o m o h A O, et al. Tre n ds a n d variati o n i n use of breast rec o nstr ucti o n i n patie nts 
wit h breast ca ncer u n der g oi n g mastect o m y i n t he U nite d States. J Cli n O nc ol.  2 0 1 4; 3 2( 9): 9 1 9 -
9 2 6.  
2 0 . 
Sisc o M, D u H, War ner J P, et al. Ha ve we e x pa n de d t he e q uita ble deli ver y of p ost mastect o m y 
breast rec o nstr ucti o n i n t he ne w mille n ni u m? E vi de nce fr o m t he nati o nal ca ncer data base. J A m 
C oll S ur g.  2 0 1 2; 2 1 5( 5): 6 5 8 -6 6 6; disc ussi o n 6 6 6.  
2 1 . 
M o yer A. Ps yc h os oc ial o utc o mes of breast-c o nser vi n g s ur ger y vers us mastect o m y: a meta -
a nal ytic re vie w. He alt h Psyc h ol.  1 9 9 7; 1 6( 3): 2 8 4 -2 9 8.  
2 2 . 
Ste ve ns L A, Mc Grat h M H, Dr uss R G, et al. T he ps yc h ol o gical i m pact of i m me diate breast 
rec o nstr ucti o n f or w o me n wit h earl y breast cancer. Pl astic a n d Rec o nstr uctive S ur gery.  
1 9 8 4; 7 3: 6 1 9 - 6 2 8.  
2 3 . 
Sc hai n W S. Breast rec o nstr ucti o n. U p date of ps yc h os ocial a n d pra g matic c o ncer ns. . C a ncer.  
1 9 9 1; 6 8: 1 1 7 0 - 1 1 7 5.  
2 4 . 
El der E E, Bra n d ber g Y, Bj or k u n d T, et al. Q ualit y of life a n d patie nt satis facti o n i n breast ca ncer 
patie nts after i m me diate brast rec o nstr ucti o n: a pr os pecti ve st u d y. Bre ast.  2 0 0 5; 1 4: 2 0 1 - 2 0 8.  
2 5 . 
Ja gsi R, Li Y, M orr o w M, et al. Patie nt-re p orte d Q ualit y of Life a n d Satisfacti o n Wit h C os metic 
O utc o mes After Breast C o nser vati o n a n d Mastect o m y Wit h a n d Wit h o ut Rec o nstr ucti o n: Res ults 
of a S ur ve y of Breast Ca ncer S ur vi v ors. A n n S ur g.  2 0 1 5; 2 6 1( 6): 1 1 9 8 -1 2 0 6.  
2 6 . 
Ja nz N K, M uja hi d M, La ntz P M, et al. P o p ulati o n-base d st u d y of t he relati o ns hi p of treat me nt 
a n d s oci o de m o gra p hics o n q ualit y of life f or earl y sta ge breast ca ncer. Q u al Life Res.  
2 0 0 5; 1 4( 6): 1 4 6 7 -1 4 7 9.  
2 7 . 
Gree n ber g C C, Li psitz S R, H u g hes M E, et al. I nstit uti o nal variati o n i n t he s ur gical treat me nt of 
breast ca ncer: a st u d y of t he N C C N. A n n S ur g.  2 0 1 1; 2 5 4( 2): 3 3 9 -3 4 5.  
2 8 . 
M uja hi d M S, Ja nz N K, Ha wle y S T, et al. T he i m pact of s oci o de m o gra p hic, treat me nt, a n d w or k 
s u p p ort o n misse d w or k after breast ca ncer dia g n osis. Bre ast C a ncer Res Tre at.  2 0 1 0; 1 1 9( 1): 2 1 3 -
2 2 0.  
2 9 . 
Ha wle y S T, Fa gerli n A, Ja nz N K, et al. Racial/et h nic dis parities i n  k n o wle d ge a b o ut ris ks a n d 
be nefits of breast ca ncer treat me nt: d oes it matter w here y o u g o? He alt h Serv Res.  
2 0 0 8; 4 3( 4): 1 3 6 6 -1 3 8 7.  
3 0 . 
Free d ma n R A, K o uri E M, West D W, et al. Racial/ Et h nic Dis parities i n K n o wle d ge A b o ut O ne's 
Breast Ca ncer C haracteristics.  C a ncer.  2 0 1 5; 1 2 1( 5): 7 2 4 -7 3 2.  
3 1 . 
Ja nz N K, M uja hi d M S, Ha wle y S T, et al. Racial/et h nic differe nces i n a de q uac y of i nf or mati o n 
a n d s u p p ort f or w o me n wit h breast ca ncer. C a ncer.  2 0 0 8; 1 1 3( 5): 1 0 5 8 -1 0 6 7.  
3 2 . 
Katz SJ, La ntz P M, Ja nz N K, et al. Patie nt i n v ol ve me n t i n s ur ger y treat me nt decisi o ns f or breast 
ca ncer. J Cli n O nc ol.  2 0 0 5; 2 3( 2 4): 5 5 2 6 -5 5 3 3.  
3 3 . 
P olace k G N, Ra m os M C, Ferrer R L. Breast ca ncer dis parities a n d decisi o n -ma ki n g a m o n g U. S. 
w o me n. P atie nt E d uc C o u ns.  2 0 0 7; 6 5( 2): 1 5 8 -1 6 5.  
3 4 . 
Mal y R C, Stei n J A, U me za wa Y, et al. Racial/et h nic differe nces i n breast ca ncer o utc o mes 
a m o n g ol der patie nts: effects of p h ysicia n c o m m u nicati o n a n d patie nt e m p o wer me nt. He alt h 
Psyc h ol.  2 0 0 8; 2 7( 6): 7 2 8 -7 3 6.  
3 5 . 
Bel k ora J K, V olz S, Te n g A E, et al. I m pact of decisi o n ai ds i n a s u stai ne d i m ple me ntati o n at a 
breast care ce nter. P atie nt E d uc C o u ns.  2 0 1 2; 8 6( 2): 1 9 5 -2 0 4.  
3 6 . 
Ge ntles SJ, Stace y D, Be n nett C, et al. Fact ors e x plai ni n g t he heter o ge neit y of effects of patie nt 
decisi o n ai ds o n k n o wle d ge of o utc o me pr o ba bilities: a s yste matic  re vie w s u b-a nal ysis. Syst Rev.  
2 0 1 3; 2: 9 5.  
3 7 . 
H off ma n A S, V ol k RJ, Saari ma ki A, et al. Deli veri n g patie nt decisi o n ai ds o n t he I nter net: 
defi niti o ns, t he ories, c urre nt e vi de nce, a n d e mer gi n g researc h areas. B M C Me d I nf or m Decis 
M ak.  2 0 1 3; 1 3 S u p pl 2: S 1 3.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
5 9  
3 8 . 
Si n ha G. Decisi o n ai ds hel p patie nts b ut still are n ot wi del y use d. J N atl C a ncer I nst.  
2 0 1 4; 1 0 6( 7).  
3 9 . 
El w y n G, Sc h oll I, Tiet b o hl C, et al. " Ma n y miles t o g o ...": a s yste matic re vie w of t he 
i m ple me ntati o n of patie nt decisi o n s u p p ort i nter ve nti o ns int o r o uti ne cli nical practice. B M C Me d 
I nf or m Decis M ak. 2 0 1 3; 1 3 S u p pl 2: S 1 4.  
4 0 . 
Brace C, Sc h m oc ker S, H ua n g H, et al. P h ysicia ns' A ware ness a n d Attit u des T o war d Decisi o n 
Ai ds f or Patie nts Wit h Ca ncer. J o ur n al of Cli nic al O nc ol o gy.  2 0 1 0; 2 8( 1 3): 2 2 8 6 -2 2 9 2.  
4 1 . 
Gra ha m I D, L o ga n J, O' C o n n or A, et al. A q ualitati ve st u d y of p h ysicia ns' perce pti o ns of t hree 
decisi o n ai ds. P atie nt E d uc C o u ns.  2 0 0 3; 5 0( 3): 2 7 9 -2 8 3.  
4 2 . 
O' D o n nell S, Cra n ne y A, Jac o bse n MJ, et al. U n dersta n di n g a n d o verc o mi n g t he barriers of 
i m ple me nti n g patie nt decisi o n ai ds i n cli nical practice. J Ev al Cli n Pr act.  2 0 0 6; 1 2( 2): 1 7 4 -1 8 1.  
4 3 . 
Sil via K A, Oza n ne E M, Se p uc ha K R. I m ple me nti n g breast ca ncer decisi o n ai ds i n c o m m u nit y 
sites: barriers a n d res o urces. He alt h Ex pect.  2 0 0 8; 1 1( 1): 4 6 -5 3.  
4 4 . 
Sil via K A, Se p uc ha K R. Decisi o n ai ds i n r o uti ne practice: less o ns fr o m t he breast ca ncer 
i nitiati ve. He alt h Ex pect.  2 0 0 6; 9( 3): 2 5 5 -2 6 4.  
4 5 . 
H ol mes -R o v ner M, Vala de D, O rl o ws ki C, et al. I m ple me nti n g s hare d decisi o n-ma ki n g i n r o uti ne 
practice: barriers a n d o p p ort u nities. He alt h Ex pect.  2 0 0 0; 3( 3): 1 8 2 -1 9 1.  
4 6 . 
C harles C, Gaf ni A, W hela n T. Self -re p orte d use of s hare d decisi o n-ma ki n g a m o n g breast ca ncer 
s pecialists a n d percei ve d barriers a n d facilitat ors t o i m ple me nti n g t his a p pr oac h. He alt h Ex pect.  
2 0 0 4; 7( 4): 3 3 8 -3 4 8.  
4 7 . 
Le gare F, Ratte S, Gra vel K, et al. Barriers a n d facilitat ors t o i m ple me nti n g s hare d decisi o n -
ma ki n g i n cli nical practice: u p date of a s yste matic re vie w of healt h pr ofessi o nals' perce pti o ns. 
P atie nt E d uc C o u ns.  2 0 0 8; 7 3( 3): 5 2 6 -5 3 5.  
4 8 . 
Fei bel ma n n S, Ya n g T S, Uz o gara E E, et al. W hat d oes it ta ke t o ha ve s ustai ne d use of decisi o n 
ai ds? A pr o gra m me e val uati o n f or t he Breast Ca ncer I nitiati ve. He alt h Ex pect.  2 0 1 1; 1 4 S u p pl 
1: 8 5 -9 5.  
4 9 . 
O' C o n n or A M, Lle well y n -T h o mas H A, Fl o o d A B. M o dif yi n g u n warra nte d variati o ns i n healt h 
care: s hare d decisi o n ma ki n g usi n g patie nt decisi o n ai ds. He alt h Aff ( Mill w o o d).  2 0 0 4; S u p pl 
Variati o n: V A R 6 3 -7 2.  
5 0 . 
El w y n G, Ri x A, H olt T, et al. W h y d o cli nicia ns n ot refer patie nts t o o nli ne decisi o n s u p p ort 
t o ols? I nter vie ws wit h fr o nt li ne cli nics i n t he N H S. B MJ O pe n.  2 0 1 2; 2( 6).  
5 1 . 
Bates D W, K u per ma n GJ, Wa n g S, et al. Te n c o m ma n d me nts f or effecti ve cli nical decisi o n 
s u p p ort: ma ki n g t he practice of e vi de nce -base d me dici ne a realit y. J A m Me d I nf or m Ass oc.  
2 0 0 3; 1 0( 6): 5 2 3 -5 3 0.  
5 2 . 
Lee CJ, Ra mírez A S, Le wis N, et al. L o o ki n g be y o n d t he I nter net: e xa mi ni n g s oci oec o n o mic 
i ne q ualities i n ca ncer i nf or mati o n see ki n g a m o n g ca ncer patie nts. He alt h C o m m u n . 
2 0 1 2; 2 7( 8): 8 0 6 -8 1 7.  
5 3 . 
Perri n A, D u g ga n M. " A merica ns' I nter net Access: 2 0 0 0 -2 0 1 5." Pe w Researc h Ce nter. 2 0 1 5.  
5 4 . 
Br uce J G, T uc h ol ka J L, Steffe ns N M, et al. Feasi bilit y of pr o vi di n g we b -base d i nf or mati o n t o 
breast ca ncer patie nts pri or t o a s ur gical c o ns ult. J C a ncer E d uc.  2 0 1 7;I n press.  
5 5 . 
Kil b o ur ne A M, Ne u ma n n M S, Pi nc us H A, et al. I m ple me nti n g e vi de nce -base d i nter ve nti o ns i n 
healt h care: a p plicati o n of t he re plicati n g effecti ve pr o gra ms fra me w or k. I m ple me nt Sci. 
2 0 0 7; 2: 4 2.  
5 6 . 
Bel k ora J K, Miller M F , D o u g hert y K, et al. T he nee d f or decisi o n a n d c o m m u nicati o n ai ds: a 
s ur ve y of breast ca ncer s ur vi v ors. J C o m m u nity S u p p ort O nc ol.  2 0 1 5; 1 3( 3): 1 0 4 -1 1 2.  
5 7 . 
Hac k T F, De g ner L F, Par ker P A. T he c o m m u nicati o n g oals a n d nee ds of ca ncer patie nts: a 
re vie w. Psyc h o o nc ol o gy.  2 0 0 5; 1 4( 1 0): 8 3 1 -8 4 5; disc ussi o n 8 4 6 -8 3 7.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 0  
5 8 . 
Waltz TJ, P o well BJ, Matt hie u M M, et al. Use of c o nce pt ma p pi n g t o c haracterize relati o ns hi ps 
a m o n g i m ple me ntati o n strate gies a n d assess t heir feasi bilit y a n d i m p orta nce: res ults fr o m t he 
E x pert Rec o m me n dati o ns f or I m ple me nti n g C ha n ge ( E RI C) st u d y. I m ple me nt Sci. 
2 0 1 5; 1 0( 1): 1 0 9.  
5 9 . 
Ki n d AJ, Je nc ks S, Br oc k J, et al. Nei g h b or h o o d s oci oec o n o mic disa d va nta ge a n d 3 0 -da y 
re h os pitalizati o n: a retr os pecti ve c o h ort st u d y. A n n I nter n Me d.  2 0 1 4; 1 6 1( 1 1): 7 6 5 -7 7 4.  
6 0 . 
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6 2 . 
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6 3 . 
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7 2 . 
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Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 1  
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8 1 . 
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htt p:// w w w. w 3. or g/ T R/ W C A G 2 0/ . Accesse d Fe br uar y 2 8, 2 0 1 7.  
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8 3 . 
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P u blicati o ns.  
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8 6 . 
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2 0 0 1; 3 5 8( 9 2 8 0): 4 8 3 -4 8 8.  
9 0 . 
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9 1 . 
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9 2 . 
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9 3 . 
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9 4 . 
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9 5 . 
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w hat are we tal ki n g a b o ut? Ac a d E mer g Me d.  2 0 1 3; 2 0( 5): 4 4 1 -4 4 8.  
9 6 . 
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J P hysi ot her.  2 0 1 7.  
9 7 . 
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9 8 . 
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9 9 . 
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E d uc C o u ns.  2 0 1 2; 8 7( 1): 1 2 5 -1 3 0.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 2  
1 0 0 . 
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1 0 1 . 
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1 0 6 . 
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T h o usa n d Oa ks, Calif or nia: S A G E P u blicati o ns, I nc.  
1 0 7 . 
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1 0 8 . 
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2 0 0 5; 1 5( 9): 1 2 7 7 -1 2 8 8.  
 
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 3  
1 5. 0  M O D E L IN F O R M E D C O N S E N T F O R P A TI E N T S  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 4  
St u d y Title f or P artici p a nts: I ncre asi n g P atie nts’ E n g a ge me nt i n Bre ast C a ncer 
S ur ger y Decisi o n -M a ki n g  
 
 
O ver vie w a n d Ke y I nf or m ati o n  
 
W h at a m I bei n g as ke d t o d o ?  
 
We are as ki n g y o u t o ta k e part i n a researc h st u d y.  T his st u d y has p u blic f u n di n g fr o m t he 
Nati o nal Ca ncer I nstit ute ( N CI), part of t he Nati o n al I nstit utes of Healt h ( NI H) i n t he U nite d 
States De part me nt of Healt h a n d H u ma n Ser vices. We d o res earc h st u dies t o tr y t o a ns wer 
q uesti o ns a b o ut h o w t o pre ve nt, dia g n ose, a n d treat diseases li ke ca ncer.  
 
We are as ki n g y o u t o ta k e part i n t his researc h st u d y beca use y o u ha ve a n a p p oi nt me nt wit h y o ur 
s ur ge o n t o disc uss treat m e nt f or breast ca n cer. 
 
 
Ta ki n g p art i n t his st u d y is y o ur c h oice.  
 
Y o u ca n c h o os e t o ta ke p art or y o u ca n c h o ose n ot t o ta ke  part i n t his st u d y.  Y o u als o ca n 
c ha n ge y o ur mi n d at a n y ti me.  W hate ver c h oice y o u ma ke, y o u will n ot l ose access t o y o ur 
me dical care or gi ve u p a n y le gal ri g hts or be nefits.  
 
T his d oc u me nt has i m p orta nt i nf or mati o n t o hel p y o u ma ke y o ur c h oice. Ta ke t i me t o rea d it.  
Tal k t o t he st u d y staff, y o ur fa mil y, or frie n ds a b o ut t he ris ks a n d be nefits of ta ki n g part i n t he 
st u d y.  It’s i m p orta nt t hat y o u ha ve as m uc h i nf or mati o n as y o u nee d a n d t hat all y o ur q uesti o ns 
are a ns were d.  See t he “ W here ca n I get m o re i nf or mati o n?” secti o n f or res o urces f or m ore 
cli nical trials a n d ge neral ca ncer i nf or mati o n.  
 
 
W h y is t his st u d y bei n g d o ne ?  
 
T his st u d y is bei n g d o ne t o a ns wer t he f oll o wi n g q uesti o n:  
 
H o w ca n w e best hel p p atie nts a n d t heir s ur ge o ns ma ke decisi o ns a b o ut br east ca ncer s ur ger y? 
 
We are d oi n g t his st u d y beca use we w a nt t o better u n dersta n d h o w t o s u p p ort patie nts i n ma ki n g 
t heir decisi o n a b o ut breast ca ncer s ur ger y. 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 5  
 
W h at is t he us u al a p pro ac h t o m y di a g n osis ?  
 
T he us ual a p pr o ac h f or patie nts w h o are n ot i n a st u d y is t o get a d vice a b o ut breast ca n cer 
s ur ger y fr o m t heir d oct or.   
 
 
W h at are m y c h oices if I deci de n ot t o t a ke p art i n t his st u d y ?  
 
• 
Y o u ma y c h o ose t o ha v e t he us ual a p pr oac h descri be d a b o ve.  
• 
Y o u ma y c h o ose t o ta ke part i n a differe nt r esearc h st u d y, if o ne is a vaila ble.  
 
 
W h at will h a p pe n if I deci de t o t a ke p art i n t his st u d y ?  
 
If y o u deci d e t o ta ke part i n t his st u d y, y o u will be as ke d t o c o m plete s ur ve ys bef ore a n d aft er 
y o ur a p p oi nt me nt wit h y o ur s ur ge o n. Y o u will als o be as ke d f or per missi o n t o a u di o -rec or d t he 
c o n versati o n bet w ee n y o u a n d y o ur s ur ge o n.  We e x pect y o ur p artici pati o n will last less t ha n 3 
wee ks.   
 
S o me st u d y partici pa nts will be c o ntacte d at t he ver y e n d of t h e st u d y a n d as ke d t o partici pat e i n 
a n o pti o nal o ne -o n -o n e i nter vie w or f oc us gr o u p. Y o u ca n deci de at t hat ti me w het her y o u wa nt 
t o partici pate i n t hat i nter vie w. 
 
 
W h at are t he ris ks a n d be nefits of t a ki n g p art i n t his st u d y ?
 
 
T here are b ot h ris ks a n d be nefits t o ta ki n g part i n t his st u d y.  It is i m p orta nt f or y o u t o t hi n k 
caref ull y a b o ut t hese as y o u ma ke y o ur decisi o n.  
 
Ris ks  
 
Y o u ma y ha ve t he f oll o wi n g disc o mf orts:  
• 
Be as ke d se nsiti ve or pri vate q uesti o ns a b o ut t hi n gs y o u n or mall y d o n ot disc uss.  
 
M ore s pecifi call y:  
• 
Y o u ma y feel a n xi o us k n o wi n g t he c o n versati o n wit h y o ur s ur ge o n is bei n g rec or de d or 
fi n d it har d t o e x press all of y o ur c o ncer ns beca us e of t he prese n ce of a n a u di o rec or der. 
If y o u feel u nc o mf orta bl e a b o ut bei n g a u di o rec or de d after t he rec or di n g h as be g u n, tell 
t he s ur ge o n a n d h e or s he will i m me diatel y st o p t he rec or di n g.  
• 
It is als o p ossi ble t hat y o u ma y ha ve s o me a n xi et y fr o m a ns weri n g q uesti o ns a b o ut y o ur 
treat me nt decisi o n d uri n g t he s ur ve ys wit h st u dy staff. We rec o g nize t h at t his is a 
se nsiti ve s u bject a n d s o me pe o ple w o ul d pr efer n ot t o tal k a b o ut t hese iss ues. If y o u feel 
u nc o mf orta ble or ner v o us w hile c o m pleti n g t he s ur ve ys, tell t he st u d y staff a n d he or s he 
will i m me diatel y st o p t he s ur ve y. I n a d diti o n, y o u ma y s ki p a n y q uesti o ns o n t he s ur ve ys 
t hat y o u feel u nc o mf orta ble a ns weri n g. 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 6  
• 
Lastl y, t here is a s mall ris k t hat y o ur st u d y i nf or mati o n c o ul d bec o me k n o w n t o s o me o ne 
w h o is n ot i n v ol ve d i n perf or mi n g or m o nit ori n g t his st u d y. H o we ver, we ma ke  e ver y 
eff ort t o pr otect y o ur pri v ac y.  
 
 
Be nefits  
 
Y o u are n ot e x pecte d t o ha ve a n y dir ect me dical be nefit fr o m partici pati n g i n t his st u d y.  
 
H o we ver, it ma y hel p t he st u d y d oct ors lear n m ore a b o ut h o w s ur ge o ns a n d patie nts ma ke 
decisi o ns a b o ut breast ca ncer s ur g er y.  T his st u d y ma y hel p t he st u d y d oct ors lear n t hi n gs t hat 
ma y hel p ot her pe o ple i n t he f ut ure.  
 
 
If I deci de t o t a ke p art i n t his st u d y, c a n I st o p l ater ? 
 
Yes, y o u ca n d eci de t o st o p ta ki n g part i n t he st u d y at a n y ti me.  
 
If y o u deci d e t o st o p, let y o ur st u d y d oct or k n o w as s o o n as p ossi ble. Y o u als o ma y c h o ose t o 
st o p partici pati o n or s ki p a n y q uesti o ns i n t he s ur ve ys t hat y o u d o n ot feel c o mf orta ble 
a ns weri n g.  
 
