Families Addressing Cancer Together (FACT): A Pilot Randomized Trial
Phase: NA
Conditions: Neoplasms, Cancer, Parenting, Communication, Parents, Parent-Child Relations
Sponsor: UNC Lineberger Comprehensive Cancer Center

A m e n d m e nt C ov er S h e et T e m pl at e  
L C C C 2 1 5 0 A m e n d m e nt 2 
D oc u m e nt #: D T -0 2 -v 1 
T H E A T T A C H E D V E R SI O N D A T E D 2 0 2 2 -3 -3 1  I N C O R P O R A T E S T H E A B O V E R E VI SI O N S 
A T T A C H T O T H E F R O N T O F E V E R Y C O P Y O F P R O T O C O L  
Pa ge i of 3 1  
P R O T O C O L A M E N D M E N T # 2  
L C C C  2 1 5 0 :  Fa milies A d dressi n g Ca ncer T o get her ( F A C T): A Pil ot Ra n d o mize d 
C o ntr olle d Trial  
A M E N D M E N T I N C O R P O R A T E S  (c hec k all t h at a p pl y): 
_ x _ E dit orial, a d mi nistrati ve c ha n ges  
_ x _ Scie ntific c ha n ges (I R B a p pr o val)  
_ _ _ T hera p y c ha n ges (I R B a p pr o val)  
_ _ _ Eli gi bilit y C ha n ges (I R B a p pr o val)  
A M E N D M E N T R A TI O N A L E A N D S U M M A R Y:  
E dit orial c ha n ges  
(I)
T he versi o n n u m ber a n d date ha ve b ee n c ha n ge d t hr o u g h o ut t he d oc u me nt.
(II)
We ha v e u p date d t he PI na me t hr o u g h o ut t he d oc u me nt.
(III)
Ne da Pa dilla a n d Sa v a n n a h B o wers ha v e bee n re m o ve d  as pr ot oc ol c o -
c o or di nat ors.
(I V)
Yes y L o pez h as bee n a d d e d as a pr ot o c ol c o or di nat or.
Scie ntific c ha n ges  
(I)
We ha v e a d de d Dr. Ze v Na ka m ura as Pri nci pal I n vesti gat or t o re place Dr. Eliza
Par k.

LI N E B E R G E R C O M P R E H E N SI V E C A N C E R C E N T E R  Healt h Ser vices Researc h  
C LI NI C A L O N C O L O G Y R E S E A R C H P R O G R A M  
 
Se pte m ber 2 0 1 4  
U NI V E R SI T Y O F N O R T H C A R O LI N A A T C H A P E L HI L L  
 
 
L C C C 2 1 5 0 :  F a milies A d dressi n g C a ncer T o get her ( F A C T) : A P il ot R a n d o mize d 
C o ntr olle d T ri al 
 
 
Pri nci p al I n vesti g at or  
Ze v N a k a m ur a, M D  
1 0 1 Ma n ni n g Dri ve  
Ca m p us B o x 7 1 6 0  
C ha pel Hill, N C 2 7 5 9 9  
 
( F A X) 
E mail:  ze v _ na ka m ur a @ me d. u nc.e d u  
 
C o -I n vesti g at ors(s) 
Eliza Par k, M D  
 
 
 
  
 
 
 
D o nal d R ose nstei n, M D  
3 1 3 4 P h ysicia n’s Office B uil di n g  
1 7 0 Ma n ni n g Dri ve , Ca m p us B o x 7 3 0 5  
C ha pel Hill, N C 2 7 5 9 9 -7 3 0 5  
9
  
 
E mail: D o nal d _r ose nstei n @ me d. u nc.e d u  
 
J usti n M. Y o p p, P h D  
1 0 1 Ma n ni n g Dri ve , Ca m p us B o x 7 2 1 8  
C ha pel Hill, N C 2 7 5 9 9 -7 3 0 5  
  
) 
E mail: J usti n _ y o p p @ me d. u nc.e d u  
 
Car mi na G. Valle, P h D, M P H  
De part me nt of N utriti o n  
1 3 5 Da uer Dri ve M H R C 2 0 0 4, C B # 7 4 6 1  
 
 
E mail: car mi na. valle @ u nc.e d u  
 
La ura C Ha ns o n, M D, M P H  

LI N E B E R G E R C O M P R E H E N SI V E C A N C E R C E N T E R  Healt h Ser vices Researc h  
C LI NI C A L O N C O L O G Y R E S E A R C H P R O G R A M  
 
Se pte m ber 2 0 1 4  
U NI V E R SI T Y O F N O R T H C A R O LI N A A T C H A P E L HI L L  
 
 
De part me nt of Geriatric Me dici ne  
5 0 0 3 Ol d Cli nic B uil di n g , Ca m p us B o x 7 5 5 0  
C ha pel Hill, N C 2 7 5 9 9 -7 5 5 0  
 
 
E mail: l ha ns o n @ me d. u nc.e d u  
 
Mi -K y u n g S o n g, P h D, R N  
Nell H o d gs o n W o o dr uff Sc h o ol of N ursi n g  
E m or y U ni versit y  
1 5 2 0 Clift o n R oa d, N E  
Atla nta, G A 3 0 3 2 2 -4 0 2 7  
 
E mail: mi -k y u n g.s o n g @e m or y.e d u  
 
Allis o n Lazar d, P h D  
Sc h o ol of J o ur nalis m a n d Me dia 
Carr oll Hall  
C ha pel Hill, N C 2 7 5 9 9  
 
E mail: lazar d @ u nc. e d u  
 
A hra n g J u n g, P h D, R N  
Sc h o ol of N ursi n g, U ni versit y of N ort h Car oli na –  Gree ns b or o  
Visiti n g Sc h olar, U ni versit y of N ort h Car oli na  –  C ha pel Hill  
P O B o x 2 6 1 7 0, Gree ns b or o, N C 2 7 4 0 2 -6 1 7 0  
 
E mail: a _j u n g @ u nc g.e d u  
 
St u d y C o or di n at or s 
Yes y L o pez  
Li ne ber ger C o m pre he nsi ve Ca ncer Ce nter  
1 0 1 Ma n ni n g Dri ve, C B 7 2 1 8  
C ha pel Hill, N C 2 7 5 9 9  
9 1 9 -9 6 6 -0 7 6 1  ( P H O N E) 
E mail: yes y _l o pez @ me d. u nc.e d u  
 
Mic helle Ma n ni n g  
Li ne ber ger C o m pre he nsi ve Ca ncer Ce nter  
1 7 0 0 Marti n L ut her Ki n g Jr. Bl v d  
C ha pel Hill, N C 2 7 5 1 4  
9 1 9 -8 4 3 -8 5 0 6 ( P H O N E)  
E mail: ml ma n ni n @e mail. u nc.e d u  
 
Bi ost atistici a n  
Allis o n M Deal, M S  

LI N E B E R G E R C O M P R E H E N SI V E C A N C E R C E N T E R  Healt h Ser vices Researc h  
C LI NI C A L O N C O L O G Y R E S E A R C H P R O G R A M  
 
Se pte m ber 2 0 1 4  
U NI V E R SI T Y O F N O R T H C A R O LI N A A T C H A P E L HI L L  
 
 
Li ne ber ger C o m pre he nsi ve Ca ncer Ce nter  
Ca m p us B o x 7 2 9 5  
C ha pel Hill, N C 2 7 5 9 9 -7 2 9 5  
9 1 9 -9 6 6 -1 3 8 7 ( P H O N E)  
9 1 9 -9 6 6 -4 2 4 4 ( F A X)  
E mail: Allis o n _ deal @ me d. u nc.e d u   
 
S p o ns or :  Li ne ber ger C o m pre he nsi ve Ca ncer Ce nter 
 
F u n di n g S o urce : NI H  (K 0 7 C A 2 1 8 1 6 7 ), F o u n d ati o n of H o pe  a war de d t o Dr. Par k.  
 
Versi o n D ate:   Marc h 3 1, 2 0 2 3  

L C C C 2 1 5 0  
 
C O N FI D E N TI A L  
PI:  Ze v N a k a m ur a , M D 
 
U NI V E R SI T Y O F N O R T H C A R O LI N A  
Versi o n/ D ate 3 . 0/M ar  3 1 st, 2 0 23  
 Healt h Ser vices Researc h  Se pte m ber 2 0 1 4 Versi o n  
 
i 
M aster P r ot oc ol –  S u m m ar y of c h a n ges fr o m pre vi o us versi o n  
 
 
Versi o n  V. D ate  
Re visi o n s u m m ar y  
P R C st at us  
I R B st at us 
1. 0  
1 1/ 1 2/ 2 1  
n/a –  I nitial s u b missi o n 
S u b mitte d 
1 1/ 1 9/ 2 1  
A p pr o ve d 
2/ 2 3/ 2 2  
2. 0  
0 2/ 2 2/ 2 2  
1.  U p date d d urati o n of m eas ures  
2.  Re place P H Q -9 wit h P H Q -2  
3.  P H Q s uici dalit y m o nit ori n g  
4.  Re m o ve d F A C T -G m eas ure  
5.  Re place d  P C C Q wit h u p date d 
w or di n g  
6.  Re place d  1 5 -ite m p are nt -c hil d 
relati o ns hi p q ualit y meas ure wit h 
si n gle-ite m meas ure  
7.  Re place de m o gra p hic f or m  
8.  A d de d Ne d a Pa dilla a n d Mic helle 
Ma n ni n g a d de d as c o or di nat ors  
S u b mitte d  
2/ 2 2/ 2 2  
A p pr o ve d  
3. 0  
3/ 3 1/ 2 3  
1. A d de d Dr. Z e v Na k a m ura as PI, Yes y 
L o pez as st u d y c o or di nat or  
2. Re m o ve d Sa va n na h B o wers a n d Ne da 
Pa dilla as c o or di nat ors  
S u b mitte d  
 
S u b mitte d  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

L C C C 2 1 5 0  
 
C O N FI D E N TI A L  
PI:  Ze v N a k a m ur a , M D 
 
U NI V E R SI T Y O F N O R T H C A R O LI N A  
Versi o n/ D ate 3 . 0/M ar  3 1 st, 2 0 23  
 Healt h Ser vices Researc h  Se pte m ber 2 0 1 4 Versi o n  
 
ii 
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 A N D R A TI O N A L E  ..................................................................4  
1. 1  
St u d y S y n o psis  ..................................................................................................... 4  
1. 2  
Bac k gr o u n d  .......................................................................................................... 4  
1. 3  
P ur p ose a n d Rati o nale  .......................................................................................... 5  
2. 0  
S T U D Y O B J E C TI V E S  ...........................................................................................5  
2. 1  
Pri mar y O bjecti ve  ................................................................................................ 5  
2. 2  
Sec o n dar y O bj ecti ve  ............................................................................................ 5  
2. 3  
E x pl orat or y O bjecti ves  ......................................................................................... 5  
3. 0  
P A TI E N T E LI GI BI LI T Y  ......................................................................................6  
3. 1  
I n cl usi o n Criteria .................................................................................................. 6  
3. 2  
E xcl usi o n Criteria  ................................................................................................. 6  
4. 0  
S T U D Y P L A N  .........................................................................................................6  
4. 1  
Sc he ma  ................................................................................................................. 6  
4. 2  
D urati o n of St u d y  ................................................................................................. 7  
4. 3  
St u d y Details  ........................................................................................................ 7  
4. 4  
C o m pe nsati o n  ..................................................................................................... 1 4  
4. 5  
E x pecte d Ris ks  ................................................................................................... 1 4  
4. 6  
A de q uac y of Pr otecti o n A gai nst Ris ks ............................................................... 1 5  
4. 7  
Re m o val of Patie nts fr o m Pr ot oc ol  .................................................................... 1 7  
5. 0  
TI M E A N D E V E N T S T A B L E  .............................................................................1 7  
5. 1  
Ti me a n d E ve nts Ta ble  ....................................................................................... 1 7  
6. 0  
U N A N TI CI P A T E D P R O B L E M S  .......................................................................1 8  
6. 1  
Defi niti o n  ........................................................................................................... 1 8  
6. 2  
Re p orti n g  ............................................................................................................ 1 8  
7. 0  
S T A TI S TI C A L C O N SI D E R A TI O N S  ................................................................1 8  
7. 1  
St u d y Desi g n  ...................................................................................................... 1 8  
7. 2  
Sa m ple Size a n d Accr ual .................................................................................... 1 8  
7. 3  
Data A nal ysis Pla ns  ............................................................................................ 1 9  
T o e val uate feasi bilit y of i nter ve nti o n,  ......................................................................... 2 0  
7. 4  
Data Ma na g e me nt/ A u dit  .................................................................................... 2 1  

L C C C 2 1 5 0  
 
C O N FI D E N TI A L  
PI:  Ze v N a k a m ur a , M D 
 
U NI V E R SI T Y O F N O R T H C A R O LI N A  
Versi o n/ D ate 3 . 0/M ar  3 1 st, 2 0 23  
 Healt h Ser vices Researc h  Se pte m ber 2 0 1 4 Versi o n  
 
iii 
8. 0  
S T U D Y M A N A G E M E N T  ....................................................................................2 1  
8. 1  
I nstit uti o nal Re vie w B oar d (I R B) A p pr o val a n d C o nse nt ................................. 2 1  
8. 2  
Re q uire d D oc u me nt ati o n .................................................................................... 2 2  
8. 3  
Re gistrati o n Pr oce d ures ...................................................................................... 2 2  
8. 4  
A d here n ce t o t he Pr ot oc ol  .................................................................................. 2 2  
8. 5  
A me n d me nts t o t he Pr ot oc ol  .............................................................................. 2 3  
8. 6  
Rec or d Rete nti o n  ................................................................................................ 2 4  
8. 7  
O bli gati o ns of I n v esti gat ors  ............................................................................... 2 4  
9. 0  
R E F E R E N C E S  ......................................................................................................2 4  
1 0. 0  A P P E N DI C E S  .......................................................................................................2 6  

