Feasibility and Acceptability of A RN-Led Palliative and Supportive Care Intervention for Adults With Acute Leukemia
Phase: NA
Conditions: Acute Myeloid Leukemia
Sponsor: UNC Lineberger Comprehensive Cancer Center

1 
 
 
L C C C 1 8 4 8: Feasi bilit y a n d Acce pta b ilit y of A R N- Le d Palliati ve a n d C olla b orati ve 
Care I nter ve nti o n f or A d ults wit h Ac ute M yel oi d Le u ke mia  
 
Pri nci p al I n vesti g at or 
As hle y Lea k Br ya nt P h D, R N- B C, O C N 
4 0 1 Carri n gt o n Hall 
Ca m p us B o x 7 4 6 0 
C ha pel Hill, N C 2 7 5 9 9- 7 4 6 0 
T he U ni versit y of N ort h Car oli na at C ha pel Hill  
 
9 1 9- 9 6 6- 5 3 2 9 ( P h o ne) 
9 1 9- 8 4 3- 9 9 0 0 ( Fa x) 
as hle y _ br ya nt @ u nc.e d u 
 
C o-I n vesti g at or(s) 
La ura C. Ha ns o n M D  
S usa n C o p p ola O T D, O T/ L 
R ut h A n ders o n P h D, R N 
Da niel Ric har ds o n, M D 
Matt he w F oster M D 
Rac hel Hirsc he y P h D, R N  
Dier dra Ric ks B S, P T 
Crista Cree dle, R N, B S N 
S u m mer C hee k R N, B S N  
Farrell Wi g gi ns O T 
K orre Sc ott P T 
La ura A n dre ws P T 
Ale xis Pette wa y O T 
As hle y Le wis P T 
Mic helle Le bla nc P T 
Re be ka h Jarrett O T 
Ste p ha nie Matt o n d o O T 
C hrist o p her Je nse n M D 
Katie B u hli n ger P har m D, C P P 
Be n ya m M ul u ne h P har m D 
 
Bi ost atistici a n  
Xia n mi n g Ta n, P h D 
E mail: xia n mi n g @e mail. u nc.e d u   
 
C o ns ult a nt 
Mac ke nzi Per g ol otti P h D, O T L/ R 
 
St u d y C o or di n at or  
Ya- Ni n g C ha n, M S N, R N 
 
Rese arc h Assist a nt 

2 
 
 
Ste p ha nie Beta nc ur Gr o n d o na B S N, R N 
Katie L o we B S N, R N, O C N 
 
Ot her 
C o urt ne y Berr y B S, M A, B S N, R N, O C N 
A m y Eli n off B S N, R N, O C N 
 
P atie nt- Re p orte d O utc o mes- C ore  
Mattias J o nss o n 
Mic helle J o h ns o n 
 
S p o ns or : U N C Li ne ber ger C o m pre he nsi ve Ca ncer Ce nter 
F u n di n g S o urce : Li ne ber ger De vel o p me nt Gra nt  
 
Versi o n 1 D ate: N o ve m ber 4, 2 0 1 9 
Versi o n 2 D ate: J ul y 1 4, 2 0 2 0  
Versi o n 3 D ate: N o ve m ber 2 4, 2 0 2 0 
 
 
 
L C C C 1 8 4 8 : Feasi bilit y a n d Acce pta b ilit y of A R N- Le d Palliati ve a n d S u p p orti ve Care 
I nter ve nti o n f or A d ults wit h Ac ute Le u ke mia  
 
Pri nci p al I n vesti g at or 
As hle y Lea k Br ya nt P h D, R N- B C, O C N 
4 0 1 Carri n gt o n Hall 
Ca m p us B o x 7 4 6 0 
C ha pel Hill, N C 2 7 5 9 9- 7 4 6 0 
T he U ni versit y of N ort h Car oli na at C ha pel Hill  
9 1 9- 9 6 6- 5 3 2 9 ( P h o ne) 
9 1 9- 8 4 3- 9 9 0 0 ( Fa x) 
as hle y _ br ya nt @ u nc.e d u 
 
 
Si g n at ure P a ge 
 
T he si g nat ure bel o w c o nstit utes t he a p pr o val of t his pr ot oc ol a n d t he attac h me nts, a n d 
pr o vi des  t he  necessar y  ass ura nces  t hat  t his  trial  will  be  c o n d ucte d  acc or di n g  t o  all  
sti p ulati o ns  of  t he  pr ot oc ol,  i ncl u di n g  all  state me nts  re gar di n g  c o nfi de ntialit y,  a n d  
acc or di n g t o l ocal le gal a n d re g ul at or y re q uire me nts a n d a p plica ble U. S. fe deral re g ulati o ns 
a n d I C H g ui deli nes. 
 
Pri nci p al I n vesti g at or ( PI) N a me : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
PI Si g n at ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
D ate: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
i 
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  
St u d y P o p ulati o n Bac k gr o u n d ............................................................................. 4  
1. 3  
S y m pt o m Ma na ge me nt I nter ve nti o n.................................................................... 5  
1. 4  
Weara ble P h ysi ol o gical M o nit ori n g ( Gar mi n Vi v ofit 4) ...................................... 6  
1. 5  
S y m pt o m Re p orti n g a n d Assess me nt .................................................................. 7  
1. 6  
A da pti ve Lea ders hi p Fra me w or k ....................................................................... 1 0  
1. 7  
Rati o nale ............................................................................................................ 1 2  
2. 0  
S T U D Y P U R P O S E A N D D E SI G N .................................................................... 1 2  
3. 0  
S T U D Y O B J E C TI V E S/ E N D P OI N T S ............................................................... 1 3  
3. 1  
Pri mar y O bjecti ve .............................................................................................. 1 3  
3. 4  
Pri mar y E n d p oi nt ............................................................................................... 1 3  
3. 5  
E x pl orat or y O utc o mes ....................................................................................... 1 3  
4. 0  
P A TI E N T E LI GI BI LI T Y ................................................................................... 1 3  
4. 1  
I ncl usi o n Criteria ............................................................................................... 1 3 
4. 2  
E xcl usi o n Criteria .............................................................................................. 1 4  
5. 0  
S T U D Y P L A N ...................................................................................................... 1 4  
5. 1  
Patie nt I de ntificati o n a n d C o nse nt / St u d y Sc he ma ............................................ 1 4  
5. 2  
St u d y Assess me nts ............................................................................................. 1 5  
5. 3  
Descri pti o n of Assess me n ts a n d Q uesti o n naires ............................................... 1 5 
5. 4  
D urati o n of St u d y ............................................................................................... 1 9  
5. 5  
A bstracti o n of Me dical Rec or ds a n d Patie nt F oll o w- u p C o ntact ...................... 1 9  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
ii 
6. 0  
A S S E S S M E N T O F S A F E T Y .............................................................................. 1 9  
7. 0  
A S S E S S M E N T O F E F FI C A C Y ......................................................................... 1 9  
8. 0  
TI M E A N D E V E N T S T A B L E ............................................................................ 2 0  
9. 0  
E X P E C T E D RI S K S/ U N A N TI CI P A T E D P R O B L E M S/ S A F E T Y 
M O NI T O RI N G ................................................................................................................ 2 1  
9. 1  
E x pecte d Ris ks ................................................................................................... 2 1  
9. 2  
Pr otecti o n A gai nst Ris ks .................................................................................... 2 1  
9. 3  
U na ntici pate d Pr o ble ms ..................................................................................... 2 2  
9. 4  
Re m o val of Patie nts fr o m Pr ot oc ol .................................................................... 2 2 
9. 5  
Data a n d Safet y M o nit ori n g Pla n ....................................................................... 2 3  
1 0. 0  
S T A TI S TI C A L C O N SI D E R A TI O N S ............................................................... 2 3  
1 0. 1  
St u d y Desi g n ...................................................................................................... 2 3  
1 0. 2  
Sa m ple Size a n d Accr ual ................................................................................... 2 3  
1 0. 3  
Data A nal ysis Pla ns ........................................................................................... 2 4  
1 1. 0  
S T U D Y M A N A G E M E N T ................................................................................... 2 5  
1 1. 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 5 
1 1. 2  
Re q uire d D oc u me ntati o n ................................................................................... 2 6  
1 1. 3  
Re gistrati o n Pr oce d ures ..................................................................................... 2 6  
1 1. 4  
Data Ma na ge me nt a n d M o nit ori n g/ A u diti n g ..................................................... 2 6  
1 1. 5  
A d here nce t o t he Pr ot oc ol .................................................................................. 2 7  
1 1. 6  
A me n d me nts t o t he Pr ot oc ol .............................................................................. 2 8  
1 1. 7  
Rec or d Rete nti o n ............................................................................................... 2 8  
1 1. 8  
O bli gati o ns of I n vesti gat ors ............................................................................... 2 8  
1 2. 0  
R E F E R E N C E S ..................................................................................................... 2 9  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
iii 
1 3. 0  
A P P E N DI C E S ...................................................................................................... 3 2  
1 3. 1  
A p pe n di x I – I nter vie w G ui de ........................................................................... 3 2  
1 3. 2  
Meas ures ............................................................................................................ 3 7  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
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 si n gle i nstit uti o n feasi bilit y a n d acce pta bilit y of st u d y met h o ds are t o e xa mi ne c ha n ge i n pre 
a n d p ost meas ures of s y m pt o ms, f u ncti o n, a n d Q O L c o m pari n g 1 0 c o ntr ol a n d 1 0 i nter ve nti o n 
patie nts wit h ac ute m yel oi d le u ke mia ( A M L). A M L is t he m ost c o m m o n t y pe of ac ute le u ke mia. 
T his st u d y is desi g ne d t o e xa mi ne a n o vel palliati ve a n d c olla b orat i ve care i nter ve nti o n i n w hic h 
re gistere d n urses ( R Ns), occ u pati o nal t hera pists ( O Ts) a n d p h ysical t hera pists ( P Ts) a d dress t he 
p h ysical acti vit y nee ds of ol der a d ults ( > 6 0 years) wit h A M L d uri n g c ycles 1 a n d 2 
(a p pr o xi matel y 6 0 da ys) of a P alliati ve a n d C olla b orati ve C are i nT er ve nti o n ( P A C T) 
(i nter ve nti o n ar m o nl y). T he eli gi ble p o p ulatio n will i ncl u de patie nts at t he N ort h Car oli na 
Ca ncer H os pital ( N C C H) wit h a dia g n osis of A M L,  a ge > 6 0 years, a n d recei ve h y p o met h ylati n g 
a ge nts ( H M A) or l o w- d ose c ytara bi ne + Ve net ocla x.  
1. 2  St u d y P o p ul ati o n B ac k gr o u n d 
A M L is a n a g gressi ve, seri o us he mat ol o gic ca ncer res ulti n g fr o m  ra pi d, u nc o ntr olle d gr o wt h of 
i m mat ure bl o o d cells. Pr o g n osis is p o or: 1 9, 9 4 0 pe o ple will be dia g n ose d i n 2 0 2 0, 1  a n d 1 1, 1 8 0 
will die. 1 Patie nts wit h A M L are treate d i n hi g hl y s pecialize d referral ca ncer h os pitals a n d cli nics 
offeri n g ra pi d c o m pre he nsi ve assess me nts a n d e val uati o ns. L o n g-ter m s ur vi val of A M L is 
t y picall y ac hie ve d t hr o u g h i ntensi ve m ulti-a ge nt c he m ot hera p y, e x p osi n g patie nts t o si g nifica nt 
ris ks of treat me nt-relate d c o m plicati o ns, hea v y s ym pt o m b ur de n, f u ncti o nal  decli ne, a n d l oss of 
Q O L. 2, 3 U ntil rece ntl y, i n d ucti o n c he m ot hera p y re gime ns, s uc h as c ytara bi ne pl us a n 
a nt hrac ycli ne, were deli vere d i n t he i n patie n t setti n g. T hese “i nte nsive i n d ucti o n” re gi me ns 
re q uire 7 da ys of c o nti n u o us c ytara bi ne i ntra ve n o usl y a n d 3 da ys of i nter mitte nt a nt hrac ycli nes 
d uri n g a 4- 6 wee k h os pitalizati o n. T his c o m b i nati o n c he m ot hera p y c o m m o nl y ca use d pr of o u n d 
fati g ue, fre q ue nt na usea a n d v o miti n g, a n d ofte n le d t o c o m p licati o ns s uc h as s yste mic 
i nfecti o ns.1  
 