Y o ur st u d y d oct or will tell y o u a b o ut ne w i nf or mati o n or c ha n ges i n t he  st u d y t hat ma y affect 
y o ur healt h or y o ur willi n g ness t o c o nti n ue i n t he st u d y.  
 
 
Are t here ot her re as o ns w h y I mi g ht st o p bei n g i n t he st u d y ?  
 
Yes.  T he st u d y d oct or m a y ta ke y o u off t he st u d y if:  
 
• 
T he st u d y is st o p pe d b y t he Nati o nal Ca ncer I nstit ute ( N CI), I nstit uti o nal Re vie w B oar d 
(I R B), or st u d y s p o ns or (t he Allia nce).  T h e st u d y s p o ns or is t he or ga nizati o n w h o 
o versees t he st u d y.   
• 
Y o ur healt h c h a n ges a n d t he st u d y is n o l o n ger i n y o ur best i nterest.  
 
T his st u d y is c o n d ucte d b y t he Allia nce f or Cli nical Trials i n O nc ol o g y, a nati o nal cli nical 
researc h gr o u p s u p p orte d b y t he Nati o nal Ca ncer I nstit ute. T he Allia nce is ma de u p of ca ncer 
d oct ors, healt h pr ofessi o nals, a n d la b orat or y researc hers, w h ose g oal is t o d e vel o p better 
treat me nts f or ca ncer, t o pre ve nt c a ncer, t o re d u ce si de effects fr o m ca ncer, a n d t o i m pr o ve t he 
q ualit y of life of ca n cer patie nts.  
 
 
It is i m p ort a nt t h at y o u u n derst a n d t he i nf or m ati o n i n t he i nf or me d c o nse nt bef ore m a ki n g 
y o ur decisi o n.  Please rea d, or ha ve s o me o n e rea d t o y o u, t he rest of t his d oc u me nt. If t here is 
a n yt hi n g y o u d o n’t u n dersta n d, be s ure t o as k y o ur st u d y staff or n urse.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 7  
W h at is t he p ur p ose of t his st u d y ?  
 
T his st u d y is bei n g d o ne t o lear n a b o ut h o w patie nts a n d t heir s ur ge o ns ma k e decisi o ns a b o ut 
breast c a ncer s ur ger y.  We are d oi n g t his st u d y beca use we wa nt better u n d ersta n d h o w t o 
s u p p ort patie nts i n ma ki n g t he decisi o n a b o ut breast ca ncer s ur ger y.  
 
T here will be a b o ut 6 2 5  patie nts ta ki n g part i n t his st u d y.  
 
 
W h at are t he st u d y gro u ps ?
 
 
All pat ie nts i n t his st u d y will recei ve t he us u al a p pr oac h of care, w hic h is t o get a d vice a b o ut 
breast c a ncer treat me nt fr o m t heir d oct or.  
 
 
W h at proce d ures are i n v ol ve d i n t his st u d y ?  
 
If y o u s pea k E n glis h a n d deci de t o ta ke p art i n t his st u d y, y o u will be as ked t o c o m plete t w o 
s ur ve ys. T he first s ur ve y will ta ke place bef ore y o ur a p p oi nt me nt wit h y o ur s ur ge o n.  T his 
s ur ve y will be c o m plete d i n-pers o n a n d is e x p ecte d t o ta ke 5 t o 1 0 mi n utes t o fi nis h.  T he sec o n d 
s ur ve y will ta ke place aft er y o ur a p p oi nt me nt with t he s ur ge o n.  T he s ec o n d s ur ve y will be se nt 
t o y o u b y e mail wit hi n a fe w da ys of t he s ur ge o n a p p oi nt me nt.  Y o u als o ha ve t he o pti o n of 
c o m pleti n g it o ver t he p h o ne or o n pa p er , if y o u prefer.  T h e sec o n d s ur ve y will ta ke 1 0 t o 2 0 
mi n utes t o fi nis h.  
 
Si n ce t hese s ur ve ys are b ei n g use d f or researc h, t h e res p o nses y o u pr o vi de will n ot be s hare d 
wit h y o ur d oct or. If y o u ha ve a n y seri o us healt h iss ues or ot her c o n cer ns, please tal k wit h y o ur 
d oct or or n urse ri g ht a wa y.  
 
We will als o a u di o -rec or d t he c o nser vati o n bet wee n y o u a n d y o ur s ur ge o n.  We are as ki n g t o 
a u di o rec or d t he c o n v ers ati o n wit h y o ur s ur ge o n beca use t his will be a pri vate c o n versati o n 
bet wee n y o u a n d y o ur s ur ge o n. St u d y staff will liste n t o t he rec or di n g a n d t y pe t he e ntire 
c o n versati o n. T he t y p e d c o n versati o n will n ot i ncl u de y o ur na me or a n y ot her i nf or mati o n t hat 
c o ul d i de ntif y y o u. Y o ur s ur ge o n will ne ver hear t he a u di o rec or di n g. O nl y st u d y staff will hear 
t he a u di o rec or di n g.  T he a u di o file will be destr o ye d w he n t he st u d y is c o m plete d. 
 
S t u d y staff will re vie w y o ur me dical c hart. We are d oi n g t his o nl y t o c ollect:  
o  
De m o gra p hic i nf or mati o n (s uc h as a g e)  
o  
I nf or mati o n rel ate d t o t he e val uati o n a n d treat me nt of breast c a ncer 
o  
I nf or mati o n a b o ut ot her relate d healt h c o n diti o ns  
 
S o me st u d y partici pa nts will be c o ntacte d at t he ver y e n d of t h e st u d y after we ha ve fi nis he d t he 
pr oce d ures descri be d i n t his c o nse nt f or m a n d as k e d t o partici pate i n a n o pti o nal o ne -o n -o ne 
i nter vie w or f oc us gr o u p. Y o u ca n deci de at t hat ti me w het her y o u wa nt t o partici pate i n t he 
i nter vie w or f oc us gr o u p. 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 8  
Researc h ers will use t his i nf or mati o n t o better u n dersta n d h o w t o s u p p ort p atie nts i n ma ki n g t he 
decisi o n a b o ut breast ca n cer s ur g er y.  
 
A n ot her wa y t o fi n d o ut w hat will ha p pe n t o y o u d uri n g t his st u d y is t o rea d t he c hart bel o w. 
Start rea di n g at t he left si de a n d rea d acr oss t o t he ri g ht, f oll o wi n g t he li nes a n d arr o ws.  
 
 
 
W h at are m y res p o nsi bilities i n t his st u d y ?  
 
If y o u c h o ose t o ta k e part i n t his st u d y, y o u will nee d t o:  
 
•  All o w st u d y staff t o a u di o rec or d t h e c o n versati o n bet wee n y o u a n d y o ur s ur ge o n.  
 
•  C o m plete t w o 1 0 -1 5 mi n ute s ur ve ys.  
o  Bef ore t o da y’s a p p oi nt me nt (i n -pers o n), a n d  
o  After t o da y’s a p p oi nt me nt (eit her b y e mail, o ver t he p h o ne, or  i n-p ers o n)  
 
 
W h at are t he c osts of t a ki n g p art i n t his st u d y ?  
 
Y o u a n d/ or y o ur i ns ura n ce pla n will nee d t o p a y f or t he c osts of me dical care y o u get as p art of 
t he st u d y, j ust as y o u w o ul d if y o u were g etti n g t he us ual care f or y o ur ca n cer.   
 
Ta ki n g part i n t his st u d y ma y mea n t hat y o u nee d t o ma ke m ore visits t o t he  cli nic or h os pital 
t ha n if y o u were getti n g t he us ual a p pr o ac h t o treat y o ur ca ncer.  Y o u ma y: 
 
• 
Ha ve m ore tra vel c osts.  
• 
Nee d t o ta ke m or e ti me off w or k.  
• 
Ha ve ot her a d diti o nal pers o nal c osts.  
 
T here are n o e x pect e d c osts t o y o u f or ta ki n g part i n t hi s st u d y. 
Y o u will recei ve a gift car d e q ui vale nt t o $ 1 0 f or a u di o rec or di n g t he c o n versati o n wit h y o ur 
s ur ge o n a n d t he c o m pleti o n of t he first s ur ve y. Y o u will t he n recei ve a n a d diti o nal gift car d 
e q ui vale nt t o $ 1 0 f or c o m pleti o n of t he sec o n d s ur ve y. T he ma xi m u m c o m pe nsati o n f or 
partici pati o n i n t his st u d y is $ 2 0.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
6 9  
W h o will see m y me dic al i nf or m ati o n ?  
 
Y o ur pri vac y is v er y i m p orta nt t o us.  T he st u d y d oct ors will ma ke e ver y eff ort t o pr otect it.  
H o we ver, s o me of y o ur me dical i nf or mati o n ma y be gi ve n o ut if re q uir e d b y la w.  If t his s h o ul d 
ha p pe n, t he st u d y d oct ors will d o t heir best t o ma ke s ure t hat a n y i nf or mati o n t hat g oes o ut t o 
ot hers will n ot i de ntif y w h o y o u are.  
 
S o me of y o ur healt h i nf or mati o n, s uc h as i nf or mati o n relate d t o t he e v al uati o n a n d tr eat me nt of 
y o ur breast c a ncer, will b e ke pt b y t he st u d y s p o ns or i n a ce ntr al res earc h d ata base.  If 
i nf or mati o n fr o m t his st u d y is p u blis he d or prese nte d at scie ntific meeti n gs, y o ur na me a n d ot her 
pers o nal i nf or mati o n will n ot be use d.  
 
I n or der f or t he st u d y researc h ers at t he U ni versit y of Wisc o nsi n t o be a ble t o c o ntact y o u a b o ut 
p ossi bl y partici pati n g i n t he tele p h o ne or i n -pers o n i nter vie ws a n d/ or f o c us gr o u ps, it will be 
necessar y f or y o u t o pr o vi de y o ur na me, a d dress, a n d tele p h o ne n u m ber. Y o ur c o ntact 
i nf or mati o n will be ke pt o nl y f or t he d urati o n of t he st u d y. I n a d diti o n, if y o u c h o ose t o c o m plete 
t he f oll o w u p q uesti o n naire b y e mail, we will as k y o u t o pr o vi de y o ur e mail a d dress f or o ur 
data base s o t hat w e ca n se n d y o u t he li n k t o t he s ur ve y.  
 
T here are or ga niz ati o ns t hat ma y l o o k at or recei v e c o pies of s o me of t he i nf or mati o n i n y o ur 
st u d y rec or ds.  Y o ur healt h i nf or mati o n i n t he researc h dat a base als o ma y b e s hare d wit h t hese 
or ga nizati o ns.  T he y m ust kee p y o ur i nf or mati o n pri vate, u nless re q uir e d b y la w t o gi ve it t o 
a n ot her gr o u p.   
 
S o me of t hese or ga niz ati o ns are:  
 
• 
T he st u d y s p o ns or ( Allia nce)  
• 
U ni versit y of Wisc o nsi n ( U W) a n d U ni versit y of Te xas ( U T), w here st u d y data will be 
st ore d a n d/ or a n al yze d. 
• 
T he  N CI Ce ntral  I R B, w hic h is a gr o u p of pe o ple w h o re vie w t h e res earc h wit h t he g oal 
of pr otecti n g t he pe o pl e w h o ta ke part i n t he st u d y.  
• 
T he N CI a n d t he gr o u ps it w or ks wit h t o re vie w researc h.  
• 
T he N CI’s Nati o nal Cli nical Trials Net w or k a n d t h e gr o u ps it w or ks wit h  t o c o n d uct 
researc h  
 
Y o ur st u d y rec or ds als o will be st ore d f or f ut ure use.  H o we v er, y o ur na me a n d ot her p ers o nal 
i nf or mati o n will n ot be use d.  S o me t y pes of f ut ur e researc h m a y i ncl u de l o o ki n g at y o ur rec or ds 
a n d t h ose of ot her patie nts.  H o we ver, ri ght n o w we d o n’t k n o w w hat r esearc h ma y be d o ne i n 
t he f ut ure usi n g y o ur i nf or mati o n.  T his mea ns t hat: 
 
• 
Y o u will n ot be as ke d if y o u a gree t o ta k e part i n t he s pecific f ut ure researc h st u dies 
usi n g y o ur healt h i nf or m ati o n.   
• 
Y o u a n d y o ur s ur g e o n will n ot be t ol d w he n or w hat t y pe of res earc h will be d o ne.  
• 
Y o u will n ot get re p orts or ot her i nf or mati o n a b o ut a n y researc h t hat is d o ne usi n g y o ur 
i nf or mati o n.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 0  
W here c a n I get m ore i nf or m ati o n ?  
 
 
Y o u ma y visit t he N CI w e b site at htt p://ca ncer. g o v/ f or m ore i nf or mati o n a b o ut st u dies or 
ge neral i nf or mati o n a b o ut ca ncer.  Y o u ma y als o call t he N CI Ca n cer I nf or mati o n Ser vice t o get 
t he sa me i nf or mati o n at: 
 
 
A descri pti o n of t his cli nical trial will be a vaila bl e o n 
 as re q uire d 
b y U. S. La w.  T his We b site will n ot i ncl u de i nf or mati o n t hat ca n i de ntif y y o u.  At m ost, t he 
We b site will i ncl u de a s u m mar y of t he res ults.  Y o u ca n searc h t his We b site at a n y ti me.  
 
Y o u ca n tal k t o t he st u d y staff a b o ut a n y q uesti o ns or c o ncer ns y o u ha v e a b o ut t his st u d y.  
C o ntact t he st u d y staff ( *i nsert na me of st u d y staff *) at ( *i nsert tele p h o ne n u m ber, a n d e mail 
a d dress if a p pr o priate *) . 
 
F or q uesti o ns a b o ut y o ur ri g hts w hile i n t his st u d y, call t he ( *i nsert na m e of or ga nizati o n or 
ce nter *) I nstit uti o nal Re vie w B oar d at ( *i nsert tele p h o ne n u m ber *).  
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 1  
M y si g n at ure a greei n g t o t a ke p art i n t he st u d y  
 
I h a ve rea d t his c o nse nt f or m or ha d it rea d t o me.  I h a ve disc usse d it wit h t he st u d y d oct or a n d 
m y q uesti o ns ha ve bee n a ns were d.  I will be gi ve n a si g ne d a n d date d c o p y of t his f or m.  I a gree 
t o ta ke part i n t he mai n st u d y.  
 
 
P artici p a nt’s si g n at ure  
 
 
 
 
Date of si g nat ur e  
 
 
 
 
Si g n at ure of pers o n(s) c o n d ucti n g t he i nf or me d c o nse n t disc ussi o n 
 
 
 
 
Date of si g nat ur e  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 2  
1 6. 0  M O D E L IN F O R M E D C O N S E N T F O R S U R G E O N S  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 3  
Title of St u d y: I ncre asi n g P atie nts’ E n g a ge me nt i n Bre ast C a ncer S ur ger y Decisi o n 
M a ki n g T hro u g h a S h are d Decisi o n M a ki n g I nter ve nti o n  
 
W h y a m I bei n g as k e d t o p artici p ate ? 
Y o u are i n vite d t o partici pate beca use y o u r o uti nel y assist i n t he care of t h ose patie nts ne wl y 
dia g n ose d wit h breast c a ncer. T his st u d y will e nr oll a t otal of 2 0 -3 0 s ur ge o ns, 1 0 cli nic staff a n d 
6 2 5  patie nts acr oss m ulti ple sites i n t he U nite d States. A p pr o xi matel y 2 -3 s ur ge o ns a n d 1 0 9 
patie nts will be e nr olle d at t his i nstit uti o n.  
 
T his st u d y is c o n d ucte d b y t he Allia nce f or Cli nical Trials i n O nc ol o g y, a nati o nal cli nical 
researc h gr o u p s u p p orte d b y t he Nati o nal Ca ncer I nstit ute. T he Allia nce is ma de u p of ca ncer 
d oct ors, healt h pr ofessi o nals, a n d la b orat or y researc hers, w h ose g oal is t o d e vel o p better 
treat me nts f or ca ncer, t o pre ve nt c a ncer, t o re d u ce si de effects fr o m ca ncer, a n d t o i m pr o ve t he 
q ualit y of life of ca n cer patie nts.  
 
W h y is t his st u d y bei n g d o ne ? 
T he o bjecti ve of t his st u d y is t o test t he effecti ve n ess of a decisi o n ai d i n i ncreasi n g p atie nt 
e n ga ge me nt i n S D M ( S h are d D ecisi o n Ma ki n g) a n d i de ntif y barriers t o e n ga ge me nt n ot 
miti gate d b y t he decisi o n ai d t hat c o ul d be tar g et s f or a dj u nct S D M i nter ve nti o ns. 
 
W h at will m y p artici p ati o n i n v ol ve ?  
If y o u deci d e t o partici pate i n t his researc h st u d y, y o u will be as ke d t o parti ci pate i n a n i nitial 
assess me nt meeti n g t o i de ntif y p ossi ble barriers a n d facilitat ors of t he i m ple me ntati o n of t he 
decisi o n ai d a n d c o m plet e o ne baseli ne s ur ve y bef ore patie nt e nr oll me nt be gi ns. T his s ur ve y will 
as k a b o ut y o ur attit u des t o war ds s hare d decisi o n ma ki n g. O nce patie nt e nr oll me nt be gi ns, y o u 
will be as ke d t o ha ve y o ur c o n vers ati o n a b o ut s ur gical tr eat me nt o pti o ns wit h e nr olle d patie nts 
a u di o rec or de d. Patie nts ma y o pt o ut of t his a u di o rec or di n g.  Y o ur patie nts will g o o n t o 
c o m plete t w o s h ort s ur ve ys.  
 
At a cert ai n ti me p oi nt i n t he st u d y, y o u a n d y o ur cli nic will t he n be as ke d t o m o ve i nt o t he 
i nter ve nti o n ar m. O nce i n t he i nter ve nti o n gr o u p, we will se n d all y o ur ne w patie nts w h o will be 
prese nti n g f or a n a p p oi nt me nt t o disc uss treat me nt decisi o ns o ur i nter ve nti o n, a breast ca ncer 
s ur ge o n decisi o n ai d. A g ai n, y o u will be as ke d t o ha ve y o ur c o n vers ati o n a b o ut s ur gical 
treat me nt o pti o ns wit h e nr olle d patie nts a u di o rec or de d. T h ose p atie nts will als o c o m plete t w o 
s h ort s ur ve ys a n d p ossi bl y partici pate i n a n a d diti o nal i nter vie w a n d/ or f oc us gr o u p.  
 
T he deter mi nati o n of w h e n y o u a n d y o ur cli nic will m o ve o ver t o t he i nter ve nti o n gr o u p will be 
ra n d o mize d. Pleas e n ote t hat o nce y o u cr oss o v er t o t he decisi o n ai d i nter v e nti o n ar m, y o ur r ole 
i n t he st u d y will n ot c ha n ge a n d y o u will c o nti n ue wit h y o ur us ual practice f or seei n g patie nts. 
O verall, we will e n r oll a p pr o xi matel y 1 0 9 of y o ur patie nts t hr o u g h o ut a 2-year peri o d. Y o ur 
partici pati o n will re q uire a b o ut 2 a d diti o nal h o urs f or partici pati o n i n t he i m ple me ntati o n 
acti vities a b o ut 1 h o ur), s ur ve ys (a b o ut 1 0 mi n utes) a n d t he a u di o -rec or di n gs. 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 4  
S o me s ur ge o ns will be c o ntacte d at t he ver y e n d of t he st u d y after we ha v e fi nis he d t he 
pr oce d ures descri be d i n t his c o nse nt f or m a n d as k e d t o partici pate i n a n o pti o nal f oc us gr o u p. 
Y o u ca n deci de at t hat ti me w het her y o u wa nt t o partici pate i n t he i nter vie w or f oc u s gr o u p. 
 
W h at are t he ris ks of t a ki n g p art i n t his st u d y ?  
T here is a ris k t hat y o ur st u d y i nf or mati o n c o ul d bec o me k n o w n t o s o me o ne w h o is n ot i n v ol ve d 
i n perf or mi n g or m o nit ori n g t his st u d y. It is als o p ossi ble t hat y o u ma y feel a n xi o us fr o m 
k n o wi n g t he c o n vers ati o ns wit h y o ur patie nts are bei n g rec or de d a n d y o u  ma y feel y o u are 
u na ble t o e x press all of y o ur c o ncer ns beca use of t he prese n ce of a rec or der. If y o u feel 
u nc o mf orta ble a b o ut bei n g a u di o rec or de d after t he rec or di n g has be g u n, y o u ma y st o p t he a u di o 
rec or der at a n y ti me.  
 
If t here are a n y patie nts y o u feel s h o ul d n ot partici pate i n t he st u d y, y o u will ha ve t he 
o p p ort u nit y t o tell st u d y staff t o e xcl u de t h e m fr o m t he st u d y a n d t he y will n ot be a p pr oac he d b y 
st u d y staff. Lastl y, t here is a ris k t hat w he n y o u cr oss i nt o t he i nter ve nti o n ar m a n d patie nts be gi n 
usi n g t he i nter ve nti o n t hat y o ur c o n versati o ns wit h t hese patie nts ma y ta ke a bit l o n ger t ha n 
us ual d ue t o i ncrease d patie nt partici pati o n.   
 
A ris k f or y o ur p atie nts is de vel o pi n g s o me a n xiet y or cli nical q uesti o ns fr o m partici pati n g i n t he 
s ur ve ys a n d i nter vie w a n d/ or f oc us gr o u p wit h st u d y staff. T here is a c h a nce t he y will wa nt t o 
s pea k wit h y o u or a me m ber of y o ur care tea m aft er a st u d y s ur ve y or i nter vie w. If t his re q uir es 
a n offic e visit or p h o ne call, y o u will n ot  be a ble t o c har ge a fee if it is c o v ere d u n der t he gl o bal 
pa y me nt f or s ur g er y.  
 
W h at are t he be nefits of t a ki n g p art i n t his st u d y ?  
Y o u are n ot e x pecte d t o be nefit directl y fr o m partici pati n g i n t his st u d y. Y o ur partici pati o n i n 
t his researc h st u d y ma y benefit ot her pe o ple i n t he f ut ure b y hel pi n g us lear n m ore a b o ut breast 
ca ncer s ur ger y decisi o n ma ki n g bet wee n s ur ge o ns a n d patie nts.  
 
Will I be p ai d f or m y p artici p ati o n ?  
Y o u will n ot recei ve a n y c o m pe nsati o n f or y o ur partici pati o n i n t he st u d y.  
 
H o w will m y c o nfi de nti alit y be protecte d ?  
C o n versati o ns t hat are rec or de d t hr o u g h o ut y o ur partici pati o n will be tra nscri be d a n d c o d e d wit h 
a st u d y I D n u m ber. O nl y st u d y staff a n d trai ne d tra nscri pti o nists will ha ve access t o t he a u di o 
files. All i de ntif yi n g i nf or mati o n will be re dacte d i n t he writte n tra nscri pt. T he a u di o files will be 
destr o ye d o nce t he st u d y is c o m plete.  Retai ne d data (tra nscri pts a n d s ur ve ys) will be de -
i de ntifie d o nce dat a c ollecti o n is c o m plete.  
 