 
 
D oc u m e nt #: D T -0 2 -v 1 
4  
1. 0  
B A C K G R O U N D A N D R A TI O N A L E  
1. 1  
St u d y S y n o psis  
T his is a  si n gle ce nter, t w o-ar m pil ot ra n d o mize d c o ntr olle d trial ( R C T) e val uati n g t he 
feasi bilit y a n d acce pta bilit y of a n o vel ps yc h os oci al i nter ve nti o n, Fa milies A d dressi n g 
Ca ncer T o g et her  ( F A C T) deli vere d as a m o bile res p o nse we b a p plicati o n (m o bile we b 
a p p). F A C T is a t he or y -g ui de d,  ps yc h oe d ucati o nal i nter ve nti o n desi g ne d t o i m pr o ve 
pare nts’ c o nfi de nce a n d a bilit y t o tal k a b o ut t heir  ca ncer wit h t heir mi n or c hil dre n.  We 
will e nr oll 4 0 patie nts wit h ca ncer w h o ha v e a mi n or c hil d t o partici pate i n t his 6 -wee k 
st u d y. T he pri mar y h y p ot hesis bei n g teste d is t hat a n i nter ve nti o n t hat assists pare nt s wit h 
t heir c o m m u nicati o n nee ds wit h t heir c hil dre n ca n be feasi ble, acce pta ble, a n d i m pr o ve 
pare ntal c o m m u nic ati o n self -efficac y w he n c o m pare d wit h a waitlist c o ntr ol c o n diti o n.  
Fi n di n gs fr o m t his st u d y will i nf or m a f ut ure gra nt a p plicati o n t o f urt her test t his 
i nter ve nti o n i n a ra n d o mi ze d f ull efficac y trial.  
 
 
1. 2  
B ac k gr o u n d  
 
Pare nts wit h ca ncer are e nc o ura ge d t o b e “ h o nest a n d o pe n” wit h t heir mi n or c hil dre n 
a b o ut t heir ill ness. Yet, f or t he nearl y t w o milli o n U S pare nts faci n g a ne w ca ncer 
dia g n osis a n d treat me nt, 1 m ost will recei ve mi ni mal g ui da nce fr o m t heir o n c ol o g y or 
ps yc h os ocial o nc ol o g y pr o vi ders f or t his diffic ult tas k. F or pare nts wit h ca n cer, t he 
disease creates m aj or disr u pti o ns t o t he fa mil y u nit, t hreate ns pare nts’ desir e t o pr otect 
t heir c hil dre n fr o m har m, a n d lea ds t o s u bsta ntial de pressi o n a n d a n xiet y.2, 3 C o ncer ns 
a b o ut c o m m u nicati o n wit h c hil dre n c o ntri b ute t o t his hei g hte ne d distress: pare nts re p ort 
u ncertai nt y a b o ut w h at t o tell t heir c hil dre n, t he o pti mal ti mi n g of discl os ure, a n d h o w t o 
pr o vi de de vel o p me ntall y a p pr o priate, e m oti o nall y -c har ge d i nf or mat i o n.4, 5 F or pare nts 
wit h a d va nce d dise ase, disc ussi n g life -li miti n g pr o g n oses are p artic ularl y c halle n gi n g. 
Pare ntal c o m m u nicati o n a b o ut ill ness is li n ke d t o better e m oti o nal a dj ust me nt f or b ot h 
t he msel ves a n d t heir c hil dre n,6 -8 yet m ost ca ncer ce nters lac k t h e res o urces t o a d dress 
t hese patie nts’ nee ds. La y p u blicati o ns t o s u p p ort pare ntal ill ness c o m m u nicati o n e xist, 
b ut patie nts prefer tail ore d res o urces s pecifi c t o t heir c o ncer ns a n d disease. 9, 1 0 
 
T he fe w e vi de nce -bas e d i nter ve nti o ns t o facilitate pare ntal ca ncer c o m m u nicati o n 
de m o nstrate hi g h acce pta bilit y, yet are li mite d b y t he nee d f or e xte nsi ve i nfrastr uct ure or 
hi g hl y s pecialize d pr o vi d ers, t h us li miti n g disse mi nati o n. W hat re mai ns u n k n o w n is h o w 
t o deli ver ti mel y, c ust o mize d pare ntal c o m m u nicati o n g ui da nce acr oss ca n cer treat me nt 
setti n gs. Wit h o ut t his s u p p ort , pare nts wit h ca n cer a n d t heir c hil dre n e x peri e nce 
a v oi da ble ps yc h os oci al distress. I n or der t o b etter s u p p ort pare ntal c o m m u nicati o n n ee ds 
i n ca ncer, ps yc h os ocial i nter ve nti o ns t hat ca n b e i m ple me nte d acr oss cli nical practice  
setti n gs are nee d e d.   
 
T o a d dress t his ga p, we h a ve de v el o pe d F A C T –  a t he or y-g ui de d, ps yc h o -e d ucati o nal 
i nter ve nti o n t o hel p pare nts wit h ca ncer t al k a b o ut t heir ill ness wit h t heir c hil dre n i n a 
de vel o p me ntall y a p pr o priate wa y. We desi g ne d F A C T t o be res p o nsi ve t o pare nts’ 

 
 
D oc u m e nt #: D T -0 2 -v 1 
5  
c o ncer ns a n d c o m m u nicati o n g oals a n d t o s u p p ort n ua nce d c o m m u nicati o n t hat c o nsi ders 
pare nts’ disease, treat me nt, pr o g n osis, a n d mat urit y of t heir c hil d. F A C T acc o m plis hes 
t his c ust o mizati o n via c o m p uter-tail ore d al g orit h ms a n d > 1 0 0 0 messa ge li brar y. Pare nts 
c o m plete a se p arate t ail ori n g assess me nt f or eac h c hil d, all o wi n g F A C T t o ge nerat e 
c hil d-s pecific c o nte nt. F A C T pairs e d ucati o nal c o nte nt wit h c o n versati o n scri pts (“ w or ds 
y o u ca n use”) – user -teste d e xa m ples f or i ntr o d uci n g c o m ple x or e m oti o nall y i nte nse 
i nf or mati o n. As a m o bile res p o nsi ve we b a p plicati o n, F A C T ca n b e use d wit h a variet y of 
de vices.  
 
F A C T  was d e vel o pe d t hr o u g h a n e xte nsi ve re vie w of t he scie ntific literat ure a n d p u blicl y 
a vaila ble res o urces, c o ns ultati o n wit h me ntal healt h, s ocial w or k, o nc ol o g y, a n d palliati ve 
care cli nicia ns , patie nt a n d care gi v er sta ke h ol d er i nter vie ws, a n d d ata fr o m t he PI’s pri or 
o bser vati o nal st u dies wit h pare nts li vi n g wit h ca n cer.  
 
1. 3  
P ur p ose a n d R ati o n ale  
T his pil ot st u d y  wi ll pr o vi de t he necessar y dat a t o i nf or m t he de vel o p me nt a n d f ull 
effic ac y testi n g of a n o v el ps yc h os ocial i nter ve nti o n t o s u p p ort pare nts wit h ca ncer i n 
c o m m u nicati n g  wit h t heir c hil dre n a b o ut ca ncer. T he researc h q uesti o n s t o be a ns were d 
b y t his st u d y are  w het her t he i nter ve nti o n bei n g teste d ca n be feasi ble , b e acce pta bl e, a n d 
pr o vi de preli mi nar y esti mates of i m pr o veme nt i n  pare ntal c o m m u nicati o n a n d 
ps yc h ol o gical o utc o mes as c o m pare d t o a waitlist c o ntr ol c o n diti o n.  
2. 0  
S T U D Y O B J E C TI V E S  
2. 1  
Pri m ar y O bjecti ve  
T he pri mar y o bje cti ve of t his st u d y is t o e val uate t he acce pta bilit y of F A C T w he n 
deli vere d as a m o bile  we b a p p.  Acce pta bilit y will be defi ne d t hr o u g h p artici pa nt 
satisfacti o n rati n gs a n d a nal ysis of se mi -str uct ure d i nter vie w data.  
2. 2  
Sec o n d ar y O bjecti ve  
A sec o n dar y o bjecti ve of t his st u d y is t o e val uate t he feasi bilit y of t he st u d y a n d st u d y 
pr oce d ures i n pre p arati o n f or a f ut ure efficac y R C T of t he i nter ve nti o n. We will  re p ort o n 
partici pa nt scree ni n g, recr uit me nt, a n d rete nti on . 
 
2. 3  
E x pl or at or y O bjecti ves  
 
 
 
 
 
 
 
 
 

 
 
D oc u m e nt #: D T -0 2 -v 1 
6  
3. 0  
P A TI E N T E LI GI BI LI T Y  
3. 1  
I ncl usi o n Criteri a 
C o nfir mati o n of eli gi bilit y criteria is r e q uire d f or all p ote ntial st u d y partici pa nt s pri or t o 
st u d y e nr oll me nt. Partici pa nt s will be eli gi ble f or st u d y partici pati o n as defi ne d b y t he 
i ncl usi o n a n d e xcl usi o n criteria as f oll o ws: 
 
3. 1. 1.  I nf or me d c o nse nt r e vie we d a n d si g ne d; 
3. 1. 2.  A ge e q ual t o or a b o ve 1 8 years ; 
3. 1. 3.  A bilit y t o u n dersta n d a n d c o m pl y wit h st u d y pr oce d ures ; 
3. 1. 4.  A ble t o c o m plete all st u d y meas ures a n d visits i n E n glis h;  
3. 1. 5.  Be a pare nt ( defi n e d as bi ol o gical, a d o pti ve, f oster, or ste p -p are nt), ki n care gi v er 
( defi ne d as a relati ve or s o me o ne wit h a si g nifica nt e m oti o nal relati o ns hi p w h o pr o vi des 
f ull-ti me care a n d n urt uri n g of a c hil d), or le gal g u ar dia n of a c hil d a ge 3 t o 1 7 years of 
a ge w h o ca n s pea k a n d u n dersta n d E n glis h;  
3. 1. 6.  Ha ve a di a g n osis of Sta ge II -I V ( or e q ui vale nt) i n vasi ve s oli d t u m or n ot  i n 
s ur veilla nce or s ur vi v ors hi p 
3. 2  
E xcl usi o n Criteri a  
Eli gi ble partici pa nt s m ust n ot ha ve a n y of t he f oll o wi n g t o be e nr olle d i n t he st u d y. 
 
3. 2. 1  U na ble t o c o m plete self -re p ort i nstr u me nts d ue t o illiterac y, ne ur ol o gic ill ness, 
i na bilit y t o s pea k or rea d E n glis h, or ot her ca uses; 
3. 2. 2  Pri or partici pati o n i n t he pil ot trial ( L C C C 2 0 3 0) or de vel o p me nt a n d us er t esti n g 
pr ot oc ol  ( L C C C 1 9 5 2) preli mi nar y t o t his st u d y ; 
3. 2. 3.    N o c urre nt or e x p ecte d c o nt act wit h t heir c hil d; or  
3. 2. 4 .   E xiste nce of ot her c o -m or bi d diseas e, w hi c h i n t he o pi ni o n of t he i n vesti gat or, 
pr o hi bits partici pati o n i n t he pr ot oc ol.  
4. 0  
S T U D Y P L A N  
4. 1  
Sc he m a  
 
 
T his is a t w o-ar m, ra n d o mize d c o ntr olle d trial of 4 0  patie nts wit h ca ncer  w h o are pare nts 
of mi n or c hil dre n . Partici pa nt s will be a p pr oac he d i n h os pital or cli nic setti n gs, c o m plete 

 
 
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baseli ne assess me nts, ra n d o mize d t o i nter ve nti o n ( F A C T) vs. c o ntr ol (waitlist c o ntr ol ), 
a n d c o m plete f oll o w -u p assess me nts 3 -wee ks  p ost -ra n d o mizati o n a n d 6 -wee ks p ost -
ra n d o mizati o n. St u d y visits will occ ur at N C C H , via tele p h o ne , or sec ure vi de o. We 
a ntici pate e nr olli n g parti ci pa nt s o ver a si x -m o nt h peri o d a n d t hat acti ve partici pati o n will 
last f or a 2 -m o nt h  peri o d .   
4. 2  
D ur ati o n of St u d y  
T he d urati o n of i n di vi d ual partici pati o n is esti mate d t o be tw o  m o nt hs  per partici pa nt . 
I n di vi d ual st u d y partici p ati o n is e x pecte d t o c o nsist of e nr oll me nt, baseli ne assess me nt , 
assi g n me nt t o treat me nt ar ms,  a n d t w o f oll o w-u p assess me nt s i ncl usi ve of s ur ve ys a n d a 
se mi-str uct ured  i nter vi e w.  
 