I n 2 0 1 8 t he treat me nt para di g m c ha n ge d f or ol der A M L patie nts wit h t he a p pr o val of m ulti ple 
ne w effecti ve oral a ge nts. T he m ost wi del y use d  re gi me n is ve net ocla x ( V E N; ta ke n orall y) i n 
a d diti o n t o l o w- d ose c ytara bi ne or a h y p o met h y lati n g a ge nt ( H M A C ycle 2, da ys 3 1- 3 7, starts 
eit her i n t he h os pital or cli nic  de pe n di n g o n t he patie nts’ cli nical stat us. Patie nts ret ur n h o me 
fr o m da ys 3 8- 6 0 w hile ta ki n g V E N u ntil t he y ret ur n t o t he h os pital f or a n ot her b o ne marr o w 
bi o ps y. T he patie nt ta kes V E N t hr o u g h o ut t he e ntire c ycle b y i njecti o n or i nf usi o n) ( Fi g ure 1). 
H M A or l o w- d ose c ytara bi ne + V E N ca n res ult i n  c o m plete re missi o n rates of u p t o 7 0 %, si milar 
t o rates f or hist orical i n patie nt c he m ot hera p y.4  Patie nts ha ve s u bsta ntiall y fe wer ac ute si de 
effects ass ociate d wit h H M A or l o w- d ose c yta ra bi ne + V E N t ha n wit h i n patie nt i n d ucti o n 
c he m ot hera p y. H o we ver, patie nts still e x perie nce c u m ulati ve fati g ue, f u ncti o nal decli ne, a n d are 
ofte n a d mitte d t o t he h os pital f or c o m pli cati o ns e ve n wit h s u p p ort fr o m t heir care gi vers.5- 7 
Alt h o u g h H M A or l o w- d ose c ytara bi ne + V E N ca n be  deli vere d e ntirel y i n t he o ut patie nt setti n g, 
it is ofte n gi ve n i nitiall y i n t he i n patie nt setti n g o ver 1- 7 da ys d ue t o t he ris k of ac ute 
c o m plicati o ns s uc h as t u m or l y sis a n d i nfecti o n. Patients lea ve t he h os pital a n d ret ur n h o me f or 
da ys 8- 3 0 w hile ta ki n g V E N, after w hic h t he y u n der g o a b o ne marr o w bi o ps y. Patie nts sta y o n 
H M A or l o w- d ose c ytara bi ne + V E N f or at least t w o 3 0- da y c ycles a n d, if res p o n di n g, 
i n defi nitel y u ntil disease rela pse. I n o ur st u d y, we will f oll o w patie nts f or t he first 4 c ycles. 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 
S u bsta ntial o p p ort u nit y e xists t o i nter ve ne d uri n g i nitial treat me nt t o hel p patie nts mai ntai n or 
i m pr o ve f u ncti o nal a n d Q O L o utc o mes.8, 9 C urre ntl y, t he H M A or l o w- d ose c ytara bi ne + V E N 
re gi me n is ofte n gi ve n at lar ge ca ncer ce nters; i n t he f ut ure t his l ocati o n of treat me nt li kel y will 
c o nti n ue f or hi g h-ris k patie nts b ut will occ ur i n c o m m u nit y ca ncer ce nters f or l o w-ris k a n d n o n-
c o m plicate d A M L patie nts . 
 
Si nce 2 0 1 2, R C Ts ha ve de m o nstrate d t hat a m o n g pa tie nts wit h a d va nce d ca ncer, palliati ve care i n 
c o nj u ncti o n  wit h  sta n dar d  o nc ol o g y  care  mai ntai ns  or  i m pr o ves  s y m pt o ms,  Q O L  a n d  e ve n  
s ur vi val.1 0, 1 1 I n 2 0 1 7, t he A merica n S ociet y of Cli nic al O nc ol o g y p u blis he d cli nical practice 
g ui deli nes base d o n str o n g cli nical a n d researc h e v i de nce f or i nte grati o n of palliati ve care i nt o 
sta n dar d  o nc ol o g y  care. Des pite k n o w n  be nefits  of  earl y  pa lliati ve  care,  i nitiati o n  of  f or m al 
palliati ve care earl y i n he mat ol o gical ca ncers is li mite d. 1 2, 1 3  T h us, we s u g gest t hat i nte grate d 
palliati ve a n d c olla b orati ve care is m ore accessi ble beca use it is deli vere d b y us ual care staff a n d 
is a n i n n o vati ve m o del t o cl ose t he ga p i n care f or ol der a d ults wit h A M L. 
1. 3  S y m pt o m M a n a ge me nt I nter ve nti o n 
T he pr o p ose d s y m pt o m ma na ge me nt i nter ve n ti o n, P A C T, utilizes a c olla b orati ve, 
m ulti disci pli nar y, i nte grate d tea m i ncl u di n g R Ns, O Ts a n d P Ts. T he P A C T i nter ve nti o n is 
u ni q ue i n its i nter disci pli nar y a p pr oac h a n d was desi g ne d t o facilitate t he i nte grati o n a m o n g t he 
tea m t o pla n, i m ple me nt a n d e val uate o utc o mes.  
 
T he R N, O T a n d P T will use t he A da pti ve Lea ders hi p Fra me w or k f or C hr o nic Ill ness 8 as a g ui de 
f or t he i nter ve nti o n.  
1.  T he R N will c o m plete a s y m pt o m assess me nt wit hi n 2 da ys of patie nt a d missi o n a n d 
will c o nti n ue t o m o nit or t he patie nt’s s y m p t o ms dail y t hr o u g h o ut h os pitalizati o n. O T 
a n d P T pr oject staff will asse ss a n d m o nit or f u ncti o n a n d p h ysical healt h stat us wit hi n 2 
da ys of patie nt a d missi o n a n d will c o nti n ue  t o m o nit or t he patie nt’s s y m pt o ms at 
baseli ne, da y 4 a n d at disc har ge.  
2.  C olla b orati n g wit h t he patie nt, R N, O T, a n d P T  will i de ntif y a n d m o nit or s y m pt o ms of 
A M L treat me nt-relate d a n d c hr o nic ill ness s y m pt o ms t hat mi g ht i nterfere wit h t he 
pate nt’s a bilit y t o e n ga ge i n f u ncti o nal a n d p h ysical acti vities, s uc h as dressi n g, 
gr o o mi n g, or wal ki n g a n d getti n g o ut of be d. 
3.  T he R N, O T, a n d P T will meet wit h t he pati e nt t o e xc ha n ge i nf or mati o n a n d de vel o p a 
s hare d u n dersta n di n g, defi ned b y ac k n o wle d ge me nt of s y m pt o ms a n d treat me nt relate d 
c halle n ges a n d a n a gree d- u p o n pla n f or eac h O T  a n d P T visit. S hare d u n dersta n di n g will 
be deter mi ne d b y e val uati n g electr o nic n otes  a n d c o nse ns us bet wee n t he R N, P T, a n d 
O T.  
4.  T his s hare d u n dersta n di n g bec o mes t he basis f or de vel o pi n g a pla n of care j oi ntl y t hat 
will be re vie we d a n d u p date d as t he patie nt’s  s y m pt o ms, f u ncti o nal le vel a n d/ or p h ysical 
healt h c ha n ges. F or ex a m ple, if t he p atie nt s h ares wit h t he R N, O T, a n d P T t h at he/s he is 
ex perie nci n g f ati g ue ( a n a d a ptive c h alle n ge),  t he n t he R N, O T, a n d P T will a d d t o t he 
s h are d me a ni n g by ex pl ai ni n g t he esse nti al nee d f or m ove me nt t o i ncre ase t he p atie nt’s 
a bility t o e n g a ge i n f u ncti o n al a n d p hysic al he alt h activities t o re d uce f ati g ue. T he j oi nt 
pl a n will defi ne s h are d me a ni n g acr oss te a m me m bers wit h t he p atie nt.  
5.  T he R N, O T, a n d P T will a d dress tec h nical c halle n ges, f or ex a m ple, if a p atie nt h as 
diffic ulty slee pi n g, R N c a n a d dress me dic ati o n a d mi nistr ati o n, t he O T c a n pr ovi de 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
6 
str ate gies f or slee p hy gie ne a n d a d dress f ati g ue, a n d t he P T c a n a d dress st ayi n g active 
d uri n g h os pit aliz ati o n t o m ai nt ai n p hysic al he alt h nee de d f or i m pr ove d slee p.  
6. T he P A C T tea m a n d patie nt wi ll use t he s hare d u n dersta n di n g of a da pti ve c halle n ges t o fi n d 
creati ve wa ys t o d o t he a da pti ve w or k t o re d uc e t he i m pact of s y m pt o ms, f u ncti o n, a n d p h ysical 
healt h.   
7.  T he patie nt a n d P A C T tea m will esta blis h S mart, Meas ura ble, acti o na ble, Realistic, a n d 
Ti me d ( S M A R T) g oals, w hic h are reassesse d t wice wee kl y a n d l ocate d o n t he patie nt’s dr y erase 
b oar d i n t heir h os pital r o o m. T he a da pti ve w or k ca n be i ntr o d uce d i n s mall, ac hie va ble g oals t o 
o pti mall y e n ga ge i n P A C T.  
1. 4  We ar a ble P h ysi ol o gic al M o ni t ori n g ( G ar mi n Vi v ofit 4) 
Acceler o metr y is a met h o d of trac ki n g p h ysic al acti vit y t hr o u g h m o nit ori n g a n d detecti n g 
c ha n ges i n m o ve me nt, t h us all o wi n g f or assess me nts of t otal acti vit y (e. g. ste ps per da y) a n d 
i nte nsit y of acti vit y (e. g. mil d, mo derate, vi g or o us) o n a dail y a n d e v e n h o url y basis. I n pre vi o us 
st u dies, p h ysical acti vit y assess me nt b y acceler o metr y has discri mi nate d  ca ncer patie nts fr o m 
c o ntr ols 1 7, 1 8 a n d has bee n ass ociate d wit h fu ncti o nal stat us a n d q ualit y of life  1 9. Acceler o metr y 
has als o bee n use d i n a n i nter ve nti o nal wa y t o  hel p atte n uate t he effects of cac he xia a n d t o 
i ncrease p h ysical acti vit y i n ca ncer s ur vi v ors. 2 0, 2 1 
 
Weara ble tec h n ol o g y acti vit y m o nit or: Partici pa nts  will be pr o vi de d wit h a Gar mi n Vi v ofit 4 ® 
acti vit y m o nit or, w hic h t he y are as ke d t o wear c o nti n u o usl y f or u p t o 6 m o nt hs. T his is a wrist-
w or n de vice t hat c o ntai ns f u ncti o ns s uc h as di s pla yi n g ste ps, dista nce, cal ories a n d slee p/rest 
ti me. Briefl y, t he Gar mi n Vi v ofit 4® d oes n ot nee d t o be c har ge d (i t uses a b uilt-i n batter y lasti n g 
1 year), a n d it pr o vi des i nacti vit y alerts vis uall y via a re d bar o n t he dis pla y a n d a n a u di ble bee p. 
T he m o ve bar is reset b y wal ki n g f or a fe w mi n utes. O ne li mitati o n of m ost weara ble 
tec h n ol o gies t hat pr o vi de s uc h i nacti vit y alerts is t hat t he y ma y c o u nt sta n di n g ti me as i nacti ve 
ti me. T heref ore, partici pa nts will be c o u nselle d t o i g n ore pr o mpts t hat occ ur w he n t he y are 
m o vi n g or sta n di n g b ut e nc o ura ge d t o ta ke s o me e xtra ste ps t o reset t he m o ve bar. T he de vice 
ca n st ore m o ve me nt a n d slee p data  f or u p t o 7 da ys; t hese data are u pl oa de d t o t he Gar mi n a p p 
via Bl uet o ot h. Partici pa nts are hel pe d t o i nst all t he s mart p h o ne/ta blet / P C a p plicati o n, a n d t o 
acti vate t heir o nli ne acc o u nt, d uri n g t he face-t o-face sessi o n wit h a researc h staff me m ber.  
 
Preli mi nar y e vi de nce s h o ws si g ni fica nt ass ociati o ns bet wee n pe d o metr y data a n d patie nt-
re p orte d o utc o mes. A rece nt st u d y c o n d ucte d at t he U ni versit y of N ort h Car oli na e val uate d a 
pre-tra ns pla nt e xercise i nte r ve nti o n i n a d ult patie nts u n der goi n g he mat o p oietic ste m cell 
tra ns pla nt ( H S C T) f or treat me nt of le u ke mia, l y m p h o ma, m yel o ma, a n d ot her disease. Patie nts 
w ore pe d o meters a n d c o m plete d P R O assess me nts  wit h 7- da y recall d uri n g p ost-tra ns pla nt 
h os pitalizati o n ( 4 wee ks) a n d u p t o 4 wee ks p ost- disc har ge. O n a vera ge, partici pa nts t o o k 3 2 5 3 
( S D = 2 2 8 2) ste ps per da y. Fi g ures 1 a n d 2 s h o w t he a vera ge s y m pt o ms sc or es a n d a vera ge dail y 
ste ps per eac h wee k of treat me nt a n d ill ustrate t he c orrelati o n of s y m pt o ms a n d ste ps. W he n 
wit hi n- patie nt c ha n ges o ver ti me, fr o m pri or we e k t o c urre nt wee k, were c o m pare d bet wee n 
s y m pt o ms a n d ste ps, re gressi o n m o del c oefficie nts ( beta) i n dicate d a decrease i n a vera ge dail y 
ste ps ass ociate d wit h u nit i ncrease i n pai n ( beta = 7 5 0 fe wer ste ps per i ncrease i n pai n sc ore, 
p < 0. 0 0 3), s h ort ness of breat h ( beta = 9 7 8, p < 0. 0 0 4) , a n d dizzi ness ( beta = 8 6 1, p < 0. 0 3 1). Re d uce d 
p h ysical acti vit y a n d re d uce d p h ysical healt h were n ot si g nifica ntl y ass ociate d wit h fe wer ste ps 
wit hi n- patie nt, b ut were str o n gl y ass ociate d wit h diffe re nces i n ste ps bet wee n patie nts (re d uce d 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
7 
p h ysical acti vit y: beta = 8 4 9, p < 0. 0 0 2; re d uce d p h ysical healt h: beta = 6 7 6, p < 0. 0 3 1). T he 
meas ures of me ntal healt h a n d e m oti o nal well- bei n g were n ot si g ni fica ntl y ass ociate d wit h dail y 
ste ps. I n t his sa m ple of H S C T reci pie nts, m ore se vere s y m pt o ms i ncl u di n g pai n a n d fati g ue, 
i m paire d p h ysical healt h, a n d restricti o ns i n t he perf or ma nce of us ual dail y acti vities were 
ass ociate d wit h statisticall y si g nifica n t decre me nts i n a vera ge dail y ste ps. 
 