W hile t here will li kel y be p u blicati o ns as a res ult of t his st u d y, y o ur na me will n ot be use d. O nl y 
gr o u p c haracteristics will be p u blis he d.  
If y o u partici pat e i n t his st u d y, we w o ul d li ke t o be a ble t o q u ote t he w or ds y o u ha ve use d 
wit h o ut usi n g y o ur na me. If y o u a gree t o all o w us t o q u ote y o u i n p u blicati o ns, please i nitial t he 
state me nt at t he b ott o m of t his f or m. 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 5  
A descri pti o n of t his cli nical trial will be a vaila bl e o n 
 as re q uire d 
b y U. S. La w.  T his We b site will n ot i ncl u de i nf or mati o n t hat ca n i de ntif y y o u.  At m o st, t he 
We b site will i ncl u de a s u m mar y of t he res ults.  Y o u ca n searc h t his We b site at a n y ti me.  
 
W h at if I h a ve q uesti o ns or c o ncer ns ?  
If y o u ha ve a n y q uesti o ns a b o ut t his st u d y at a n y ti me, c o ntact t he site Pri nci pal I n vesti gat or [ PI 
N A M E] at [ PI P H O N E  N U M B E R].  
 
If y o u are n ot satisfie d wit h t he res p o nse of t he researc h t ea m, ha ve m ore q uesti o ns, or wa nt t o 
tal k wit h s o me o ne a b o ut y o ur ri g hts as a researc h partici pa nt, c o ntact t he [ SI T E P A TI E N T 
R E L A TI O N S R E P R E S E N T A TI V E] at [ P H O N E N U M B E R].  
 
  
Y o ur partic i pati o n is c o m pletel y v ol u ntar y. If y o u deci de n ot t o partici pat e or t o wit h dra w fr o m 
t he st u d y it will ha ve n o effect o n a n y ser vices or treat me nt y o u are c urre ntl y recei vi n g or gi vi n g 
or y o ur pr ofessi o nal sta n di n g.  
 
Y o ur si g nat ure i n dicat es t hat y o u ha ve  rea d t his c o nse nt f or m, ha d a n o p p ort u nit y t o as k a n y 
q uesti o ns a b o ut y o ur partici pati o n i n t his researc h a n d v ol u ntaril y c o nse nt t o partici pate. Y o u 
will recei ve a c o p y of t his f or m f or y o ur rec or ds.  
 
Partici pa nt Na me ( pl ease pri nt ): __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Si g nat ure of Partici pa nt  
 
 
 
 
 
Date  
 
I gi ve m y p er missi o n t o be q u ote d directl y i n p u blicati o ns wit h o ut usi n g m y na me. 
 
   I nitials 
 
 
 
 
Y O U WI L L R E C EI V E A C O P Y O F T HI S F O R M A F T E R SI G NI N G I T.  
 
Si g nat ure of pers o n o btai ni n g c o nse nt:  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Si g nat ure  
 
 
 
 
 
 
Date  
 
F U T U R E R E S E A R C H  
I n t he f ut ure, ot her res earc hers ma y fi n d it val ua bl e t o use t he tra nscri pts of t he a u di o rec or de d 
c o n versati o n o btai ne d fr o m t his st u d y. W hile we are o nl y i ntereste d i n t he c o n versati o n t o 
a nal yze h o w patie nts ma ke treat me nt decisi o ns t hat are t he best f or t he m, ot her i n vesti gat ors ma y 
be i nt ereste d i n differe nt parts of t he visit bet wee n patie nts a n d s ur ge o ns, f or e xa m ple, h o w d o 
s ur ge o ns as k patie nts a b o ut t heir pr o ble ms or h o w d o s ur ge o ns c o mf ort t heir patie nts. Beca us e 

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Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 6  
t he tra nscri pts of t he a u di ota pes ha ve p ossi ble val u e t o ot her res earc hers, we w o ul d li ke y o ur 
per missi o n t o let ot her researc h ers use t hes e tra ns cri pts f or f ut ure res earc h st u dies. T hese 
researc hers w o ul d n ot ha ve a n y i nf or mati o n a b o ut w h o y o u are. 
 
I gi ve m y p er missi o n f or t he use of t he de-i de ntifie d tra nscri pts f or f ut ure researc h: 
 
_ _ _ _ _ _ Y E S  
 
_ _ _ _ _ _ N O  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 7  
A P P E N DI X I:  U S U A L  C A R E  –  P A TI E N T B A S E LI N E S U R V E Y  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 8  
 
 
 
Y o u h a ve bee n gi ve n a b o o klet t o c o m plete f or t his st u d y.   T he b o o klet c o nt ai ns s o me q uesti o ns we 
w o ul d li ke t o as k y o u bef ore y o u meet wit h y o ur s ur ge o n.  
 
 
 
1.  Directi o ns o n h o w t o c o m plete eac h set of q uesti o ns are writte n o n t he t o p of eac h set.  
 
2.  Y o u will be gi ve n t he site c o or di nat or’s na me a n d tele p h o ne n u m ber.  Y o u ca n call a n y ti me 
wit h a n y c o ncer ns or q uesti o ns.  
 
3.  It is ver y i m p orta nt t hat y o u ret ur n t he b oo klet t o us.  
 
4.  Please ha n d t he c o m plete d s ur ve y t o t he site c o or di nat or.  
 
 
 
 
 
T h a n k y o u f or t a ki n g t he ti me t o hel p us.  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
7 9  
P A TI E N T B A S E LI N E ( T 0) S U R V E Y —  U S U A L C A R E  
Rese arc h C o or di n at or: T ha n k y o u f or a greei n g t o partici pate i n t he st u d y. I j ust ha ve a fe w s h ort q uesti o ns 
I w o ul d li ke t o as k y o u bef ore y o u meet wit h y o ur s ur ge o n. T his s h o ul d ta ke a b o ut 5 t o 1 0 mi n utes t o 
c o m plete. A n d bef ore we get starte d wit h t h ose q uesti o ns, I j ust ha ve fe w t hi n gs I w o ul d li ke t o me nti o n. 
First, y o ur d oct ors a n d n urse s k n o w t hat y o u are hel pi n g us wit h t his researc h b ut t he y will n ot be a ble t o 
hear or see y o ur res p o nses t o t he q uesti o ns I a m g oi n g t o as k y o u. Sec o n d, t his is n ot a q uiz; t here is n o 
ri g ht or wr o n g a ns wer, I a m j ust i ntereste d heari n g y o ur t h o u g hts a n d feeli n gs. Lastl y, if y o u feel 
u nc o mf orta ble at a n y ti me, please let me k n o w. Y o ur partici pati o n i n t his st u d y is v ol u ntar y, a n d y o u d o 
n ot ha ve t o a ns wer a n y q uesti o ns t hat y o u d o n ot wa nt t o.  
A n y q uesti o ns bef ore we start?  
Great. E ver y pers o n is differe nt  w he n it c o mes t o h o w i n v ol ve d t he y are i n ma ki n g me dical decisi o ns. F or 
e xa m ple, s o me pe o ple sa y, “I’ d rat her ha ve d oct ors ma ke t he decisi o ns a b o ut w hat’s best t ha n f or t he 
d oct ors t o gi ve me c h oices” a n d s o me pe o ple sa y “I’ d rat her be gi ve n c h oices a b o ut  w hat’s best f or m y 
healt h t ha n t o ha ve t he d oct or ma ke t he decisi o ns f or me.”  
1.  
W hat is y o ur prefere nce f or ma ki n g decisi o ns a b o ut y o ur healt h care?  
 
 I prefer t o ma ke t he decisi o n a b o ut w hic h treat me nt I will recei ve. 
 I prefer t o ma ke t he fi nal decisi o n a b o ut m y treat me nt after seri o usl y c o nsi deri n g m y d oct or’s o pi ni o n.  
 I prefer t hat m y d oct or a n d I ma ke t he decisi o n t o get her a b o ut w hic h treat me nt is best f or me. 
 I prefer t hat t he d oct or ma kes t he fi nal decisi o n a b o ut treat me nt t hat will be use d, w hile seri o usl y c o nsi deri n g 
m y o pi ni o n.  
 I prefer lea vi n g all decisi o ns a b o ut m y treat me nt t o m y d oct ors. 
 
2.  O n a scale fr o m 0 t o 1 0, w here 1 0 mea ns e xtre mel y well -i nf or me d a n d 0 mea ns n ot i nf or me d at 
all, h o w i nf or me d d o y o u feel a b o ut s ur gical o pti o ns f or y o ur breast ca ncer? 
N ot at all  
i nf or me d 
 
 
 
 
 
 
 
 
E xtre mel y  
well -i nf or me d 
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 0  
T his set of q uesti o ns i ncl u des s o me reas o ns ot her w o me n ha ve gi ve n f or c h o osi n g t heir breast ca ncer 
s ur ger y. We are i ntereste d i n w hat is i m p orta nt t o y o u. O n a scale fr o m 0 t o 1 0, h o w i m p orta nt are eac h of 
t he f oll o wi n g t o y o u as y o u c o nsi der differe nt s ur ger y o pti o ns f or y o ur breast ca ncer? 
H o w i m p orta nt is it t o y o u t o …  
 
N ot at all 
i m p ort a nt 
 
 
 
 
 
 
 
E xtre mel y 
I m p ort a nt 
3.  
kee p y o ur breast?  
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
4.  
re m o ve y o ur 
e ntire breast i n 
atte m pt t o gai n 
peace of mi n d?  
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
5.  
a v oi d ha vi n g 
ra diati o n 
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
6.  
(If y o u c urre ntly h ave a prefere nce t o tre at y o ur e arly st a ge bre ast c a ncer ), w hic h treat me nt d o y o u prefer?  
 
 I a m n ot s ure 
 L u m pect o m y a n d ra diati o n  
 L u m pect o m y o nl y  
 Mastect o m y  
 Ot her s ur ger y  
 
Ot her S ur ger y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
7.  
Ha ve y o u met wit h y o ur o nc ol o gist t o disc uss treat me nt o pti o ns pri or t o t his visit wit h t he s ur ge o n?   
 Yes  
 N o  
 
(If yes), w h o di d y o u meet wit h?  
 A n ot her s ur ge o n  
 Me dical o nc ol o gist  
 Ra diati o n o nc ol o gist  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 1  
 
 
8.  
Di d y o u re vie w a n y i nf or mati o n bef ore c o mi n g t o see y o ur s ur ge o n t o da y?  
 Yes  
 N o  
 
(If yes), w hat t y pes of i nf or mati o n di d y o u re vie w bef ore meeti n g y o ur s ur ge o n?  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
(If yes), h o w m uc h ti me di d y o u s pe n d re vie wi n g t he i nf or mati o n? 
 Less t ha n 1 5 mi n utes  
 1 5 - 6 0 mi n utes  
 M ore t ha n 1 h o ur  
 
 
(If n o), ca n y o u tell me w h y y o u di d n ot re vie w a n y i nf or mati o n? 
       _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
       _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
If p atie nt is u ncert ai n, offer c ate g ories t o see if t h at pr o m pts a res p o nse: 
 I sa w m y s ur ge o n ver y q uic kl y after m y dia g n osis 
 I di d n’t l o o k f or a n y  
 I was feeli n g t o o stresse d 
 Ot her _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 2  
9.  
Di d y o u ha ve a n y tr o u ble fi n di n g i nf or mati o n?  
 Yes  
 N o  
 
(If yes), ca n y o u tell me w hat was har d a b o ut it?  
       _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
       _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 0.  H o w c o nfi de nt are y o u filli n g o ut me dical f or ms b y y o urself?  
 N ot at all  
 A little bit  
 S o me w hat  
 Q uite a bit  
 E xtre mel y  
1 1.  
H o w ofte n d o y o u ha ve s o me o ne hel p y o u rea d h os pital materials?   
 Al wa ys  
 Ofte n  
 S o meti mes  
 Occasi o nall y  
 Ne ver  
1 2.  
H o w ofte n d o y o u ha ve pr o ble ms lear ni n g a b o ut y o ur me dical c o n diti o n beca use of diffic ult y u n dersta n di n g 
writte n i nf or mati o n?  
 Al wa ys  
 Ofte n  
 S o meti mes  
 Occasi o nall y  
 Ne ver  
 
 
 
 
 

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8 3  
1 3.   W hat is t he preferre d e mail a d dress f or us t o se n d t he f oll o w -u p s ur ve y?  
N O T E:  T his i nf or m ati o n will be e ntere d i nt o t he R a ve electr o nic d at a e ntr y s yste m o n t he 
P atie nt St at us: B aseli ne f or m b y c o or di n at or, a n d use d o nl y b y a we b ser vice t o se n d y o u t h e 
li n k f or t he f oll o w-u p s ur ve y.  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 4.  W hat is t he preferre d maili n g a d dress f or us t o se n d t he i nce nti ve after y o u c o m plete t he f oll o w -u p 
s ur ve y? 
N O T E:  T his i nf or m ati o n bel o w will N O T be e ntere d i nt o t he R a ve electr o nic d at a e ntr y 
s yste m. 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 4  
A P P E N DI X II:  I N T E R V E N TI O N –  P A TI E N T B A S E LI N E S U R V E Y  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 5  
 
 
 
Y o u h a ve bee n gi ve n a b o o klet t o c o m plete f or t his st u d y.   T he b o o klet c o nt ai ns s o me q uesti o ns we 
w o ul d li ke t o as k y o u bef ore y o u meet wit h y o ur s ur ge o n.  
 
 
 
1.  Directi o ns o n h o w t o c o m plete eac h set of q uesti o ns are writte n o n t he t o p of eac h set.  
 
2.  Y o u will be gi ve n t he site c o or di nat or’s na me a n d tele p h o ne n u m ber.  Y o u ca n cal l a n y ti me 
wit h a n y c o ncer ns or q uesti o ns.  
 
3.  It is ver y i m p orta nt t hat y o u ret ur n t he b o o klet t o us. 
 
4.  Please ha n d t he c o m plete d s ur ve y t o t he site c o or di nat or.  
 
 
 
 
 
T h a n k y o u f or t a ki n g t he ti me t o hel p us.  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 6  
P A TI E N T B A S E LI N E ( T 0) S U R V E Y —  I N T E R V E N TI O N  
Rese arc h C o or di n at or: T ha n k y o u f or a greei n g t o partici pate i n t he st u d y. I j ust ha ve a fe w s h ort q uesti o ns 
I w o ul d li ke t o as k y o u bef ore y o u meet wit h y o ur s ur ge o n. T his s h o ul d ta ke a b o ut 5 t o 1 0 mi n utes t o 
c o m plete. A n d bef ore we get starte d wit h t h ose q uesti o ns, I j ust ha ve fe w t hi n gs I w o ul d li ke t o me nti o n. 
First, y o ur d oct ors a n d n urses k n o w t hat y o u are hel pi n g us wit h t his researc h b ut t he y will n ot be a ble t o 
hear or see y o ur res p o nses t o t he q uesti o ns I  a m g oi n g t o as k y o u. Sec o n d, t his is n ot a q uiz; t here is n o 
ri g ht or wr o n g a ns wer, I a m j ust i ntereste d heari n g y o ur t h o u g hts a n d feeli n gs. Lastl y, if y o u feel 
u nc o mf orta ble at a n y ti me, please let me k n o w. Y o ur partici pati o n i n t his st u d y is v ol u ntar y, a n d y o u d o 
n ot ha ve t o a ns wer a n y q uesti o ns t hat y o u d o n ot wa nt t o.  
 
A n y q uesti o ns bef ore we start?  
 
Great. E ver y pers o n is differe nt w he n it c o mes t o h o w i n v ol ve d t he y are i n ma ki n g me dical decisi o ns. F or 
e xa m ple, s o me pe o ple sa y, “I’ d rat her ha ve d oct or s ma ke t he decisi o ns a b o ut w hat’s best t ha n f or t he 
d oct ors t o gi ve me c h oices” a n d s o me pe o ple sa y “I’ d rat her be gi ve n c h oices a b o ut w hat’s best f or m y 
healt h t ha n t o ha ve t he d oct or ma ke t he decisi o ns f or me.”  
1.  W hat is y o ur prefere nce f or ma ki n g decisi o ns a b o ut y o ur healt h care?  
 
 I prefer t o ma ke t he decisi o n a b o ut w hic h treat me nt I will recei ve. 
 I prefer t o ma ke t he fi nal decisi o n a b o ut m y treat me nt after seri o usl y c o nsi deri n g m y d oct or’s o pi ni o n. 
 I prefer t hat m y d oct or a n d I ma ke t he decisi o n t o get her a b o ut w hic h treat me nt is best f or me.  
 I prefer t hat t he d oct or ma kes t he fi nal decisi o n a b o ut treat me nt t hat will be use d, w hile seri o usl y c o nsi deri n g 
m y o pi ni o n.  
 I prefer lea vi n g all decisi o ns a b o ut m y treat me nt t o m y d oct ors. 
2.  O n a scale fr o m 0 t o 1 0, w here 1 0 mea ns e xtre mel y well -i nf or me d a n d 0 mea ns n ot i nf or me d at all, 
h o w i nf or me d d o y o u feel a b o ut s ur gical o pti o ns f or y o ur breast ca ncer?  
N ot at all  
i nf or me d 
 
 
 
 
 
 
 
 
E xtre mel y  
well -i nf or me d 
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 7  
T his set of q uesti o ns i ncl u des s o me reas o ns ot her w o me n ha ve gi ve n f or c h o osi n g t heir breast ca ncer 
s ur ger y. We are i ntereste d i n w hat is i m p orta nt t o y o u. O n a scale fr o m 0 t o 1 0, h o w i m p orta nt are eac h of 
t he f oll o wi n g t o y o u as y o u c o nsi der differe nt s ur ger y o pti o ns f or y o ur breast ca ncer? 
H o w i m p orta nt is it t o y o u t o . . .  
 
N ot at all 
i m p ort a nt 
 
 
 
 
 
 
 
E xtre mel y 
I m p ort a nt 
3.  kee p y o ur breast?  
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
4.  
re m o ve y o ur 
e ntire breast i n 
atte m pt t o gai n 
peace of mi n d?  
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
5.  
a v oi d ha vi n g 
ra diati o n 
 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
6.  
(If y o u c urre ntly h ave a prefere nce t o tre at y o ur e arly st a ge bre ast c a ncer), w hic h treat me nt d o y o u prefer?  
 
 I a m n ot s ure 
 L u m pect o m y a n d ra diati o n  
 L u m pect o m y o nl y  
 Mastect o m y  
 Ot her s ur ger y 
 
Ot her  s ur ger y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
7.  
Ha ve y o u met wit h y o ur o nc ol o gist t o disc uss treat me nt o pti o ns pri or t o t his visit wit h t he s ur ge o n?   
 
 Yes  
 N o  
 
(If yes), w h o di d y o u meet wit h?  
 A n ot her s ur ge o n  
 Me dical o nc ol o gist  
 Ra diati o n o nc ol o gist  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
8.  Di d t he cli nic offer t o se n d y o u a we bsite t o re vie w bef ore c o mi n g t o see y o ur s ur ge o n t o da y?  
 Yes  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 8  
 N o  
 
If y o u a ns were d “ Yes ” t o q uesti o n # 8, ple ase c o nti n ue bel o w.    
 
If y o u a ns were d “ N o ” t o q uesti o n # 8, ple ase pr ocee d directly t o q uesti o n # 1 5. 
 
 
9.  Di d y o u a gree t o ha ve t he m se n d t he we bsite t o y o u t o re vie w?    
 Yes  
 N o  
 
If y o u a ns were d “ Yes ” t o q uesti o n # 9, ple ase c o nti n ue bel o w.    
 
If y o u a ns were d “ N o ” t o q uesti o n # 9, ple ase pr ocee d directly t o q uesti o n # 1 5. 
 
1 0.  Were y o u a ble t o re vie w t he we bsite se nt t o y o u bef ore c o mi n g t o see y o ur s ur ge o n t o da y?  
 Yes  
 N o  
 
(If yes), h o w m uc h ti me di d y o u s pe n d re vie wi n g t h e we bsite t hat was se nt t o y o u?  
 Less t ha n 1 5 mi n utes  
 1 5 - 6 0 mi n utes  
 M ore t ha n 1 h o ur  
 
(If n o), w h y di d y o u n ot re vie w t he we bsite? 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
If p atie nt is u ncert ai n, offer c ate g ories t o see if t h at pr o m pts a res p o nse: 
 I sa w m y s ur ge o n ver y q uic kl y after recei vi n g we bsite 
 I di d n’t ha ve i nter net access bet wee n w he n I recei ve d t he we bsite a n d w he n I sa w m y s ur ge o n 
 I di d n’t recei ve t he e mail 
 I c o ul d n’t ma ke t he li n k t o t he we bsite w or k 
 I was feeli n g t o o stresse d 
 I di d n’t t hi n k I nee de d a n y i nf or mati o n  
 Ot her _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 1.  Di d y o u ha ve a n y tr o u ble o pe ni n g or usi n g t he we bsite?  
 Yes  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
8 9  
 N o  
        
(If yes), ca n y o u tell me w hat was har d a b o ut it?  
       _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
       _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 2.  
Di d y o u li ke getti n g t he we bsite se nt t o y o u b y e mail? 
 Yes  
 N o  
 
(If n o), w hat di d y o u n ot li ke a b o ut it?  
        _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
        _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
1 3.  
O n a scale of 0 t o 1 0, w here 1 0 mea ns ver y hel pf ul a n d 0 mea ns n ot at all hel pf ul, h o w hel pf ul di d y o u fi n d t he 
breast ca ncer we bsites t hat were e maile d t o y o u?  
 