4. 2. 1  B aseli ne assess me nt ( T 0):  
Base d o n o ur pri or s ur v e y -base d researc h st u dies, w e a ntici pate t he baseli n e  assess me nt 
q uesti o n naire t o last a p pr o xi matel y 1 0 -1 5 mi n utes.  
 
4. 2. 2  T re at me nt assi g n me nt:  
Partici pa nts assi g ne d t o t he st u d y i nter ve nti o n will recei ve access t o t he o nli ne p ortal 
wit hi n w hic h t he y ca n create a n d re vie w  t h eir c ust o mize d c o m m u nicati o n g ui da nce. We 
a ntici pate t hat t he creati o n pr ocess will last 5 -1 0 mi n utes. Partici pa nts’ access will be 
mai ntai ne d t hr o u g h o ut t he c o urse of t heir partici pati o n; as s uc h, d urati o n a n d fre q ue n c y 
of acti ve i nteracti o n wit h i nter ve nti o n assess me nts will be c o m pletel y at t he discreti o n of 
eac h i n di vi d ual partici p a nt.  
 
4. 2. 3  3 -wee k f oll o w -u p  assess me nt ( T 1 ):  
T he 3 -wee k p ost -i nter ve nti o n assess me nt c o nsists of str uct ure d s ur ve ys, w hic h we 
esti mate will ta ke a p pr o xi matel y 1 0 -1 5 mi n utes.  
 
4. 2. 4  6 -wee k f oll o w -u p  assess me nt ( T 2 ):  
T he 6 -wee k p ost -i nter ve nti o n assess me nt c o nsists of str uct ure d s ur ve ys a n d a se mi-
str uct ure d i nter vie w wit h eac h p artici pa nt t o pr o vi de fee d b ac k o n t he i nter ve nti o n (if 
assi g ne d t o t he treat me nt ar m) a n d st u d y pr o ce d ures  ( b ot h ar ms). T h e i nter vie w is 
e x pecte d t o last a p pr o xi matel y 3 0 mi n utes. T he s ur ve ys will ta ke a p pr o xi matel y 1 0 -1 5 
mi n utes.  
 
4. 3  
St u d y Det ails  
 

 
 
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4. 3. 1  Pre -st u d y Assess m e nts 
4. 3. 1. 1  Scree ni n g  
We will use t he scree ni n g pr oce d ures  in place f or Dr. Par k’s L C C C 2 0 3 0  st u d y, “A Pil ot 
St u d y of t he Fa milies A d dressi n g Ca ncer t o get her ( F A C T) T o ol . ” P ote ntial  st u d y 
partici pa nt s will be i de ntifie d t hr o u g h c o n versati o ns wit h t he partici pa nt ’s atte n di n g 
o nc ol o gists or C o m pre he nsi ve Ca ncer S u p p ort Pr o gra m ( C C S P) c o ns ulti n g cli nicia ns, 
re vie w of o ut p atie nt m ulti disci pli nar y a n d he mat ol o g y/ o nc ol o g y cli nic patie nt r osters, 
re vie w of ra diati o n o nc ol o g y a n d c he m ot hera p y i nf usi o n r o o m r osters a n d re vie w of 
i n patie nt o nc ol o g y ser vice r osters or o nc ol o g y c o ns ultati o n ser vice r osters. We will 
re q uest a wai ver of HI PA A a ut h orizati o n t o c o n d uct t his scree ni n g beca use of t he hi g h 
perce nt a ge of patie nts wit h ca ncer at U N C w h o mi g ht n ot be eli gi ble f or t he st u d y d ue t o 
t heir a ge or disease stat us. 
 
4. 3. 1. 2  Recr uit me nt a n d i nf or me d c o nse nt  
T he PI  a n d ot her me m b ers of t he researc h t ea m will i de ntif y eli gi ble patie nts t hr o u g h 
electr o nic me di cal rec or d ( E M R) re vie w  a n d recei ve per missi o n fr o m t he p atie nt’s 
o nc ol o g y cli nicia n(s) bef ore a p pr oac hi n g eli gi ble patie nts. As s uc h, patie nts w h o m t he 
o nc ol o g y tea m belie ves are at hi g h ris k of e m oti o n al distress fr o m st u d y partici pati o n will 
n ot be a p pr oac he d. All p artici pa nt s will pr o vi de i nf or me d c o ns e nt f or t he st u d y a n d 
HI P A A a ut h orizati o n. C o pies will be gi ve n t o partici pa nt s, a n d si g ne d f or ms will be ke pt 
l oc ke d i n t he offic e of t h e PI or st u d y c o or di nat or . W he n a p pr oac hi n g a n eli gi ble patie nt, 
t he researc h te a m me m ber will descri be t he nat ure of t he st u d y q uesti o ns a n d t heir 
p ur p ose s a n d writte n or electr o nic i nf or me d c o nse nt will be s o u g ht. 
W he n t he treati n g o nc ol o g y tea m belie v es it ma y be m ore acce pt a ble t o an i n di vi d ual  
patie nt, a me m ber of t he o nc ol o g y tea m ma y first i ntr o d uce t he st u d y. T he pr o vi der will 
briefl y descri be t he st u d y, pr o vi de a n a p pr o ve d br oc h ure t o t he patie nt, a n d assess 
willi n g ness t o be c o ntact e d b y t he st u d y tea m.  
I n a d diti o n t o i n-pers o n recr uit me nt, recr uit me nt will occ ur b y tele p h o ne. T h is met h o d of 
recr uit me nt will be use d t o recr uit p ote ntial partici pa nt s w he n i n-pers o n recr uit me nt is 
u nfeasi ble or restricte d (e. g., d ue t o C O VI D -1 9 ). T his met h o d will als o be use d t o recr uit 
p ote ntial partici pa nt s w h o e x press i nterest i n t he st u d y b ut w h o d o n ot pr o vi de writte n or 
electr o nic i nf or me d c o ns e nt at t he ti me of i nitial i n-pers o n recr uit me nt. As wit h i n -pers o n 
recr uit me nt, tele p h o n e recr uit me nt will o nl y occ ur after recei vi n g healt hcare cli nicia n 
per missi o n t o a p pr oac h t he patie nt a n d ver bal stat e me nts fr o m t he patie nt t hat t he st u d y 
tea m ca n call t he m t o f urt her disc uss t he st u d y. Patie nts w h o ca n n ot be reac he d b y p h o ne 
after t hree atte m pts will recei ve a n e mail, if a p plica ble, fr o m t he st u d y tea m. T he c o nte nt 
of a n y s uc h e m ail will be li mite d s uc h t hat o nl y t he  f oll o wi n g i nf or mati o n will be 
discl ose d:  t he caller’s na me, t hat he/s he/t he y is calli n g  t o f oll o w u p a b o ut a U N C 
researc h st u d y, a n d staff c o ntact i nf or mati o n. 
Partici pati o n i n t his st u d y is v ol u ntar y. Patie nts w h o c h o ose n ot t o partici p ate i n t his 
st u d y will n ot be s u bject t o prej u dice i n t he deli ver y of healt h care b y t h eir p h ysicia ns a n d 
cli nical staff n or b y t h e researc h i nstit uti o n. T he i nf or me d c o ns e nt disc ussi o n will occ ur 
wit h a trai ne d me m ber of t he researc h tea m  a n d will i ncl u de re vie w of t h e p ur p ose of t he 

 
 
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researc h, pr oce d ures, ris ks, be nefits, a n d partici pa nt ’s ri g hts. St u d y partici pa nt s ca n 
c o ntact t he PI t o a d dress all q uesti o ns b ot h pri or t o a n d after c o nse nti n g t o partici pate i n 
t he st u d y. All partici pa nt s will be s pecificall y re mi n de d t hat t he y ma y wit h dra w at a n y 
ti me wit h o ut i m pacti n g t heir treat me nt or relati o ns hi p wit h t heir cli nical tea m a n d t hat 
t he y ma y c h o ose n ot t o a ns wer a n y st u d y q uesti o ns t he y w o ul d rat her n ot a ns wer, wit h 
e xce pti o n t o t he tail ori n g q uesti o n naire ite ms use d t o ge nerate t h eir  i nter ve nti o n 
materials .  
 
Ite ms i n t he tail ori n g q uesti o n naire will be f orce d-res p o nse, as missi n g ite ms w o ul d res ult 
i n t he st u d y i nter ve nti o n bei n g u na ble t o ge nerate partici pa nts’ materials. Partici pa nts will 
be t ol d d uri n g t he i nf or me d c o nse nt pr o cess t hat t h ose s pecific ite ms will b e f orce d -
res p o nse, will ha ve t he o p p ort u nit y t o pre vie w t he ite ms bef ore c o ns e nti n g if desire d, a n d 
will be i nf or me d as t o t he rati o nale f or ma ki n g t h ese ite ms f orce d -res p o ns e. T he 
c o nse nti n g st u d y tea m me m ber will reaffir m t hat all ot her st u d y q uest i o ns ma y still be 
s ki p pe d if preferre d. 
 
4. 3. 2  St u d y assess me nts  
4. 3. 2. 1  B aseli ne st u d y assess me nt  ( T 0) 
After recei vi n g c o ns e nt, eac h p artici pa nt will be assi g ne d a u ni q ue a n d ra n d o m st u d y I D. 
All data c ollecte d will be ass ociate d o nl y wit h t his I D. T he researc h tea m me m ber will 
t he n o btai n baseli ne assess me nt i nf or mati o n fr o m t h e partici pa nt . Partici pa nt s will 
c o m plete t he st u d y f or ms o nli ne via a sec ure R E D Ca p  li n k or wit h  pe n a n d pa per .  
 
T he baseli ne st u d y assess me nt c o nsists of a de m o gra p hic f or m a n d se vera l p atie nt-
re p orte d o utc o m e meas ur es. See t he S t u d y M eas ures secti o n a n d A p pe n dices f or details 
a b o ut t he meas ur es a n d h o w t he y will be a d mi nistere d. Baseli ne assess me nts m ust be 
c o m plete d bef ore ra n d o mizati o n. 
 
4. 3. 2. 2  R a n d o miz ati o n   
Partici pa nts will be ra n d o mize d t o o ne of t w o ar ms: ( 1) i nter ve nti o n ar m, or ( 2) c o ntr ol 
ar m. Partici pa nts will be assi g ne d wit h a n all ocati o n rati o of 1: 1  a n d stratifie d b y disease 
stat us: a d va nce d (st a ge I V or e q ui vale nt) vs n o n-a d va nce d . T his will be i m ple me nte d 
t hr o u g h R E D Ca p’s ra n d o mizati o n m o d ule w hic h will directl y f oll o w e ntr y of baseli ne 
data. Set u p of t he ra n d o mizati o n m o d ule will be d o ne o nl y b y t he PI or C R C, a n d t he 
st u d y bi ostatisticia n will c o nfir m t hat t he ra n d o mi zati o n sc he me l o gic is f u ncti o nal bef ore 
a n y data is c ollect e d.  T his l o gic will be preser ve d s uc h t hat gr o u p assi g n me nt ca n n ot be 
altere d or m a ni p ulate d w he n accr ual be gi ns.  
 
Gi ve n t he nat ure of t his st u d y, a d o u ble -bli n d  desi g n  is n ot p ossi ble as b ot h t he 
partici pa nt s a n d recr uiti n g staff will be a ble t o easil y i nfer gr o u p assi g n me nt.  
 

 
 
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4. 3. 2. 3  I nter ve nti o n ar m ( F A C T) 
T he F A C T i nter ve nti o n is a n i nteracti ve m o bile res p o nsi ve we b a p plicati o n t hat pr o vi des 
pers o nall y tail ore d c o m m u nicati o n g ui da nce t o pare nts wit h ca ncer t o hel p t he m tal k 
a b o ut t heir ill ness wit h t heir mi n or c hil dre n.  
 
U p o n accessi n g t he m o bile res p o nsi ve we b a p plicati o n, partici pa nts will be pr o m pte d t o 
e nter t heir st u d y I D a n d t he n c o m plete a tail ori n g assess me nt. T he ass ess me nt a d dresses 
c hil d a n d fa mil y c haracteristics, t he partici pa nt’s disease c h aracteristics, t hei r 
c o m m u nicati o n g oals, c o m m u nicati o n c o ncer ns, a n d pri or c o m m u nicati o n e x perie n ces. 
Usi n g st u d y -s pecific c o m p uter tail ori n g al g orit h ms, t he we b a p plicati o n t he n pr o vi des t he 
partici pa nt wit h c ust o mize d c o m m u nicati o n fee d b ac k. Partici pa nts c o m plet e t he tail ori n g 
assess me nt i n di vi d uall y f or eac h c hil d f or w hic h t he y see k c ust o mize d fee d bac k, 
h o we ver, t he y will be as ke d t o c o m plete o utc o me meas ures i n r efere nce t o o ne selecte d 
c hil d. T hr o u g h o ut t he st u d y peri o d, t he partici p a nt ca n access t he we b a p pli cati o n a t a 
fre q ue n c y, d urati o n, a n d ti mi n g of t heir c h o osi n g a n d ma y re-ta ke t he assess me nt t o 
recei v e u p date d i nf or mati o n. T he y will n ot pr o vi de i de ntifia ble data vi a t he we b 
a p plicati o n b ut t he y ca n c h o ose t o sa ve t heir d ata f or later re vie w. Partici pa nts will be 
i nf or me d t hat t he res earc h tea m will m o nit or user-l o g meta data (e. g., l o g i ns, we b pa ge 
vie ws) a n d t hat t he p artici pa nt ma y occ ur data c h ar ges relat e d t o t heir use of t he F A C T 
we b a p plicati o n bas e d o n t heir i n di vi d ual data pla n.  
 