I n t he past, hi g hl y s pecialize d a n d e x pe nsi ve e qui p me nt has bee n nee de d  t o m o nit or acti vit y. 
Rece ntl y t here has bee n a pr olif erati o n of relati vel y i ne x pe nsi ve, weara ble de vices t hat 
acc o m plis h t his g oal. Fit Bit, Ni ke, a n d Ja w b o ne n o w  offer user-frie n dl y de vices t hat all o w f or 
acti vit y trac ki n g o ver e xte n de d peri o ds of ti me. De vices s uc h as t he Fit Bit Fle x offer n ot o nl y 
acceler o metr y b ut ot her l o n git u di na l p h ysi ol o gical data strea ms, s uc h as slee p m o nit ori n g. A user 
ca n ca pt ure t otal mi n utes sle pt a n d ti mes a wa ke ne d o n a ni g htl y  basis b y ta p pi n g t he wrist ba n d 
bef ore g oi n g t o slee p a n d u p o n wa ki n g u p. 
 
G ar mi n Vi v ofit 4 descri pti o n  
De vice
 I ma g e
 Descri pti o n  
Gar mi n Vi v ofit 4 
 
w w w. gar mi n.c o m  
 
- 
Ste p c o u nter via tri-
a xial acceler o meter 
- 
A ut o matic acti vit y 
detecti o n 
- 
1 + year batter y life 
- 
Ca n c o ntr ol w het her 
ste p c o u nt is or is n ot 
dis pla ye d o n de vice 
face 
 
1. 5  S y m pt o m Re p orti n g a n d Assess me nt 
Patie nt- Re p orte d O utc o mes ( P R Os) refer t o “a n y  re p ort o n t he stat us of a patie nt’s healt h 
c o n diti o n t hat c o mes direc tl y fr o m t he patie nt, with o ut i nter pretati o n of t he patie nt’s res p o nse b y 
a cli nicia n or a n y o ne else”  3. S y m pt o ms are o ne t y pe of P R O.  
 
Sta n dar dize d electr o nic P R O s ur ve y s as ki n g patie nts a b o ut s pecific s y m pt o ms offer t he a bilit y t o 
i de ntif y s y m pt o ms of c o ncer n an d pr o vi de cli nicia ns wit h a n o p p or t u nit y t o re me d y eac h of t hese 
deficie ncies. T here are n o w se veral sta n dar di ze d s y m pt o m assess me nt q uesti o n naires a vaila ble 
f or r o uti ne care i ncl u di n g t he P R O versi o n of t he C o m m o n Ter mi n ol o g y f or A d verse E ve nts 
( C T C A E), de vel o pe d at t he Nati o nal Ca ncer I nstit ute. T he P R O- C T C AE, de vel o pe d u n der a 
c o ntract wit h Dr. Et ha n Basc h at t he U ni versit y of N ort h Car oli na at C ha pel Hill, is a t o ol t hat 
all o ws patie nts t o self-re p ort s y m pt o m- base d a d ve rse e ve nts ( A Es) liste d i n t he N CI’s C T C A E. 
I n t otal, t here are 7 8 q uesti o ns t hat assess different attri b utes (e. g., fre q ue nc y, se verit y, 
i nterfere nce, prese nce of c o n diti o n) of 8 1 s y m pt o ms t hat are re prese nte d i n b ot h t he C T C A E 
( versi o n 4) a n d t he Me dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A) a d verse e ve nt 
le xic o ns. T hese 7 8 q uesti o ns ha ve bee n e xte nsi vel y e val uate d b y ca ncer pa tie nts usi n g c o g niti ve 
testi n g met h o ds a n d f o u n d t o be clear, c o m pre he nsi ble, a n d ca pa ble of meas uri n g t he s y m pt o ms 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
8 
of i nterest.  
 
I n t his st u d y, we will use t he 1 9 patie nt-re p orte d s y m pt o ms fr o m t he C T C A E t o calc ulate a 
s y m pt o m sc ore t hat ma y ra n ge fr o m 0- 7 6 eac h day. T his s y m pt o m sc ore re prese nts t he s y m pt o m 
b ur de n f or t he patie nt o n t hat partic ular da y.  
 
Ta ble 1 uses t he a da pti ve lea ders hi p  fra me w or k t o li n k t he or y- base d beha vi or c ha n ge met h o ds use d i n 
t his pr o p ose d st u d y, t he ti mi n g of w he n t he c olla b orati ve w or k will be c o n d ucte d, a n d details of t he 
P A C T P T, O T, a n d P T  assess me nts.   
 
 
 
 
Tr ai ni n g of te a m ( R Ns, O Ts, a n d P Ts). T he P A C T i nter ve nti o n tea m c o nsists of e xisti n g 
e m pl o yees of t he st u d y site. We wi ll trai n 4 R Ns, 2 O Ts, a n d 2 P Ts s o t he y ca n pr o vi de c o vera ge 
T a ble 1. A d a pti ve Le a ders hi p Fr a me w or k C oll a b or ati ve W or k of R N, O T, a n d P T D uri n g C ycle 1 a n d 2 
B ol de d  e xa m ples s u g gest acti o n is nee de d. 
C oll a b or ati ve W or k a n d Ti mi n g   
Det ails of Cli nici a n Assess me nts ( b ol de d) 
 
Da ys 1- 7 & 3 1- 3 7 dail y: 
C oll a b or ati ve W or k , R N a n d 
patie nt; 2 x a wee k, R N, O T, P T 
a n d patie nt 
 
Da ys 8- 3 0 & 3 8- 6 0: R N will 
call p atie nt 2 x/ week  
 Disc uss wit h p atie nt  a n d re vie w k n o wle d ge a b o ut c olla b orati ve w or k pla ns.1 4 
 S hift pers pecti ve  t o u n dersta n d patie nt’s vie w of pr o gress. 1 5 
 Revie w existi n g c are g ui deli nes f or sy m pt o ms a n d f u ncti o n  
 Re vie w o utc o me a n d be h a vi or al g o als  usi n g t he ele me nts of c olla b orati ve w or k descri be d 
pre vi o usl y. 1 6, 1 7 
 Da ys 1- 7 & 3 1- 3 7: R N M o nit ors 
s y m pt o ms & f u ncti o n d ail y; 2 x 
wee k f or P T a n d O T 
 Da ys 8- 3 0 & 3 8- 6 0: R N will call 
p atie nt 2 x/ wee k  
 Assess  a n d m o nit or 1 9 s y m pt o ms usi n g P R O- C T C A E. 
 Disc uss  res ults wit h patie nt t o i ncrease patie nt’s k n o wle d ge a b o ut i nterrelate d ness of s y m pt o ms. 1 4 
 Disc uss  patie nt’s e x perie nce of t he s y m pt o m  
 Disc uss or al me dic ati o ns a n d a d here nce wit h p atie nts  
 Da ys 1- 7 & 3 1- 3 7: Assess 
a d a pti ve c h alle n ges  
 Da ys 8- 3 0 & 3 8- 6 0: R N will call 
p atie nt 2 x/ wee k  
 Pl a n c o pi n g res p o nses  t o i de ntif y c halle n ges ass ociate d wit h s y m pt o ms t hat i m pe de e n ga ge me nt i n self-
ma na ge me nt a n d f u ncti o n a n d wa ys t o o verc o me t he m. 1 8 
 E n ga ge i n c olla b orati ve w or k wit h pa tie nt (a n d P T/ O T w he n a p pr o priate) t o s hift pers pecti ve of staff 
b eliefs a b o ut w hat c halle n g es mea n t o t he patie nt. 1 5 
 Da ys 1- 7 & 3 1- 3 7 : E xc h a n ge 
i nf or m ati o n ( dail y: R N a n d 
patie nt; 2 x a wee k: R N, O T, P T 
a n d patie nt 
Da ys 8- 3 0 & 3 8- 6 0: R N will call 
p atie nt 2 x/ wee k  
 Elicit patie nt’s u n dersta n di n g of t he s y m pt o ms a n d a d a pti ve c halle n ges a n d h o w t hese i nterfere wit h 
his/ her A D Ls. 
 R N lea ds disc ussi o n t o verif y t hat he/s he u n dersta n ds t he patients’ pers pecti ve a n d t o i ncrease patie nt 
k n o wle d ge a b o ut s y m pt o ms a n d f u ncti o n 1 4. 
 R N, O T a n d P T pr o be t he patie nt t o el a b or ate  o n w hat t he y ha ve lear ne d d uri n g t heir disc ussi o n.1 9 
 Da ys 1- 7 & 3 1- 3 7  S h are d 
u n derst a n di n g  ( dail y: R N a n d 
patie nt; 2 x a wee k: R N, O T, P T 
a n d patie nt 
 Da ys 8- 3 0 & 3 8- 6 0: R N will call 
p atie nt 2 x/ wee k  
 R N le a ds t he patie nt a n d tea m t o s y nt hesize t he vari o us pers pecti ves t o de vel o p s hare d u n dersta n di n g of 
c halle n ge(s), c o nfir mi n g t he mea ni n g f or t he patie nt. T his disc ussi o n ma y lea d t o s hift i n e ac h ot her’s 
pers pecti ves  t o esta blis h a s hare d basis f or t he pla n of w or k.1 5 
 J oi nt pl a n of w or k  ( dail y: R N 
a n d patie nt; 2 x a wee k: R N, O T, 
P T a n d patie nt): R N, P T, O T 
facilitate patie nt t o esta blis h 
be ha vi oral g oals 1 6  
 
 Da ys 8- 3 0 & 3 8- 6 0: R N will call 
patie nt 2/ wee k 
 Use res ults of assess me nts t o est a blis h a p pr o priate tec h nical w or k f or R N, P T a n d O T t o a d dress 
s y m pt o m ma na ge me nt (e. g., me dicati o ns, assisti ve de vices). 
 Usi n g res ults of R N assess me nts a n d i de ntifie d c halle n ges, R N s u g gests patie nt self- ma na ge me nt 
strate gies.  
 Usi n g res ults of O T assess me nts  a n d i de ntifie d c halle n ges, O T s u g gests strate gies t o a d dress barriers t o 
occ u pati o nal acti vit y (e. g. e ner g y c o ns er vati o n strate gies, pr o ble m s ol vi n g). 1 8 
 Usi n g res ults of P T assess me nts a n d i de ntifie d c halle n ges ; P T s u g gests c o pi n g strate gies t o a d dress 
barriers t o m o ve me nt (e. g. r o uti n e t o decrease ris k f or falls).  1 8 
 C olla b orati vel y set S mart, Meas ura ble, Acti o na ble, Realistic, a n d Ti me d ( * S M A R T) g oals2 0 t o a d dress 
tec h nical a n d/ or a da pti ve w or k.  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
9 
as nee de d (i.e. a tea m me m ber gets sic k). T h e R Ns are bac hel or’s- pre pare d a n d O Ts a n d P Ts are 
master’s- pre pare d t hera pists, all wit h cli nic al bac k gr o u n ds i n o nc ol o g y. T he trai ni n g will be 
facilitate d b y o nc ol o g y a n d palliati ve care e d ucat ors a n d e x perts: Dr s. Br ya nt ( PI), Ha ns o n ( C o-I), 
a n d A n ders o n ( C o-I) will facilitate  3 2 h o urs of trai ni n g of di dactic (e. g. we bi nars a n d self- pace d 
c o urse)  a n d  e x perie ntial  (e. g.  r ole- pla yi n g)  lear ni n g  i n  palliati ve  care  a n d  use  of  a da pti ve  
lea ders hi p a p pr oac hes t o e n ga ge i n c olla b orati ve w or k wit h patie nts a n d facilitate be ha vi or c ha n ge. 
T he tea m ( R N, O T, P T) will perf or m i nter ve nti o n  acti vities o n a pre-arra n ge d m o difie d sc he d ule 
a n d ha ve a decrease d w or kl oa d  w he n c o m pleti n g st u d y acti vities. T he O T/ P T a d mi nistrati ve 
direct or a n d n urse ma na ge r’s letters of s u p p ort a d dress decrease d w or kl oa d.  
       