N ot at all hel pf ul  
 
 
 
 
 
             Ver y hel pf ul  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
 
1 4.  
W o ul d y o u rec o m me n d recei vi n g breast ca ncer i nf or mati o n via e mail t o ot her patie nts w h o are faci n g t he 
decisi o n f or breast ca ncer s ur ger y?  
 I w o ul d rec o m me n d it 
 I d o n’t ha ve a n o pi ni o n o ne wa y or t he ot her  
 I w o ul d n ot rec o m me n d it 
 
1 5.   H o w c o nfi de nt are y o u filli n g o ut me dical f or ms b y y o urself?  
 N ot at all  
 A little bit  
 S o me w hat  
 Q uite a bit  
 E xtre mel y  
  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 0  
 
1 6.  H o w ofte n d o y o u ha ve s o me o ne hel p y o u rea d h os pital materials?   
 Al wa ys  
 Ofte n  
 S o meti mes  
 Occasi o nall y  
 Ne ver  
1 7.  H o w ofte n d o y o u ha ve pr o ble ms lear ni n g a b o ut y o ur me dical c o n diti o n beca use of diffic ult y u n dersta n di n g 
writte n i nf or mati o n? 
 Al wa ys  
 Ofte n  
 S o meti mes  
 Occasi o nall y  
 Ne ver  
 
1 8.  W hat is t he preferre d e mail a d dress f or us t o se n d t he f oll o w -u p s ur ve y?  
N O T E:  T his i nf or m ati o n will be e ntere d i nt o t he R a ve electr o nic d at a e ntr y s yste m o n t he 
P atie nt St at us: B aseli ne f or m b y c o or di n at or, a n d use d o nl y b y a we b ser vice t o se n d y o u t he 
li n k f or t he f oll o w-u p s ur ve y.  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 9.  W hat is t he preferre d maili n g a d dress f or us t o se n d t he i nce nti ve after y o u c o m plete t he f oll o w -u p 
s ur ve y? 
N O T E:  T his i nf or m ati o n bel o w will N O T be e ntere d i nt o t he R a ve electr o nic d at a e ntr y 
s yste m. 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 1  
A P P E N DI X III:  U S U A L  C A R E  –  P A TI E N T F O L L O W -U P S U R V E Y  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 2  
 
 
Y o u h a ve bee n gi ve n a b o o klet t o c o m plete f or t his st u d y.  T he b o o klet c o nt ai ns s o me q uesti o ns 
rel ate d t o visits wit h y o ur s ur ge o n, a b o ut w h at w as i m p ort a nt t o y o u w he n y o u t h o u g ht a b o ut y o ur 
decisi o n f or bre ast c a ncer s ur ger y, a n d a n y m ateri als t h at hel pe d y o u m a ke a decisi o n.  Y o ur 
a ns wers will hel p us t o better u n derst a n d h o w t o s u p p ort p atie nts i n m a ki n g t heir decisi o n a b o ut 
bre ast c a ncer s ur ger y.  
 
 
 
1.  Directi o ns o n h o w t o c o m plete eac h set of q uesti o ns are writte n o n t he t o p of eac h set.  
 
2.  Y o u will be gi ve n t he site c o or di nat or’s na me a n d tele p h o ne n u m ber.  Y o u ca n call a n y ti me 
wit h a n y c o ncer ns or q uesti o ns.  
 
3.  It is ver y i m p orta nt t hat y o u ret ur n t he b o o klet t o us. 
 
4.  Please ha n d t he c o m plete d s ur ve y t o t he site c o or di nat or or use t he sta m pe d a n d a d dress e d 
e n vel o pe pr o vi de d t o mail t he c o m plete d s ur ve y t o t he site c o or di nat or. If we d o n ot hear 
fr o m y o u i n t he ne xt wee k, we will c o ntact y o u a gai n. 
 
 
 
 
 
T h a n k y o u f or t a ki n g t he ti me t o hel p us.  
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 3  
P A TI E N T F O L L O W -U P ( T 2) S U R V E Y —  U S U A L C A R E  
T ha n k y o u f or t a ki n g t he ti me t o c o m plete t his s ur ve y. T his s ur ve y is a b o ut 5 0 q uesti o ns a n d s h o ul d ta ke 
a b o ut 1 0 t o 2 0 mi n utes t o c o m plete.  
 
T he first set of q uesti o ns c o ntai ns ite ms t hat are relate d t o visits wit h a s ur ge o n. Please a ns wer eac h 
state me nt t o t he best of y o ur a bilit y.  
 
 
 
 
 
N ot at all 
c o nfi de nt 
( 1) 
( 2) 
 ( 3) 
( 4) 
Ver y 
c o nfi de nt 
( 5) 
1.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o k n o w 
w h at q uesti o ns t o as k a s ur ge o n ?  
  
  
  
  
  
2.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o a ns wer all of y o ur q uesti o ns ?  
  
  
  
  
  
3.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o m a ke 
t he m ost of y o ur visit wit h a s ur ge o n ? 
  
  
  
  
  
4.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o t a ke y o ur c hief he alt h c o ncer ns 
seri o usl y ? 
  
  
  
  
  
5.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o d o s o met hi n g a b o ut y o ur c hief he alt h 
c o ncer n ? 
  
  
  
  
  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 4  
T he sec o n d set of q uesti o ns c o ntai ns ite ms t hat are relate d t o y o ur rece nt visit wit h y o ur s ur ge o n. S ur ge o ns 
ha ve differe nt st yles i n h o w t he y i nteract wit h patie nts a n d we w o ul d li ke t o k n o w m ore a b o ut h o w y o u felt 
a b o ut y o ur visit wit h y o ur s ur ge o n. Please i n dicate h o w m uc h y o u a gree or disa gree wit h eac h state me nt. 
Please a ns wer t o t he best of y o ur a bilit y.  
 
 
 
 
 
 
 
Str o n gl y 
dis a gree 
( 1) 
 ( 2) 
 ( 3) 
Ne utr al 
( 4) 
 ( 5) 
 ( 6) 
Str o n gl y 
a gree  
( 7) 
6.  
I feel t h at m y s ur ge o n h as 
pr o vi de d me c h oices a n d 
o pti o ns.  
  
  
  
  
  
  
  
7.  
I feel u n derst o o d b y m y 
s ur ge o n. 
  
  
  
  
  
  
  
8.  
I a m a ble t o be o pe n wit h m y 
s ur ge o n at o ur meeti n gs. 
  
  
  
  
  
  
  
9.  
M y s ur ge o n c o n ve ys 
c o nfi de nce i n m y a bilit y t o 
m a ke tre at me nt c h oices. 
  
  
  
  
  
  
  
1 0.  I feel t h at m y s ur ge o n acce pts 
me.  
  
  
  
  
  
  
  
1 1.  M y s ur ge o n h as m a de s ure I 
re all y u n derst a n d a b o ut m y 
c o n diti o n a n d w h at I nee d t o 
d o.  
  
  
  
  
  
  
  
1 2.  M y s ur ge o n e nc o ur a ges me t o 
as k q uesti o ns.  
  
  
  
  
  
  
  
1 3.  I feel a l ot of tr ust i n m y 
s ur ge o n. 
  
  
  
  
  
  
  
1 4.  M y s ur ge o n a ns wers m y 
q uesti o ns f ull y a n d c aref ull y.  
  
  
  
  
  
  
  
1 5.  M y s ur ge o n liste ns t o h o w I 
w o ul d li ke t o d o t hi n gs.  
  
  
  
  
  
  
  
1 6.  M y s ur ge o n h a n dles pe o ple's 
e m oti o ns ver y well.  
  
  
  
  
  
  
  
1 7.  I feel t h at m y s ur ge o n c ares 
a b o ut me as a pers o n.  
  
  
  
  
  
  
  
1 8.  I d o n't feel ver y g o o d a b o ut 
t he w a y m y s ur ge o n t al ks t o 
me.  
  
  
  
  
  
  
  
1 9.  M y s ur ge o n tries t o 
u n derst a n d h o w I see t hi n gs 
bef ore s u g gesti n g h o w t o d o 
t hi n gs. 
  
  
  
  
  
  
  
2 0.  I feel a ble t o s h are m y feeli n gs 
wit h m y s ur ge o n.  
  
  
  
  
  
  
  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 5  
T he ne xt set of q uesti o ns as ks a b o ut s o me facts t hat s ur ge o ns t hi n k are i m p orta nt f or patie nts t o k n o w a b o ut 
breast ca ncer. T he c orrect a ns wer t o eac h q uesti o n is base d o n me dical researc h. Please a ns wer t o t he best 
of y o ur a bilit y.  
 
 
2 1.  
F or m ost w o me n wit h earl y breast ca nc er, h o w m uc h w o ul d waiti n g a fe w wee ks t o ma ke a 
treat me nt decisi o n affect t heir c ha nces of s ur vi val? 
 
A little or n ot at all  
 
A l ot  
 
S o me  
 
2 2.  
Wit h treat me nt , a b o ut h o w ma n y w o me n dia g n ose d wit h earl y breast ca ncer will e ve nt uall y die of 
breast ca ncer? 
 
A b o ut half will die of breast ca ncer  
 
M ost will die of breast ca ncer  
 
M ost will die of s o met hi n g else  
 
 
2 3.  
After w hic h treat me nt is it m ore li kel y t hat w o me n will nee d t o ha ve a n ot her o perati o n t o re m o ve 
m ore t u m or cells?  
 
L u m pect o m y  
 
Mastect o m y  
 
E q uall y li kel y f or b ot h  
 
 
2 4.  
O n a vera ge, w hic h w o me n wit h earl y breast ca ncer li ve l o n ger?  
 
W o me n w h o ha ve a mastect o m y  
 
W o me n w h o ha ve a l u m pect o m y a n d ra diati o n  
 
T here is n o differe nce  
 
 
2 5.  
O n a vera ge, w hic h w o me n ha ve a hi g her c ha nce of ha vi n g ca ncer c o me bac k i n t he breast t hat has 
bee n treate d?  
 
W o me n w h o ha ve a mastect o m y  
 
W o me n w h o ha ve a l u m pect o m y a n d ra diati o n  
 
T here is n o differe nce  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 6  
We are i ntereste d i n w hat was i m p orta nt t o y o u w he n y o u ma de t he decisi o n a b o ut breast ca ncer s ur ger y. 
We as ke d y o u t hese sa me q uesti o ns bef ore y o u met wit h y o ur s ur ge o n, a n d are as ki n g a gai n t o see if 
a n yt hi n g has c ha n ge d.  Please mar k o n a scale fr o m 0 t o 1 0, h o w i m p orta nt were eac h of t he f oll o wi n g t o 
y o u as y o u ma ke  y o ur decisi o n a b o ut s ur ger y.  
H o w i m p ort a nt w as it t o y o u t o . . .  
 
 
N ot at all 
i m p orta nt 
  
 
 
 
 
 
E xtre mel y 
I m p orta nt 
 
2 6.  
kee p y o ur breast?  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
2 7.  
re m o ve y o ur e ntire 
breast t o gai n 
peace of mi n d?  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
2 8.  
a v oi d ha vi n g 
ra diati o n 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
2 9.  
(N o w t h at y o ur cli nic visit is over, if y o u c urre ntly h ave a prefere nce t o tre at y o ur e arly st a ge bre ast 
c a ncer ), w hic h treat me nt d o y o u prefer? 
 
I a m n ot s ure 
 
L u m pect o m y a n d ra diati o n  
 
L u m pect o m y o nl y  
 
Mastect o m y  
 
Ot her s ur ger y  
 
Ot her  s ur ger y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 0.  
D o y o u feel s ure a b o ut t he best c h oice f or y o u?  
 
Yes  
 
N o  
 
3 1.  
D o y o u k n o w t he be nefits a n d ris ks of eac h o pti o n?  
 
Yes  
 
N o  
 
3 2.  
Are y o u clear a b o ut w hic h be nefits a n d ris ks matter m ost t o y o u?  
 
Yes  
 
N o  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 7  
3 3.  
D o y o u ha ve e n o u g h s u p p ort a n d a d vice t o ma ke a c h oice?  
 
Yes  
 
N o  
 
T he ne xt q uesti o ns as k a b o ut a n y materials t hat hel pe d y o u pre pare t o meet wit h y o ur s ur ge o n a n d ma ke a 
decisi o n f or breast ca ncer s ur ger y.   
 
3 4.  
Di d y o u re vie w a n y i nf or mati o n after  seei n g y o ur s ur ge o n?  
 
Yes  
 
N o  
If y o u a ns were d “ N o ” t o q uesti o n # 3 4, ple ase pr ocee d directly t o q uesti o n # 3 5.  
 
(If yes), w hat t y pes of i nf or mati o n di d y o u re vie w after meeti n g y o ur s ur ge o n?  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
(If yes), h o w m uc h ti me di d y o u s pe n d re vie wi n g t he i nf or mati o n? 
 
 Less t ha n 1 5 mi n utes  
 1 5 - 6 0 mi n utes  
 M ore t ha n 1 h o ur  
 
If y o u a ns were d “ Yes ” t o q uesti o n # 3 4, ple ase pr ocee d directly t o q uesti o n # 3 6. 
 
If y o u a ns were d “ N o ” t o q uesti o n # 3 4, ple ase a ns wer q uesti o n # 3 5.  
 
 
3 5.   Di d y o u recei ve a n y i nf or mati o n at a n y ti me? 
 
 Yes, I re vie we d i nf or mati o n (eit her bef ore or after seei n g t he s ur ge o n).  
 
 
 N o, I di d n ot re vie w a n y i nf or mati o n.  
 
 
If y o u a ns were d “ Yes ” t o q uesti o n # 3 5, ple ase a ns wer q uesti o n # 3 6.   
 
If y o u a ns were d “ N o ” t o q uesti o n # 3 5, ple ase pr ocee d directly t o q uesti o n # 4 8. 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 8  
 
4 6.  W here di d y o u re vie w t he i nf or mati o n? C hec k all t hat a p pl y.  
 O n m y o w n c o m p uter at h o me 
 O n a c o m p uter at m y fa mil y or frie n d’s h o me  
 O n m y o w n ta blet or m o bile p h o ne  
 O n m y fa mil y or frie n d’s ta blet or m o bile p h o ne  
 O n a p u blic c o m p uter (e x. li brar y)  
 O n a i Pa d i n cli nic  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
N ot at all  
A little  
S o me w hat  
Q uite a bit  
A great deal  
3 6 . Di d t he i nf or m ati o n hel p y o u 
rec o g nize t h at a decisi o n nee ds t o be 
m a de ?  
1  
2  
3  
4  
5  
3 7 . Di d t he i nf or m ati o n pre p are y o u t o 
m a ke a better decisi o n ?  
1  
2  
3  
4  
5  
3 8 . Di d t he i nf or m ati o n hel p y o u t hi n k 
a b o ut t he pr os a n d c o ns of e ac h 
o pti o n ?  
1  
2  
3  
4  
5  
3 9 . Di d t he i nf or m ati o n hel p y o u t hi n k 
a b o ut w hic h pr os a n d c o ns are m ost 
i m p ort a nt ? 
1  
2  
3  
4  
5  
4 0 . Di d t he i nf or m ati o n hel p y o u k n o w 
t h at t he decisi o n de pe n ds o n w h at 
m atter m ost t o y o u ?  
1  
2  
3  
4  
5  
4 1 . Di d t he i nf or m ati o n hel p y o u 
or g a nize y o ur o w n t h o u g hts a b o ut 
t he decisi o n ? 
1  
2  
3  
4  
5  
4 2 . Di d t he i nf or m ati o n hel p y o u t hi n k 
a b o ut h o w i n v ol ve d y o u w a nt t o be i n 
t his decisi o n ? 
1  
2  
3  
4  
5  
4 3 . Di d t he i nf or m ati o n hel p y o u i de ntif y 
q uesti o ns y o u w a nt t o as k y o ur 
s ur ge o n ? 
1  
2  
3  
4  
5  
4 4 . Di d t he i nf or m ati o n pre p are y o u t o 
t al k t o y o ur s ur ge o n a b o ut w h at 
m atters m ost t o y o u ?  
1  
2  
3  
4  
5  
4 5 . Di d t he i nf or m ati o n pre p are y o u f or 
a f oll o w -u p visit wit h y o ur s ur ge o n ?  
1  
2  
3  
4  
5  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
9 9  
 
4 7.  Di d a n y o ne else re vie w t he i nf or mati o n? ( Eit her wit h y o u or y o u se n di n g t he m t he i nf or mati o n)  
 Yes  
 N o  
 
(If yes), w h o? C hec k all t hat a p pl y.  
 Part ner/s p o use  
 Fa mil y me m ber  
 
(If  f a mily me m ber), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 Frie n d  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
 
T he f oll o wi n g q uesti o ns are f or all p atie nts, re g ar dless of w het her t hey di d or di d n ot revie w a ny 
m ateri als t o hel p m a ke a decisi o n a b o ut t he ty pe of bre ast c a ncer s ur gery t o h ave.  
 
4 8.  W o ul d y o u li ke t o recei ve i nf or mati o n fr o m t he cli nic?  
 Yes  
 N o  
 
4 9.  W hat d o y o u t hi n k w o ul d be t he best f or mat f or y o u t o recei ve a n d re vie w i nf or mati o n fr o m t he cli nic?  
 Pa per versi o n  
 C o m p uter -base d versi o n  
 D V D -base d versi o n  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 0  
5 0.  If t he cli nic se nt we b-base d material pri or t o t he first a p p oi nt me nt wit h t he s ur ge o n, w hat w o ul d be t he best 
wa y t o recei ve t his  i nf or mati o n? 
 B y e mail  
 B y electr o nic me dical rec or d, s uc h as usi n g a patie nt p ortal ( M y C hart)  
 B y te xt  
 B y mail  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
Bel o w are s o me q uesti o ns s o we ca n lear n a little m ore a b o ut y o u. T his i nf or mati o n will hel p us 
u n dersta n d h o w decisi o n ma ki n g bet wee n t he s ur ge o n a n d patie nt ma y be differ bet wee n patie nts, a n d 
h o w t o better s u p p ort patie nts i n ma ki n g t heir decisi o n a b o ut  breast ca ncer s ur ger y.   
 
1.  
W hat is t he hi g hest  le vel of sc h o ol or de gree y o u ha ve c o m plete d? 
 
□  S o me hi g h sc h o ol or less  
 
□  Hi g h sc h o ol di pl o ma or G E D  
 
□  V ocati o nal de gree or s o me c olle ge  
 
□  C olle ge de gree  
 
□  Gra d uate sc h o ol de gree or hi g her  
2.  
Are y o u of His pa nic, Lati n o, or S pa nis h ori gi n?  
 
□  Yes  
 
□  N o  
3.  
H o w w o ul d y o u descri be y o ur racial bac k gr o u n d?  
 
□  W hite or Ca ucasia n  
 
□  Blac k or Africa n A merica n  
 
□  Asia n  
 
□  A merica n I n dia n of Alas ka Nati ve  
 
□  Nati ve Ha waiia n or ot her Pacific Isla n der  
 
□  Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
4.  W hat d o y o u c o nsi der t o be y o ur pri mar y la n g ua ge?  
 
□  E n glis h  
 
□  S pa nis h  
□  Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 1  
5.  W hat is y o ur c urre nt marital stat us? 
 
□  Si n gle, ne ver marrie d  
 
□  Marrie d or d o mestic part ners hi p  
 
□  Wi d o we d  
 
□  Di v orce d  
 
□  Se parate d  
6.  W hat is y o ur h o use h ol d a n n ual i nc o me?  
 
□  < $ 2 5, 0 0 0 per year  
 
□  $ 2 5, 0 0 0 - $ 4 9, 9 9 9 per year  
 
□  $ 5 0, 0 0 0 - $ 9 9, 9 9 9 per year  
 
□  > $ 1 0 0, 0 0 0 per year  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 2  
A P P E N DI X I V:  I N T E R V E N TI O N –  A C C E P T E D  D A  –  P A TI E N T F O L L O W -U P S U R V E Y  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 3  
 
 
Y o u h a ve bee n gi ve n a b o o klet t o c o m plete f or t his st u d y.  T he b o o klet c o nt ai ns s o me q uesti o ns 
rel ate d t o visits wit h y o ur s ur ge o n, a b o ut w h at w as i m p ort a nt t o y o u w he n y o u t h o u g ht a b o ut y o ur 
decisi o n f or bre ast c a ncer s ur ger y, a n d a n y m ateri als t h at hel pe d y o u m a ke a decisi o n.  Y o ur 
a ns wers will hel p us t o better u n derst a n d h o w t o s u p p ort p atie nts i n m a ki n g t heir decisi o n a b o ut 
bre ast c a ncer s ur ger y . 
 
 
 
1.  Directi o ns o n h o w t o c o m plete eac h set of q uesti o ns are writte n o n t he t o p of 
eac h set. 
 
2.  Y o u will be gi ve n t he site c o or di nat or’s na me a n d tele p h o ne n u m ber.  Y o u 
ca n call a n y ti me wit h a n y c o ncer ns or q uesti o ns.  
 
3.  It is ver y i m p orta nt t hat y o u ret ur n t he b o o klet t o us. 
 
4.  Please ha n d t he c o m plete d s ur ve y t o t he site c o or di nat or or use t he sta m pe d 
a n d a d dresse d e n vel o pe pr o vi de d t o mail t he c o m plete d s ur ve y t o t he site 
c o or di nat or. If we d o n ot hear fr o m y o u i n t he ne xt wee k, we will c o ntact y o u 
a gai n. 
 
 
 
 
 
T h a n k y o u f or t a ki n g t he ti me t o hel p us.  
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 4  
I N T E R V E N TI O N A R M –  A C C E P T E D D E CI SI O N AI D  
P A TI E N T F O L L O W -U P ( T 2) S U R V E Y  
T ha n k y o u f or ta ki n g t he ti me t o c o m plete t his s ur ve y. T his s ur ve y is a b o ut 5 0 q uesti o ns a n d s h o ul d ta ke 
a b o ut 1 0 t o 2 0 mi n utes t o c o m plete.  
 
T he first set of q uesti o ns c o ntai ns ite ms t hat are relate d t o visits wit h a s ur ge o n. Please a ns wer eac h 
state me nt t o t he best of y o ur a bilit y. 
 
 
 
 
 
N ot at all 
c o nfi de nt 
( 1) 
( 2) 
 ( 3) 
( 4) 
Ver y 
c o nfi de nt 
( 5) 
1.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o k n o w 
w h at q uesti o ns t o as k a s ur ge o n ?  
  
  
  
  
  
2.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o a ns wer all of y o ur q uesti o ns ? 
  
  
  
  
  
3.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o m a ke 
t he m ost of y o ur visit wit h a s ur ge o n ? 
  
  
  
  
  
4.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o t a ke y o ur c hief he alt h c o ncer ns 
seri o usl y ? 
  
  
  
  
  
5.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o d o s o met hi n g a b o ut y o ur c hief he alt h 
c o ncer n ? 
  
  
  
  
  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 5  
T he sec o n d set of q uesti o ns c o ntai ns ite ms t hat are relate d t o y o ur rece nt visit wit h y o ur s ur ge o n. S ur ge o ns 
ha ve differe nt st yles i n h o w t he y i nteract wit h patie nts a n d we w o ul d li ke t o k n o w m ore a b o ut h o w y o u felt 
a b o ut y o ur visit wit h y o ur s ur ge o n. Please i n dicate h o w m uc h y o u a gr ee or disa gree wit h eac h state me nt. 
Please a ns wer t o t he best of y o ur a bilit y.  
 
 
 
 
 
 
 
Str o n gl y 
dis a gree 
( 1) 
 ( 2) 
 ( 3) 
Ne utr al 
( 4) 
 ( 5) 
 ( 6) 
Str o n gl y 
a gree  
( 7) 
6.  
I feel t h at m y s ur ge o n h as 
pr o vi de d me c h oices a n d 
o pti o ns.  
  