I ncl usi o n of p artici p a nts f or w h o m b arriers t o i nter net access exist 
F or partici pa nt s w h o lac k relia ble h o me i nter net access, we will offer i n-h os pital u se of a 
pass w or d -pr ot ecte d st u d y ta blet t o access t h e i nter ve nti o n. T hese partici pa nt s will ha ve 
t he o p p ort u nit y t o pri nt t heir c ust o mize d materials a n d/ or re-us e t he st u d y ta blet d uri n g 
s u bse q ue nt h os pital visits.  
 
C heck -i n p h o ne c all  or mess a ge  
N o m ore t ha n o ne wee k after a partici pa nt h as recei ve d access t o t he o nli ne F A C T p ortal, 
a me m ber of t h e st u d y tea m will c o ntact t he partici pa nt via t heir preferre d 
c o m m u nicati o n met h o d. T his will ser ve t he p ur p ose of q uic kl y i de ntif yi n g a n d res ol vi n g 
a n y l o gi n or ot her iss ues s h o ul d a partici pa nt e x p erie nce t he m.  
 
F orce d -res p o ns e ite ms 
All tail ori n g i te ms wit hi n  t he o nli ne i nter ve nti o n i nterface  will be f orce d -res p o nse, as 
missi n g ite ms w o ul d res ult i n t he bei n g u na ble t o ge nerat e partici pa nts' tail ore d materi als.  
T his will be clearl y discl ose d d uri n g t he i nf or me d c o nse nt pr ocess a n d i n i nf or me d 
c o nse nt d oc u me nts  as descri be d a b o v e . 
 
4. 3. 2. 4  C o ntr ol ar m ( W aitlist c o ntr ol ) 
Partici pa nts i n t he waitlist c o ntr ol c o n diti o n will recei ve t heir us u al care –  w hic h i ncl u des 
access t o t he U N C C C S P (f or w hic h t h e PI s er ves as t he De p ut y Dir ect or of Cli nical 
O perati o ns) b y cli nicia n - or self -referral. A  waitlist c o ntr ol m o del  all o ws t he researc h 
tea m t o c ollect ma xi mall y ri g or o us  data w hile  a d dressi n g t he et hical c o nsi d erati o ns of 
c o m pletel y wit h h ol di n g t he st u d y i nter ve nti o n fr o m partici pa nts assi g ne d t o t his ar m. 

 
 
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T hese i n di vi d uals will partici pate o n t he s a me s c h e d ule as t he treat me nt ar m b ut  recei ve 
t he st u d y i nter ve nti o n aft er t heir dat a c ollecti o n acti vities are c o m plete . Gi v e n t he 
ele vate d ps yc h ol o gical distress t hat pare nts wit h ca ncer e x perie nce  a n d t he l o w ris k 
pr ofile of t he pr ot o c ol, use of a waitlist c o ntr ol gr o u p is a p pr o priate.  
 
4. 3. 2. 5  3 -Wee k F oll o w -u p  assess me nt ( T 1 ) 
Partici pa nts will c o m plete f oll o w -u p s ur ve ys vi a sec ure R E D C a p li n k or pe n -a n d-pa p er.  
 
4. 3. 2. 6  6 -Wee k F oll o w -u p  assess me nt ( T 2 ) 
Partici pa nts will c o m plete f oll o w -u p s ur ve ys vi a sec ure R E D C a p li n k or pe n -a n d-pa p er.  
 
T he p ost -i nter ve nti o n se mi-str uct ure d i nter vie w ma y  be c o n d uct e d i n pers o n at N C C H, 
b y tele p h o ne, or b y sec ure vi de o. T he i nter vi e w c o nte nt  will as k partici pa nts t o disc uss  
barriers a n d facilitat ors t o i nter ve nti o n use, desire d c o m m u nicati o n c o nte nt areas n ot 
a d dresse d i n t he c urre nt c o m m u nicati o n t o ol  (treat me nt ar m o nl y), fee d bac k o n t heir 
e x perie n ces c o m m u nic ati n g wit h t heir c hil dre n , o pi ni o ns o n st u d y pr oce d ures, 
s u g gesti o ns f or i m pr o ve me nt t o t he i nter ve nti o n a n d/ or st u d y acti vities, a n d a n y 
ps yc h os oci al f oll o w-u p n ee ds. T he i nter vi e w is e x pecte d t o last a p pr o xi mat el y 3 0 
mi n utes a n d will be c o n d ucte d b y a me m ber of t he st u d y tea m w it h trai ni n g i n c o n d ucti n g 
s uc h researc h i nter vie ws wit h patie nts. Partici pa nt s are n ot re q uire d t o a ns wer q uesti o ns 
t he y fi n d e m oti o nall y distressi n g a n d are re mi n de d of t his ri g ht pri or t o be gi n ni n g t he 
i nter vie w. All i nter vie ws will be a u di ota pe d a n d t h e n tra nscri b e d f or a nal ysis.  
 
4. 3. 3  E M R  a bstr acti o n  
R esearc h  t ea m me m bers will a bstract basic dat a fr o m t he E M R a b o ut partici pa nts’ 
eli gi bilit y, de m o gra p hics, ca ncer a n d its treat me nt, a n d ca n cer s u p p ort i nter ve nti o n use.  
T o facilitate scree ni n g pr oce d ures, researc h st aff will o btai n i nf or mati o n a b o ut patie nts’ 
pare ntal stat us a n d ca ncer t y pe a n d sta ge t hr o u g h re vie w of t h e E M R. E M R data will be 
st ore d electr o ni call y o n t he R E D Ca p data bas e f or t he d urati o n of st u d y recr uit m e nt s o 
t hat we d o n ot re-c o ntact i n di vi d uals w h o m we ha ve pre vi o usl y i de ntifie d as i neli gi ble or 
w h o decli ne st u d y partici pati o n. F oll o wi n g t he c o ncl usi o n of st u d y recr uit me nt, t his 
i nf or mati o n will be destr o ye d. F or partici pa nts w h o e nr oll i n t he st u d y, researc h staff will 
a d diti o nall y c ollect i nf or mati o n o n t heir ca ncer a n d its treat me nt a n d s u p p orti ve care 
i nter ve nti o n use after o bt ai ni n g HI P A A A ut h orizati o n f or researc h. 
4. 3. 4  I nter ve nti o n us a ge metrics 
F or partici pa nts i n t he i nter ve nti o n c o n diti o n, t he pass w or d -pr ot ecte d, m o bile res p o nsi ve 
we b a p plicati o n creat e d b y C H AI ( C o n necte d Healt h f or A p plicati o ns a n d I nter ve nti o ns) 
C ore at U N C will trac k user -l o g meta dat a s uc h as n u m ber of user l o g i ns, s essi o n 
d urati o n a n d pa ges accesse d. T his data will be st ore d electr o nicall y o n t he C H AI C ore at 
U N C sec ure ser ver.  

 
 
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c o nse q ue nces of disc ussi o ns  wit h t heir c hil dre n a b o ut ca ncer  ( o utc o me e x p ecta nci es), 
a n d t heir c o m m u nicati o n be ha vi ors  wit h t heir c hil dre n . Pare nts w h o h a ve e n ga ge d i n a n y 
c o m m u nicati o n wit h t heir c hil dre n a b o ut ca ncer will als o be as ke d q uesti o ns a b o ut t heir 
c hil d(re n)’s res p o nse t o t hese disc ussi o ns (see A p pe n di x C ). T he esti mate d ti me t o 
c o m plete t hese ite ms is 5 -7  mi n utes.  
 
4. 3. 5. 5  Ge ner alize d A n xiet y Dis or der –  7 ( G A D -7)  
T he G A D -7 is a c o m m o n  meas ure of a n xiet y c o nsisti n g of 7 ite ms  ( A p pe n di x D). T he 
scale ca pt ures t he ele me nts of t h o u g hts, e m oti o ns, a n d p h ysical s y m pt o ms ass ociate d 
wit h ge neral a n xi et y.  T he G A D -7 is ver y well -vali date d f or t he g e neral p o p ulati o n i n 
a d diti o n t o use f or cli nical assess me nt (e. g. ps yc hi atric dis or ders). Ite ms are sc ore d o n a 
f o ur-p oi nt Li kert scale wit h res p o nse s sc ores ra n gi n g fr o m 0 (l o w/ n o a n xiet y) t o 3 ( hi g h 
a n xiet y). Sc ores a b o ut 1 0 are c o nsi d ere d t o be cli nicall y si g nifica nt f or a n xi et y .1 3 T he 
esti mate d ti me t o c o m plete t his meas ure is n o m or e t ha n 5 mi n utes.  
 
4. 3. 5. 6  P atie nt He alt h Q uesti o n n aire –  2  ( P H Q-2 ) 
T he P H Q -2  is a brief, well-vali date d meas ure of se verit y of de pressi o n s y m pt o ms a n d is 
use d e xte nsi vel y i n cli nic al a n d res earc h setti n gs  ( A p pe n di x E).1 4 Partici pa nts are as ke d 
t o res p o n d t o 2  ite ms, res pecti vel y meas uri n g d e presse d m o o d a n d a n h e d o nia, a n d 
i n dicate t he e xte nt t o w hi c h t he y were b ot here d b y t hat s y m pt o m i n t he t w o wee ks pri or 
t o t he q uesti o n naire. Ite ms are Li kert-t y pe a n d h a v e res p o nse o pti o ns of 0 (“ n ot at all”), 1 
(“se veral da ys ”), 2 (“ m or e t ha n half t he d a ys”), a n d 3 (“ nearl y e ver y da y”). T he esti mate d 
ti me t o c o m plete t his meas ure is n o m ore t ha n 1  mi n ute.  
 
4. 3. 5. 7  C o m m u nic ati o n S elf-E ffic ac y S c ale ( C S E S) 
T he ni ne -ite m C S E S  is a da pte d fr o m M ur p h y et. al.’s mater nal HI V discl os ure self-
effic ac y scale 1 6 (see A p p e n di x G ). Partici pa nt s rate ni ne state me nts assessi n g t heir le vel 
of c o nfi de n ce i n t heir a bilit y t o tell t heir c hil d a b o ut t heir dia g n osis usi n g a vis ual 
a nal o g ue scale. T his scal e has bee n e xte nsi vel y us e d i n t he pare nt al HI V c o m m u nicati o n 
literat ure. I n pri or st u dies t he Cr o n bac h’s al p ha f or t he scale was 0. 9 0. 
 
4. 3. 5. 8  F A C T S atisf acti o n sc ale 
T he i nter ve nti o n satisfacti o n assess me nt is c o m p ose d of si x i n vesti gat or-desi g ne d 
q uesti o n ite ms assessi n g t he rele va n ce a n d acce pt a bilit y of t he st u d y i nter ve nti o n (see 
A p pe n di x H ) a n d a si n gle free te xt q uesti o n f or s u g gesti o ns. Partici pa nt s rate eac h ite m 
o n a 4 -p oi nt or di nal scale ra n gi n g fr o m 0 t o 3. T he q uesti o ns ha ve bee n a da pte d fr o m 
ot her assess me nts of ps y c h os ocial i nter ve nti o n satisfacti o n/acce pta bilit y i n t he literat ure. 
T he esti mate d ti me t o c o m plete t hese ite ms is 2  mi n utes.  
 

 
 
D oc u m e nt #: D T -0 2 -v 1 
1 4  
4. 3. 5. 9  Si n gle -ite m P are nt-c hil d rel ati o ns hi p q u alit y assess me nt  
Si n gle ite m assessi n g partici pa nts’ percei ve d rel ati o ns hi p cl ose ness wit h t heir c hil d. T his 
ite m is a da pte d fr o m Sa n dler, et al.  i n t heir fa mil y i nter ve nti o n st u dies. We selecte d t his 
ite m i n lie u of l o n ger meas ures t o mi ni m ize partici pa nt s ur ve y b ur de n. T h e esti mate d 
ti me t o c o m plete t his ite m is n o m ore t ha n 1 mi n ute. 
 
4. 3. 5. 1 0  Ot her res o urce use  
Si n gle ite m assessi n g partici pa nts’ use of i nf or mal a n d pr ofessi o nal res o urces wit h 
res pect t o t heir c o m m u nicati o n wit h t heir c hil dre n ( A p pe n di x J). T he esti mate d ti me t o 
c o m plete t his q uesti o n ite m is o ne mi n ute.  
 