P alli ati ve c are tr ai ni n g ( 1 6 h o urs):  Dr. Ha ns o n is a n acti ve Palliati ve Care Researc h 
C o o perati ve ( P C R C) me m ber wit h s u bsta ntial palliati ve ca re e d ucati o n a n d e x pertise. Dr. Br ya nt 
has cli nical e x pertise i n s u p p orti ve care 
nee ds a n d atte n de d t he P C R C 2 0 2 0 
Palliati ve Care Trial I nte nsi ve i n Fe br uar y 
2 0 2 0, w here s he recei ve d fee d bac k t o 
stre n gt he n t he i nter ve nti o n trai ni n g a n d 
ot her secti o ns i n t he pr o p osal. T he 
palliati ve care e x pert, Dr. Ha ns o n, will 
re vie w t he A S C O a n d A S H cli nical practice 
g ui deli nes f or i nte gra ti o n of palliati ve care 
i nt o sta n dar d o nc ol o g y care.2 1, 3 3 T he e x perts will pr o vi de basic ma na ge me nt of pai n, de pressi ve 
s y m pt o ms, a n xiet y, slee p, c ha n ge i n c o g niti o n, A ML s y m pt o ms a n d treat me nt-relate d s y m pt o ms, 
disc ussi o n of pr o g n osis, g oals of  care a n d c o de stat us (see T a ble 3 ). Dr. Br ya nt will disc uss 
s u p p orti ve care nee ds i ncl u di n g a descri pti o n of c o nce pts a n d differe ntiate t he r oles of t he R N, 
O T a n d P T i n t his i nter ve nti o n (see T a ble 3 ). Dr. Br ya nt will pr o vi de a n o ver vie w of A M L a n d 
e x plai n h o w t he disease  pr ocess ofte n lea ds t o hi g h s y m pt o m b ur de n a n d f u ncti o nal decli ne. 
I nter ve nti o n trai ni n g will i ncl u de case sce nari os a n d res o urces o n pr o vi di n g h olistic care i n 
disc o mf ort, s y m pt o ms, a n d distress of ol der a d ults  wit h A M L. Res o urces will i ncl u de self- pace d 
c o urses fr o m t he Ce nter t o A d va nc e Palliati ve Care s uc h as “ A n I n- De pt h L o o k at Palliati ve 
Care a n d Its Ser vices,” a n d cas e sce nari os fr o m t he H os pice a n d Palliati ve N urses Ass ociati o n, 
t he A merica n P h ysical T hera p y Ass ociatio n, a n d t he A merica n Occ u pati o nal T hera p y 
Ass ociati o n.    
 
A d a pti ve Le a ders hi p Tr ai ni n g ( 1 6 h o urs):  Dr. A n ders o n, als o a n d P C R C me m ber has 
s u bsta ntial e x perie nce trai ni n g i nter ve nti o nists fr o m her researc h. 2 2 T o pics will i ncl u de t he 
c olla b orati ve w or k ( Fi g ure 3) pr ocess f or eliciti n g patie nts’ c hal le n ges a n d de vel o pi n g a tail ore d 
care pla n. T hr o u g h case sce nari os, trai nees will l ear n t o: a) descri be c o nce pts of a da pti ve 
lea ders hi p; b) assess a n d distin g uis h tec h nical vs. a da pti ve c ha lle n ges; c) i de ntif y a p pr o priate 
tec h nical w or k t o a d dress tec h nical c halle n ges; a n d d) i de ntif y a p pr o priate a da pti ve w or k t o 
facilitate be ha vi or c ha n ge a n d s kill de vel o p me nt f or self- ma na ge me nt. We will use r ole- pla y t o 
rei nf orce s kill de vel o p me nt. After t he trai ni n g sessi o ns, eac h tea m me m ber will de m o nstrate 
a bilit y t o i m ple me nt t he i nter v e nti o n wit h a patie nt w hile bei n g o bser ve d b y Drs. A n ders o n a n d 
Br ya nt. Sessi o ns are a u di o-rec or d e d s o t he tea m ca n re vie w t o ge t her t o pr o vi de fee d bac k a n d 
i m pr o ve s kills ( Ta ble 4). T hese ste ps will be re peate d u ntil tea m me m bers a n d Drs. A n ders o n 
a n d Br ya nt are ass ure d t hat t he i nter ve nti o n tea m  f oll o ws t he pr ot oc ol. Dr. A n ders o n will pre pare 
T a ble 3. P alli ati ve C are Tr ai ni n g f or 
I nter ve nti o n Te a m 
Tr ai ni n g
 G o al/ O utc o me
  
P alli ati ve 
C are 2 1 
B asic m a n a ge me nt/ k n o wle d ge of:  
* pai n, de pressi ve s y m pt o m, a n xiet y,   
  slee p a n d A M L s y m pt o ms  
* pr o g n osis, g oals of t hera p y , c o de stat us   
C oll a b or ati ve 
C are M o del  
* Descri be c o nce pts of  c olla b orati ve care. 
* Differe ntiate r ole of R N, O T, a n d P T 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
1 0 
Dr. Br ya nt t o c o n d uct trai ni n g a n d fi delit y c hec ki n g. Aca de mic deta ili n g sessi o ns will be 
m o nt hl y wit h st u d y R Ns, O Ts a n d P Ts. D uri n g a ca de mic detaili n g, a strate g y Dr. A n ders o n use d 
i n her R 0 1 ( N R 0 0 3 1 7 8- 1 3),2 2 t he P A C T tea m will c o ns ult wit h Drs. A n ders o n, Br ya nt, C o p p ola, 
a n d Ha ns o n a b o ut patie nts wit h diffic ult a da pti ve c halle n ges, s y m pt o ms, or f u ncti o nal iss ues. 
T o get her, t he gr o u p will m o del t he case a n d e x pl ore diffic ult as pects. Dr. Per g ol otti will use 
vi de oc o nfere nci n g t o j oi n Dr. C o p p ola f or o n-s ite trai ni n g. Vi de oc o nfere nci n g all o ws face-t o-
face disc ussi o ns, s hari n g scree ns, rec or di n g of sessi o ns, a n d pr o vi des a we b li n k f or vie wi n g 
later, w hic h has bee n s uccessf ul i n ot her virt ual tea ms 2 3. 
 
I nter ve nti o n Fi delit y. We will use t he treat me nt fi delit y de vel o pe d b y t he Treat me nt Fi delit y 
W or k gr o u p of t he NI H 
Be ha vi or C ha n ge C o ns orti u m 
t o re d uce u ns yste matic 
variati o n i n deli ver y t hat 
c o ul d i m pact i nter nal a n d 
e xter nal vali dit y. 2 4 D E SI G N . 
T o e ns ure desi g n fi delit y 2 4, 
we sta n dar dize d t he 
i nter ve nti o n pr ot oc ol t o a 
s pecifie d d ose i n ter ms of 
n u m ber, fre q ue nc y, a n d set of 
i nter ve nti o n acti vities. ( Ta ble 
2). T R AI NI N G . T he pr ot oc ol 
s pecifies trai ni n g c o nte nt, str uct ure d practice, a n d r ole- pla y e xercises t o e ns ure t hat i nter ve nti o nists’ 
s kills meet esta blis he d sta n dar ds. D E LI V E R Y . T o e ns ure t hat P A C T is deli vere d as s pecifie d, t he PI will 
o bser ve a n d a u di o-rec or d t he P A C T me m ber 2 0 % of t he ti mes he/s he c o m pletes sta n dar dize d c hec klists. 
T he i nter ve nti o nists, t he PI a n d Dr. A n ders o n will disc uss t he res ult s a n d pr o ble m-s ol ve barriers t o 
a d here nce wit h re peat of c o nce pts a n d r ole- pla y as nee de d ( Ta ble 3). R E C EI P T O F IN T E R V E N TI O N .  F or 
P A C T patie nts, t he pr ot oc ol pr o vi des a n o p p ort u nit y t o s yste maticall y assess patie nts’ u n dersta n di n g of 
t he i nter ve nti o n. C olla b orati ve w or k is desi g ne d t o e ns ure t he patie nt i de ntifies S M A R T g oals a n d 
disc usses t he m wit h t he P A C T R N , O T a n d P T. T he R N, O T, a n d P T will e ns ure t he patie nt ca n use 
a p pr o priate be ha vi oral s kills (e. g. self- ma na ge me n t or acti vities) b y o bser vi n g t heir acti vities a n d 
disc ussi n g use of t heir s kill.  P A TI E N T  E N A C T M E N T O F S KI L L S . T he PI will assess e nact me nt bet wee n t he 
R N, O T, a n d P T a n d t he patie nt s yst e maticall y. T he pr oject O T or P T will use a c hec klist t o deter mi ne 
h o w ofte n t he patie nt e n ga ges i n acti vit y. 
1. 6  A d a pti ve Le a ders hi p Fr a me w or k  
We will use a m ulti disci pli nar y ca ncer re ha bil itati o n tea m a p pr oac h t o a d dress c o m ple x 
s y m pt o ms. T his a p pr oac h is critical gi ve n t he c o m ple xit y of i nteracti n g, fl uct uati n g s y m pt o ms 
d uri n g i nitial a n d mai nte na nce t hera p y t hat ca n af fect f u ncti o nal stat us a n d Q O L ne gati vel y. T his 
a p pr oac h bri n gs t o get her rele va nt disci pli ne s ( n ursi n g, O T, P T) t o re d uce s y m pt o m b ur de n b y 
ma na gi n g c o m ple x s y m pt o ms, a n d t o pers o nalize i n ter ve nti o n a p pr oac hes t o ma xi mize patie nts’ 
e n ga ge me nt i n t heir o w n care. Ye t, researc h i n ca ncer re ha bilitati o n has bee n tra diti o nall y 
u n der utilize d b y o nc ol o g y pr o vi ders. T he maj orit y of t he ca ncer re ha bilitati o n literat ure f oc uses 
narr o wl y o n p h ysical i m pair me nts after t he y ha ve occ urre d. O ur ( P A C T) i nter ve nti o n bri n gs a n 
T a ble 4.  A d a pti ve Le a ders hi p Tr ai ni n g a n d G o als f or I nter ve nti o n 
Te a m  
Le ar ni n g A d a pti ve 
Le a ders hi p R ole  
* Descri be c o nce pts of  a da pti ve lea ders hi p. 
* Disti n g uis h tec h nical vs a da pti ve c halle n ges. 
*I de ntif y t y pes of tec h nical a n d a da pti ve w or k. 
* De vel o p s kills f or c olla b orati ve w or k ( Fi g ure 3). 
De m o nstr ate 
C o m pete nce  
* R ole pla y t o hel p rei nf orce s kill de vel o p me nt. 
* R N, O T, a n d P T will de m o nstrate a bilit y t o 
i m ple me nt i nter ve nti o n. 
* Sessi o ns a u di o-rec or de d & fee d bac k gi ve n t o 
i m pr o ve s kill. 
Ac a de mic Det aili n g  
* M o nt hl y trai ni n g sessi o ns wit h R N, O T, P T 
* C ollecti vel y, gr o u p will m o del t he case & e x pl ore 
as pects t hat were diffic ult. 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
1 2 
de vel o p a n y ne w s kills nee de d f or a da pti ve w or k. T h us, o ur i nter ve nti o n will facilitate a da pti ve 
lea ders hi p a m o n g t he R N, O T, a n d P T i nte grate d care tea m me m bers t o carr y o ut a p pr o priate 
tec h nical w or k a n d t o e m p o wer t he patie nt i n acc o m plis hi n g a da pti ve w or k t o ma na ge 
s y m pt o ms, lesse n f u ncti o nal decli ne a n d mai ntai n or i m pr o ve Q O L. 
1. 7  R ati o n ale  
T his pr o p osal a d dresses a ce ntral  c halle n ge i n ca ncer pre ve ntio n a n d c o ntr ol - de vel o pi n g a n 
effecti ve i nter ve nti o n usi n g a m ulti disci pli nar y te a m. Ol der a d ults wit h ac ute m yel oi d le u ke mia 
( A M L) are at ris k f or w orse ni n g s y m pt o ms an d f u ncti o nal decli ne d uri n g i nitial treat me nt. 
S y m pt o m ma na ge me nt a n d c o nsiste nt m o nit ori n g are nee de d t o i de ntif y s y m pt o m a n d f u ncti o nal 
nee ds earl y t o i m pr o ve s y m pt o ms a n d mi ni mize f u ncti o nal decli ne.  
 
T his st u d y will pr o vi de ne w fi n di n gs i n t hree i m p orta nt areas. First, we will test P A C T, t he first 
m ulti- disci pli nar y a n d i nte grate d i nter ve nti o n desi g ne d t o i m pr o ve f u ncti o n f or pers o ns 
dia g n ose d wit h ac ute le u ke mia, w h o are at  hi g h ris k f or p o or Q O L, s y m pt o m b ur de n, a n d 
f u ncti o nal decli ne. Sec o n d, beca use of li mite d access t o s pecialt y-trai n e d palliati ve care 
pr o vi ders, t his i nter ve nti o n trai ns  n o n-s pecialt y pr o vi ders i n t he disci pli nes of n ursi n g, O T, a n d 
P T t o pr o vi de palliati ve a n d s u p p orti ve care, t h us filli n g a ga p i n  care. T hir d, we rec o g nize t hat 
ma na gi n g s y m pt o ms a n d f u nc ti o n al o ne is n ot s ufficie nt t o achie ve mea ni n gf ul be ha vi or c ha n ge; 
b y fra mi n g t he i nter ve nti o n i n t he A da pti ve Lea d ers hi p Fra me w or k f or C hr o nic Ill ness, we 
a d dress t he patie nts’ a da pti ve c halle n ges, s uc h as e m oti o nal, m oti vati o nal, attit u di nal barriers, s o 
t hat patie nts e n ga ge m ore f ull y i n w or k re q uire d of self- ma na ge me nt f or re d uci n g s y m pt o ms a n d 
f u ncti o nal decli ne.  
 