  
  
  
  
  
  
7.  
I feel u n derst o o d b y m y 
s ur ge o n. 
  
  
  
  
  
  
  
8.  
I a m a ble t o be o pe n wit h m y 
s ur ge o n at o ur meeti n gs. 
  
  
  
  
  
  
  
9.  
M y s ur ge o n c o n ve ys 
c o nfi de nce i n m y a bilit y t o 
m a ke tre at me nt c h oices.  
  
  
  
  
  
  
  
1 0.  I feel t h at m y s ur ge o n acce pts 
me.  
  
  
  
  
  
  
  
1 1.  M y s ur ge o n h as m a de s ure I 
re all y u n derst a n d a b o ut m y 
c o n diti o n a n d w h at I nee d t o 
d o.  
  
  
  
  
  
  
  
1 2.  M y s ur ge o n e nc o ur a ges me t o 
as k q uesti o ns.  
  
  
  
  
  
  
  
1 3.  I feel a l ot of tr ust i n m y 
s ur ge o n. 
  
  
  
  
  
  
  
1 4.  M y s ur ge o n a ns wers m y 
q uesti o ns f ull y a n d c aref ull y.  
  
  
  
  
  
  
  
1 5.  M y s ur ge o n liste ns t o h o w I 
w o ul d li ke t o d o t hi n gs. 
  
  
  
  
  
  
  
1 6.  M y s ur ge o n h a n dles pe o ple's 
e m oti o ns ver y well.  
  
  
  
  
  
  
  
1 7.  I feel t h at m y s ur ge o n c ares 
a b o ut me as a pers o n.  
  
  
  
  
  
  
  
1 8.  I d o n't feel ver y g o o d a b o ut 
t he w a y m y s ur ge o n t al ks t o 
me.  
  
  
  
  
  
  
  
1 9.  M y s ur ge o n tries t o 
u n derst a n d h o w I see t hi n gs 
bef ore s u g gesti n g h o w t o d o 
t hi n gs. 
  
  
  
  
  
  
  
2 0.  I feel a ble t o s h are m y feeli n gs 
wit h m y s ur ge o n.  
  
  
  
  
  
  
  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 6  
T he ne xt set of q uesti o ns as ks a b o ut s o me facts t hat s ur ge o ns t hi n k are i m p orta nt f or patie nts t o k n o w a b o ut 
breast ca ncer. T he c orrect a ns wer t o eac h q uesti o n is base d o n me dical researc h.  Please a ns wer t o t he best 
of y o ur a bilit y.  
 
 
2 1.  
F or m ost w o me n wit h earl y breast ca ncer, h o w m uc h w o ul d waiti n g a fe w wee ks t o ma ke a 
treat me nt decisi o n affect t heir c ha nces of s ur vi val? 
 
A little or n ot at all  
 
A l ot  
 
S o me  
 
2 2.  
Wit h treat me nt , a b o ut h o w ma n y w o me n dia g n ose d wit h earl y breast ca ncer will e ve nt uall y die of 
breast ca ncer?  
 
A b o ut half will die of breast ca ncer  
 
M ost will die of breast ca ncer  
 
M ost will die of s o met hi n g else  
 
 
2 3.  
After w hic h treat me nt is it m ore li kel y t hat w o me n will nee d t o ha ve a n ot her o perati o n t o re m o ve 
m ore t u m or cells?  
 
L u m pect o m y  
 
Mastect o m y  
 
E q uall y li kel y f or b ot h  
 
 
2 4.  
O n a vera ge, w hic h w o me n wit h earl y breast ca ncer li ve l o n ger?  
 
W o me n w h o ha ve a mastect o m y  
 
W o me n w h o ha ve a l u m pect o m y a n d ra diati o n  
 
T here is n o differe nce  
 
 
2 5.  
O n a vera ge, w hic h w o me n ha ve a hi g her c ha nce of ha vi n g ca ncer c o me bac k i n t he breast t hat has 
bee n treate d?  
 
W o me n w h o ha ve a mastect o m y  
 
W o me n w h o ha ve a l u m pect o m y a n d ra diati o n 
 
T here is n o differe nce  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 7  
We are i ntereste d i n w hat was i m p orta nt t o y o u w he n y o u ma de t he decisi o n a b o ut breast ca ncer s ur ger y. 
We as ke d y o u t hese sa me q uesti o ns bef ore y o u met wit h y o ur s ur ge o n, a n d are as ki n g a gai n t o see if 
a n yt hi n g has c ha n ge d.  Please mar k o n a scale fr o m 0 t o 1 0, h o w i m p orta nt were eac h of t he f oll o wi n g t o 
y o u as y o u ma ke y o ur decisi o n a b o ut s ur ger y.  
 
H o w i m p ort a nt w as it t o y o u t o . . .  
 
 
N ot at all 
i m p orta nt 
  
 
 
 
 
 
E xtre mel y 
I m p orta nt 
 
2 6.  
kee p y o ur breast?  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
2 7.  
re m o ve y o ur e ntire 
breast t o gai n 
peace of mi n d?  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
2 8.  
a v oi d ha vi n g 
ra diati o n 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
2 9.  
(N o w t h at y o ur cli nic visit is over, if y o u c urre ntly h ave a prefere nce t o tre at y o ur e arly st a ge bre ast 
c a ncer ), w hic h treat me nt d o y o u prefer? 
 
I a m n ot s ure 
 
L u m pect o m y a n d ra diati o n  
 
L u m pect o m y o nl y  
 
Mastect o m y  
 
Ot her  s ur ger y 
 
Ot her s ur ger y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 0.  
D o y o u feel s ure a b o ut t he best c h oice f or y o u?  
 
Yes  
 
N o  
 
3 1.  
D o y o u k n o w t he be nefits a n d ris ks of eac h o pti o n?  
 
Yes  
 
N o  
 
3 2.  
Are y o u clear a b o ut w hic h be nefits a n d ris ks matter m ost t o y o u?  
 
Yes  
 
N o  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 8  
3 3.  
D o y o u ha ve e n o u g h s u p p ort a n d a d vice t o ma ke a c h oice?  
 
Yes  
 
N o  
 
Y o u recei ve d a li n k t o a we bsite fr o m y o ur cli nic pri or t o seei n g y o ur s ur ge o n.  T he ne xt q uesti o ns as k 
a b o ut h o w t his material hel pe d y o u pre pare t o meet wit h y o ur s ur ge o n a n d ma ke a decisi o n f or breast ca ncer 
s ur ger y.  
 
3 4.  
Di d y o u re vie w t he we bsite se nt t o  y o u after  seei n g y o ur s ur ge o n?  
 Yes  
 N o  
 
 
(If yes), h o w m uc h ti me di d y o u s pe n d re vie wi n g t he we bsite? 
 
 Less t ha n 1 5 mi n utes  
 1 5 - 6 0 mi n utes  
 M ore t ha n 1 h o ur  
 
3 5.  
After y o ur i nitial p h o ne call w he n cli nic staff offere d y o u t he we bsite i nf or mati o n, h o w i m p orta nt di d y o u 
t hi n k it was f or y o u t o re vie w t he we bsite se nt t o y o u? 
 Ver y i m p orta nt  
 Neit her i m p orta nt or u ni m p orta nt  
 N ot at all i m p orta nt  
 
3 6.  
W h y di d y o u t hi n k it was i m p orta nt or n ot i m p orta nt f or y o u t o re vie w t he we bsite?  
 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 7.   Di d y o u re vie w t he we bsite se nt t o y o u at a n y ti me ? 
 
 Yes, I re vie we d t he we bsite (eit her bef ore or after seei n g t he s ur ge o n).  
 
 N o, I di d n ot re vie w t he decisi o n ai d.  
 
If y o u a ns were d “ Yes ” t o q uesti o ns # 3 4 or # 3 7, ple ase c o nti n ue directly t o q uesti o n 3 8. 
If y o u a ns were d “ N o ” t o q uesti o ns # 3 4 a n d # 3 7, ple ase g o directly t o q uesti o n # 5 1.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 0 9  
 
 
4 8.  W here di d y o u re vie w t he we bsite? C hec k all t hat a p pl y.  
 O n m y o w n c o m p uter at h o me  
 O n a c o m p uter at m y fa mil y or frie n d’s h o me  
 O n m y o w n ta blet or m o bile p h o ne  
 O n m y fa mil y or frie n d’s ta blet or m o bile p h o ne  
 O n a p u blic c o m p uter (e x. li brar y)  
 O n a i Pa d i n cli nic  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
 
 
N ot at all  
A little  
S o me w hat  
Q uite a bit  
A great deal  
3 8 . Di d t he we bsite  hel p y o u rec o g nize 
t hat a decisi o n nee ds t o be ma de? 
1  
2  
3  
4  
5  
3 9 . Di d t he we bsite  pre pare y o u t o ma ke a 
better decisi o n?  
1  
2  
3  
4  
5  
4 0 . Di d t he we bsite hel p y o u t hi n k a b o ut 
t he pr os a n d c o ns of eac h o pti o n? 
1  
2  
3  
4  
5  
4 1 . Di d t he we bsite  hel p y o u t hi n k a b o ut 
w hic h pr os a n d c o ns are m ost 
i m p orta nt? 
1  
2  
3  
4  
5  
4 2 . Di d t he we bsite  hel p y o u k n o w t hat t he 
decisi o n de pe n ds o n w hat matters m ost 
t o y o u? 
1  
2  
3  
4  
5  
4 3 . Di d t he we bsite  hel p y o u or ga nize 
y o ur o w n t h o u g hts a b o ut t he decisi o n?  
1  
2  
3  
4  
5  
4 4 . Di d t he we bsite  hel p y o u t hi n k a b o ut 
h o w i n v ol ve d y o u wa nt t o be i n t his 
decisi o n?  
1  
2  
3  
4  
5  
4 5 . Di d t he we bsite  hel p y o u i de ntif y 
q uesti o ns y o u wa nt t o as k y o ur 
s ur ge o n? 
1  
2  
3  
4  
5  
4 6 . Di d t he we bsite  pre pare y o u t o tal k t o 
y o ur s ur ge o n a b o ut w hat matters m ost 
t o y o u? 
1  
2  
3  
4  
5  
4 7 . Di d t he we bsite  pre pare y o u f or a 
f oll o w-u p visit wit h y o ur s ur ge o n?  
1  
2  
3  
4  
5  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 0  
 
4 9.  Di d a n y o ne else re vie w t he we bsite? ( Eit her wit h y o u or y o u se n di n g t he m t he li n k)  
 Yes  
 N o  
(If yes), w h o? C hec k all t hat a p pl y.  
 Part ner/s p o use  
 Fa mil y me m ber  
 
(If  f a mily me m ber), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 Frie n d  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
5 0.  Di d y o u ha ve a n y tr o u ble o pe ni n g or usi n g t he we bsite?  
 Yes  
 N o  
 
(If yes), w hat was har d a b o ut it?  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
T he f oll o wi n g q uesti o ns are f or all p atie nts, re g ar dless of w het her t hey di d a n d di d n ot revie w t he we bsite se nt 
t o t he m fr o m t he cli nic. 
 
5 1.  Di d y o u li ke getti n g t he we bsite se nt t o y o u b y e mail?  
 Yes  
 N o  
 
(If n o), w hat di d y o u n ot li ke a b o ut it?  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 1  
 
5 2.  W hat d o y o u t hi n k w o ul d be t he best f or mat f or y o u t o recei ve a n d re vie w i nf or mati o n fr o m t he cli nic?  
 Pa per versi o n  
 C o m p uter -base d versi o n  
 D V D -base d versi o n  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
5 3.  If t he cli nic c o nti n ue d t o se n d we b-base d material pri or t o t he first a p p oi nt me nt wit h t he s ur ge o n, w hat 
w o ul d be t he best wa y t o recei ve t his material?  
 B y e mail  
 B y electr o nic me dical rec or d, s uc h as usi n g a patie nt p ortal ( M y C hart)  
 B y te xt  
 B y mail  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 2  
Bel o w are s o me q uesti o ns s o we c a n le ar n a little m ore a b o ut y o u. T his i nf or m ati o n will hel p us 
u n derst a n d h o w decisi o n m a ki n g bet wee n t he s ur ge o n a n d p atie nt m a y be differ bet wee n p atie nts, 
a n d h o w t o better s u p p ort p atie nts i n m a ki n g t heir decisi o n a b o ut  bre ast c a ncer s ur ger y.   
 
1.  W hat is t he hi g hest  le vel of sc h o ol or de gree y o u ha ve c o m plete d? 
 
□  S o me hi g h sc h o ol or less  
 
□  Hi g h sc h o ol di pl o ma or G E D  
 
□  V ocati o nal de gree or s o me c olle ge  
 
□  C olle ge de gree  
 
□  Gra d uate sc h o ol de gree or hi g her  
2.  
Are y o u of His pa nic, Lati n o, or S pa nis h ori gi n?  
 
□  Yes  
 
□  N o  
3.  
H o w w o ul d y o u descri be y o ur racial bac k gr o u n d?  
 
□  W hite or Ca ucasia n  
 
□  Blac k or Africa n A merica n  
 
□  Asia n  
 
□  A merica n I n dia n of Alas ka Nati ve  
 
□  Nati ve Ha waiia n or ot her Pacific Isla n der  
 
□  Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
4.  W hat d o y o u c o nsi der t o be y o ur pri mar y la n g ua ge?  
 
□  E n glis h  
 
□  S pa nis h  
□  Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
5.  W hat is y o ur c urre nt marital stat us? 
 
□  Si n gle, ne ver marrie d  
 
□  Marrie d or d o mestic part ners hi p  
 
□  Wi d o we d  
 
□  Di v orce d  
 
□  Se parate d  
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 3  
6.  W hat is y o ur h o use h ol d a n n ual i nc o me?  
 
□  < $ 2 5, 0 0 0 per year  
 
□  $ 2 5, 0 0 0 - $ 4 9, 9 9 9 per year  
 
□  $ 5 0, 0 0 0 - $ 9 9, 9 9 9 per year  
 
□  > $ 1 0 0, 0 0 0 per year  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 4  
A P P E N DI X V:    I N T E R V E N TI O N –  D E C LI N E D  D A  –  P A TI E N T F O L L O W -U P S U R V E Y  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 5  
 
 
Y o u h a ve bee n gi ve n a b o o klet t o c o m plete f or t his st u d y.  T he b o o klet c o nt ai ns s o me q uesti o ns 
rel ate d t o visits wit h y o ur s ur ge o n, a b o ut w h at w as i m p ort a nt t o y o u w he n y o u t h o u g ht a b o ut y o ur 
decisi o n f or bre ast c a ncer s ur ger y, a n d a n y m ateri als t h at hel pe d y o u m a ke a decisi o n.  Y o ur 
a ns wers will hel p us t o better u n derst a n d h o w t o s u p p ort p atie nts i n m a ki n g t heir decisi o n a b o ut 
bre ast c a ncer s ur ger y . 
 
 
 
1.  Directi o ns o n h o w t o c o m plete eac h set of q uesti o ns are writte n o n t he t o p of 
eac h set. 
 
2.  Y o u will be gi ve n t he site c o or di nat or’s na me a n d tele p h o ne n u m ber.  Y o u 
ca n call a n y ti me wit h a n y c o ncer ns or q uesti o ns.  
 
3.  It is ver y i m p orta nt t hat y o u ret ur n the b o o klet t o us.  
 
4.  Please ha n d t he c o m plete d s ur ve y t o t he site c o or di nat or or use t he sta m pe d 
a n d a d dresse d e n vel o pe pr o vi de d t o mail t he c o m plete d s ur ve y t o t he site 
c o or di nat or. If we d o n ot hear fr o m y o u i n t he ne xt wee k, we will c o ntact y o u 
a gai n. 
 
 
 
 
 
T h a n k y o u f or t a ki n g t he ti me t o hel p us.  
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 6  
I N T E R V E N TI O N A R M –  D E C LI N E D D E CI SI O N AI D  
P A TI E N T F O L L O W -U P ( T 2) S U R V E Y  
T ha n k y o u f or ta ki n g t he ti me t o c o m plete t his s ur ve y. T his s ur ve y is a b o ut 5 0 q uesti o ns a n d s h o ul d ta ke 
a b o ut 1 0 t o 2 0 mi n utes t o c o m plete.  
 
T he first set of q uesti o ns c o ntai ns ite ms t hat are relate d t o visits wit h a s ur ge o n. Please a ns wer eac h 
state me nt t o t he best of y o ur a bilit y. 
 
 
 
 
 
N ot at all 
c o nfi de nt 
( 1) 
( 2) 
 ( 3) 
( 4) 
Ver y 
c o nfi de nt 
( 5) 
1.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o k n o w 
w h at q uesti o ns t o as k a s ur ge o n ?  
  
  
  
  
  
2.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o a ns wer all of y o ur q uesti o ns ?  
  
  
  
  
  
3.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o m a ke 
t he m ost of y o ur visit wit h a s ur ge o n ? 
  
  
  
  
  
4.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o t a ke y o ur c hief he alt h c o ncer ns 
seri o usl y ? 
  
  
  
  
  
5.  H o w c o nfi de nt are y o u i n y o ur a bilit y t o get a 
s ur ge o n t o d o s o met hi n g a b o ut y o ur c hief he alt h 
c o ncer n ? 
  
  
  
  
  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 7  
T he sec o n d set of q uesti o ns c o ntai ns ite ms t hat are relate d t o y o ur rece nt visit wit h y o ur s ur ge o n. S ur ge o ns 
ha ve differe nt st yles i n h o w t he y i nteract wit h patie nts a n d we w o ul d li ke t o k n o w m ore a b o ut h o w y o u felt 
a b o ut y o ur visit wit h y o ur s ur ge o n. Please i n dicate h o w m uc h y o u a gree or disa gree wit h eac h state me nt. 
Please a ns wer t o t he best of y o ur a bilit y.  
 
 
 
 
 
 
 
Str o n gl y 
dis a gree 
( 1) 
 ( 2) 
 ( 3) 
Ne utr al 
( 4) 
 ( 5) 
 ( 6) 
Str o n gl y 
a gree  
( 7) 
6.  
I feel t h at m y s ur ge o n h as 
pr o vi de d me c h oices a n d 
o pti o ns.  
  
  
  
  
  
  
  
7.  
I feel u n derst o o d b y m y 
s ur ge o n. 
  
  
  
  
  
  
  
8.  
I a m a ble t o be o pe n wit h m y 
s ur ge o n at o ur meeti n gs. 
  
  
  
  
  
  
  
9.  
M y s ur ge o n c o n ve ys 
c o nfi de nce i n m y a bilit y t o 
m a ke tre at me nt c h oices. 
  
  
  
  
  
  
  
1 0.  I feel t h at m y s ur ge o n acce pts 
me.  
  
  
  
  
  
  
  
1 1.  M y s ur ge o n h as m a de s ure I 
re all y u n derst a n d a b o ut m y 
c o n diti o n a n d w h at I nee d t o 
d o.  
  
  
  
  
  
  
  
1 2.  M y s ur ge o n e nc o ur a ges me t o 
as k q uesti o ns.  
  
  
  
  
  
  
  
1 3.  I feel a l ot of tr ust i n m y 
s ur ge o n. 
  
  
  
  
  
  
  
1 4.  M y s ur ge o n a ns wers m y 
q uesti o ns f ull y a n d c aref ull y.  
  
  
  
  
  
  
  
1 5.  M y s ur ge o n liste ns t o h o w I 
w o ul d li ke t o d o t hi n gs.  
  
  
  
  
  
  
  
1 6.  M y s ur ge o n h a n dles pe o ple's 
e m oti o ns ver y well.  
  
  
  
  
  
  
  
1 7.  I feel t h at m y s ur ge o n c ares 
a b o ut me as a pers o n.  
  
  
  
  
  
  
  
1 8.  I d o n't feel ver y g o o d a b o ut 
t he w a y m y s ur ge o n t al ks t o 
me.  
  
  
  
  
  
  
  
1 9.  M y s ur ge o n tries t o 
u n derst a n d h o w I see t hi n gs 
bef ore s u g gesti n g h o w t o d o 
t hi n gs. 
  
  
  
  
  
  
  
2 0.  I feel a ble t o s h are m y feeli n gs 
wit h m y s ur ge o n.  
  
  
  
  
  
  
  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 8  
T he ne xt set of q uesti o ns as ks a b o ut s o me facts t hat s ur ge o ns t hi n k are i m p orta nt f or patie nts t o k n o w a b o ut 
breast ca ncer. T he c orrect a ns wer t o eac h q uesti o n is base d o n me dical researc h.  Please a ns wer t o t he best 
of y o ur a bilit y.  
 
 
2 1.  
F or m ost w o me n wit h earl y breast ca ncer, h o w m uc h w o ul d waiti n g  a fe w wee ks t o ma ke a 
treat me nt decisi o n affect t heir c ha nces of s ur vi val? 
 
A little or n ot at all  
 
A l ot  
 
S o me  
 
2 2.  
Wit h treat me nt , a b o ut h o w ma n y w o me n dia g n ose d wit h earl y breast ca ncer will e ve nt uall y die of 
breast ca ncer?  
 
A b o ut half will die of breast ca ncer  
 
M ost will die of breast ca ncer  
 
M ost will die of s o met hi n g else  
 
 
2 3.  
After w hic h treat me nt is it m ore li kel y t hat w o me n will nee d t o ha ve a n ot her o perati o n t o re m o ve 
m ore t u m or cells?  
 
L u m pect o m y  
 
Mastect o m y  
 
E q uall y li kel y f or b ot h  
 
 
2 4.  
O n a vera ge, w hic h w o me n wit h earl y breast ca ncer li ve l o n ger?  
 
W o me n w h o ha ve a mastect o m y  
 
W o me n w h o ha ve a l u m pect o m y a n d ra diati o n  
 
T here is n o differe nce  
 
 
2 5.  
O n a vera ge, w hic h w o me n ha ve a hi g her c ha nce of ha vi n g ca ncer c o me bac k i n t he breast t hat has 
bee n treate d?  
 
W o me n w h o ha ve a mastect o m y  
 
W o me n w h o ha ve a l u m pect o m y a n d ra diati o n  
 
T here is n o differe nce  
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 1 9  
We are i ntereste d i n w hat was i m p orta nt t o y o u w he n y o u ma de t he decisi o n a b o ut breast ca ncer s ur ger y. 
We as ke d y o u t hese sa me q uesti o ns bef ore y o u met wit h y o ur s ur ge o n, a n d are as ki n g a gai n t o see if 
a n yt hi n g has c ha n ge d.  Please mar k o n a scale fr o m 0 t o 1 0, h o w i m p orta nt were eac h of t he f oll o wi n g t o 
y o u as y o u ma ke y o ur decisi o n a b o ut s ur ger y.  
 
H o w i m p ort a nt w as it  t o y o u t o . . . 
 
 
N ot at all 
i m p orta nt 
  
 
 
 
 
 
E xtre mel y 
I m p orta nt 
 
2 6.  
kee p y o ur breast?  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
2 7.  
re m o ve y o ur e ntire 
breast t o gai n 
peace of mi n d?  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
2 8.  
a v oi d ha vi n g 
ra diati o n 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
 
2 9.  
(N o w t h at y o ur cli nic visit is over, if y o u c urre ntly h ave a prefere nce t o tre at y o ur e arly st a ge bre ast 
c a ncer ), w hic h treat me nt d o y o u prefer? 
 