4. 3. 5. 1 1  F oll o w -u p  i nter vie w 
Partici pa nt s will partici pate i n a se mi -str uct ur e d i nter vie w wit h a me m ber of t he st u d y 
tea m t o o btai n fee d b ac k o n t he i nter ve nti o n (see A p pe n di x K ). If partici pa nt s assi g ne d t o 
t he treat me nt ar m elect t o wit h dra w pri or t o recei vi n g t he st u d y i nter ve nti o n, t he y will 
re mai n eli gi ble t o partici pate i n t his i nter vie w. T he p ost-i nter ve nti o n i nter vie w will occ ur 
face-t o-face i n a pri vate r o o m of N C C H, via tele p h o ne , or sec ure vi de o . T h e i nter vie w is 
e x pecte d t o ta k e 3 0  mi n utes. Partici pa nt s are n ot r e q uire d t o a ns w er q uesti o ns t he y fi n d 
e m oti o nall y distressi n g  a n d are re mi n de d of t his ri g ht bef ore b e gi n ni n g t he i nter vie w . All 
i nter vie ws will be a u di ot a pe d a n d t he n tra nscri b e d. I nter vie w a u di o files a n d tra nscri pts 
will be st ore d i n a pass w or d -pr otect e d file wit hi n a n electr o ni c fire wall -sec ure d ser ver 
mai ntai ne d b y t he U N C Sc h o ol of Me dici ne . A u di o files will be  i m me diatel y u pl oa de d 
p ost -i nter vie w a n d t he n i m me diatel y erase d fr o m t he e xter nal a u di o rec or der. A u di o files 
will be c o m pletel y eras e d  at st u d y cl os ure.  
 
4. 3. 6  P ost -st u d y Assess m e nts 
N o ne. Partici pa nt s w h o p artici pate i n t his st u d y will n ot be eli gi ble f or t he a ntici pate d 
ra n d o mize d c o ntr olle d trial t hat will f or mall y test t he effi cac y of t he i nter ve nti o n. 
 
4. 4  
C o m pe ns ati o n  
Partici pa nt s will be c o m pe nsate d f or c o m pleti n g st u d y assess me nts. St u d y c o m pe nsati o n 
is str uct ure d s uc h t hat partici pa nts will recei ve $ 2 0 f or c o m pleti n g T 0, $ 2 0 f or 
c o m pleti n g T 1  assess me nts , a n d $2 0 f or c o m pleti n g T 2  s ur ve y assess me nts . Partici pa nts 
will als o recei ve a n a d diti o nal $ 2 0 f or c o m pleti n g t he se mi -str uct ure d i nter vie w at T2  f or 
a ma xi m u m t otal of $ 8 0 . I n t he e ve nt of earl y disc o nti n uati o n, c o m pe nsati o n will be pr o-
rate d acc or di n g t o t he a b o ve sc he d ule. 
 
4. 5  
E x pecte d Ris ks  
T he pri mar y ris ks i n t his st u d y are a l oss of pri v ac y, l oss of patie nt c o nfi de ntialit y, a n d 
t he ris k of e m oti o nal distress elicite d d uri n g t he i nter vie ws.  
 

 
 
D oc u m e nt #: D T -0 2 -v 1 
1 5  
L oss of pri vac y  
A p pr oac hi n g p atie nts a b o ut e nr oll me nt i n t he cli nic p oses a ris k t o pri vac y. We e x p ect 
t his ris k t o be l o w. I n t he U N C a m b ulat or y o nc ol o g y cli nics, researc h staff r o uti nel y 
a p pr oac h p atie nts f or e nr oll me nt i n cli nical st u dies, a n d me m bers of o ur tea m ha ve 
c o m plete d pri or s ur v e y a n d i nter vie w -bas e d st u dies a n d ps yc h os oci al i nter ve nti o n 
cli nical trials wit h caref ul atte nti o n t o patie nt pri vac y a n d hi g h acce pta bilit y o n t he part of 
partici pa nt s. A p pr oac hi n g patie nts via tele p h o ne als o p oses a ris k t o pri vac y alt h o u g h we 
e x pect t his ris k t o be l o w. O ur res earc h tea m has s uccessf ull y a p pr oac h e d p atie nts a b o ut 
e nr oll me nt via tele p h o ne wit h atte nti o n t o patie nt pri vac y a n d hi g h acce pta bilit y o n t he 
p art of partici p a nt s.  
 
L oss of c o nfi de ntialit y  
L oss of c o nfi de ntialit y c o ul d occ ur if t he st u d y data base was breac he d. T his ris k will be 
mi ni mize d wit h  n u mer o us ste ps t o pr otect c o nfi de ntialit y (see A de q uac y of Pr otecti o n 
A gai nst Ris ks, bel o w). T he alter nati ve of n ot kee pi n g i de ntifia ble i nf or mati o n is n ot 
p ossi ble, beca use we will nee d t o access t he me di cal rec or d t o o btai n  ill ness i nf or mati o n. 
 
Ris k of e m oti o nal distress  
All eli gi ble partici pa nt s f or t his st u d y will ha ve or rece ntl y ha d a dia g n osis of ca ncer –  
ill nesses t hat are fre q ue ntl y ass ociate d wit h  e m oti o nal, p h ysical a n d s pirit ual distress. 
Eli gi ble partici pa nt s ma y be at hi g her ris k f or brief a d diti o nal e m oti o nal disc o mf ort or 
distress d ue t o t his st u d y. Q uesti o ns a b o ut c o m m u nicati o n c o ncer ns  ma y be te m p oraril y 
u nc o mf orta ble or distr essi n g f or s o me partici pa nt s. We e x p ect t he ris ks of disc o mf ort or 
distress t o be l o w relati ve t o t he o verall distress t hat t he patie n ts e x perie nce d ue t o t heir 
seri o us ill ness. We ha ve s uccessf ull y c o n d u cte d st u dies e val uati n g ps yc h ol o gical distress, 
treat me nt decisi o n-ma ki n g, c o m m u nicati o n, pr o g n ostic u n dersta n di n g, a n d s u p p orti ve 
care n ee ds wit h pare nts wit h ca ncer . Partici pa nt s wit h a wi de ra n g e of e d u cati o nal 
bac k gr o u n ds, ill ness se verit y, a n d ps yc h ol o gical a dj ust me nt ha ve descri be d o ur st u d y 
practices as a p pr o priate a n d acce pta ble.  
 
4. 6  
A de q u ac y of Pr otecti o n A g ai nst Ris ks  
Recr uit me nt a n d i nf or me d c o nse nt  
T he researc h tea m will recei ve per missi o n fr o m t he patie nt’s o nc ol o g y  cli ni cia n(s)  bef ore 
a p pr oac hi n g a n y eli gi ble patie nts. As s uc h, patie nts w h o m  t he o nc ol o g y tea m belie ves are 
at hi g h ris k of e m oti o nal distress fr o m st u d y partici pati o n will n ot be a p pr oac he d. All 
partici pa nt s will pr o vi de i nf or me d c o nse nt f or t he st u d y a n d HI P A A a ut h orizati o n. 
C o pies will be gi ve n t o partici pa nt s, a n d si g ne d f or ms will be ke pt l oc ke d i n t he PI’s 
office. W he n a p pr oac hi n g a n eli gi ble patie nt, t he researc h tea m me m ber will descri be t he 
nat ure of t he st u d y q uesti o ns a n d t heir p ur p oses  a n d writte n i nf or me d c o ns e nt will be 
s o u g ht. F or tele p h o ne recr uit me nt, partici pa nt s will pr o vi de st u d y a n d HI P A A c o nse nt 
electr o nicall y t hr o u g h sec ure Q ualtrics li n k.  A c o p y of t he c o nse nt f or m a n d HI P A A f or m 
will be e maile d t o partici pa nt s w h o wis h t o retai n a c o p y f or t h eir o w n rec or ds. 
 
Partici pati o n i n t his st u d y is v ol u ntar y.  Patie nts w h o c h o ose n ot t o partici p ate i n t his 
st u d y will n ot be partici pa nt  t o prej u dice i n t he deli ver y of healt h care b y t heir p h ysicia ns 

 
 
D oc u m e nt #: D T -0 2 -v 1 
1 6  
a n d cli nical staff n or b y t he researc h i nstit uti o n.  T he i nf or me d c o ns e nt disc ussi o n will 
occ ur wit h a tr ai ne d me m ber of t he researc h tea m . T he i nf or me d c o ns e nt pr ocess will 
i ncl u de re vie w of t he p ur p ose of t he res earc h, pr oce d ures, ris ks, be nefits, a n d 
partici pa nt ’s ri g hts. St u d y partici pa nt s ca n c o ntact t he PI t o a d dress all q uesti o ns b ot h 
pri or t o a n d after c o nse nti n g t o partici pate i n t he st u d y. All partici pa nt s will be 
s pecificall y re mi n de d t hat t he y ma y wit h dra w at a n y ti me wit h o ut i m pacti n g t heir 
treat me nt or relati o ns hi p wit h t heir cli nical tea m a n d t hat t he y ma y c h o ose n ot t o a ns wer 
a n y st u d y q uesti o n t he y w o ul d rat her n ot a ns wer.  
 
All me m bers of t he st u d y tea m will u n der g o a n d mai ntai n trai ni n g i n t he res p o nsi ble 
c o n d uct of researc h.  
 
Pr otecti o n a gai nst l oss of pri vac y  
A ll st u d y-relate d i nteracti o ns will be c o n d ucte d i n pri vate s paces at U N C H os pital or 
cli nics or via tele p h o ne  or sec ure vi de o  after as certai ni n g wit h t he partici pa nt s t hat t heir 
l ocati o n is pri vate. Per U N C I R B g ui deli nes, we will use u ne ncr y pte d c o m m u nicati o n 
(e. g., te xt messa ges) f or s ur ve y re mi n ders o nl y if partici pa nts se paratel y pr o vi de c o nse nt 
f or t his c o m m u nicati o n m o dalit y. We will use t he U N C Tra ns missi o n of Se nsiti ve 
I nf or mati o n Sta n dar d’s exce pti o n re q uir e me nts f or o btai ni n g c o nse nt.   
 
Pr otecti o n a gai nst t he ris k of a l oss of c o nfi d e ntialit y  
W e will ta ke se v eral ste ps t o miti gate t his ris k. All researc h staff will be t h or o u g hl y 
trai ne d i n t he nee d t o mai ntai n strict c o nfi de ntialit y. Data will be re p orte d i n a g gre gat e 
f or m o nl y. All partici pa nts are assi g ne d a u ni q ue st u d y i de ntifier a n d all partici pa nt-
i de ntif yi n g i nf or mati o n o n pa per will be ke pt i n l o c ke d files accessi ble o nl y t o researc h 
staff. All electr o nic i nf or mati o n will be pass w or d pr otecte d. N o i nf or mati o n o btai ne d 
d uri n g t he st u d y will be use d f or a n y p ur p ose ot h er t ha n t he p ur p os e f or w hic h t he pers o n 
has c o nse nte d. T h e p h ysical ris ks of t he st u d y pr oce d ures are mi ni mal a n d t he p ote ntial 
ris ks ha ve bee n o utli ne d a b o ve. T he cli nical care of a n y gi ve n partici pa nt will be ha n dle d 
e ntirel y b y t he partici pa nt's o nc ol o gist, u nless e mer ge nc y care is nee de d d u e t o s uici dalit y 
( detaile d bel o w), a n d st u d y partici pa nts will be ma de a ware of t his at t he ti me of 
e nr oll me nt. Si milarl y, a n y me dical pr o ble m t hat arises d uri n g st u d y partici pati o n will be 
referre d t o t he p artici pa nt's o nc ol o g y pr o vi der.  
 
O nl y t he researc h te a m will ha ve access t o i de ntifia ble i nf or mati o n or t o t he st u d y 
data base. T h e st u d y data base will be pass w or d -pr otecte d a n d h o use d o n a HI P A A -
c o m plia nt, sec ure s er ver at t he N C Tra C S I nstit ute at U N C t hat are o nl y accessi ble t o 
I R B-a p pr o ve d p ers o n nel. T he i n vesti gat ors a n d researc h staff will o nl y access t he 
data base t hr o u g h e ncr y pt e d, pass w or d -pr otect e d c o m p uters. Researc h staff will tra ns p ort 
pa per s ur v e ys a n d c o ns e nt f or ms fr o m t he cli nic t o t he l oc ke d offi ce of t he PI 
i m me diatel y after cli nic a n d will c o n d uct all data e ntr y of pe n -a n d-p a per d oc u me nts i n 
t he office. S ur ve ys a n d c o nse nt f or ms will be ke pt i n a l oc ke d ca bi net i n t he l oc ke d office 
of t he PI a n d will be destr o ye d u p o n st u d y c o m pleti o n.  
 
Pr otecti o n a gai nst t he ris k of e m oti o nal distress or disc o mf ort  

 
 
D oc u m e nt #: D T -0 2 -v 1 
1 7  
W he n disc ussi n g t he st u d y wit h eli gi ble patie nts, researc h staff will descri b e t he nat ure of 
t he st u d y q uesti o ns a n d i nter ve nti o n a n d t heir p ur p oses. We will ta ke se v eral meas ures t o 
re d uce t h e ris k of e m oti o nal distress t hat ma y occ ur i n s o me st u d y partici pa nts. First, as 
descri be d a b o ve, a m e m ber of t he researc h tea m will recei ve per missi o n fr o m a patie nt’s 
o nc ol o g y cli nicia n  bef ore a p pr oac hi n g t he m. As s u c h, patie nts w h o m t he treati n g 
o nc ol o g y cli nicia n  belie v es are at hi g h ris k of e m oti o nal distress fr o m st u d y partici pati o n 
will n ot be a p pr oac h e d. Sec o n d, res earc h staff w h o ha ve direct c o ntact wit h partici pa nts 
will u n der g o trai ni n g b y t he PI a n d C o -I n vesti gat or, Dr. Y o p p, o n h o w t o assess a n d 
res p o n d t o partici pa nt distress. B ot h Drs. Par k a n d Y o p p are e x peri e nce d m e ntal healt h 
pr ofessi o nals w h o fre q ue ntl y pr o vi de cli nical care f or seri o usl y ill patie nts wit h 
e m oti o nal distress. T hir d, partici pa nts c o m plete m eas ures of ps yc h ol o gical distress, 
i ncl u di n g t he Patie nt Healt h Q uesti o n naire-2  ( P H Q-2 ) d uri n g t he b aseli ne a n d f oll o w-u p 
assess me nts.  
 