2. 0  
S T U D Y P U R P O S E A N D D E SI G N 
T his is a si n gle i nstit uti o n, feasi bilit y trial of 2 0 ( 1 0 c o ntr ol a n d 1 0 i nter ve nti o n) patie nts wit h t he 
pri mar y o bjecti ve of assessi n g feas i bilit y, acce pta bilit y, a n d c ha n ge i n pre a n d p ost meas ures of 
s y m pt o ms, f u ncti o n, a n d Q O L b y a d mi nisteri n g t he P A C T i nter ve nti o n.  
 
St u d y s u bjects will be i de ntifie d b y t he St u d y C o or di nat or t hr o u g h pre-scree ni n g t hr o u g h t he 
electr o nic healt h rec or d after be i n g referre d b y t he o nc ol o gists a n d p har macists. Eli gi ble patie nts 
will be a p pr oac he d b y t he St u d y C o or di nat or t o c o nfir m eli gi bilit y, w hic h i ncl u des re q uesti n g 
per missi o n of t he patie nt’s atte n d i n g p h ysicia n. Se ve n da ys pri or t o a n d wit hi n t hree da ys after 
i nitiati o n 1st c ycle H M A or l o w- d ose c ytara bi ne + V E N E, writte n i nf or me d c o nse nt will be 
o btai ne d ( A t otal of 1 0 da ys of recr uit me nt peri o d a n d baseli ne assess me nt).  
 
First, te n partici pa nts i n t he c o ntr ol gr o u p will recei ve us ual care. After t he c o ntr ol patie nts ha ve 
c o m plete d t he st u d y, t he n 1 0 i nter ve nti o n partici p a nts will recei ve t he P A C T i nter ve nti o n, a 
n o vel s y m pt o m ma na ge me nt i nter ve nti o n, w hic h ai ms  t o b uil d patie nt s kills t o ma na ge A M L 
treat me nt-relate d, a n d c hr o nic ill ness s y m pt o ms. Beca use patie nts recei ve c he m ot hera p y d uri n g 
t he first 7 da ys of h os pitalizati o n or cli nic visit, t he i nter ve nti o n will start at da y 1 or da y 2 of 
c he m ot hera p y. D uri n g h os pitalizati o n, t he P A C T R N will assess A M L s y m pt o ms dail y ( usi n g 
P R O- C T C A E), a n d P A C T O T a n d P T will assess f u nc ti o n at baseli ne ( da y 1 or 2), da ys 3 or 4, 
a n d da ys 6 or 7. T his st u d y uses U N C hire d staff of R Ns, O Ts, a n d P Ts t o deli ver t he 
i nter ve nti o n.  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
1 4 
2.  Dia g n osis of A M L  
3.  Pla n t o recei ve H M A or l o w- d ose c ytara bi ne + Ve net ocla x  
4.  Ha ve care gi ver(s) willi n g t o partici pate  
4. 2  E xcl usi o n Criteri a 
1.  Patie nts recei vi n g h os pice care 
2.  Patie nts will be e xcl u de d if t he y are u n a ble t o partici pate per t heir o nc ol o g y 
pr o vi der 
5. 0  
S T U D Y P L A N 
5. 1  P atie nt I de ntific ati o n a n d C o nse nt / St u d y Sc he m a  
P ote ntiall y eli gi ble patie nts will be i de ntifie d t hr o u g h pre-scr ee ni n g t he Electr o nic Healt h Rec or d 
after referri n g b y o nc ol o gists or p har macists. E li gi ble patie nts will be a p pr oac he d t o c o nfir m 
eli gi bilit y ( w hic h i ncl u des re q ue sti n g per missi o n of t he patie nt’s atte n di n g p h ysicia n). T he st u d y 
c o or di nat or will pr o vi de i nf or mati o n a b o ut t he st u d y a n d i n vite part ici pati o n. Se ve n da ys pri or t o 
a n d wit hi n t hree da ys after i nitiati o n 1 st c ycle H M A or l o w- d ose c ytara bi ne + V E N E, writte n 
i nf or me d c o nse nt will be o btaine d fr o m t h ose eli gi ble a n d i nte reste d i n partici pati n g. If 
a p plica ble, reas o ns f o r decli ni n g partici pati o n i n t he st u d y will be rec or de d.  
 
St u d y Sc he m a  
 
 
Recr uit me nt of P atie nts 
 
A p pr o xi matel y 1 0 0- 1 5 0 patie nts wit h ac ute le u k e mia are a d mitte d t o U N C f or treat me nt 
a n n uall y. We ai m t o e nr oll 2 0 patie nts ( 1 0 c o ntr o l a n d 1 0 i nter ve nti o n) wit h A M L o ver 2 years. 
Gi ve n t hat recr uit me nt t o a pil ot cl uster ra n d o mize d feasi bilit y a n d acce pta bilit y trial ma y be 
l o wer t ha n f or a n o bser vati o nal st u d y, we pr oject ac hie vi n g o ur tar get sa m ple wit hi n t his 
ti mefra me. 
 
P ote ntiall y eli gi ble patie nts ( d ia g n osis wit h A M L) will be a p proac he d f or e nr oll me nt b y t he 
st u d y c o or di nat or. O nc ol o gists a n d n urse na vi gat ors will be pr o vi de d a recr uit me nt flier f or t he 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
1 7 
Sc ores of scales a n d si n gle-ite m meas ures ra n ge fr o m 0- 1 0 0; hi g her sc ores i n dicate better Q O L. 
C o n versel y, i n s y m pt o m scales a n d s y m pt o m ite ms, hi g her sc ores re prese nt w orse Q O L.3 0 
We will use t he P R O versi o n of t he C o m m o n Ter mi n ol o g y f or A d verse E ve nts ( P R O- 
C T C A E) 3 1 t o pr o vi de a detaile d vie w of dail y treat me nt-relate d s y m pt o ms a n d h o w t he y 
fl uct uate.  
5. 3. 2  P R O- C T C A E ( d ail y me as ures)  
T his 7 8-ite m meas ure, de vel o pe d at t he Nati o nal Ca ncer I nstit ute ( N CI) all o ws patie nts t o self-
re p ort s y m pt o m- base d a d verse e ve nts. We will use a s u bset of 19  s y m pt o ms t o assess s y m pt o m 
attri b utes (e. g., prese nce, fre q ue nc y, se verit y, i nterfere nce wit h s y m pt o m) dee me d rele va nt f or 
ca ncer patie nts; t hese s y m pt o m-ite ms ha ve bee n e xte nsi vel y e val uate d b y  ca ncer patie nts usi n g 
c o g niti ve i nter vie w 3 2 met h o ds a n d f o u n d t o be clear, c o m prehe nsi ble, a n d ca pa ble of meas uri n g 
t he s y m pt o ms of i nterest a n d are m ost rele vant f or t his p o p ulati o n, s uc h  as na usea a n d v o miti n g. 
I n o ur b o ne marr o w tra ns pla nt st u d y ( preli mi nar y st u d y 3, i n w hic h m ost of t he patie nts ha d 
s o me t y pe of le u ke mia, t hese ite ms ca pt ure d s y m pt o ms of fati g ue, diarr hea, heart b ur n, na usea, 
a p petite, a n xiet y, m o ut h s ores, v o miti n g, pai n, c o nsti pati o n, sa d ness, c heeri n g- u p, i ns o m nia, 
c o u g h, ras h, a n d s h ort ness of breat h. I n t he pr o p ose d st u d y, b ot h t he c o ntr ol a n d i nter ve nti o n 
gr o u ps will be as ke d t o a ns wer t he 1 9 q uesti o ns dail y t o ca pt ure c ha n ge s o ver ti me. Rece nt data 
ha ve s h o w n t hat dail y c ollecti o n of patie nt-re p orte d s y m pt o ms is feasi ble  a n d acce pta ble t o b o ne 
marr o w tra ns pla nt patie nts i n t he i n patie nt setti n g, w h o are ofte n patie nts wit h A M L. 3 3 We will 
calc ulate a t otal s y m pt o m sc ore. T his s y m pt o m sc ore re prese nts treat me nt-relate d s y m pt o m 
b ur de n f or t hat patie nt o n t hat partic ular da y.   
5. 3. 3  F u ncti o n al Assess me nts 
 
T he f oll o wi n g assess me nts will c o nsist of t he p h ysical perf or ma nce e val uati o n: Rate of Percei ve d 
E xerti o n, Acti vit y Meas ure i n P ost- Ac ute Care , Cli nicia n rate d Kar n ofs k y Perf or ma nce Scale 
( K P S), P ossi bilities f or Acti vit y Scale ( P A C T S)3 4(acti vit y self-efficac y an d e x pectati o ns, relate d 
t o  e n ga ge me nt  i n  mea ni n gf ul  acti vit y),  Ti med  U p  a n d  G o,  m uscle  stre n gt h  usi n g  ha n d  
d y na m o meter,  B E R G  bala nce,  Perf or ma nce  Assess me nt  of  Sel f-care  S kills  ( P A S S),  cl oc k  
dra wi n g, a n d Ca na dia n Occ u pati o nal Perf or ma nce M eas ure ( C O P M).  
 
R ole
 Assess me nts
 
O T 
P A S S-  Perf or ma nce  Rate  Assess me nt  of  Self- Care  S kills,  Ha n d  gri p  stre n gt h,  
Acti vit y Meas ure f or P ost- Ac ute Care ( A M- P A C) “ 6 clic ks” - 6 ite ms f or O T, cl oc k 
dra wi n g  
P T 
Ber g bala nce test, Ti me d U p a n d G o, Acti vit y Meas ure f or P ost- Ac ute Care ( A M-
P A C) “ 6 clic ks” - 6 ite ms f o r O T; 6 ite ms f or P T; α  = . 9 2 - . 9 4  
 
A M- P A C: O T a n d P T cli nicia ns will o bject i vel y meas ure f u ncti o n usi n g t he acti vit y Meas ure i n 
P ost- Ac ute Care ( A M- P A C) “ 6 clic ks.” T he A M - P A C “ 6 clic ks” is a vali d t o ol f or assessi n g 
f u ncti o n i n patie nts recei vi n g p ost-ac ute care.3 5 T he t o ol i ncl u des t hree d o mai ns: basic m o bilit y 
f u ncti o n, a n d a n ot her f or m assesses dail y acti vit y f u ncti o n. Eac h ite m sc ores fr o m 1 t o 4, t he 
l o wer t he sc ore, t he l o wer t he f u ncti o n. D ue t o t he cli nic e n vir o n me nt c o nsi derati o n, we will o nl y 
assess 5 ite ms i n t he P T c o m p o ne nts (e xcl u di n g “cli m bi n g 3- 5 ste ps wit h a raili n g”). 
 
K ar n ofs k y Perf or m a nce Sc ale ( K P S) cli nici a n-r ate d:  T he K P S i n de x all o ws patie nts t o be 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
1 8 
classifie d as t o t heir f u ncti o nal i m pair me nt. T his ca n be use d t o c o m pare effecti ve ness of differe nt 
t hera pies a n d t o assess t he pr o g n osis i n i n di vi d ual patie nts. T he l o wer t he Kar n ofs k y sc ore, t he 
w orse t he s ur vi val f or m ost seri o us ill ne sses. We will use t he cli nicia n rate d K P S. 3 6, 3 7 
 
P ossi bilities f or acti vit y Sc ale ( P A C T S) 3 4 meas ures t he mea ni n gf ul acti vit y partici pa nts 
partici pate d i n. T he scale i ncl u des t w o s u b d o mai ns: acti vit y self -efficac y a n d acti vit y 
e x pectati o ns. 3 4 Eac h ite m is sc ore d i n a Li kert-t y pe f or mat ra n gi n g fr om 1 c orres p o n ds wit h 
“ ver y little” t o 5 re prese nts “ q ui te a l ot”. T he t otal sc ore ra n ges fr o m 1 2 t o 6 0 wit h hi g her sc ores 
i n dicati n g t hat partici pa nts had hi g her self-efficac y a n d e x pectati o n o n partici pati n g i n 
mea ni n gf ul acti vit y. 3 4 
Ti me d U p a n d G o:  T he Ti me d U p a n d G o is a perf or ma nce test of p h ysical m o bilit y, a n d 
meas ures h o w l o n g it ta kes t he patie nt, i n sec o n ds, t o sta n d u p fr o m a sta n dar d ar m c hair, wal k a 
dista nce of a p pr o xi matel y 1 0 feet, t u r n, wal k bac k t o t he c hair, an d sit d o w n a gai n ( Vi nce nt et al, 
2 0 1 0).  
 