I a m n ot s ure 
 
L u m pect o m y a n d ra diati o n  
 
L u m pect o m y o nl y  
 
Mastect o m y  
 
Ot her  s ur ger y 
 
Ot her S ur ger y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 0.  
D o y o u feel s ure a b o ut t he best c h oice f or y o u?  
 
Yes  
 
N o  
 
3 1.  
D o y o u k n o w t he be nefits a n d ris ks of eac h o pti o n?  
 
Yes  
 
N o  
 
3 2.  
Are y o u clear a b o ut w hic h be nefits a n d ris ks matter m ost t o y o u?  
 
Yes  
 
N o  
 
 
 

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1 2 0  
 
3 3.  
D o y o u ha ve e n o u g h s u p p ort a n d a d vice t o ma ke a c h oice?  
 
Yes  
 
N o  
 
T he ne xt q uesti o ns as k a b o ut a n y materials t hat hel pe d y o u pre pare t o meet wit h y o ur s ur ge o n a n d ma ke a 
decisi o n f or breast ca ncer s ur ger y.   
 
3 4.  Di d y o u re vie w a n y i nf or mati o n after  seei n g y o ur s ur ge o n?  
 
Yes  
 
N o  
 
If y o u a ns were d “ N o ” t o q uesti o n # 3 4, ple ase pr ocee d directly t o q uesti o n # 3 5.  
 
(If yes), w hat t y pes of i nf or mati o n di d y o u re vie w after meeti n g y o ur s ur ge o n?  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
(If yes), h o w m uc h ti me di d y o u s pe n d re vie wi n g t he i nf or mati o n? 
 
 Less t ha n 1 5 mi n utes  
 1 5 - 6 0 mi n utes  
 M ore t ha n 1 h o ur  
 
If y o u a ns were d “ Yes ” t o q uesti o n # 3 4, ple ase pr ocee d directly t o Q uesti o n # 3 6. 
 
If y o u a ns were d “ N o ” t o q uesti o n # 3 4, ple ase a ns wer Q uesti o n # 3 5. 
 
3 5.   
Di d y o u re vie w a n y i nf or mati o n at a n y ti me?  
 
 
Yes, I re vie we d i nf or mati o n (eit her bef ore or after seei n g t he s ur ge o n). 
 
 
N o, I di d n ot re vie w a n y i nf or mati o n.  
 
If y o u a ns were d “ Yes ” t o q uesti o n # 3 5, c o nti n ue t o q uesti o n # 3 6.  
 
 If y o u a ns were d “ N o ” t o q uesti o n # 3 6, g o directly t o q uesti o n # 4 8. 
 
 
 

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U p date # 0 6  
1 2 1  
 
4 6.  W here di d y o u re vie w t he i nf or mati o n? C hec k all t hat a p pl y.  
 O n m y o w n c o m p uter at h o me  
 O n a c o m p uter at m y fa mil y or frie n d’s h o me  
 O n m y o w n ta blet or m o bile p h o ne  
 O n m y fa mil y or frie n d’s ta blet or m o bile p h o ne 
 O n a p u blic c o m p uter (e x. li brar y)  
 O n a i Pa d i n cli nic  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
 
N ot at all  
A little  
S o me w hat  
Q uite a bit  
A great deal  
3 6.   Di d t he i nf or m ati o n hel p y o u 
rec o g nize t h at a decisi o n nee ds t o be 
m a de ?  
1  
2  
3  
4  
5  
3 7.   Di d t he i nf or m ati o n pre p are y o u t o 
m a ke a better decisi o n ?  
1  
2  
3  
4  
5  
3 8.   Di d t he i nf or m ati o n hel p y o u t hi n k 
a b o ut t he pr os a n d c o ns of e ac h 
o pti o n ?  
1  
2  
3  
4  
5  
3 9.   Di d t he i nf or m ati o n hel p y o u t hi n k 
a b o ut w hic h pr os a n d c o ns are m ost 
i m p ort a nt ? 
1  
2  
3  
4  
5  
4 0.   Di d t he i nf or m ati o n hel p y o u k n o w 
t h at t he decisi o n de pe n ds o n w h at 
m atters m ost t o y o u ?  
1  
2  
3  
4  
5  
4 1.   Di d t he i nf or m ati o n hel p y o u 
or g a nize y o ur o w n t h o u g hts a b o ut 
t he decisi o n ? 
1  
2  
3  
4  
5  
4 2.   Di d t he  i nf or m ati o n hel p y o u t hi n k 
a b o ut h o w i n v ol ve d y o u w a nt t o be 
i n t his decisi o n ? 
1  
2  
3  
4  
5  
4 3.   Di d t he i nf or m ati o n hel p y o u 
i de ntif y q uesti o ns y o u w a nt t o as k 
y o ur s ur ge o n ?  
1  
2  
3  
4  
5  
4 4.   Di d t he i nf or m ati o n pre p are y o u t o 
t al k t o y o ur s ur ge o n a b o ut w h at 
m atters m ost t o y o u ?  
1  
2  
3  
4  
5  
4 5.   Di d t he i nf or m ati o n pre p are y o u f or 
a f oll o w -u p visit wit h y o ur s ur ge o n ?  
1  
2  
3  
4  
5  

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Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 2 2  
 
 
4 7.  
Di d a n y o ne else re vie w t he i nf or mati o n? ( Eit her wit h y o u or y o u se n di n g t he m t he i nf or mati o n) 
 Yes  
 N o  
 
(If yes), w h o? C hec k all t hat a p pl y.  
 Part ner/s p o use  
 Fa mil y me m ber  
 
(If  f a mily me m ber), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 Frie n d  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
T he f oll o wi n g q uesti o ns are f or all p atie nts, re g ar dless of w het her t hey di d a n d di d n ot revie w a ny 
m ateri als t o hel p m a ke a decisi o n a b o ut t he ty pe of bre ast c a ncer s ur gery t o h ave.  
 
4 8.  W o ul d y o u li ke t o recei ve i nf or mati o n fr o m t he cli nic? 
 Yes  
 N o  
 
4 9.  W hat d o y o u t hi n k w o ul d be t he best f or mat f or y o u t o recei ve a n d re vie w i nf or mati o n fr o m t he cli nic?  
 Pa per versi o n  
 C o m p uter -base d versi o n  
 D V D -base d versi o n  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
5 0.  If t he cli nic se nt we b-base d material pri or t o t he first a p p oi nt me nt wit h t he s ur ge o n, w hat w o ul d be t he best 
wa y t o recei ve t his  i nf or mati o n? 
 B y e mail  
 B y electr o nic me dical rec or d, s uc h as usi n g a patie nt p ortal ( M y C hart)  
 B y te xt  
 B y mail  
 Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
 

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Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 2 3  
 
Bel o w are s o me q uesti o ns s o we c a n le ar n a little m ore a b o ut y o u. T his i nf or m ati o n will hel p us 
u n derst a n d h o w decisi o n m a ki n g bet wee n t he s ur ge o n a n d p atie nt m a y be differ bet wee n p atie nts, 
a n d h o w t o better s u p p ort p atie nts i n m a ki n g t heir decisi o n a b o ut  bre ast c a ncer s ur ger y.   
 
1.  W hat is t he hi g hest  le vel of sc h o ol or de gree y o u ha ve c o m plete d? 
 
□  S o me hi g h sc h o ol or less  
 
□  Hi g h sc h o ol di pl o ma or G E D  
 
□  V ocati o nal de gree or s o me c olle ge  
 
□  C olle ge de gree  
 
□  Gra d uate sc h o ol de gree or hi g her  
2.  
Are y o u of His pa nic, Lati n o, or S pa nis h ori gi n?  
 
□  Yes  
 
□  N o  
3.  
H o w w o ul d y o u descri be y o ur racial bac k gr o u n d?  
 
□  W hite or Ca ucasia n  
 
□  Blac k or Africa n A merica n  
 
□  Asia n  
 
□  A merica n I n dia n of Alas ka Nati ve  
 
□  Nati ve Ha waiia n or ot her Pacific Isla n der  
 
□  Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
4.  W hat d o y o u c o nsi der t o be y o ur pri mar y la n g ua ge?  
 
□  E n glis h  
 
□  S pa nis h  
□  Ot her  
 
(If ot her), s pecif y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
5.  W hat is y o ur c urre nt marital stat us? 
 
□  Si n gle, ne ver marrie d  
 
□  Marrie d or d o mestic part ners hi p  
 
□  Wi d o we d  
 
□  Di v orce d  
 
□  Se parate d  

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1 2 4  
6.  W hat is y o ur h o use h ol d a n n ual i nc o me?  
 
□  < $ 2 5, 0 0 0 per year  
 
□  $ 2 5, 0 0 0 - $ 4 9, 9 9 9 per year  
 
□  $ 5 0, 0 0 0 - $ 9 9, 9 9 9 per year  
 
□  > $ 1 0 0, 0 0 0 per year  
 
 
 
 

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1 2 5  
A P P E N DI X VI:   S U R G E O N B A S E LI N E S U R V E Y  
 
 

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Versi o n D ate 0 1 /0 5 /2 2  
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1 2 6  
 
 
 
Y o u h a ve bee n gi ve n a b o o klet t o c o m plete f or t his st u d y.  T he b o o klet c o nt ai ns s o me q uesti o ns 
rel ate d t o t he r ole of t he p atie nt wit hi n t he cli nic al c o ns ult ati o n. Y o ur a ns wers will hel p us t o better 
u n derst a n d h o w t o s u p p ort p atie nts i n m a ki n g t heir decisi o n a b o ut bre ast c a ncer s ur ger y.  
 
 
 
1.  Directi o ns o n h o w t o c o m plete eac h set of q uesti o ns are writte n o n t he t o p of 
eac h set. 
 
2.  Y o u will be gi ve n t he site c o or di nat or’s na me a n d tele p h o ne n u m ber.  Y o u 
ca n call a n y ti me wit h a n y c o ncer ns or q uesti o ns.  
 
3.  It is ver y i m p orta nt t hat y o u ret ur n t he b o o klet t o us. 
 
4.  Please ha n d t he c o m plete d s ur ve y t o t he site c o or di nat or.  
 
 
 
 
 
T h a n k y o u f or t a ki n g t he ti me t o hel p us.  
 
 
 

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1 2 7  
S U R G E O N B A S E LI N E S U R V E Y  
T he f oll o wi n g q uesti o ns f oc us o n t he r ole of t he patie nt wit hi n t he cli nical c o ns ultati o ns.  Y o u s h o ul d 
t hi n k a b o ut t he a vera ge breast ca ncer patie nt c o ns ult i n y o ur cli nic w he n a ns weri n g t hese q uesti o ns. 
 
 
Str o n gl y 
Dis a gree  
M o der ate
l y 
Dis a gree  
Sli g htl y 
Dis a gre
e 
Sli g htl y 
A gree  
M o der ate
l y  A gree  
Str o n gl y 
A gree  
1.  T he s ur ge o n is t he o ne w h o 
s h o ul d deci de w h at gets t al ke d 
a b o ut d uri n g t he c o ns ult.  
  
  
  
  
  
  
2.  Alt h o u g h he alt h c are is less 
pers o n al t hese d a ys, t his is a 
s m all price t o p a y f or me dic al 
a d v a nces.  
  
  
  
  
  
  
3.  T he m ost i m p ort a nt p art of t he 
st a n d ar d c o ns ult f or bre ast 
c a ncer is t he p h ysic al e x a m.  
  
  
  
  
  
  
4.  It is ofte n best f or p atie nts if 
t he y d o n ot h a ve a f ull 
e x pl a n ati o n of t heir bre ast 
c a ncer. 
  
  
  
  
  
  
5.  P atie nts s h o ul d rel y o n t heir 
s ur ge o ns’ k n o wle d ge a n d n ot 
tr y t o fi n d o ut a b o ut t heir 
bre ast c a ncer o n t heir o w n.  
  
  
  
  
  
  
6.  W he n s ur ge o ns as k a l ot of 
q uesti o ns a b o ut a p atie nt’s 
b ac k gr o u n d, t he y are pr yi n g 
t o o m uc h i nt o pers o n al m atters. 
  
  
  
  
  
  
7.  If s ur ge o ns are tr ul y g o o d at 
di a g n osis a n d tre at me nt, t he 
w a y t he y rel ate t o p atie nts is 
n ot t h at i m p ort a nt.  
  
  
  
  
  
  
8.  M a n y p atie nts c o nti n ue as ki n g 
q uesti o ns e ve n t h o u g h t he y are 
n ot le ar ni n g a n yt hi n g ne w.  
  
  
  
  
  
  
9.  P atie nts s h o ul d be tre ate d as if 
t he y were p art ners wit h t he 
s ur ge o n, e q u al i n p o wer a n d 
st at us. 
  
  
  
  
  
  
1 0.  P atie nts ge ner all y w a nt 
re ass ur a nce r at her t h a n 
i nf or m ati o n a b o ut t heir 
bre ast c a ncer.  
  
  
  
  
  
  
1 1.  If a s ur ge o n’s pri m ar y t o ols 
are bei n g o pe n a n d w ar m, t he 
s ur ge o n will n ot h a ve a l ot of 
s uccess. 
  
  
  
  
  
  

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1 2 8  
  
1 9.  
H o w ma n y years ha ve y o u bee n i n practice? _ _ _ _ _ _ _ _ _ _ _ _  
 
2 0.  
Ha ve y o u c o m plete d a breast or s ur gical o nc ol o g y fell o ws hi p?   Yes     or      N o  
 
2 1.  
W hat perce nta ge of y o ur cli nical practice is c o m prise d of breast ca ncer patie nts?  _ _ _ _ _ _ _ _ _ _  
 
2 2.  W hat is y o ur ge n der?  
 
Male  or  
Fe male  
 
2 3.  Are y o u of His pa nic, Lati n o, or S pa nis h ori gi n?     Yes     or      N o  
 
2 4.   H o w w o ul d y o u descri be y o ur racial bac k gr o u n d?  
 A merica n I n dia n or Alas ka n Nati ve  
 Asia n  
 Blac k or Africa n A merica n  
 Nati ve Ha waiia n or Ot her Pacific Isla n der  
 W hite  
 Ot her: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
1 2.  W he n p atie nts dis a gree wit h 
t heir s ur ge o n, t his is a si g n 
t h at t he s ur ge o n d oes n ot 
h a ve t he p atie nt’s res pect a n d 
tr ust. 
  
  
  
  
  
  
1 3.  A s ur gic al pl a n c a n n ot 
s uccee d if it is i n c o nflict wit h 
a p atie nt’s lifest yle or v al ues.  
  
  
  
  
  
  
1 4.  M ost p atie nts w a nt t o get i n 
a n d o ut of t he s ur ge o n’s office 
as q uic kl y as p ossi ble.  
  
  
  
  
  
  
1 5.  T he p atie nt m ust al w a ys be 
a w are t h at t he s ur ge o n is i n 
c h ar ge. 
  
  
  
  
  
  
1 6.  It is n ot t h at i m p ort a nt t o 
k n o w a p atie nt’s c ult ure a n d 
b ac k gr o u n d i n or der t o tre at 
t heir bre ast c a ncer. 
  
  
  
  
  
  
1 7.  H u m or is a m aj or i n gre die nt 
i n t he s ur ge o n’s tre at me nt of 
t he p atie nt. 
  
  
  
  
  
  
1 8.  W he n p atie nts l o o k u p 
i nf or m ati o n a b o ut t heir 
bre ast c a ncer o n t heir o w n, 
t his us u all y c o nf uses m ore 
t h a n it hel ps. 
  
  
  
  
  
  

Allia nce A 2 3 1 7 0 1 C D  
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A P P E N DI X VII:   P A TI E N T A C C E S SI BI LI T Y T E L E P H O N E IN T E R VI E W G UI D E  

Allia nce A 2 3 1 7 0 1 C D  
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1 3 0  
I ncr e asi n g P ati e nts’ E n g a g e m e nt i n Br e ast C a nc er S ur g er y D ecisi o n M a ki n g  
ALLI A N C E A 2 3 1 7 0 1 C D  
 
Acc essi bilit y I nt er vi e w G ui d e  
F or p ati e nts t h at acc e pt e d  t h e d ecisi o n ai d b ut r e p ort e d diffic ult y acc essi n g or usi n g t h e 
d ecisi o n ai d w e bsit e.  
 
* * T his i ntervie w g ui de i ncl u des s a m ple q uesti o ns a d dressi n g sever al c o nst a nt d o m ai ns. Wit hi n e ac h 
d o m ai n, t he i ntervie wer m ay pr o be t he p artici p a nt f or m ore i n -de pt h re s p o nses or cl arific ati o n of t he 
res p o nse. T hr o u g h o ut t he i ntervie ws, t hese d o m ai ns will re m ai n c o nst a nt b ut t he E X A C T Q U E S TI O N S 
m ay be m o difie d b ase d o n p artici p a nt res p o nses * *  
 
Ra ve  I D: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
Date of i nter vie w: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
I ntr o d ucti o n: 
 
H ell o. M y n a m e is [ N a m e]. T h a n k y o u f or t a ki n g t h e ti m e t o t al k wit h m e t o d a y. I’ m c alli n g 
b ec a us e y o u a gr e e d t o p artici p a t e i n a s h ort i nt er vi e w. Ar e y o u still i nt er est e d i n t al ki n g ? 
 
•  If N O : T h a n k y o u f or c o nsi d eri n g t his. H a v e a gr e at d a y!  
 
•  If Y E S : 
Gr e at. Y o ur br e ast c a nc er s ur g e o n a n d cli nic t e a m k n o w t h at y o u ar e h el pi n g us wit h t his 
r es e arc h b ut t h e y will n ot b e a bl e t o h e ar or s e e t h e r es ults of t his i nt er vi e w. 
T h e d ecisi o n f or t y p e of s ur g er y is h ar d f or m a n y  w o m e n di a g n os e d wit h br e ast c a nc er. 
T h e r es e arc h t e a m is i nt er est e d i n fi n di n g w a ys t o h el p w o m e n w h o n e e d t o m a k e t his 
d ecisi o n.  Pl e as e l et us k n o w if y o u ar e u nc o mf ort a bl e or w o ul d pr ef er n ot t o a ns w er a 
s p ecific q u esti o n. T his is n’t a q uiz; t h er e ar e n o ri g ht or wr o n g a ns w ers. W e w o ul d j ust li k e 
t o h e ar y o ur t h o u g hts a n d f e eli n gs. 
As w e disc uss e d w h e n I first t al k e d t o y o u a b o ut t h e i nt er vi e w , w e w o ul d li k e t o a u di o -
r ec or d t h e i nt er vi e w s o t h at I c a n f oc us o n o ur c o n v ers ati o n r at h er t h a n n ot e-t a ki n g. Is 
t h at still all ri g ht wit h y o u ?  
I nt ervi e w er N ot e : If i nt ervi e w e e i n dic at es t h at it is o k ay t o b e gi n, pl e as e st art a u di o r ec or d er. If 
t h ey s ay it is n ot o k ay, pr oc e e d wit h t h e i nt ervi e w wit h ex p a n d e d n ot e-t aki n g as y o u ar e a bl e. 
Is it O K if w e g et st art e d ? Pl e as e l et m e k n o w if y o u h a v e q u esti o ns or c o nc er ns at a n y 
ti m e.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 1  
 
Pri or t o m e eti n g wit h y o ur s ur g e o n f or t h e first ti m e, y o u w er e off er e d t h e c h a nc e t o r e vi e w a 
w e bsit e t h at h a d i nf or m ati o n a b o ut br e ast c a nc er s ur g er y. W e ar e i nt er est e d i n l e ar ni n g 
a b o ut h o w t h e cli nic t al k e d a b o ut t h e w e bsit e wit h y o u. Y o u pr o b a bl y w o ul d h a v e t al k e d t o 
[ N a m e] a b o ut t h e w e bsit e.   
 
1.  Aft er [ N a m e] d escri b e d t h e w e bsit e t o y o u, w er e y o u i nt er est e d i n r e vi e wi n g t h e w e bsit e ?   
 
I nt ervi e w er Not e:   
If p artici p a nt s ays “I d o n’t r e m e m b er t al ki n g a b o ut t h e w e bsit e ,” pr ovi d e m or e r e mi n d er 
pr o m pts a b o ut it  a n d →  pr oc e e d t o Q u esti o n 2.  
 
If p artici p a nt still d o es n’t r e m e m b er, →  g o t o Q U E S TI O N S E T # 2: M E T H O D O F D E CI SI O N AI D 
D ELI V E R Y.  
 
2.  Fr o m w h at y o u w er e t ol d b y [ N a m e], i n w h at w a ys di d y o u t hi n k t h e w e bsit e w o ul d b e 
h el pf ul ?  
 
3.  If y o u w er e t o r ec o m m e n d t h e w e bsit e t o a n ot h er w o m a n t h at h a d b e e n di a g n os e d wit h 
br e ast c a nc er, w h at w o ul d y o u s a y t o h er t o e nc o ur a g e h er t o l o o k at t h e w e bsit e ?  
→  G o t o Q U E S TI O N S E T # 2: M E T H O D O F D E CI SI O N AI D D ELI V E R Y.  
 
 
 
4.  I nt ervi e w er N ot e:  
If y o u d o n ot k n o w  h o w t h e p ati e nt w as s e nt t h e w e bsit e, st art wit h 4 a.  
 
If y o u d o k n o w , st art wit h  4 b.  
 
4 a. W e k n o w t h at p ati e nts w h o p artici p at e d i n t h e r es e arc h st u d y w er e gi v e n  a n d us e d t h e 
w e bsit e i n diff er e nt w a ys. C a n y o u t ell m e a b o ut h o w y o u w er e gi v e n t h e w e bsit e ?  
P R O B E:  
•  F or  e x a m pl e, s o m e p e o pl e h a d t h e w e bsit e li n k s e nt t o t h eir e m ail. Ot h er p e o pl e 
h a d it s e nt t o a f a mil y m e m b er’s e m ail or acc ess e d t h e w e bsit e fr o m a w e b li n k o n 
a c ar d. Ot h ers j ust r e vi e w e d t h e w e bsit e i n cli nic. H o w w er e y o u gi v e n t h e 
w e bsit e ?  
→  G o t o n ext p a g e.  
4 b. Y o u w er e s e nt t h e w e bsit e vi a [ e m ail t o p ers o n al e m ail, ot h er w a y]. Is t h at c orr ect ?  
→  G o t o n ext p a g e.  
Q U E S TI O N S E T # 1: P R E S E N T A TI O N O F T H E D E CI SI O N AI D T O P A TI E N T S  
Q U E S TI O N S E T # 2: M E T H O D O F D E CI SI O N AI D D ELI V E R  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 2  
W e ar e tr yi n g t o l e ar n t h e b est w a y t o g et t h e w e bsit e t o w o m e n w h o h a v e b e e n di a g n os e d 
wit h br e ast c a nc er. I n t h e n e xt f e w q u esti o ns, w e ar e l o o ki n g f or y o ur a d vic e a b o ut t h e b est 
w a y t o d o t his.  
If p ati e nt r ec eiv e d w e bsit e by E M AI L t o P E R S O N AL e m ail acc o u nt : 
5 . W h at ar e t h e a d v a nt a g es of b ei n g s e nt t h e w e bsit e t hr o u g h e m ail ?   
 