I n t he u nli kel y e ve nt t hat a partici pa nt ver ball y e n d orses s uici dalit y d uri n g st u d y-relate d 
i nteracti o ns, res earc h staff will i m me diatel y c o ntact t he PI ( Dr. R ose nstei n if s he is 
u na vaila ble). F o urt h, if a d verse e v e nts d uri n g or b et wee n st u d y visits s uc h a s t he u nli kel y 
e ve nt of se v ere e m oti o nal distress occ ur, t he y will be re p ort e d t o t he I R B b y t he PI — a 
b oar d -certifie d ps yc hi atrist wit h s pecialize d trai ni n g i n ps yc h o -o nc ol o g y, a n d t he 
partici pa nt’s pri mar y o n c ol o gist will be n otifie d. S h o ul d researc h staf f o bser ve e m oti o nal 
reacti o ns necessitati n g cli nical i nter ve nti o n, t he st u d y partici pa nt will be offere d s u p p ort 
ser vices i n t he f or m of ps yc h o-o nc ol o g y ass ess me nt b y a trai ne d me m ber of t he U N C 
C C S P ps yc h o -o nc ol o g y ser vice w hi c h C o -I n vesti g at or, Dr. Y o p p, o v ersees.  
 
T he PI will i n di vi d uall y m o nit or t he data c o nti n u o usl y t o e ns ure t he safet y of t he 
partici pa nts. T he PI will als o m o nit or data t hr o u g h wee kl y meeti n gs wit h researc h staff 
a n d m o nt hl y  gr o u p meeti n gs of ke y st u d y pers o n nel. T his trial will be a u dite d b y t he 
L C C C  e ver y si x t o t wel ve m o nt hs per t he a u dit c o m mittee's g ui deli nes a n d assi g ne d a 
L C C C Data Safet y M o nit ori n g C o m mittee ( D S M C) per Li ne ber ger g ui d eli nes.  
4. 7  
Re m o v al of P atie nts fr o m Pr ot oc ol  
Partici pa nt s will be re m o ve d fr o m t he st u d y w he n a n y of t he criteria liste d i n Secti o n 3. 2 
a p pl y or t he partici p a nt  elects t o wit h dra w fr o m t h e st u d y. If t his occ urs, t h e PI will be 
n otifie d a n d t he reas o n f or st u d y re m o val a n d t he date t he partici p a nt  was re m o ve d will 
be d oc u me nte d i n t he Case Re p ort F or m.   
 
I n or der t o s u p p ort t he st atistical i nte grit y of a nal yses, t he pre-ra n d o mizati o n 
disc o nti n uati o n of a n y partici pa nt will tri g ger t he recr uit me nt a n d e nr oll me nt of a n 
a d diti o nal partici pa nt. Partici pa nts w h o disc o nti n ue after ra n d o mizati o n will n ot be 
“re place d” i n t his ma n ner.  
5. 0  
TI M E A N D E V E N T S T A B L E  
5. 1  
Ti m e a n d E ve nts T a ble        
 
Pre -
st u d y 
B aseli ne 
assess m e nt  
( T 0) 
R a n d o miz ati o n  
Da y  0  
3 -W ee k 
F oll o w -U p  
( T1 ) 
6 -W ee k 
F oll o w -U p  
( T2 ) 

 
 
D oc u m e nt #: D T -0 2 -v 1 
1 8  
Da y  0  
Da y  2 1  (±  1 4 ) 
Da y  4 2  (± 1 4)  
E M R  eli gi bilit y scree ni n g 
X  
 
 
 
 
O nc ol o g y cli nicia n a p pr o val  
X  
 
 
 
 
I nf or me d co nse nt  a n d 
e nr oll me nt 
X  
 
 
 
 
S ur ve y o utc o me 
assess me nts  
 
X  
 
X  
X  
St u d y gr o u p assi g n me nt  
 
 
X  
 
 
S e mi-str uct ure d i nter vie w 
 
 
 
 
X  
E M R a bstracti o n  
 
X  
 
X  
X  
      
6. 0  
U N A N TI CI P A T E D P R O B L E M S  
6. 1  
Defi niti o n  
As defi ne d b y U N C’s I R B, u na ntici pate d pr o ble ms i n v ol vi n g ris ks t o st u d y partici pa nt s 
or ot hers ( U PI R S O) refers t o a n y i nci de nt, e x peri e nce, or o utc o me t h at:  
•  
Is u n e x pect e d (i n ter ms of nat ure, se v erit y, or fre q ue nc y) gi ve n (a) t he researc h 
pr oce d ures t hat are descri be d i n t he pr ot oc ol -rel ate d d oc u me nts, s uc h as t h e I R B-
a p pr o ve d researc h pr ot o c ol a n d i nf or me d c o nse nt d oc u me nt; a n d ( b) t he 
c haracteristics of t he p artici pa nt  p o p ulati o n bei n g st u die d;  
•  
Is relate d or p ossi bl y relate d t o a partici pa nt ’s partici pati o n i n t he researc h; a n d  
•  
S u g gests t hat t he researc h places partici pa nt s or ot hers at a greater ris k of h ar m 
(i ncl u di n g p h ysical, ps yc h ol o gical, ec o n o mic, or s ocial har m) relate d t o t he 
researc h t ha n was pre vi o usl y k n o w n or rec o g ni ze d. 
6. 2  
Re p orti n g  
A n y U PI R S O  t hat occ urs d uri n g t he c o n d uct of t his st u d y a n d t hat meets all t hree criteria 
liste d i n 6. 1  m ust be re p orte d t o t he U N C I R B usi n g t he I R B’s we b -bas e d re p orti n g 
s yste m.   
7. 0  
S T A TI S TI C A L C O N SI D E R A TI O N S  
7. 1  
St u d y Desi g n  
T his is a t w o-ar m pil ot R C T testi n g t he  acce pta bilit y, feasi bilit y, a n d preli mi nar y 
e vi de nce of efficac y f or a n o vel c o m m u nicati o n i nter ve nti o n f or pare nts wit h ca ncer .  
 
T he pri mar y o bje cti ve of acce pta bilit y will be meas ure d usi n g t he 6 -ite m satisfacti o n 
s ur ve y. T otal sc ores ra n g e fr o m 0-1 8 , s o a s c ore of 1 2  or hi g her will be c o nsi dere d 
“acce pta ble”.  If t he p erce nta ge of patie nts w h o re p ort t he i nter ve nti o n is acce pta ble is 
7 5 % or hi g her, t he i nter ve nti o n will be c o nsi dere d f or f ut ure t esti n g.   
7. 2  
S a m ple Size a n d Accr u al  
We will recr uit 5 5 patie nts o ver 6 m o nt hs f or t he pr o p ose d st u d y, wit h t he h o pe of at least 
2 0 patie nts c o m pleti n g T 1 meas ures. A 9 5 % e xact bi n o mial c o nfi de nce i nter val ( CI) will 

 
 
D oc u m e nt #: D T -0 2 -v 1 
1 9  
be re p ort e d f or t he acce pt a bilit y  rate ( o nl y i n t he i nter ve nti o n gr o u p), a n d wit h n = 2 0, t he 
CI will ha ve precisi o n n o m ore t ha n +/ - 2 3 %. If t h e rate is 7 5 %, t he CI will be 5 0. 9 %, 
9 1. 3 %).  
 
F or q ualitati ve i nter vie w data, sa m ple size esti mati o n is base d o n pr ojecti o ns of t he 
n u m ber of partici p a nt s nee de d t o r eac h s at urati o n of t he c o nce pt. T he sa m ple size f or t he 
pr o p ose d st u d y is a de q uate f or q ualitati ve a n al ysis a n d c o nsiste nt wit h ps yc h os ocial 
i nter ve nti o n de vel o p me nt.1 8, 1 9 
 
We are c o nfi de nt we h a v e a de q u ate access t o t he pr o p ose d sa m ple d uri n g t he st u d y ti me 
fra me. I n 2 0 1 9, N C C H rec or ds i ncl u de d 5 2 2 E n glis h-s pea ki n g a d ults a ges 2 2-5 4 years 
wit h a sta ge I V s oli d t u m or. O ur scree ni n g r ec or ds s u g gest ~ 6 0 -7 0 % N C C H patie nts i n 
t his a ge ra n ge are p are nts of mi n or c hil dre n. Dat a fr o m e pi de mi ol o gic st u dies i n dicate 
t hat a n esti mate d 3 0 % of all a d ult breast ca ncer patie nts are pare nts of mi n or c hil dre n. 1  
 
Base d o n t he PI’s ot her researc h st u dies wit h pare nts wit h ca ncer, w e c o ns er vati vel y 
e x pect t o recr uit, c o nse nt, a n d e nr oll ~ 1 0  patie nts/ m o nt h  f or si x m o nt hs. T he n u m ber of 
eli gi ble patie nts per m o nt h is hi g her, h o we ver we c o nsi der fact ors t hat t y picall y  lea d t o 
deferre d e nr oll me nt/c o nse nt s uc h as patie nt f ati g ue, cli nic sc he d uli n g dela ys, a n d 
i nter ve ni n g me dical e v e nts .  
 
7. 3  
D at a A n al ysis Pl a ns  
7. 3. 1  E v al u ate acce pt a bilit y of t he i nter ve nti o n  
T o e val uate acce pta bilit y of t he i nter ve nti o n, we will a d mi nister a satisfacti o n assess me nt  
t o eac h partici pa nt after eac h f oll o w -u p st u d y visit ( T1  a n d T2 ) a n d c o n d uct p ost -
i nter ve nti o n i nter vie ws at T 2. We will re p ort t he acce pta bilit y rate at T 1, al o n g wit h a n 
e xact 9 5 % c o nfi de n ce i nt er val .  
 
7. 3. 2  A n al ysis of i nter vie w d at a  
I n t he f oll o w-u p  i nter vie ws, we will see k i n p ut fr o m partici pa nts i n t he treat me nt ar m o n: 
( 1) t he rel e va nce of i nter ve nti o n c o m p o ne nts; ( 2) i nter ve nti o n acce pta bilit y a n d 
t olera bilit y; ( 3) la n g ua ge (t o ne a n d p hrasi n g, tail ori n g); a n d ( 4) e m oti o nal a n d c ult ural 
se nsiti vit y. Partici pa nts assi g ne d t o t he waitlist c o ntr ol ar m will be as ke d t o disc uss: ( 1) 
t he rele va n ce of t he st u d y’s s u bject matter; ( 2) t h eir e x perie nces re g ar di n g ca ncer-relate d 
c o m m u nicati o n wit h t heir c hil dre n; ( 3) t h eir e x pectati o ns of t he st u d y i nter ve nti o n, w hic h 
will be ma de a vaila ble at t he e n d of t heir p artici pati o n, a n d ( 4)  perce pti o ns of, a n d 
fee d bac k o n, st u d y desi g n a n d o perati o ns. 
 
We will use c o nte nt a n al ysis, a wi del y acce pte d q ualitati ve a nal ysis a p pr oac h i n healt h 
researc h, t o i de ntif y maj or t he mes fr o m i nter vie ws.2 0 T he  st u d y tea m will re vie w 
i nter vie w tra nscri pts, c o di n g a n d cate g ori zi n g t he data b y e x pa n di n g a n d c olla psi n g 
cate g ories u ntil t he matic sat urati o n is reac he d. 2 1 We will use best practices f or q ualitati ve 
researc h s uc h as me m ber c hec ki n g, a n d creati o n of a n a u dit trail.2 2 We will use t his 

 
 
D oc u m e nt #: D T -0 2 -v 1 
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fee d bac k t o refi ne t he i nt er ve nti o n pri or t o la u nc hi n g t he f ull efficac y trial. We will use 
q ualitati ve a nal ysis s oft w are t o ai d wit h a nal yses. Descri pti ve statistics fr o m t he 
q ua ntitati ve rati n g scale a n d q ualitati ve i nter vie w data will be c ollecte d c o n c urre ntl y, 
a nal yze d s e paratel y, a n d t he t w o sets of fi n di n gs c o n ver ge d. 2 3  
 
7. 3. 3  E v al u ate fe asi bilit y of t he i nter ve nti o n  
T o e val uate feasi bilit y of i nter ve nti o n,  we will re p ort t he perce nta ge of pati e nts  w h o  are 
a p pr oac h e d a b o ut t he st u d y w h o : 
•  E nr oll i n t he i nter ve nti o n (p erce nt a p pr o ac he d)  
•  C o m plete  t he i nter ve nti o n at eac h ti me p oi nt (p erce nt c o m plete d per visit a n d 
o verall)  
 
We will als o use descri pti ve statistics t o assess t he de m o gra p hic c h aracteristics of 
patie nts w h o e nter, re mai n i n, a n d dr o p o ut of t he st u d y. C o m paris o ns will be ma de usi n g 
Wilc o x o n Ra n k s u m tests f or c o nti n u o us c haracteristics a n d Fis her’s E xact tests f or 
cate g oric al c haract eristics.  
 