B E R G b al a nce sc ale 3 8 is a 1 4-ite m scale use d t o meas ure bala nce of t he ol der a d ult i n cli nical 
setti n g. Partici pa nts will be as ke d t o perf or m t heir bala nce a bilit y f oll o wi ng t he i nstr ucti o ns, s uc h 
as sta n di n g t o sitti n g or sta n di n g o n o ne f o ot. T hese tas ks are c o m m o n m o ve me nt i n dail y life. 3 8 
Eac h ite m is sc ore d fr o m 0 t o 4, t he hi g her t he sc ore, t he hi g her t he le vel of f u ncti o n. 
 
M uscle Stre n gt h:  Ma xi mal m uscle stre n gt h of t he f orear m fle x or m uscles will be meas ure d 
usi n g p orta ble d y na m o meters ( Ne x Ge n Er g o n o mics, Q ue bec, Ca na da). Ma xi mal m uscle stre n gt h 
of t he f orear m fle x ors will be pe rf or me d i n a sta n di n g p ositi o n wit h eac h f orear m fle xe d at 9 0 
de grees. Wit h t he ha n d i n a ne utral ( ha n ds ha ke) p ositi o n, t he partici pa nt w ill be i nstr ucte d t o 
i n hale. T he n, d uri n g t he e x hale, ma xi mall y gri p t he d y na m o meter f or 3- 5 sec o n ds w hile 
strai g hte ni n g t he f orear m l o n git u di nall y t o t he b o d y. 
 
C a n a di a n Occ u p ati o n al Perf or m a nce Me as ure ( C O P M )3 9, a d mi nistere d b y O T, is a t o ol t o 
i de ntif y, pri oritize, a n d e val uate patie nt’s perce pti o n of perf ormi n g dail y acti vit y. Base d o n t his 
t o ol, O Ts will be a ble t o i de ntif y pri oritizi n g occ u pati o nal tas k a n d de vel o p g oals f or partici pa nts 
i n t he i nter ve nti o n gr o u p. 
 
Perf or m a nce Assess me nt of Self-c are S kills ( P A S S) 4 0, a d mi nistere d b y O T, is a t o ol t o assess 
f u ncti o n. T here are se veral c o m p o ne nts i n t he P A S S. I n o ur st u d y, we will o nl y use t he 
me dicati o n ma na ge me nt c o m p o ne nt, w hic h will assess i n de pe n de nce, safet y, a n d a de q uac y. 
A d diti o nall y, base d o n t he oral h y gie ne a n d t oileti n g ma na ge me nt c o m p o ne nts, o ur O T tea m 
de vel o p was hi n g ha n ds c o m p o ne nt.    
 
Cl oc k Dr a wi n g , a d mi nistere d b y O T, is a t o ol t o assess c o g niti o n. T his assess me nt t o ol has bee n 
i de ntifie d t o be a relia ble t o ol t o scree n de mentia a n d c o g niti ve i m pair m e nt, w hic h is easil y 
a d mi nistere d. 4 1  
 
De m o gr a p hic a n d Cli nic al C h ar acteristics:  We pla n t o use Nati o nal I nstit utes of N ursi n g 
Researc h ( NI N R) de m o gra p hic c o m m o n data ele me n ts: date of birt h/a ge, se x, race/et h nicit y, 
i ns ura nce, e d ucati o n, i nc o me, marital/ part ner stat us, n u m ber of pe o ple i n t he h o use h ol d, 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
1 9 
e m pl o y me nt stat us, i ns ura nce t y pe, falls i n last  6 m o nt hs. We will o btai n cli nical data o n t y pe 
a n d a m o u nt of pri or ca ncer treat me nt, me dical c o m or bi dities a n d me dicati o ns, t y pe/ d ose/ date of 
A M L treat me nt, da ys h os pitalize d  d uri n g ca ncer treat me nt (i nclu di n g o utsi de h os pitalizati o n if 
directl y tra nsferre d t o U N C fr o m a n ot her facilit y),  s u bse q ue nt h os pitalizatio ns, date of deat h (if 
a p pr o priate), electr o nic n otes of  occ u pati o nal a n d p h ysical t herap y, bl o o d test res ults (s uc h as 
w hite bl o o d cell c o u nt, A bs ol ute ne utr o p hil c o u nt,  he m o gl o bi n, platelet, lactate de h y dr o ge nase, 
C- Reacti ve Pr otei n), a n d re missi o n stat us. 
 
F A C T- Le u a d diti o n al c o ncer n s u bsc ale  is a 1 7-ite m q uesti o n naire. Eac h ite m is assesse d b y 0 
t o 4, t he hi g her t he sc ore, t he better t he Q O L. 
5. 4  D ur ati o n of St u d y 
Acti ve partici pati o n b y a gi ve n s u bj ect will be c o m plete a p pr o xi ma tel y 6 m o nt hs after c ycles 1, 
2, 3, a n d 4 base d o n partici pa nts’ treat me nt sc he d ule. O n g oi n g data c olle cti o n t hr o u g h me dical 
rec or d a bstracti o n will c o nti n ue f or c ollecti o n of use of U N C ser vices.  
5. 5  A bstr acti o n of Me dic al Rec or ds a n d P atie nt F oll o w- u p C o nt act 
Data a bstracti o n will occ ur peri o dicall y t hr o u g h o ut t he d urati o n of t he st u d y at least wee kl y. 
 
Varia bles t hat will be e xtracte d fr o m t he me di cal rec or ds f or eac h patie nt i ncl u de, b ut are n ot 
li mite d t o: a ge, ge n der, race, eth nicit y, dia g n osis, e d ucati o n le ve l, t y pe a n d a m o u nt of pri or 
ca ncer treat me nt, me dical c o m or bi dities a n d me dicati o ns, t y pe/ d ose/ da te of A M L treat me nt, 
da ys h os pitalize d d uri n g ca ncer treat me nt (i ncl u di n g o utsi de h os pitalizati o n if directl y 
tra nsferre d t o U N C fr o m a n ot her facilit y), s u bse q ue nt h os pitalizati o ns, date of deat h (if 
a p pr o priate), electr o nic n otes of  occ u pati o nal a n d p h ysical t herap y, bl o o d test res ults (s uc h as 
w hite bl o o d cell c o u nt, A bs ol ute ne utr o p hil c o u nt,  he m o gl o bi n, platelet, lactate de h y dr o ge nase, 
C- Reacti ve Pr otei n), a n d re missi o n stat us. 
6. 0  
A S S E S S M E N T O F S A F E T Y 
Safet y will be m o nit ore d i n all pati e nts fr o m t he ti me of e nr oll me nt. 
7. 0  
A S S E S S M E N T O F E F FI C A C Y 
 
Patie nts wit h a bs ol ute c o ntrai n dicati o ns t o acti vit y m o nit ori n g i ncl u di n g bilateral l o wer 
e xtre mit y a m p utati o n, u nilateral l o wer e xtre mit y a m p utati o n wit h o ut pr ost h esis a n d u nsta ble  
a n gi na or m y ocar dial i nfarcti o n d uri n g t he pre v i o us m o nt h will n ot be e xcl u de d fr o m t he st u d y. 
T hese patie nts, t heref ore, will n ot be i ncl u de d i n a n y a nal yses re q uiri n g t hese meas ures. 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 1 
9. 0  
E X P E C T E D RI S K S/ U N A N TI CI P A T E D P R O B L E M S/ S A F E T Y 
M O NI T O RI N G 
9. 1  E x pecte d Ris ks  
T o mi ni mize t he ris k of i nfec ti o ns, si nce t he le u kemia p o p ulati o n bec o mes ver y s usce pti ble t o 
i nfecti o ns d uri n g treat me nt, all me m bers of t he researc h tea m will f oll o w sta n dar d ne utr o pe nic 
a n d pr otecti ve preca uti o ns. Als o, t he researc h tea m  will atte m pt t o is olate eac h piece of e xercise 
e q ui p me nt t o a partic ular patie n t r o o m. I n case a partic ular piece of e q ui p me nt nee ds t o be 
m o ve d fr o m o ne r o o m t o a n ot her, t he e q ui p me nt w ill be disi nfecte d f oll o wi n g sta n dar d pr ot oc ols 
alrea d y i n place o n t he o nc ol o g y fl o ors. D uri n g t he st u d y, n o e q ui p me nt will lea ve t he o nc ol o g y 
fl o ors. If a researc h tea m me m ber is ill, he or s he will n ot be assi g ne d t o see a n y patie nts d uri n g 
t he ill ness. Als o, d ue t o t he strin ge nt criteria f or partici pati o n i n  t he st u d y, o nl y patie nts dee me d 
ca pa ble b y t heir o nc ol o gists wi ll be e nr olle d i n t he st u d y. 
 
9. 1. 1  P h ysic al Ris ks 
Ti me d wal k testi n g re q uires p h ys ical e xerti o n a n d ma y res ult i n m usc ul os keletal i nj ur y. Patie nts 
wit h c o ntrai n dicati o ns t o p h ysical acti vit y will n o t be as ke d t o partici pate i n wal ki n g. Pre vi o usl y 
p u blis he d data 1 6 ha ve de m o nstrate d t hat e xercise testi n g i n t he ta r get patie nt p o p ulati o n is 
feasi ble a n d safe. T he researc h tea m will ta ke all a p pr o priate preca uti o ns t o pre ve nt i nj ur y. I n t he 
u nli kel y e ve nt of i nj ur y d uri n g t he fit ness assess me nts, s uc h as m uscle diste nsi o ns a n d j oi nt 
tra u ma, me dical pr ofessi o nals o n t he researc h tea m will pr o vi de t he a p pr o priate care. 
9. 1. 2  E m oti o n al Ris ks 
S o me q uesti o ns i n t he patie nt q uesti o n naires c o ul d create e m oti o nal di stress or c o nf usi o n.  
Patie nts will be i nstr ucte d t hat t he q uesti o n naire s are f or researc h p ur p oses o nl y a n d a n y pr o ble m 
or s y m pt o m s h o ul d als o be re p orte d t o t heir tra ns pla nt p h ysicia n or n urse.  
 
9. 2  Pr otecti o n A g ai nst Ris ks  
Ris ks of p h ysical perf or ma nce testi n g will be mi ni mize d b y pr o vi di n g caref ul s u per visi o n wit h 
c o ntact g uar d p ost ure assista nce t o pr o vi de sta bil it y. Patie nts will be i nstr ucte d t o re p ort a n y 
s y m pt o ms of fati g ue, s h ort ness of breat h or c hest disc o mf ort, i m me diatel y pr o m pti n g 
disc o nti n uati o n of acti vit y a n d a p pr o priate me dical ma na ge me nt. A ssess me nts will be carrie d o ut 
i n 4 O nc ol o g y (i n patie nt me dical o nc ol o g y) u nits, i nf usi o n cli nic, or o ncol o g y cli nic wit h f ull 
a n d i m me diate me dical res p o nse ca p acit y a vaila ble. T he acti vit y i nter ve nti o n will ta ke place i n 
t he h os pital i n t he prese nce of trai ne d pers o n nel t o mi ni mize ris ks. Patie nts will recei ve caref ul 
i nstr ucti o n o n t he acti vit y tec h ni q ue, a n d eac h sessio n will be tail ore d t o t he i n di vi d ual's le vel of 
f u ncti o ni n g, s y m pt o ms a n d c o nfi de nce. Pri or t o a p pr oac hi n g eac h patie nt o n a dail y basis, t he 
i nter ve nti o nist will re vie w a c hec klist wit h t he patie nt’s n urse t o i de ntif y a n y me dical 
c o ntrai n dicati o ns t o partici pati o n. I n a d diti o n, t he partici pa nts s u per visi n g atte n di n g o nc ol o gist 
will c o nfir m me dical eli gi bilit y of eac h  s u bject pri or t o e nr oll me nt o n st u d y.  
 
C o nfi de ntialit y of data is mai ntai ne d b y usi n g researc h i de ntificati o n n u m bers t hat u ni q uel y 
i de ntif y eac h patie nt. A p pr o priate meas ures are ta ke n t o pre ve nt u na ut h orize d use of st u d y 
i nf or mati o n. T he researc h I D n u m ber will be use d. A n y pa per researc h rec or ds will be ke pt i n a 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 2 
l oc ke d ca bi net i n t he st u d y co or di nat or’s office. T he files ma tc hi n g partici pa nts' na mes a n d 
de m o gra p hic i nf or mati o n wit h researc h I D n u m be rs will be ke pt se paratel y i n a pass w or d 
pr otecte d data file. O nl y selecte d st u d y pers o n ne l will ha ve access t o t hese files. After t he st u d y 
is c o m plete d, pa per rec or ds will be st ore d wit h ot her c o m plete d researc h st u dies i n a sec ure d 
st ora ge va ult. Data will be use d o nl y i n a g gre gate a n d n o i de ntif yi n g c haracteristics of 
i n di vi d uals will be p u blis he d or prese nte d. 
 