6. W h at diffic ulti es di d y o u h a v e  g etti n g t h e w e bsit e b y  e m ail ?  
 
 
7 . W o ul d y o u h a v e pr ef err e d t o h a v e b e e n gi v e n t h e  w e bsit e i n a diff er e nt w a y ?  
o  
If N O , →  pr oc e e d  t o Q u esti o n # 8 . 
 
o  
If Y E S :  
7 a.  H o w w o ul d h a v e pr ef err e d t o r ec ei v e t h e w e bsit e?  
7 b.  W h y d o y o u t hi n k t h at w o ul d b e a b ett er w a y t o b e gi v e n t h e w e bsit e ?  
     →  pr oc e e d  t o Q u esti o n # 8 . 
8 . H o w c o ul d w e d o a b ett er j o b i n s e n di n g o ut t h e w e bsit e ?  
→  G o t o n ext p a g e . 
 
If p ati e nt r ec eiv e d w e bsit e A N O T H E R W A Y  ( ot h er t h a n e m ail t o t h eir p ers o n al acc o u nt): 
9 . W h at ar e t h e a d v a nt a g es of g etti n g t h e w e bsit e b y  [i ns ert m et h o d of r ec ei vi n g w e bsit e 
fr o m i nt er vi e w Q u esti o n 4 a or 4 b]? 
 
1 0. W h at diffic ulti es di d y o u h a v e  g etti n g t h e w e bsit e i n t his w a y ? 
 
1 1 . W h y di d y o u c h os e t o g et t h e w e bsit e t his w a y ? 
 
P R O B E  if t h ey s ay “I di d n ot c h os e t his m et h o d”:  
•  H o w w o ul d y o u h a v e pr ef err e d t o r ec ei v e t h e w e bsit e ?  
 
•  
W h y w o ul d t his b e a b ett er w a y t o b e gi v e n t h e w e bsit e ?  
 
1 2 . H o w d o y o u t hi n k t h e pr oc ess of g etti n g t h e w e bsit e c o ul d b e i m pr o v e d ?  
→  G o t o n ext p a g e.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 3  
I nt ervi e w er N ot e : 
If pati e nt di d n ot  r evi e w t h e w e bsit e pri or t o m e eti n g t h e s ur g e o n ( Q u esti o n 1 0 of t h e 
b as el i n e s urv ey), →  g o t o Q U E S TI O N S E T # 3 : R E AS O NS F O R N O T R E VI E WI N G P RI O R T O 
S U R G E O N C O NS UL T . 
 
If p ati e nt di d r evi e w t h e w e bsit e pri or t o m e eti n g t h e s ur g e o n  ( Q u esti o n 1 0 of t h e 
b as eli n e s urv ey), →  g o  t o Q U E S TI O N S E T # 4 : P E R C EI V E D V AL U E O F R E C EI VI N G D E CI SI O N 
AI D.  
 
 
 
1 3.  O n o n e of t h e s ur v e ys t h at y o u c o m pl et e d f or t h e r es e arc h st u d y , y o u s ai d y o u di d n ot r e vi e w 
t h e w e bsit e b ef or e m e eti n g wit h y o ur s ur g e o n. Y o u m e nti o n e d, “[i ns ert p ati e nt r es p o ns e t o 
Q u esti o n 1 0 o n b as eli n e s ur v e y]”. I’ d li k e t o u n d erst a n d t h at m or e.    
 
I nt ervi e w er Not e : All o w p ati e nt t o m ak e a n i niti al r es p o ns e h er e. 
 
I nt ervi e w er Not e : A d diti o n al f oll o w-u p q u esti o ns ar e b as e d o n p ati e nt’s a ns w er t o Q u esti o n 1 0 
o n t h e b as eli n e s urv ey. →  G o t o a p pr o pri at e s ecti o n b el o w  b as e d o n t h e p ati e nt’s s urv ey 
r es p o ns e a n d as k t h es e q u esti o ns if t h ey ar e n ot c ov er e d i n t h e p ati e nt’s i niti al r es p o ns e t o 
Q u esti o n # 1 3 .  
 
•  1 3 a. S urv ey R es p o ns e  » »  “I di d n’t h av e i nt er n et acc ess b et w e e n w h e n I r ec eiv e d t h e 
w e bsit e a n d w h e n  I s a w my s ur g e o n.” 
 
o  1 3 a. 1.  H o w d o y o u us u all y acc ess t h e i nt er n et ?   
 
P R O B E:  
▪ W h er e d o y o u acc ess t h e i nt er n et ? F or e x a m pl e, s o m e p e o pl e 
us e a c o m p ut er at h o m e. Ot h ers us e a s m art p h o n e or g o t h e 
l oc al li br ar y.  
 
o  1 3 a. 2.  W h at c h all e n g es  d o  y o u h a v e i n  acc essi n g t h e i nt er n et ?  
 
→  Pr oc e e d t o Q u esti o n # 1 4.  
 
 
 
 
 
Q U E S TI O N S E T # 3: R E A S O N S F O R N O T R E VI E WI N G P RI O R T O S U R G E O N 
C O N S UL T  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 4  
•  1 3 b. S urv ey R es p o ns e  » »  “I w as f e eli n g t o o str ess e d.” 
 
W e r e all y w a nt t o l e ar n m or e a b o ut t his b ec a us e t his is s o m et hi n g t h at m a n y 
w o m e n f e el. W e k n o w t h at s o m e w o m e n w h o r e vi e w t h e w e bsit e act u all y f e el 
l ess str ess e d aft er g etti n g t his i nf or m ati o n fr o m t h eir s ur g e o n. W e ar e tr yi n g t o 
l e ar n h o w t o d o a b ett er j o b e x pl ai ni n g t o w o m e n h o w t h e w e bsit e c o ul d h el p 
t h e m wit h t h eir f e eli n gs of str ess.   
 
o  1 3 b. 1.  W h y di d y o u t hi n k t h at t h e w e bsit e w as s o m et hi n g t h at w o ul d n ot 
b e us ef ul t o y o u ?  
 
o  1 3 b. 2.  Is t h er e s o m et hi n g t h at w e c o ul d h a v e t ol d y o u a b o ut t h e w e bsit e 
t h at w o ul d h a v e e x pl ai n e d h o w t h e w e bsit e c o ul d l ess e n y o ur str ess ?  
→  Pr oc e e d t o Q u esti o n # 1 4.  
 
 
•  1 3c. S urv ey R es p o ns e  » »  “I di d n’t t hi nk I n e e d e d a ny i nf or m ati o n .” 
 
o  1 3c. 1.  I’ d li k e t o u n d erst a n d m or e a b o ut w h y y o u t h o u g ht y o u di d n’t n e e d 
a n y  i nf or m ati o n. C a n y o u t ell m e m or e a b o ut w h y y o u g a v e t his a ns w er ? 
→  P r oc e e d t o Q u esti o n # 1 4.  
 
•  1 3 d. S urv ey R es p o ns e  » »   “I s a w my s ur g e o n v ery q uic kly aft er r ec eivi n g t h e w e bsit e, ” “I 
di d n’t r ec eiv e t h e e m ail ,” or “I c o ul d n’t m ak e t h e li nk t o t h e w e bsit e w or k ,” t h er e ar e n o 
f urt h er q u esti o ns.   
→  Pr oc e e d t o Q u esti o n # 1 4.  
 
 
 
 
 
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 5  
1 4.  Di d y o u e n d u p r e vi e wi n g t h e w e bsit e aft er m e eti n g wit h y o ur s ur g e o n ? 
If N O , →  g o t o Q U E S TI O N S E T # 5 FI N AL Q U E S TI O N A N D W R A P U P.  
 
If Y E S : 
•  1 4 a.  N o w t h at y o u h a v e h a d ti m e t o r e vi e w t h e w e bsit e, d o y o u t hi n k it w o ul d h a v e 
b e e n h el pf ul t o r e vi e w e arli er aft er y o ur di a g n osis t o h el p pr e p ar e y o u t o m e et wit h 
y o ur s ur g e o n ?  
 
 
•  1 4 b.  W h at c o ul d w e c h a n g e t h at w o ul d m a k e t h e i nf or m ati o n m or e h el p f ul ? 
 
If n o t hi n g c o ul d b e c h a n g e d, →  g o t o Q U E S TI O N S E T # 5 FI N AL Q U E S TI O N A N D 
W R A P U P . 
 
If s o m et hi n g c o ul d b e c h a n g e d: 
1 4 b. 1.  L o o ki n g b ac k, h o w c o ul d [ N a m e] h a v e e x pl ai n e d t h e w e bsit e diff er e ntl y 
t o b ett er s h o w h o w it c o ul d h el p y o u pr e p ar e t o m e et wit h y o ur s ur g e o n ? 
 
→  G o t o Q U E S TI O N S E T # 5 FI N AL Q U E S TI O N A N D W R A P U P . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 6  
 
T h e n e xt f e w q u esti o ns ar e a b o ut w a ys w e c o ul d p ot e nti all y i m pr o v e h o w w e s h ar e 
i nf or m ati o n wit h p ati e nts a b o ut br e ast c a nc er s ur g er y. 
 
1 5.  H o w w as t h e i nf or m ati o n h el pf ul t o y o u i n pr e p ari n g t o m e et wit h y o ur s ur g e o n ?  
 
1 6.  W h at c o ul d w e c h a n g e t h at w o ul d m a k e t h e i nf or m ati o n m or e h el pf ul ?  
 
1 7.  W h at ar e y o ur t h o u g hts a b o ut t h e s ur g er y cli nic pr o vi di n g  y o u t his i nf or m ati o n b ef or e y o ur 
first visit wit h t h e s ur g e o n ?   
 
I nt ervi e w er N ot e : T h e n ext q u esti o n r el at es t o t h e p ati e nt’s r es p o ns e t o Q u esti o n # 1 1 o n t h e 
b as eli n e s urv ey.  
If p ati e nt a ns w er e d “ N o” t o Q u esti o n # 1 1 o n b as eli n e s urv ey, →  g o t o Q U E S TI O N S E T # 5: 
FI N AL Q U E S TI O NS A N D W R A P U P.  
 
If p ati e nt  a ns w er e d “ Yes ” t o Q u esti o n # 1 1 o n  b as eli n e s urv ey , as k: 
1 7 a. I s a w o n y o ur s ur v e y t h at y o u h a d tr o u bl e usi n g t h e w e bsite. Pl e as e t ell m e 
m or e a b o ut t h at . 
 
 
→  G o t o Q U E S TI O N S E T # 5: FI N AL Q U E S TI O NS A N D W R A P U P .  
 
 
 
 
 
 
W e h a v e o n e fi n al q u esti o n. I’ d li k e y o u t o t hi n k a b o ut y o ur o w n p ers o n al e x p eri e nc e wit h 
b ei n g di a g n os e d wit h br e ast c a nc er a n d m e eti n g wit h y o ur s ur g e o n.   
 
1 8.  W h at ot h er t hi n gs c a n  y o u  t hi n k of t h at w o ul d h el p y o u pr e p ar e  t o m e et wit h y o ur s ur g e o n f or 
t h e first ti m e ? 
 
 
T h a n k y o u a g ai n f or t a ki n g t h e ti m e t o t al k wit h m e. Is t h er e a n yt hi n g I h a v e n’t as k e d y o u t h at 
y o u t hi n k is i m p ort a nt f or us t o k n o w ?  
 
 
-- E N D  -- 
 
 
Q U E S TI O N S E T # 4: P E R C EI V E D V AL U E O F R E C EI VI N G D E CI SI O N AI D  
C O N S UL T  
Q U E S TI O N S E T # 5: FI N AL Q U ES TI O N S A N D W R A P U P  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 7  
I ncr e asi n g P ati e nts’ E n g a g e m e nt i n Br e ast C a nc er S ur g er y D ecisi o n M a ki n g  
ALLI A N C E A 2 3 1 7 0 1 C D  
 
Acc essi bilit y I nt er vi e w G ui d e  
F or p ati e nts t h at d ecli n e d t h e d ecisi o n ai d. 
* * T his i ntervie w g ui de i ncl u des s a m ple q uesti o ns a d dressi n g sever al c o nst a nt d o m ai ns. Wit hi n e ac h 
d o m ai n, t he i ntervie wer m ay pr o be t he p artici p a nt f or m ore i n -de pt h res p o nses or cl arific ati o n of t he 
res p o nse. T hr o u g h o ut t he i ntervie ws, t hese d o m ai ns will re m ai n c o nst a nt b ut t he E X A C T Q U E S TI O N S 
m ay be m o difie d b ase d o n p artici p a nt res p o nses * * 
 
Ra ve  I D: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
Date of i nter vie w: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
I ntr o d ucti o n: 
 
H ell o. M y n a m e is [ N a m e]. T h a n k y o u f or t a ki n g t h e ti m e t o t al k wit h m e t o d a y. I’ m c alli n g 
b ec a us e y o u a gr e e d t o p artici p at e i n a s h ort i nt er vi e w. Ar e y o u still i nt er est e d i n t al ki n g ?  
 
•  If N O : T h a n k y o u f or c o nsi d eri n g t his. H a v e a gr e at d a y!  
 
•  If Y E S : 
Gr e at. Y o ur br e ast c a nc er s ur g e o n a n d cli nic t e a m k n o w t h at y o u ar e h el pi n g us wit h t his 
r es e arc h b ut t h e y will n ot b e a bl e t o h e ar or s e e t h e r es ults of t his i nt er vi e w. 
T h e d ecisi o n f or t y p e of s ur g er y is h ar d f or m a n y  w o m e n di a g n os e d wit h br e ast c a nc er. 
T h e r es e arc h t e a m is i nt er est e d i n fi n di n g w a ys t o h el p w o m e n w h o n e e d t o m a k e t his 
d ecisi o n.  Pl e as e l et us k n o w if y o u ar e u nc o mf ort a bl e or w o ul d pr ef er n ot t o a ns w er a n y 
s p ecific q u esti o n. T his is n’t a q uiz; t h er e ar e n o ri g ht or wr o n g a ns w ers. W e w o ul d j ust li k e 
t o h e ar y o ur t h o u g hts a n d f e eli n gs. 
As w e disc uss e d w h e n I first t al k e d t o y o u a b o ut t h e i nt er vi e w , w e w o ul d li k e t o a u di o-
r ec or d t h e i nt er vi e w s o t h at I c a n f oc us o n o ur c o n v ers ati o n r at h er t h a n n ot e-t a ki n g. Is 
t h at still all ri g ht wit h y o u ?  
I nt ervi e w er N ot e : If i nt ervi e w e e i n dic at es t h at it is o k ay t o b e gi n, pl e as e st art a u di o r ec or d er. If 
t h ey s ay it is n ot o k ay, pr oc e e d wit h t h e i nt ervi e w wit h ex p a n d e d n ot e-t aki n g as y o u ar e a bl e. 
Is it O K if w e g et st art e d ? Pl e as e l et m e k n o w if y o u h a v e q u esti o ns or c o nc er ns at a n y 
ti m e.  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 8  
 
Pri or t o m e eti n g wit h y o ur s ur g e o n f or t h e first ti m e, y o u w er e off er e d t h e c h a nc e t o r e vi e w a 
w e bsit e t h at h a d i nf or m ati o n a b o ut br e ast c a nc er s ur g er y. W e k n o w t h at y o u d eci d e d y o u 
w er e n ot i nt er est e d i n r e vi e wi n g t h e w e bsit e at t h at ti m e.  
H o w e v er, w e ar e i nt er est e d i n l e ar ni n g a b o ut h o w t h e cli nic t al k e d a b o ut t h e w e bsit e wit h 
y o u. Y o u pr o b a bl y w o ul d h a v e t al k e d t o [ N a m e] a b o ut t h e w e bsit e.   
 
1.  H o w di d [ N a m e] d escri b e t h e w e bsit e t o y o u ?  
 
I nt ervi e w er Not e:  If t h ey s ay “I d o n’t r e m e m b er t al ki n g a b o ut t h e we bsit e ,” pr ovi d e m or e 
r e mi n d er pr o m pts a b o ut it. If t h ey still d o n’t r e m e m b er, →  g o t o Q U E S TI O N SE T # 2 : R E A S O NS 
F O R D E CLI NI N G T H E D E CI SI O N AI D  
 
2.  Fr o m w h at y o u w er e t ol d b y [ N a m e], i n w h at w a ys di d y o u t hi n k t h e w e bsit e w o ul d b e 
h el pf ul ?  
 
→  G o t o Q U E S TI O N SE T # 2 : R E A S O NS F O R D E CLI NI N G T H E D E CI SI O N AI D 
  
 
 
 
 
 
 
 
 
W h e n t h e cli nic disc uss e d t h e w e bsit e wit h y o u, y o u s ai d “[i ns ert r e as o n fr o m d ecli n e l o g]” w h e n y o u 
w er e t al ki n g wit h t h e cli nic st aff.  I’ d li k e t o u n d erst a n d t h at m or e.  
 
I nt ervi e w er n ot e: All o w p ati e nts t o m ak e a n i niti al r es p o ns e h er e.  
 
P R O B E  b as e d o n  r e as o n f or d ecli n e if n e e d e d, p ers o n aliz e d t o t h eir r es p o ns e. 
 
 
3.  W e ar e tr yi n g t o l e ar n t h e b est w a y t o g et t h e w e bsit e t o w o m e n w h o h a v e b e e n di a g n os e d 
wit h br e ast c a nc er. L o o ki n g b ac k, h o w c o ul d [ N a m e] h a v e e x pl ai n e d t h e w e bsit e diff er e ntl y 
t o b ett er s h o w h o w it c o ul d h el p y o u pr e p ar e t o m e et wit h y o ur s ur g e o n ?  
 
→  G o  t o Q U E S TI O N S E T # 3: O P P O R T U NI TI E S T O C H A N G E I N F O R M A TI O N D ELI V E R Y 
 
 
Q U E S TI O N S E T # 1: P R E S E N T A TI O N O F T H E D E CI SI O N AI D T O P A TI E N T S  
Q U E S TI O N S E T # 2: R E A S O N S F O R D E CLI NI N G T H E D E CI SI O N AI D  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 3 9  
 
W e ar e i nt er est e d i n i m pr o vi n g h o w w e s h ar e i nf or m ati o n wit h br e ast c a nc er p ati e nts t o h el p 
t h e m pr e p ar e t o m e et wit h t h eir s ur g e o n.  
 
4.  W o ul d y o u h a v e pr ef err e d t o g et t h e i nf or m ati o n i n a diff er e nt w a y  ot h er t h a n t hr o u g h a 
w e bsit e , s uc h as a p a p er b o o kl et or a D V D ?  
 
If N O : →  pr oc e e d t o Q u esti o n 6.  
 
If Y E S :  
5 a.  W h at w a y w o ul d y o u pr ef er ? W h y  d o y o u t hi n k t h at w a y w o ul d b e b ett er 
f or y o u ?  
 
5.  I n t his r es e arc h st u d y, p ati e nts w er e off er e d t h e w e bsit e b ef or e t h e y m et wit h t h eir s ur g e o n. 
I k n o w t h at y o u w er e n ot i nt er est e d i n r e vi e wi n g t h e w e bsit e d uri n g t his ti m e wi n d o w. W h e n 
d o y o u t hi n k it w o ul d h a v e b e e n a b ett er ti m e f or y o u t o b e gi v e n i nf or m ati o n a b o ut br e ast 
c a nc er s ur g er y ?  
 
→  G o t o Q U E S TI O N S E T # 4 : FI N AL Q U E S TI O NS A N D W R A P U P 
 
 
 
 
 
 
 
 
 
W e h a v e o n e fi n al q u esti o n. I’ d li k e y o u t o t hi n k a b o ut y o ur o w n p ers o n al e x p eri e nc e wit h 
b ei n g di a g n os e d wit h br e ast c a nc er a n d m e eti n g wit h y o ur s ur g e o n.   
 
6.  W h at ot h er t hi n gs c a n y o u t hi n k of t h at w o ul d h el p y o u pr e p ar e t o m e et wit h y o ur s ur g e o n f or 
t h e first ti m e ? 
 
T h a n k y o u a g ai n f or t a ki n g t h e ti m e t o t al k wit h m e. Is t h er e a n yt hi n g I h a v e n’t as k e d y o u t h at 
y o u t hi n k is i m p ort a nt f or us t o k n o w ?  
 
 
-- E N D  -- 
 
Q U E S TI O N S E T # 3: O P P O R T U NI TI ES T O C H A N G E I N F O R M A TI O N D ELI V E R  
Q U E S TI O N S E T # 4 : FI N AL Q U ES TI O N S A N D W R A P U P  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 0  
A P P E N DI X V III:  P A TI E N T P R E P A R A T O R Y /I N T E R A C TI O N A L IN -P E R S O N IN T E R VI E W G UI D E  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 1  
* * T his i ntervie w g ui de i ncl u des s a m ple q uesti o ns a d dressi n g sever al c o nst a nt d o m ai ns. Wit hi n e ac h 
d o m ai n, t he i ntervie wer m ay pr o be t he p artici p a nt f or m ore i n -de pt h res p o nses or cl arific ati o n of t he 
res p o nse. T hr o u g h o ut t he i ntervie ws, t hese d o m ai ns will re m ai n c o nst a nt b ut t he E X A C T Q U E S TI O N S 
A N D W O R DI N G O F T H E Q U E S TI O N S m ay be m o difie d b ase d o n p artici p a nt res p o nses * *  
R A V E I D: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
L ocati o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Da te of c o m pleti o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Brief i ntr o d ucti o n :  
T ha n k y o u f or ta ki n g t he ti me t o tal k wit h me t o da y.  
T here are differe nt s ur gical o pti o ns a vaila ble f or w o me n dia g n ose d wit h breast ca ncer. We are i ntereste d 
i n f urther u n dersta n di n g h o w y o u lear ne d a b o ut t he differe nt o pti o ns f or s ur ger y. We als o wa nt t o hear 
a b o ut t he c o n versati o n y o u ha d wit h y o ur s ur ge o n a b o ut t he differe nt o pti o ns. B y u n dersta n di n g y o ur 
t h o u g hts a n d e x perie nces, we h o pe t hat we ca n i m pr o ve t he e xperie nce ar o u n d s ur gical decisi o n ma ki n g 
f or w o me n w h o are dia g n ose d wit h breast ca ncer i n t he f ut ure.   
W e w o ul d li ke t o a u di o -ta pe t he i nter vie w s o t hat I d o n’t ha ve t o ta ke as ma n y n otes w hile I’ m liste ni n g 
t o y o u. Is t hat alri g ht wit h y o u?  
D o y o u ha ve  a n y q uesti o ns bef ore we get starte d?  
 