I n a d diti o n, we will e val uate feasi bilit y of st u d y pr oce d ures i ncl u di n g: 
•  N u m ber of patie nts scree ne d eac h m o nt h  
•  N u m ber of c o nt acts necessar y t o e nr oll partici pa nt s a n d sc he d ule f oll o w -u p 
a p p oi nt me nts  
•  Pr o p orti o n of c o m plete d st u d y meas ures at eac h visit  
 
A lt h o u g h a d verse e ve nts are u nli kel y, we will e xa mi ne t he pr oce d ures f or a d verse e v e nt 
re p orti n g a n d t he st u d y tea ms’ res p o nse s h o ul d t his occ ur.  
 
We will use q ualitati ve a nal yses of t he se mi-str uct ure d i nter vie w data t o e x pl ore barri ers 
a n d facilitat ors t o partici pati o n, i ncl u di n g reas o ns f or e nr oll me nt, n o n-p artici pati o n (e. g. 
fears of u ni nte n de d o utc o mes, c o m peti n g de ma n ds, etc.), i neli gi bilit y, or wit h dra wal a n d 
use t his i nf or mati o n t o refi ne st u d y pr oce d ures i n pre parati o n f or a l ar ger-s cale st u d y.  
 
7. 3. 4  E x pl ore i m p act of i nter ve nti o n o n t ar get o utc o mes  
We will re p ort o n c ha n ges i n C S E S  sc ores fr o m pre - ( T 0) t o p ost -i nter ve nti o n ( T1 , T 2) . 
T his pil ot st u d y is n ot desi g ne d n or p o were d t o detect differe nces as t he pri mar y 
o bjecti ves are t o e val uate t he acce pta bilit y a n d feasi bilit y  of t he i nter ve nti o n  as c o m pare d 
t o treat me nt as us ual. 
 
We will als o re p ort o n c h a n ges i n ot her patie nt -re p orte d o utc o mes of i nterest i ncl u di n g 
G A D -7  a n d P H Q -2  sc ores.   
 
We will use descri pti ve statistics t o re p ort o n t he perce nt a ge of patie nts w h o e n ga ge i n 
a n y c o m m u nicati o n be ha vi ors a b o ut ca ncer wit h t heir c hil dre n, t he de pt h of t heir 
disc ussi o n, a n d t heir assess me nts of h o w t heir c hil dre n res p o n d e d t o t hese c o n versati o ns.  
 

 
 
D oc u m e nt #: D T -0 2 -v 1 
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Data fr o m t his st u d y will be use d f or preli mi nar y esti mates (f or w hic h t h e CS E S  will be 
t he pri mar y o utc o me me as ure) t o p o wer a f ut ure R 0 1 testi n g t he i nter ve nti o n. T he 
pr ojecte d effect size will be base d o n mea n differe nces i n S D f or t he C S E S  fr o m t his pil ot 
st u d y.  
 
7. 4  
D at a M a n a ge me nt/ A u dit  
T he PI a n d st u d y c o or di n at or  will c o or di nate a n d ma na ge dat a f or q u alit y c o ntr ol 
ass ura nce a n d i nte grit y. T he rec or de d i nter vie w data will be ke pt i n a pass w or d -pr otecte d 
electr o nic file h o use d wit hi n a sec ure ser ver wit hi n t he U N C De part me nt of Ps yc hiatr y  of 
t he U N C Sc h o ol of Me di ci ne. I nter vi e w data will be i m me diatel y eras e d fr o m e xter nal 
a u di o rec or ders after c o nfir mi n g s uccessf ul tra nsfer t o t he sec ure ser ver. D e -i de ntifie d 
tra nscri pti o ns will be e nt ere d i nt o a q ualitati ve a n al ysis pr o gra m w hic h is accesse d o n 
pass w or d -pr ot ecte d, e ncr y pte d c o m p uters b y t he st u d y tea m.  
 
Se veral ele m e nts  will be e m be d de d wit hi n t he R E D Ca p data bas e i n or der  t o e ns ure dat a 
q ualit y a n d c o m plia nce. T hese i ncl u de  a “ Data Hist or y” f u ncti o n  w hic h ge nerates a n d 
rec or ds a n a u dit trail f or all data ; t heref ore, all data will be rec or de d wit h a f ull hist or y 
i ncl u di n g val ues e ntere d . A n y c ha n ges t o d ata will be rec or de d a n d s pecif y w he n t he 
c ha n ge o cc urre d, w hic h R E D Ca p user c h a n ge d t h e val ue, a n d t h e ti me of t he c ha n g e. 
 
As a n i n vesti gat or -i nitiate d st u d y, t his trial will als o be a u dite d b y t he Li ne ber ger Ca n cer 
Ce nter a u dit c o m mittee e ver y si x or t wel ve m o nt hs, de pe n di n g o n t he parti ci pati o n of 
affiliate sites.  
8. 0  
S T U D Y M A N A G E M E N T  
8. 1  
I nstit uti o n al Re vie w B o ar d (I R B) A p pr o v al a n d C o nse nt 
It is e x p ecte d t hat t he I R B will ha ve t he pr o per re prese ntati o n a n d f u n cti o n i n acc or da nce 
wit h fe derall y ma n date d re g ulati o ns.  T he I R B will  a p pr o ve t he c o ns e nt f or m a n d 
pr ot oc ol.  
 
I n o btai ni n g a n d d o c u me nti n g i nf or me d c o nse nt, t he i n vesti gat or will  c o m pl y wit h t he 
a p plica ble re g ulat or y re q uire me nt(s ) a n d s h o ul d a d here t o G o o d Cli nical Practice ( G C P) 
a n d t o et hical pri nci ples t hat ha ve t heir ori gi n i n t he Decl arati o n of Helsi n ki.  
 
 
 
Bef ore recr uit me nt a n d e nr oll me nt o nt o t his st u d y, t he patie nt will be gi ve n a f ull 
e x pla nati o n of t he st u d y a n d will be gi ve n t he o p p ort u nit y t o re vie w t he c o nse nt f or m. 
Eac h c o ns e nt f or m m ust i ncl u de all t he rel e va nt el e me nts c urre ntl y re q uire d b y fe deral, 
l ocal, or state re g ulati o ns. O nce t his esse ntial i nf or mati o n has bee n pr o vi de d t o t he 
patie nt a n d t he i n vesti gat or is ass ure d t hat t he pati e nt u n dersta n ds t he i m plicati o ns of 
partici pati n g i n t he st u d y, t he patie nt will be as ke d t o gi ve c o nse nt t o parti ci pate i n t he 
st u d y b y si g ni n g a n I R B-a p pr o ve d c o ns e nt f or m.  
 

 
 
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Pri or t o a patie nt’s partici pati o n i n t he trial, t he writte n i nf or me d c o nse nt f or m will  be 
si g ne d a n d pers o n all y date d b y t he patie nt a n d b y t he pers o n w h o c o n d ucte d t he i nf or me d 
c o nse nt disc ussi o n.  T he partici pa nt will recei ve c o pies of t he si g ne d c o nse nt f or m(s).  
8. 2  
Re q uire d D oc u me nt ati o n  
F ulfill me nt of t he f oll o wi n g d oc u me ntati o n m ust prece d e i nitiati o n of a n y st u d y 
pr oce d ures:  
•  Dele gati o n of Res p o nsi bilities L o g  a n d st u d y pers o n nel trai ni n g rec or ds  
•  O fficial I R B a p pr o val letter f or t he pr ot oc ol a n d i nf or me d c o ns e nt 
•  Si g ne d C V  (wit hi n 2 years ) a n d me dical  or pr ofessi o nal  lice ns ure f or all st u d y 
i n vesti gat ors; s u p ple me ntal d oc u me ntati o n, if a p plica ble, t o d oc u me nt 
i n vesti gati o n q ualificati o ns ma y be a d de d  
•  C o p y of t he a p pr o ve d pr ot oc ol  a n d ass ociate d d oc u me nts,  i ncl u di n g 
o  Inf or me d c o ns e nt d oc u m e nts  
o  Recr uit me nt materials  
o  Ot her writte n material t o be gi ve n t o st u d y partici p a nts  
•  I R B r oster(s) a n d c orres p o n de nce 
8. 3  
Re gistr ati o n Pr o ce d ures  
O nce patie nts ha v e c o ns e nte d t o partici pate i n t his trial, t he y will be assi g ne d a  u ni q ue 
a n d ra n d o m  st u d y I D t o be use d t hr o u g h o ut t he st u d y.  A s ole file li n ki n g t he st u d y I D t o 
t he partici pa nt’s i de ntifiers will be st ore d o n a pass w or d pr otect e d file o n a sec ure s er ver 
mai ntai ne d b y t he Sc h o ol of Me dici ne. P h ysical c o nse nt f or ms will be ke pt wit hi n a 
l oc ke d file ca bi net a n d office.   
 
All partici pa nt s will als o be re gistere d i n O nc ore™. 
8. 4  
A d here nce t o t he Pr ot oc ol  
E xce pt f or a n e mer ge nc y sit uati o n i n w hic h pr o per care f or t h e pr otecti o n, safet y, a n d 
well -bei n g of t he st u d y p atie nt re q uires alter nati ve treat me nt, t he st u d y s hall be 
c o n d ucte d e x actl y as des cri be d i n t he a p pr o ve d pr ot oc ol.   
8. 4. 1  E mer ge nc y M o dific ati o ns  
U N C i n vesti gat ors ma y i m ple me nt a de viati o n fr o m, or a c ha n g e of, t he pr ot oc ol t o 
eli mi nate a n i m me diate h azar d(s) t o trial partici pa nt s wit h o ut pri or U N C I R B a p pr o val.  
 
F or a n y s u c h e mer ge nc y m o dificati o n i m ple me nte d, a U N C I R B m o dificati o n f or m m ust 
be c o m plete d b y U N C R esearc h Pers o n nel wit hi n fi ve ( 5) b usi ness da ys of ma ki n g t he 
c ha n ge.   
8. 4. 2  Si n gle P atie nt/ P artici p a nt  E xce pti o ns  
A n y re q uest t o e nr oll a si n gle partici pa nt  w h o d oes n ot meet all t he eli gi bilit y criteria of 
t his st u d y re q uires t he a p pr o val of t he U N C Pri nci pal I n v esti gat or a n d t he U N C I R B.  

 
 
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8. 4. 3  Ot her Pr ot oc ol De vi ati o ns/ Vi ol ati o ns  
Acc or di n g t o U N C’s I R B, a pr ot oc ol de viati o n  is a n y u n pla n ne d varia nce fr o m a n I R B 
a p pr o ve d pr ot o c ol t hat:  
•  Is g e nerall y n ote d or rec o g nize d after it occ urs 
•  Has n o s u bsta nti ve effect o n t he ris ks t o researc h p artici pa nts  
•  Has n o s u bsta nti ve effect o n t he scie ntific i nte grit y of t he researc h pla n or t he 
val ue of t he dat a c ollect e d  
•  Di d n ot res ult fr o m willf ul or k n o wi n g misc o n d uct o n t he part of t he 
i n vesti gat or(s).  
 
A n u n pla n ne d pr ot oc ol v aria nce is c o nsi dere d a vi olati o n  if t he varia nce meets a n y of t he 
f oll o wi n g criteria:  
•  Has har me d or i ncrease d t he ris k of har m t o o ne or m ore researc h partici pa nts.  
•  Has da ma ge d t h e scie ntific i nte grit y of t he data c ollecte d f or t he st u d y.  
•  Res ults fr o m willf ul or k n o wi n g misc o n d uct o n t he part of t he i n v esti gat or(s).  
•  De m o nstrates seri o us or c o nti n ui n g n o nc o m plia nce wit h fe deral re g ul ati o ns, 
State la ws, or U ni versit y p olicies.  
 
If a de vi ati o n or vi olati o n occ urs,  st u d y pers o n nel will f oll o w t he g ui deli nes bel o w: 
 
Pr ot oc ol D e vi ati o ns: U N C pers o n nel will rec or d t he de viati o n i n O n C ore ®  ( or ot her 
a p pr o priate d ata bas e set u p f or t he st u d y), a n d re p ort t o a n y s p o ns or or data a n d safet y 
m o nit ori n g c o m mittee i n acc or da nce wit h t heir p olicies. De viati o ns s h o ul d be 
s u m marize d a n d re p orte d t o t he I R B at t he ti me of c o nti n ui n g re vie w.  
 
Pr ot oc ol Vi ol ati o ns: Vi olati o ns s h o ul d be re p ort e d b y U N C pers o n nel wit hi n o ne ( 1) 
wee k of t he i n v esti gat or bec o mi n g a ware of t h e e ve nt usi n g t he sa me I R B o nli ne 
mec ha nis m use d t o re p ort U PI R S O.   
 