9. 2. 1  P atie nt C o nfi de nti alit y  
We d o n ot a ntici pate a n y breac h of c o nfi de ntiali t y as n o rec or ds will be s hare d wit h a n y 
pers o n nel o utsi de t he cli nicia ns cari n g f or t he patie nts a n d t he researc h tea m.  A n y i nf or mati o n 
a b o ut partici pa nts o btai ne d fr o m t his researc h will be ke pt as c o nf i de ntial as p ossi ble. All data 
o btai ne d eit her t hr o u g h: Li ne ber ger  P R O- C ore s oft ware, patie nt c hart re vie w, or b y direct patie nt 
c o ntact will be st ore d wit h a st u d y I D rat her t ha n patie nt i de ntifiers. A list of patie nt na mes a n d 
t heir st u d y I Ds will be ke pt i n a l oc ke d ca bi net. Electr o nic data will be de-i de ntifie d a n d st ore d 
o n a sec ure ser ver.  
9. 3  U n a ntici p ate d Pr o ble ms 
9. 3. 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 k s t o st u d y s u bjects 
refers t o a n y i nci de nt, e xperie nce, or o utc o me t hat: 
 Is u ne x pecte d (i n ter ms of nat ure, se verity, 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-relate d d oc u me nts, s uc h as t he I R B-
a p pr o ve d researc h pr ot oc ol a n d i nf o r me d c o nse nt d oc u me nt; a n d ( b) t he 
c haracteristics of t he s u bj ect p o p ulati o n bei n g st u die d; 
 Is relate d or p ossi bl y related t o a s u bject’s partici pa ti o n i n t he researc h; a n d  
S u g gests t hat t he researc h places s u bjects or ot hers at a greater ris k of har 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 nize d. 
 
9. 4  Re m o v al of P atie nts  fr o m Pr ot oc ol  
Patie nts will be re m o ve d fr o m t he st u d y if t he y i n dicate t he y n o l o n ger wis h t o partici pate 
a n d if t he y are n ot a ble t o c o m plete t he act i vit y d ue t o disease/treat me nt c o m plicati o ns. 
A d diti o nall y, e xcl usi o ns will occ ur if t he o nc ol o gist re q uests t hat his/ her patie nt is 
e xcl u de d fr o m t he st u d y f or me dical or e m oti o nal c o ncer ns.  
 
9. 4. 1  Re p orti n g 
A n y u na ntici pate d pr o ble m 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 at 
le ast t he first t w o criteria liste d i n secti o n 9. 3. 1 9. 2. 1   m ust be re p orte d t o t he U N C I R B 
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- base d re p orti n g s yste m (see secti o n 
1 1. 5. 3). 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 3 
9. 5  D at a a n d S afet y M o nit ori n g Pl a n 
T he Pri nci pal I n vesti gat or will pr o vi de c o nti n u o us m o nit ori n g of patie nt safet y i n t his trial wit h 
peri o dic re p orti n g t o t he Data a n d Safet y  M o nit ori n g C o m mittee ( DS M C) as re q uire d.  
 
Meeti n gs/telec o nfere nces will be hel d at a fre q ue nc y de pe n de nt o n st u d y accr ual, a n d i n 
c o ns ultati o n wit h t he st u d y Bi ostatisticia n.  At t hese meeti n gs, t he researc h tea m will disc uss all 
iss ues rele va nt t o st u d y pr o gress, i ncl u di n g e nr oll me nt, safet y , re g ulat or y, data c ollecti o n, a n d 
t he tea m will pr o d uce s u m maries or mi n utes of t hese meeti ngs. T hese s u m maries will be 
a vaila ble f or i ns pecti o n w he n re q ueste d b y a n y of t he re g ulat or y b o dies c har ge d wit h t he safet y 
of h u ma n s u bjects a n d t he i nte grit y of data i ncl u di n g, b ut n ot li mi te d t o, t he o versi g ht ( Office of 
H u ma n Researc h Et hics ( O H R E) Bi o me dical I R B, t he O nc ol o g y Pr ot oc ol Re vie w C o m mittee 
( P R C) or t he N ort h Car oli na Tra C S I nstit ute Data a n d Safet y M o nit ori n g B oar d ( D S M B). 
1 0. 0  S T A TI S TI C A L C O N SI D E R A TI O N S 
1 0. 1  St u d y Desi g n 
 
T his is a pil ot cli nical trial of t he P A C T i nte r ve nti o n i n ol der a d ults wit h A M L. T he pri mar y 
o bjecti ve is t o assess t he feasi b ilit y (recr uit me nt a n d rete nti o n) a n d acce pta bilit y of P A C T 
i nter ve nti o n a n d e xa mi ne c ha n ge i n pre a n d p ost meas ures of s y m pt o ms, f u ncti o n, a n d Q O L 
c o m pari n g 1 0 c o ntr ol a n d 1 0 i nte r ve nti o n patie nts wit h A M L.  
Q ualitati ve researc h d oes n ot necessaril y pre dict w hat mi g ht occ ur, b ut hel ps t o u n dersta n d i n 
de pt h t he c haracteristics of t he sit uati o n a n d t he mea ni n g br o u g ht b y partici pa nts a n d w hat is 
ha p pe ni n g t o t he m at t hat m o me nt. 
 
I nter vie ws will be se mi-str uct ure d, face t o face wit h f oll o w- u p q uesti o ns a n d pr o bes t o facilitate 
a dee per u n dersta n di n g of t he patie nt, care gi ver perce pti o ns of t he i nter ve nti o n. I nter vie ws will 
ta ke place o n 4 o nc ol o g y i n patie nt’s h os pital r o o m or pri vate cli nic r o o m a n d will n ot last l o n ger 
t ha n o ne h o ur. A n i nter vie w g ui de, de vel o pe d i n a d va nce of data c ollecti o n, will be use d t o 
pr o vi de a str uct ure t o t he pr ocess ( A p pe n di x 1 3. 1). 
 
T he i nter vie w pr o m pts will f oc us o n t he o verall  perce pti o n of t he P A C T i nter ve nti o n. Eac h 
i nter vie w will be di gitall y a u di o-rec or de d. Brief fiel d n otes will be ma de bef ore, d uri n g (i n a 
n o n- discrete ma n ner) a n d af ter t he i nter vie ws t o ma ke n ote of p oi nts t h o u g ht t o be rele va nt at t he 
ti me. 
 
Pse u d o n y ms will be use d t o pr otect t he i de ntit y  of t he partici pa nts. T he pse u d o n y m will be 
li n ke d t o de m o gra p hic a n d cli nical i nf or mati o n i n a master l o g. T he master l o g of st u d y 
partici pa nts’ na mes a n d st u d y c o des will be ke pt i n  a sec ure file ca bi net i n t he i n vesti gat or’s 
l oc ke d office.  
1 0. 2  S a m ple Size a n d Accr u al 
Sa m ple size f or t his st u d y is mai nl y deter mi ne d b y  ti me a n d res o urce ( b u d get) c o nstrai nts. We will 
all ocate 2 6 patie nts t o t he t w o gr o u ps ( 1 2 per gr o u p). We ass u me 2 0 % of val ues will be missi n g 
or ot her wise u n usa ble, yiel di n g c o m p lete data f or 1 0 patie nts per gr o u p f or a nal yses. As state d 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 4 
a b o ve, esti mati o n rat her t ha n statisti cal i nfere nce is o ur f oc us, a n d s o it is n ot t his pr oject’s g oal t o 
ha ve a de q uate statistical p o wer. We ca n f oc us i nstea d o n precisi o n, a n d f or t he pri mar y o utc o me 
of Q O L (sta n dar dize d), t he half- wi dt h of a t w o- si de d 9 5 % c o nfi de nce i nter val w o ul d be . 9 S D, 
ass u mi n g 1 0 patie nts per ra n d o mi ze d gr o u p. We o btai ne d t his res u lt usi n g n Q uer y A d vis or v 7. 0 
s oft ware. 
We clai m s uc h a st u d y as feasi ble if a n d o nl y if b ot h (a) recr uit me nt rate ( p) is hi g h e n o u g h a n d 
( b) rete nti o n rate ( q) is s ufficie ntl y hi g h, i.e., if b ot h p a n d q are lar ge e n o u g h. M ore s pecificall y, 
t his is t o test t he f oll o wi n g h y p ot hesis:  
H 0: p < = 5 0 % or q < = 5 0 % vs H 1: p > = 8 0 % a n d q > = 7 0 %.  
 
De n ote N as t he n u m ber of eli gi ble patie nts we tr y t o recr uit, a n d Y as  t he n u m ber of patie nts 
w h o are recr uite d, X as t he n u m ber of patie nts (a m o n g t he Y w h o are e nr olle d) w h o c o m plete t he 
P A C T i nter ve nti o n. T he tar get val ue of Y is 2 0, a n d we ass u me ( 1) N f oll o ws a ne gati ve 
bi n o mial distri b uti o n, N B( 2 0, p), ( 2) X, c o n diti o na l o n ( Y = 2 0), f oll o ws a bi n o mial distri b uti o n 
B( 2 0, q). We f urt her ass u me t hat N a n d X are i n de pe n de nt. We list c ut- offs a n d ass ociate d t y pe I 
err or a n d p o wer u n der differe nt N a n d X val ues f or rejecti n g t he h y p ot hesis of p < = 5 0 % a n d t he 
h y p ot hesis of q < = 5 0 %.  
 
Recr uit me nt ( N: t ot al n u m ber of p atie nts bei n g a p pr o ac he d) 
Y  
Rejecti o n Area  T y pe I err or ( p 
< = 5 0 %) 
P o wer ( p > = 
0. 8 0) 
2 0  
N < = 2 0 + 1 2  
0. 1 0 8 
0. 9 9 4 
2 0  
N < = 2 0 + 1 3  
0. 1 4 8 
0. 9 9 7 
2 0  
N < = 2 0 + 1 4  
0. 1 9 6 
0. 9 9 9 
2 0  
N < = 2 0 + 1 5  
0. 2 5 0 
0. 9 9 9 
 
Rete nti o n ( X: t ot al n u m ber of p atie nts w h o  c o m plete t he i nter ve nti o n) 
Y  
Rejecti o n Area  T y pe I err or ( q 
< = 5 0 %) 
P o wer ( q > = 
0. 7 0) 
2 0  
X > 8 
0. 7 4 8 
0. 9 9 5 
2 0  
X > 9 
0. 5 8 8 
0. 9 8 3 
2 0  
X > 1 0 
0. 4 1 2 
0. 9 5 2 
2 0  
X > 1 1 
0. 2 5 2 
0. 8 8 7 
 
U n der t he i n de pe n de nce ass u m pti o n, t he o verall T y pe I err or rate is t he pro d uct of t w o i n di vi d ual 
t y pe I err ors, a n d t he o verall p o wer is t he pr o d uct of p o wer of t w o i n di vi d ual p o wers. We will 
reject t he h y p ot hesis of p < = 5 0% if N < = 3 4, a n d reject t he h y p ot hesis of q < = 5 0 % if X > 1 1. 
T he res ulte d o verall t y pe I err or is 4. 9 %, w hile t he o verall p o wer is 8 8. 6 %.   
 
1 0. 3  D at a A n al ysis Pl a ns 
Fe asi bilit y D at a M a n a ge me nt a n d A n al ysis 
Data will be c ollecte d o n feasi bilit y metrics. T hese i ncl u de c ollecti n g a n d rec or di n g data o n all 
patie nts a p pr oac he d f or recr uit me n t, al o n g wit h a n i n dicat or of w het her eac h patie nt is e nr olle d 
or n ot. T he pr o p orti o n of t h ose e nr olli n g, al o n g wit h its 9 5 % c o nfi de nce i nter val, will be 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 5 
c o m p ute d. Of t h ose e nr olle d, we will rec or d w het he r t here is attriti o n pri or t o eac h patie nt’s e n d 
of f oll o w- u p, as well as t he reas o ns f or s uc h attriti o n. T he pr o p orti o n of t h ose retai ne d, al o n g 
wit h its 9 5 % c o nfi de nce i nter val , will be c o m p ute d as 1 mi n us t he pr o p orti o n w h o e x perie nce d 
attriti o n fr o m t he st u d y. T he fre q ue nc y of data val ues will als o be trac ke d, a n d t he pr o p orti o n of 
n o n- missi n g data val ues, al o n g wit h its 9 5 % c o nfi de nce i nter val, will be c o m p ute d. T he 
fre q ue nc y a n d t y pe of a d verse e ve nts, i ncl u din g i nter ve nti o n-relate d a d verse e ve nts, will be 
rec or de d. Staff h o urs reflecti n g t he eff ort re q uire d t o deli ver t he i nter ve nti o n t o eac h patie nt 
e nr olle d i nt o t he i nter ve nti o n ar m will be tr ac ke d; its mea n a n d sta n dar d de viati o n will be 
c o m p ute d acr oss patie nts. 
 