 
[ q uesti o n set # 1- g o al: u n derst a n d t heir feeli n g s w he n c o mi n g i nt o t he visit , pre p ar at or y b arriers] 
I wa nt t o start b y ha vi n g y o u t hi n k bac k t o w he n y o u first met wit h Dr. [s ur ge o n na me]. Base d o n o ur 
n otes, t his w o ul d ha ve bee n o n [c o ns ult date]. D uri n g t his visit, y o u a n d Dr. [s ur ge o n na me] tal ke d a b o ut 
t he differe nt s ur ger y o pti o ns f or t he breast ca nc er. Please tell me w hat y o ur t h o u g hts were a b o ut breast 
s ur ger y bef ore t hat first visit wit h Dr. [s ur ge o n na me]. 
 
W hat were y o u e x pecti n g w o ul d ha p pe n d uri n g t he c o urse of t he visit wit h Dr. [s ur ge o n]?   
 
T here is a l ot t o k n o w a b o ut breast ca ncer a n d t he s ur ger y o pti o ns. O n t he first s ur ve y y o u c o m plete d 
w he n y o u first met  wit h Dr. [s ur ge o n], we as ke d a b o ut h o w i nf or me d y o u felt c o mi n g i nt o t he visit. 
Please t ell me m ore a b o ut h o w i nf or me d y o u were feeli n g  a b o ut t h ose s ur ger y o pti o ns w he n y o u ca me t o 
cli nic t o meet wit h y o ur s ur ge o n f or t he first ti me. 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 2  
I k n o w fr o m re vie wi n g y o ur s ur ve y t hat y o u sai d y o u w o ul d prefer t o [ ma ke t he decisi o n y o urself/ ma ke 
t he decisi o n after c o nsi deri n g s ur ge o ns rec o m me n dati o n/ ma ke decisi o n wit h s ur ger y/ ha ve s ur ger y ma ke 
decisi o n after c o nsi deri n g y o ur val ues/ ha ve s ur ge o n ma ke decisi o n].  
W o me n ha ve differe nt res p o nses t o t hat s ur ve y q uesti o n, wit h s o me w o me n wa nti n g t o be ver y i n v ol ve d 
i n ma ki n g t he decisi o n f or breast ca ncer s ur ger y a n d ot hers wa nti n g t heir s ur ge o n t o lea d t he wa y. Tell me 
a b o ut w h y y o u t h o u g ht it w o ul d be best t o [ ma ke t he decisi o n y o urself/ ma ke t he decisi o n after 
c o nsi deri n g s ur ge o ns rec o m me n dati o n/ ma ke decisi o n wit h s ur ger y/ ha ve s ur ger y ma ke decisi o n aft er 
c o nsi deri n g y o ur val u es/ ha ve s ur ge o n ma ke decisi o n] .   
 
 
[ q uesti o n set # 2: g o al- u n derst a n d w h at w as t he c o n vers ati o n, h o w t he s ur ge o n i n v ol ve d t he m, 
fi g ure o ut w h at w as i m p ort a nt t o t he p atie nt (f acilit ati ve b arriers)] 
I k n o w fr o m re vie wi n g t he a u di o -rec or di n g of y o ur first visit t hat Dr. [s ur ge o n na me] disc usse d  t he 
differe nt o pti o ns f or s ur ger y wit h y o u, t hi n gs li ke mastect o m y or l u m pect o m y. Please tell me w hat y o u 
re me m ber tal ki n g a b o ut wit h Dr. [s ur ge o n na me] re gar di n g t hese o pti o ns f or s ur ger y.  
 
W he n Dr. [s ur ge o n na me]  was descri bi n g t he o pti o ns f or breast ca ncer s ur ger y d uri n g t hat first visit, w hat 
were y o ur g ut feeli n gs a b o ut w hat ki n d of s ur ger y y o u wa nte d t o ha ve?  
C h o ose o ne of t he f oll o wi n g b ase d o n w het her s ur gery receive d differe d fr o m t h at  “ g ut feeli n g ”  
•  
I k n o w fr o m re vie wi n g y o ur rec or ds t hat y o u di d e n d u p ha vi n g a [ mastect o m y/l u m pect o m y].  
Please tell me a b o ut t he c o n versati o n  bet wee n  y o u a n d Dr. [s ur ge o n] t hat le d t o t his decisi o n.  
 
O R  
 
•  
I k n o w fr o m re vie wi n g y o ur rec or ds t hat y o ur fi nal s ur ger y differe d fr o m w hat y o u were i nitiall y 
t hi n ki n g y o u w o ul d wa nt. Please tell me w hat le d t o t hat c ha n ge. 
 
W hat , if a n yt hi n g, di d Dr. [s ur ge o n] d o t hat ma de y o u feel y o u were part of t he pla n ni n g f or y o ur breast 
s ur ger y? 
Pr o bes:  
•  
H o w well di d t he s ur ge o n liste n t o y o u d uri n g t he c o n versati o n?  
•  
W hat q uesti o ns di d t he s ur ge o n as k y o u?  
•  
We will i ncl u de a d diti o n al p atie nt -s pecific pr o bes dr a w n fr o m t heir res p o nses o n t he H C C Q  
•  
Cli m ate Q uesti o n n aire (f oll o w -u p s urvey)  
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 3  
Please tell me a l ittle bit a b o ut h o w c o nfi de nt y o u felt tal ki n g wit h y o ur s ur ge o n d uri n g t he i nitial 
c o ns ultati o n.  
Pr o be s: 
•  
W hat q uesti o ns di d y o u as k t he s ur ge o n d uri n g t he c o n versati o n?  
•  
W hat di d y o ur s ur ge o n d o t hat ma de y o u c o mf orta ble s hari n g y o ur t h o u g hts or “ g ut feeli n gs” 
a b o ut breast ca ncer s ur ger y?  
•  
L o o ki n g bac k o n t hat c o n versati o n, w hat di d y o u n ot sa y t he n t hat y o u n o w wis h y o u ha d sai d t o 
Dr. [s ur ge o n na me]? W hat d o y o u t hi n k ke pt y o u fr o m sa yi n g t hat d uri n g t he c o n versati o n?  
•  
P atie nt -s pecific a d diti o n al pr o bes dr a w n fr o m res p o nses o n t he H C C Q Cli m ate Q uesti o n n aire 
(f oll o w-u p s urvey)  
 
 
W he n y o u left t hat first visit wit h Dr. [s ur ge o n], di d y o u feel li ke t he y u n derst o o d w hat was i m p orta nt t o 
y o u i n relati o n t o y o ur breast ca ncer s ur ger y? 
W hat di d t he s ur ge o n d o t hat ma de y o u feel t hat wa y? 
Pr o be:  
•  
H o w di d t he y s h o w y o u t hat t he y k ne w w hat y o u wa nte d?  
•  
P atie nt -s pecific a d diti o n al pr o bes dr a w n fr o m res p o nses o n t he H C C Q Cli m ate Q uesti o n n aire 
(f oll o w-u p s urvey)  
 
 
T hi n ki n g a b o ut e ver yt hi n g t hat we tal ke d a b o ut, d o y o u feel li ke y o u g ot w hat y o u nee de d fr o m t he 
c o n versati o n wit h Dr. [s ur ge o n]?  
If n o, 
W hat di d y o u nee d t hat y o u di d n’t get?  
 
 
[q uesti o n set # 3 - rel ati o ns hi p bet wee n i n di vi d u al b arriers a n d decisi o n ai d b ase d o n s ur ve y 
res p o nses]  
Bef ore  meeti n g wit h Dr. [s ur ge o n] f or t he first ti me, t he s ur ger y cli nic  s hare d a we bsite li n k wit h y o u. 
T he we bsite is desi g ne d t o hel p w o me n w h o ha ve be e n dia g n ose d wit h breast ca ncer a n d will nee d t o 
u n der g o s ur ger y pre pare t o meet wit h t heir s ur ge o n. O n y o ur s ur ve y, y o u sai d t hat y o u re vie we d t he 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 4  
we bsite bef ore y o ur visit wit h Dr. [s ur ge o n]. O ur ne xt set of q uesti o ns as ks s pecificall y a b o ut t his we bsite  
a n d wa ys t o i m pr o ve it.  
 
C h ose o ne of t he f oll o wi n g b ase d o n w het her t he we bsite w as hel pf ul or n ot: 
Y o u sai d o n y o ur s ur ve y t hat t he we bsite was hel pf ul  t o y o u. Please tell us i n w hat wa ys t he we bsite was 
hel pf ul t o y o u.  
H o w di d y o u use t he we bsite t o g et rea d y f or y o ur visit wit h Dr. [s ur ge o n]?  
O R  
Y o u sai d o n y o ur s ur ve y t hat t he we bsite was n ot ver y hel pf ul  t o y o u. Please tell us w h y y o u di d n ot fi n d 
t he we bsite t o be hel pf ul t o y o u.  
H o w c o ul d we ma ke t he we bsite better?  
 
T he we bsite t hat y o u were se nt tries t o descri be t he differe nt o pti o ns f or s ur ger y. S o me w o me n feel m ore 
i nf or me d after re vie wi n g t he we bsite, w hereas ot hers t hi n k t here is still j ust s o m uc h t o k n o w. Tell me a 
little bit a b o ut y o ur t h o u g hts o n  h o w t he we b site descri be d t he o pti o ns f or s ur ger y. 
Pr o bes:  
o  H o w was t he i nf or mati o n hel pf ul?  
o  I n w hat wa ys di d it fall s h ort?  
 
A d diti o n al q uesti o n if p atie nt res p o n de d t o Q uesti o n # 1 o n t he P atie nt B aseli ne s urvey wit h “I prefer 
le avi n g all decisi o ns a b o ut my tre at me nt t o my d oct ors ”.  
S o me w o me n wa nt t o be m ore i n v ol ve d i n ma ki n g t he decisi o n f or breast ca ncer s ur ger y after re vie wi n g 
t he we bsite. I k n o w t hat y o u preferre d [lea vi n g all decisi o ns a b o ut s ur ger y t o y o ur d oct ors], e ve n after 
re vie wi n g t he we bsite. W hat c ha n ges c o ul d we ma ke t o t he we bsite t hat mi g ht ha ve i ncrease d y o ur desire 
t o be m ore i n v ol ve d i n t he decisi o n f or t he t y pe of breast ca ncer s ur ger y?   
 
If y o u were tal ki n g t o a frie n d w h o ha d rece ntl y bee n dia g n ose d wit h breast ca ncer, w hat w o ul d y o u 
s u g gest a b o ut h o w s he s h o ul d use t he we bsite?  
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 5  
T he we bsite is o ne res o urce t hat we ha ve use d t o hel p w o me n w h o are faci n g a decisi o n f or breast ca ncer 
s ur ger y. We are i ntereste d i n y o ur t h o u g hts a b o ut ot her t hi n gs t hat c o ul d hel p t hese w o me n.  
Pr o bes: As k t hese b ase d o n t heir res p o nse t o t he e arlier q uesti o ns as a l ast pr o be a b o ut s ur gery o pti o ns  
•  
W hat t hi n gs c o ul d we ha ve d o ne bef ore y o u met wit h y o ur s ur ge o n t hat w o ul d ha ve bee n hel pf ul 
f or y o u i n getti n g rea d y f or y o ur visit wit h Dr. [s ur ge o n]? 
•  
Base d o n y o ur e x perie nces, w hat c o ul d be d o ne t o hel p w o me n feel m ore i nf or me d?  
•  
W hat ot her t hi n gs c o ul d we ha ve d o ne bef ore y o u met wit h y o ur s ur ge o n t hat w o ul d ha ve hel pe d 
y o u be m ore i n v ol ve d i n ma ki n g y o ur decisi o n f or t y pe of breast ca ncer s ur ger y?  
 
 
Fi n al q uesti o n:  
W hat else s h o ul d I k n o w a b o ut y o ur e x perie nce wit h ma ki n g t he decisi o n f or breast ca ncer s ur ger y?  
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 6  
A P P E N DI X I X:  P A TI E N T F O C U S G R O U P G UI D E  
* * T his f oc us gr o u p g ui de i ncl u des s a m ple q uesti o ns a d dressi n g sever al c o nst a nt d o m ai ns.  Wit hi n e ac h 
d o m ai n, t he f acilit at or m ay pr o be t he p artici p a nts f or m ore i n -de pt h res p o nses or cl arific ati o n of t he 
res p o nse.  T hr o u g h o ut t he st u dy, t hese d o m ai ns will re m ai n c o nst a nt b ut t he e x act Q U E S TI O N S m ay 
be m o difie d b ase d o n p artici p a nt’s res p o nses * *  
 
L ocati o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Date of c o m pleti o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Brief i ntr o d ucti o n:  
T ha n k y o u f or ta ki n g t he ti me t o tal k wit h me t o da y.  We greatl y a p preciate y o ur partici pati o n i n o ur st u d y 
o ver t he past fe w years.  We are ver y e xcite d t o s hare wit h y o u s o me of o ur fi n di n gs a n d get y o ur fee d bac k.  
We are h ol di n g t his gr o u p t o s pecificall y e x pl ore o p p ort u nities t o f urt her i m pr o ve h o w we s u p p ort patie nts 
ma ki n g decisi o ns a b o ut breast ca ncer s ur ger y.  
 
P art 1:  Brief Prese nt ati o n of Over all Rese arc h Fi n di n gs  
We will prese nt t he mai n fi n di n gs fr o m Ai m 1 a n d 2 of t he st u d y f or c o nte xt.  
 
P art 2: S u m m ary of Pri oritize d B arriers t o P atie nt E n g a ge me nt i n Decisi o n M aki n g  
We will ne xt re vie w t he barriers t o e n ga ge me nt t hat were pri oritize d t hr o u g h t he a nal ysis i n Ai ms 1 a n d 2.  
T o e ns ure t hat t his disc ussi o n is as salie nt as p ossi ble t o sta ke h ol ders, we will prese nt eac h barrier usi n g 
q u otes fr o m patie nts w h o e x perie nce d t he barrier. We will briefl y elicit partici pa nts’ perce pti o ns of h o w 
t hese barriers i m pe de e n ga ge me nt as we a ntici pate t hat t he gr o u p disc ussi o n will pr o vi de a d diti o nal i nsi g ht 
be y o n d w hat was ac hie ve d i n t he q ua ntitati ve  data a n d o ne -o n -o ne i nter vie ws.  
 
P art 3: Br ai nst or mi n g of P ote nti al A dj u nct I nterve nti o ns t o S u p p ort P atie nt E n g a ge me nt  
We will t he n prese nt partici pa nts wit h p ote ntial a dj u nct i nter ve nti o ns t hat ma y tar get t he barriers disc usse d 
i n part 2; e xa m ples are prese nte d i n t he Ta ble. T hese p ossi ble i nter ve nti o ns were i de ntifie d t hr o u g h t he 
e xisti n g literat ure. We will prese nt t he m as a wa y t o tri g ger a disc ussi o n.  We will elicit fee d bac k fr o m 
sta ke h ol ders re gar di n g t he a ntici pate d effecti ve ness a n d feasi bilit y of t hese i nter ve nti o ns i n t heir cli nical 
setti n gs, a n d nee de d a da ptati o ns. We a ntici pate t hat a da ptati o n will be necessar y, as i de ntifie d i nter ve nti o ns 
are n ot li kel y t o ha ve bee n de vel o pe d wit hi n cli nics cari n g f or a hi g h pr o p orti o n of disa d va nta ge d patie n ts.  
We als o a ntici pate t hat partici pa nts will pr o p ose alter nati ve i nter ve nti o ns as part of t his disc ussi o n.  
P art # 4:  I de ntify I nterve nti o ns wit h Gre atest P ote nti al  
We will ha ve eac h partici pa nt ra n k t he p ote ntial i nter ve nti o ns.  Ra n ki n gs will be s hare d i m me diatel y wit h 
t he gr o u p.  We will facilitate disc ussi o n re gar di n g br oa d discre pa ncies i n rati n gs t o e ns ure t he pers pecti ves 
are f ull y u n derst o o d.  We will t he n as k sta ke h ol ders t o e val uate t he t hree i nter ve nti o ns wit h t he greatest 
p ote ntial.  
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 7  
A P P E N DI X X :  C LI NI C S T A K E H O L D E R F O C U S G R O U P G UI D E  
* * T his f oc us gr o u p g ui de i ncl u des a b asic o utli ne of t he f oc us gr o u p scri pt.  T he e x act c o nte nt of t he 
secti o ns will be drive n by t he rese arc h fi n di n gs. F or e ac h f oc us gr o u p, t he over all o utli ne a n d 
i nf or m ati o n s h ared will be t he s a me.  H o wever, t he fl o w of t he f oc us gr o u p will de pe n d o n t he i nter acti o n 
wit h p artici p a nts.  As a res ult, alt h o u g h t he c o nte nt will re m ai n t he s a me bet wee n gr o u ps, t he e x act 
q uesti o ns will v ary. * *  
 
L ocati o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Date of c o m pleti o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Brief i ntr o d ucti o n:  
T ha n k y o u f or ta ki n g t he ti me t o tal k wit h me t o da y.  We greatl y a p preciate y o ur partici pati o n i n o ur st u d y 
o ver t he past fe w years.  We are ver y e xcite d t o s hare wit h y o u s o me of o ur fi n di n gs a n d get y o ur fee d bac k.  
We are h ol di n g t his gr o u p t o s pecificall y e x pl ore o p p ort u nities t o f urt her i m pr o ve h o w we s u p p ort patie nts 
ma ki n g decisi o ns a b o ut breast ca ncer s ur ger y.  
 
P art 1:  Br ief Prese nt ati o n of Over all Rese arc h Fi n di n gs 
We will prese nt t he mai n fi n di n gs fr o m Ai m 1 a n d 2 of t he st u d y f or c o nte xt.  
P art 2: S u m m ary of Pri oritize d B arriers t o P atie nt E n g a ge me nt i n Decisi o n M aki n g  
We will ne xt re vie w t he barriers t o e n ga ge me nt t hat were pri oritize d t hr o u g h t he a nal ysis i n Ai ms 1 a n d 2.  
T o e ns ure t hat t his disc ussi o n is as salie nt as p ossi ble t o sta ke h ol ders, we will prese nt eac h barrier usi n g 
q u otes fr o m patie nts w h o e x perie nce d t he barrier. We will briefl y elicit partici pa nts’ perc e pti o ns of h o w 
t hese barriers i m pe de e n ga ge me nt as we a ntici pate t hat t he gr o u p disc ussi o n will pr o vi de a d diti o nal i nsi g ht 
be y o n d w hat was ac hie ve d i n t he q ua ntitati ve data a n d o ne -o n -o ne i nter vie ws.  
P art 3: Br ai nst or mi n g of P ote nti al A dj u nct I nterve nti o ns  t o S u p p ort P atie nt E n g a ge me nt 
We will t he n prese nt partici pa nts wit h p ote ntial a dj u nct i nter ve nti o ns t hat ma y tar get t he barriers disc usse d 
i n part 2; e xa m ples are prese nte d i n t he Ta ble. T hese p ossi ble i nter ve nti o ns were i de ntifie d t hr o u g h t he 
e xisti n g l iterat ure. We will prese nt t he m as a wa y t o tri g ger a disc ussi o n.  We will elicit fee d bac k fr o m 
sta ke h ol ders re gar di n g t he a ntici pate d effecti ve ness a n d feasi bilit y of t hese i nter ve nti o ns i n t heir cli nical 
setti n gs, a n d nee de d a da ptati o ns. We a ntici pate t hat a da ptati o n will be necessar y, as i de ntifie d i nter ve nti o ns 
are n ot li kel y t o ha ve bee n de vel o pe d wit hi n cli nics cari n g f or a hi g h pr o p orti o n of disa d va nta ge d patie nts.  
We als o a ntici pate t hat partici pa nts will pr o p ose alter nati ve i nter ve nti o ns as part o f t his disc ussi o n. 
P art # 4:  I de ntify I nterve nti o ns wit h Gre atest P ote nti al  
We will ha ve eac h partici pa nt ra n k t he p ote ntial i nter ve nti o ns.  Ra n ki n gs will be s hare d i m me diatel y wit h 
t he gr o u p.  We will facilitate disc ussi o n re gar di n g br oa d discre pa ncies i n rati n gs t o e ns ure t he pers pecti ves 
are f ull y u n derst o o d.  We will t he n as k sta ke h ol ders t o e val uate t he t hree i nter ve nti o ns wit h t he greatest 
p ote ntial.  

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 8  
A P P E N DI X XI:  S U R V E Y &  IN T E R VI E W T H A N K Y O U L E T T E R  
 
 
[ D A T E] 
 
 
De ar [ P A R TI CI P A N T N A M E],  
 
 
T ha n k y o u f or y o ur partici pati o n i n t he I ncre asi n g P atie nts’ E n g a ge me nt i n Bre ast C a ncer S ur gery 
Decisi o n -M aki n g  st u d y. O ur g oal f or t he researc h is t o better u n dersta n d h o w t o s u p p ort patie nts i n ma ki n g 
t heir decisi o ns f or breast ca ncer s ur ger y. Y o ur partici pati o n hel ps us t o reac h t hat ai m. 
 
We ha ve e ncl ose d a gift car d t o t ha n k y o u f or y o ur ti me.   
If y o u ha ve a n y q uesti o ns or c o ncer ns, please feel free t o c o ntact us at a n y ti me. Y o u ca n reac h us b y p h o ne 
at [ S T U D Y C O O R DI N A T O R P H O N E N U M B E R] or via e mail at [ S T U D Y C O O R DI N A T O R 
E M AI L] .  
 
T ha n k y o u a gai n f or y o ur hel p wit h t he st u d y!  
 
 
T ha n k y o u,  
 
 
[ S T U DY C O O DI N A T O R N A M E]  
[ S T U D Y C O O R DI N A T O R C O N T A C T I N F O R M A TI O N] 
 
 
 
 

Allia nce A 2 3 1 7 0 1 C D  
Versi o n D ate 0 1 /0 5 /2 2  
U p date # 0 6  
1 4 9  
A P P E N DI X XII:  E M AI L B O D Y F O R P A TI E N T Q U A L T RI C S S U R V E Y  
 
 
 
 
S u bject li ne:  Allia nce A 2 3 1 7 0 1 C D F oll o w -u p S ur ve y  
 
 
Dear Partici pa nt,  
 
T ha n k y o u f or y o ur partici pati o n i n o ur researc h st u d y e ntitle d, “ I ncreasi n g Patie nts’ E n ga ge me nt i n 
Breast Ca ncer S ur ger y Decisi o n -Ma ki n g”.  
 
T he li n k t o c o m plete t he s ur ve y f or t his researc h st u d y is bel o w.  If we d o n ot hear fr o m y o u i n t he ne xt 
fe w da ys, we will c o ntact y o u a gai n. If y o u ha ve a n y q uesti o ns or c o ncer ns, please c o ntact y o ur site 
researc h c o or di nat or w h o will be a ble t o assist y o u. 
 
< Q ualtrics li n k here >  
 
Si ncerel y,  
Allia nce A 2 3 1 7 0 1 C D St u d y Tea m