U n a ntici p ate d Pr o ble ms I n v ol vi n g Ris ks t o P artici p a nt s or Ot hers ( U PI R S O): 
A n y e ve nts t hat meet t he criteria f or “ U na ntici pate d Pr o ble ms” as defi ne d b y U N C’s I R B 
(see secti o n 6. 1 ) m ust be re p orte d b y t he St u d y C o or di nat or usi n g t he I R B’s we b-bas e d 
re p orti n g s yste m.   
8. 5  
A me n d me nts t o t he Pr ot oc ol  
S h o ul d a me n d me nts t o t he pr ot oc ol be re q uire d, t h e a me n d me nts will be ori gi nate d a n d 
d oc u me nte d b y t he Pri nci pal I n v esti gat or at U N C. It s h o ul d als o be n ote d t hat w he n a n 
a me n d me nt t o t he pr ot oc ol s u bsta ntiall y alters t he st u d y desi g n , p ote ntial ris k t o 
pa rtici pa nts, or ot her ele me nts a re vise d c o ns e nt f or m mi g ht be re q uire d.   
 
T he writte n a me n d m e nt, a n d if re q uir e d t he a me n de d c o nse nt f or m, m ust be se nt t o 
U N C’s I R B f or a p pr o val pri or t o i m ple me ntati o n. A me n d me nts wit h m o dificati o ns t o t he 
st u d y desi g n m ust be a p pr o ve d b y U N C Pr ot oc ol Re vie w C o m mittee pri or t o I R B 
s u b missi o n. 

 
 
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8. 6  
Rec or d R ete nti o n  
St u d y d oc u me ntati o n i ncl u des all Case Re p ort F or ms, data c orrecti o n f or ms or q ueries, 
s o urce d oc u m e nts, S p o ns or-I n vesti gat or c orres p o n de nce, m o nit ori n g l o gs/letters, a n d 
re g ulat or y d oc u m e nts (e. g., pr ot oc ol a n d a me n d m e nts, I R B c orres p o n d e nce a n d a p pr o val, 
si g ne d patie nt c o nse nt f or ms). 
 
S o urce d oc u me nts i ncl u d e all rec or di n gs of o bser vati o ns or n otati o ns of cli nical acti vities 
a n d all re p orts a n d rec or ds necessar y f or t he e val u ati o n a n d rec o nstr ucti o n of t he cli nical 
researc h st u d y. 
 
G o ver n me nt a g e nc y re g ulati o ns a n d directi ves re q uire t hat all st u d y d oc u me ntati o n 
pertai ni n g t o t he c o n d uct of a cli nical trial m ust be retai ne d b y t he st u d y i n v esti gat or.  I n 
acc or da nce wit h t hese para meters, d o c u me nts s h o ul d be ke pt o n file u ntil t hree years after 
t he c o m pleti o n a n d fi nal st u d y re p ort of t his i n vesti gati o nal st u d y, wit h e xce pti o n of 
i nter vie w a u di o files w hi c h will be delete d  u p o n st u d y cl os ure. 
8. 7  
O bli g ati o ns of I n vesti g at ors  
T he Pri nci pal I n vesti gat or is res p o nsi ble f or t he c o n d uct of t he cli nical trial i n acc or da nce 
wit h Title 2 1 of t he C o de of Fe d eral Re g ulati o ns a n d/ or t he Declarati o n of Helsi n ki.  T he 
Pri nci pal I n v esti gat or is r es p o nsi ble f or pers o nall y o verseei n g t he tr eat me nt of all st u d y 
patie nts.  T he Pri nci pal I n vesti gat or m ust ass ure t hat all st u d y site pers o n nel, i ncl u di n g 
s u b-i n vesti gat ors a n d ot her st u d y staff me m bers, a d here t o t he st u d y pr ot oc ol a n d 
re g ulati o ns a n d g ui deli nes re gar di n g cli nical trials b ot h d uri n g a n d after st u d y 
c o m pleti o n.  
 
T he Pri nci pal I n vesti gat or will be res p o nsi ble f or ass uri n g t hat all t he re q uire d data will 
be c ollecte d a n d e ntere d o nt o t he Case Re p ort F or ms. Peri o dicall y, m o nit ori n g visits will 
be c o n d ucte d a n d t he Pri nci pal I n vesti gat or will pr o vi de access t o his/ her  ori gi nal rec or ds 
t o per mit verificati o n of pr o per e ntr y of data. At t he c o m pleti o n of t he st u d y, all case 
re p ort f or ms will be re vie we d b y t he Pri nci pal I n v esti gat or a n d will re q uir e his/ her fi nal 
si g nat ure t o verif y t he acc urac y of t he dat a. 
9. 0  
R E F E R E N C E S  
 
 
1.  
Wea v er K E, R o wla n d J H, Alfa n o C M, et al: Pare ntal ca ncer a n d t he fa mil y: a 
p o p ulati o n -base d esti mat e of t he n u m ber of U S ca ncer s ur vi v ors resi di n g wit h t heir mi n or 
c hil dre n. Ca ncer 1 1 6: 4 3 9 5 -4 0 1, 2 0 1 0  
 
2.  
Nilss o n M E, Macieje ws ki P K, Z ha n g B, et al: Me ntal healt h, treat me nt 
prefere nces, a d v a nce care pla n ni n g, l ocati o n, a n d q ualit y of deat h i n a d va n ce d ca ncer patie nts 
wit h de pe n de nt c hil dre n. Ca ncer 1 1 5: 3 9 9 -4 0 9, 2 0 0 9  
 
3.  
Mac k J W, Cr o ni n A, Fas cia n o K, et al: Ca ncer treat me nt decisi o n‐ ma ki n g a m o n g 
y o u n g a d ults wit h l u n g a n d c ol orectal ca ncer: a c o m paris o n wit h a d ults i n mi d dle a ge. Ps yc h o‐
O nc ol o g y 2 5: 1 0 8 5 -1 0 9 1, 2 0 1 6  
 
4.  
Haile y C E, Y o p p J M, Deal A M, et al: C o m m u nicati o n wit h c hil dre n a b o ut a 
pare nt's a d v a nce d ca n cer a n d meas ur es of pare ntal a n xiet y a n d de pressi o n: a cr oss -secti o nal 
mi xe d -met h o ds st u d y. S u p p ort Care Ca ncer 2 6: 2 8 7 -2 9 5, 2 0 1 8  

 
 
D oc u m e nt #: D T -0 2 -v 1 
2 5  
 
5.  
El m ber ger E, B ol u n d C, Ma g n uss o n A, et al: Bei n g a m ot her wit h ca n cer: 
ac hie vi n g a se ns e of bal a nce i n t he tra nsiti o n pr ocess. Ca ncer N urs 3 1: 5 8 -6 6, 2 0 0 8  
 
6.  
Gre n kl o T B, Krei c ber gs U C, Val di mars d ottir U A, et al: C o m m u nicati o n a n d tr ust 
i n t he care pr o vi de d t o a d yi n g pare nt: a nati o n wi de st u d y of ca n cer-berea ve d y o ut hs. J Cli n 
O nc ol 3 1: 2 8 8 6 -9 4, 2 0 1 3  
 
7.  
Ke n ne d y V L, Ll o y d -Willia ms M: I nf or mati o n a n d c o m m u nicati o n w he n a pare nt 
has a d va nce d ca ncer. J Affect Dis or d 1 1 4: 1 4 9 -5 5, 2 0 0 9  
 
8.  
F orrest G, Pl u m b C, Zie bla n d S, et al: Breast ca n cer i n t he fa mil y --c hil dre n's 
perce pti o ns of t heir m ot her's ca n cer a n d its i nitial treat me nt: q ualitati ve st u d y. B MJ 3 3 2: 9 9 8 -
1 0 0 3, 2 0 0 6  
 
9.  
L ustria M L A, N oar S M, C ortese J, et al: A meta -a nal ysis of we b -deli vere d 
tail ore d healt h be h a vi or c ha n ge i nter ve nti o ns. J o ur nal of healt h c o m m u nicati o n 1 8: 1 0 3 9-1 0 6 9, 
2 0 1 3  
 
1 0.  
T ur ner J, Cla vari n o A, Yates P, et al: De vel o p me nt of a res o urce f or pare nts wit h 
a d va nce d ca n cer: w h at d o pare nts wa nt ? Palliat S u p p ort Care 5: 1 3 5 -4 5, 2 0 0 7  
 
1 1.  
O ke n M M, Creec h R H, T or me y D C, et al: T o xicit y a n d res p o nse criteria of t he 
Easter n C o o perati ve O nc ol o g y Gr o u p. A m J Cli n O nc ol 5: 6 4 9 -5 5, 1 9 8 2  
 
1 2.  
C o m pas B E, W ors ha m N L, E p pi n g -J or da n J E, et al: W he n m o m or da d has 
ca ncer: mar kers of ps yc h ol o gical distress i n ca ncer patie nts, s p o uses, a n d c hil dre n. Healt h 
Ps yc h ol 1 3: 5 0 7 -1 5, 1 9 9 4  
 
1 3.  
S pitzer R L, Kr oe n ke K, Willia ms J B, et al: A brief meas ure f or ass essi n g 
ge neralize d a n xiet y dis or der: t he G A D -7. Arc hi ves of i nter nal me dici ne 1 6 6: 1 0 9 2 -1 0 9 7, 2 0 0 6  
 
1 4.  
Kr oe n ke K, S pitzer R L, Willia ms J B. T he Patie nt Healt h Q uesti o n nair e -2: 
vali dit y of a t w o -ite m de pressi o n scree ner. Me d Care. 2 0 0 3 N o v; 4 1( 1 1): 1 2 8 4-9 2. d oi: 
1 0. 1 0 9 7/ 0 1. M L R. 0 0 0 0 0 9 3 4 8 7. 7 8 6 6 4. 3 C. P MI D: 1 4 5 8 3 6 9 1.  
 
1 5.  
Cella D F, T uls k y D S, Gra y G, et al: T he F u ncti o n al Assess me nt of Ca ncer 
T hera p y scale: de v el o p me nt a n d vali dati o n of t he ge neral meas ure. J Cli n O nc ol 1 1: 5 7 0 -9, 1 9 9 3  
 
1 6.  
M ur p h y D A, Ar mistea d L, Marelic h W D, et al: Pil ot trial of a discl os ure 
i nter ve nti o n f or HI V + m ot hers: t he T R A C K pr o gra m. J C o ns ult Cli n Ps yc h ol 7 9: 2 0 3-1 4, 2 0 1 1  
 
1 7.  
Pia nta R C: C hil d -pare nt relati o ns hi p scale. U n p u blis he d meas ure, U ni versit y of 
Vir gi nia 1 1: 3 9 -4 1, 1 9 9 2  
 
1 8.  
Patric k D L, B ur ke L B, G walt ne y CJ, et al: C o nte nt vali dit y --esta blis hi n g a n d 
re p orti n g t he e vi de n ce i n ne wl y de vel o pe d patie nt-re p orte d o utc o m es ( P R O) i nstr u me nts f or 
me dical pr o d uct e v al uati o n: I S P O R P R O G o o d Researc h Practices Tas k F orce re p ort: par t 2--
assessi n g res p o n de nt u n d ersta n di n g. Val ue Healt h 1 4: 9 7 8 -8 8, 2 0 1 1  
 
1 9.  
Patric k D L, B ur ke L B, G walt ne y CJ, et al: C o nte nt vali dit y --esta blis hi n g a n d 
re p orti n g t he e vi de n ce i n ne wl y de vel o pe d patie nt-re p orte d o utc o m es ( P R O) i nstr u me nts f or 
me dical pr o d uct e v al uati o n: I S P O R P R O g o o d researc h practices tas k f orce re p ort: par t 1--
eliciti n g c o nce pts f or a n e w P R O i nstr u me nt. Val ue Healt h 1 4: 9 6 7 -7 7, 2 0 1 1  
 
2 0.  
B oeije H: A p ur p osef ul a p pr oac h t o t he c o nst a nt c o m parati ve met h o d i n t he 
a nal ysis of q ualitati ve i nter vie ws. Q u alit y & Q ua ntit y 3 6: 3 9 1 -4 0 9, 2 0 0 2  
 
2 1.  
He witt -Ta yl or J: Use of c o nsta nt c o m parati ve a nal ysis i n q ualitati ve researc h. 
N urs Sta n d 1 5: 3 9 -4 2, 2 0 0 1  
 
2 2.  
Sa ge ha n d b o o k of mi xe d met h o ds i n s ocial & be ha vi oral researc h. L os A n geles, 
S A G E P u blicati o ns, 2 0 1 0  

 
 
D oc u m e nt #: D T -0 2 -v 1 
2 6  
 
2 3.  
Cres well J W, Clar k V L P: Desi g ni n g a n d c o n d ucti n g mi xe d met h o ds researc h. 
2 0 0 7  
 
 
1 0. 0  A P P E N DI C E S  
( A) De m o gra p hic f or m  
( B) Easter n C o o perati ve O nc ol o g y Gr o u p Perf or ma n ce Stat us Scale a n d Ill ness Beliefs 
F or m  
( C) Pare ntal Ca ncer C o m m u nicati o n Q uesti o n naire  ( P C C Q) 
( D) Ge neralize d A n xiet y Dis or der -7 ( G A D -7)  
( E) Patie nt Healt h Q uesti o n naire -2  ( P H Q-2 ) 
( F) F u ncti o nal Assess me nt of Ca ncer T hera p y –  Ge n eral ( F A C T -G)  
( G) C o m m u nicati o n Self -Efficac y Scale  ( C S E S) 
( H) F A C T Satisfacti o n Scale   
(I) Si n gle -ite m pare nt-c hil d relati o ns hi p assess me nt  
(J) Ot her res o urce us e  f or m 
( K) S e mi-str uct ure d i nter vie w g ui de  
( L) Recr uit me nt br oc h ure