Acce pt a bilit y D at a M a n a ge me nt a n d A n al ysis  
I nter vie ws will be tra nscri be d b y a pr ofessi o nal tra nscri pti o n a ge nc y. Usi n g Atlas.ti f or a nal ysis, 
Drs. Br ya nt a n d Ric har ds o n will rea d tra nscri pts t o deri ve c o des. T he y will re vie w a n d disc uss 
la bels t o gr o u p c o des i nt o relate d cate g ories a n d i de ntif y maj or t he mes t hr o u g h t his pr ocess. After 
we defi ne eac h maj or t he me, we will i de nti f y c orres p o n di n g e xe m plar q u otes. We will a d dress 
tr ust w ort hi ness of a nal ysis pr oce dures a n d fi n di n gs t hr o u g h creati o n of  a n a u dit trail t o rec or d data 
c ollecti o n,  c o di n g,  a n d  a nal ysis  decisi o ns.  T he  i n ter vie wer  ( Dr.  Br ya nt)  will  ma ke  refle xi ve  
me m os after eac h i nter vie w a n d re vie w me m os w it h c orres p o n di n g a u di o rec or di n gs t o discer n 
li n ka ges, ga ps, a n d q uesti o ns. W he n t he t w o c o ders d o n ot a gr ee o n t heir i nitial c o de, c o de 
ne g otiati o n a n d tra nscri pt re vie w will occ ur. 
 
A n al ysis of C h a n ge i n Pre- a n d- P ost Q O L, S y m pt o m, a n d F u ncti o n 
A nal yses will be c o n d ucte d f oll o wi n g a n i nte nti o n t o treat a p pr oac h, s u c h t hat patie nts are a nal yze d 
as all ocate d. Descri pti ve statistics will be c o m p ut e d o n all a nal ysis varia bles at eac h ti me p oi nt 
se paratel y f or eac h c o n diti o n. T hese val ues will be c o m pare d bet wee n t he c o n diti o ns at baseli ne 
t o deter mi ne w het her a n y i m bala nced. T hese i ncl u de mea ns a n d sta n dar d de viati o ns f or c o nti n u o us 
varia bles, a n d fre q ue ncies a n d perce nta ges f or cate g orical varia bles. As t h e pri mar y a nal ysis of 
pre a n d p ost val ues, we will fit a n a nal ysis of  c o varia nce ( A N C O V A) m o del f or eac h p ost o utc o me, 
wit h a mai n effect f or gr o u p (i nter ve nti o n vers us c o ntr ol) w hile c o nt r olli n g f or t he c o variate of t he 
c orres p o n di n g baseli ne ( pre) val ue.   Se nsiti vit y a nal yses will re peat t his A N C O V A b ut a d di n g 
de m o gra p hic varia bles t hat are i m bala nce d at base li ne, s u bject t o s ufficie nt sa m ple size. T his 
a p pr oac h will all o w us t o assess w het her t he m ea n p ost val ues differ bet wee n gr o u ps f or eac h 
meas ure t hr o u g h t he re gressi o n c oe fficie nt f or t he mai n effect of gr o u p, as well as its 9 5 % 
c o nfi de nce i nter val. T his i nf or mati o n will be usef ul i n pla n ni n g f or t he s u bse q ue nt R 0 1, a n d we 
will calc ulate effect sizes f or t he p ost meas ure as t he rati o of t he mea n differe nce bet wee n t he 
i nter ve nti o n a n d t he c o ntr ol gr o u ps t o its sta n dar d de viati o n. F or meas ures w here m ore t ha n o ne 
f oll o w- u p meas ure is c ollecte d, t his a p pr oac h ca n be e xte n de d t hr o u g h a li near mi xe d effects m o del 
a p pr oac h  t o  re peate d  meas ures  a nal ysis,  a n d  wit hi n- patie nt  c orrelati o n  ca n  be  esti mate d.  If  
e xte nsi ve (e. g., greater t ha n 1 0 %), m ulti ple i m p utat i o n will be c o nsi dere d f or missi n g val ues. N o 
f or mal si g nifica nce testi n g will occ ur, as t he i nte nti o n is t o e val uate a n d esti mate effect sizes rat her 
t ha n f or mal h y p ot hesis testi n g, a n d he nce m ulti plicit y is n ot a c o ncer n fr o m t his pers pecti ve.  
1 1. 0  S T U D Y M A N A G E M E N T 
1 1. 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 pecte 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 ncti o n i n acc or da nce wit h 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
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U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 6 
fe derall y ma n date d re g ulati o ns. T he I R B s h o uld a p pr o ve t he c o nse nt f or m a n d pr ot oc ol. 
 
I n o btai ni n g a n d d oc u me nti n g i nf or me d c o nse nt, t he i n vesti gat or sh o ul d 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 or i gi n i n t he Declarati 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 nse nt f or m m ust 
i ncl u de all t he rele va nt ele me nts c urre ntl y req uire d b y t he F D A Re g ulati o ns a n d 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 patie 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 partici pat e 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 nse nt 
f or m. 
 
Pri or t o a patie nt’s part ici pati o n i n t he trial, t he writte n i nf or me d c o nse nt f or m s h o ul d be si g ne d 
a n d pers o nall y date d b y t he patie nt a n d b y t h e 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. 
1 1. 2  Re q uire d D oc u me nt ati o n 
Bef ore t he st u d y ca n be i nitiate d at a n y site, t he f oll o wi n g d oc u me nt ati o n m ust be place d o n file 
(as a p plica ble). 
 
 A c o p y of t he official 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 nse nt 
 I R B me m bers hi p list 
 C Vs a n d me dical lice ns ure f or t he pri nci pa l i n vesti gat or a n d an y s u b-i n vesti gat ors 
w h o will be i n v ol ve d i n t he st u d y. 
 I n vesti gat or’s si g nat ure d oc u me nti n g u n dersta n di n g of t he pr ot oc ol a n d pr o vi di n g 
c o m mit me nt t hat t his trial w ill be c o n d ucte d acc or di n g t o all sti p ulati o ns of t he 
pr ot oc ol  
 
1 1. 3  Re gistr ati o n Pr oce d ures 
All s u bjects m ust be re gistere d  wit h t he Li ne ber ger C o m pre he nsi ve Ca ncer Ce nter. After i nitial 
c o ns ultati o n wit h Pa ul J o nes ( pa ul _e _j o nes @ me d. u nc.e d u, 9 6 6- 4 4 3 2), t he s u bjects will be 
re gistere d a n d e ntere d i nt o t he we b base d cli nical researc h platf or m, O nc ore ® . 
1 1. 4  D at a M a n a ge me nt a n d M o nit ori n g/ A u diti n g 
All st u d y data will be c ollecte d, ma na ge d, a n d st ore d via P R O C ore S ur ve y S yste m usi n g a u ni q ue 
patie nt i de ntifier. P R O C ore is a sec ure platf or m  f or c ollecti n g data via we b-e na ble d de vices. It 
facilitates st u d y ma na ge me nt t hr o u gh patie nt trac ki n g re p orts a n d e ma il re mi n ders t o pr oject staff. 
It all o ws s y m pt o ms t o be trac ke d fr o m baseli ne u p t o 2 4 wee ks p ost disc har ge. Data are st ore d i n 
a sec ure data base ma na ge d b y t he I nf or mati o n Tec h n ol o g y Scie nce (I T S) Researc h C o m p uti n g 
gr o u p at U N C.  
As a n i n vesti gat or-i nitiate d st u d y, t his trial ma y be a u dite d b y t he Li ne ber ger Ca ncer Ce nter 
a u dit c o m mittee.  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
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U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 7 
1 1. 5  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 he pr otecti on, safet y, a n d well- bei n g 
of t he st u d y patie nt re q uires alter nati ve treat m e nt, t he st u d y s hall be c o n d ucte d e xactl y as 
descri be d i n t he a p pr o ve d pr ot oc ol.   
1 1. 5. 1  E mer ge nc y M o dific ati o ns 
U N C a n d Affiliate 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 ge of, t he pr ot oc ol t o 
eli mi nate a n i m me diate hazar d(s)  t o trial s u bjects wit h o ut pri or U N C or t heir res pecti ve 
i nstit uti o n’s I R B/I E C a p pro val/fa v ora ble o pi ni o n.   
 
F or a n y s uc 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 difica ti o n f or m m ust be 
c o m plete d b y U N C Researc 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.   
1 1. 5. 2  Si n gle P atie nt/ S u bject E xce pti o ns 
A n y re q uest t o e nr oll a si n gle s u bj ect w h o d oes n ot meet all t he eli g i 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 ncipal I n vesti gat or a n d t he U N C I R B.  
1 1. 5. 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 oc ol t hat:  
 Is ge 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 ri s ks t o researc h partici 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 data c ollecte d  
 Di d n ot res ult fr o m willf ul or k n o w i 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 varia 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 he 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 vesti 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 ulati o ns, State 
la ws, or U ni versit y p olicies. 
 
If a de viati o n or vi olati o n occ urs, please f oll o w t he g ui deli nes bel o w: 
 
Pr ot oc ol De 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 ® , 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 orte d b y U N C  pers o n nel wit hi n o ne ( 1) wee k of 
t he i n vesti gat or bec o mi n g a ware of t he 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 na ntici pate d Pr o ble ms.   
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
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U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 8 
U n a ntici p ate d Pr o ble ms: 
A n y e ve nts t hat meet t he criteria f or “ U na ntic i pate d Pr o ble ms” as defi ne d b y U N C’s I R B 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- base d rep orti n g s yste m.   
1 1. 6  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 he a me n d me n ts will be ori gi nate d a n d 
d oc u me nte d b y t he Pri nci pal I n vest i 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 nt iall y alters t he st u d y desi g n or t he p ote ntial ris k t o t he patie nt, 
a re vise d c o nse nt f or m mi g ht be re q uire d.   
 
T he writte n a me n d me nt, a n d if re q uire 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.   
1 1. 7  Rec or d Rete nti o n 
St u d y d oc u me ntati o n i ncl u des all e C R Fs, data c orrecti o n f or ms or  q ueries, s o urce d oc u me 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 me nts (e. g., 
pr ot oc ol a n d a me n d me nts, I R B c orres p o n de 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 de all rec or d i 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 uati 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 ge nc y re g ulati o ns a n d directi ves re q uire t hat all st u d y d ocu 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 vesti gat or.  I n t he case of a st u d y 
wit h a dr u g see ki n g re g ulat or y a p pr o val a n d mar k eti n g, t hese d oc u me nts s hall be retai ne d f or at 
least t w o years after t he last a p pr o val of mar ketin g a p plicati o n i n a n I nte r nati o nal C o nfere nce o n 
Har m o nizati o n (I C H) re gi o n.  I n all ot her cases, st u d y d oc 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 in vesti gati o nal st u d y. 
1 1. 8  O bli g ati o ns of I n vesti g at ors 
T he Pri nci pal I n vesti gat or is re s p o nsi ble f or t he c o n d uct of t he cli nical trial at t he site i n 
acc or da nce wit h Title 2 1 of t he C o de of Fe deral Re g ulati o ns a n d/ or t he Decl arati o n of Helsi n ki.  
T he Pri nci pal I n vesti gat or is res p o nsi ble f or pers o nall y o verseei n g t he treat 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 ocol a n d all F D A/ G C P/ N CI 
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 o r 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 i nt o t he e C R Fs. Peri o dicall y, m o nit ori n g visits wi ll 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 e C R Fs will be re vie we d b y t he Pri nci pal 
I n vesti gat or a n d will re q uire his/ her fi nal si g nat ure t o verif y t he acc urac y of t he data. 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
2 9 
1 2. 0  R E F E R E N C E S 
 
1.  
S ociet y A C. Ac ute M yel oi d Le u ke mia htt ps:// w w w.ca ncer. or g/ca ncer/ac ute- m yel oi d-
le u ke mia/a b o ut/ ke y-statistics. ht ml. P u blis he d 2 0 2 0. Accesse d. 
2.  
Al brec ht T A. P h ysi ol o gic a n d ps yc h ol o gical s y m pt o ms e x perie nce d b y a d ults wit h ac ute 
le u ke mia: a n i nte grati ve literat ure re vie w. O nc ol o gy n ursi n g f or u m. 2 0 1 4; 4 1( 3): 2 8 6- 2 9 5. 
3.  
B ur he n n P S, Br ya nt A L, M ustia n K M. E x ercise Pr o m oti o n i n  Geriatric O nc ol o g y. 
C urre nt o nc ol o gy re p orts. 2 0 1 6; 1 8( 9): 5 8. 
4.  
M u k herjee S, Se keres, M. E mer gi n g a n d N o vel T hera pies f or A M L Se mi n ars i n 
O nc ol o gy N ursi n g 2 0 1 9;i n press. 
5.  
Di Nar d o C D, Pratz K, P ullar k at V, et al. Ve net ocla x c om bi ne d wit h decita bi ne or 
azaciti di ne i n treat me nt- nai ve, el derl y patie nts wit h ac ute m yel oi d le u ke mia. Bl o o d. 
2 0 1 9; 1 3 3( 1): 7- 1 7. 
6.  
Wi nters A C, G ut ma n J A, P ure v E, et al. R eal- w orl d e x perie nce of ve net ocla x wit h 
azaciti di ne f or u ntreate d patie nts wit h ac ute m yel oi d le u ke mia. Bl o o d a dv a nces. 
2 0 1 9; 3( 2 0): 2 9 1 1- 2 9 1 9. 
7.  
Gr o ver S, Ri na K, Mal h otra P, K ha d wal A. Care gi ver B ur de n i n t he Patie nts of Ac ute 
M yel o blastic Le u ke mia. I n di a n j o ur n al of he m at ol o gy & bl o o d tr a nsf usi o n : a n offici al 
j o ur n al of I n di a n S ociety of He m at ol o gy a n d Bl o o d Tr a nsf usi o n. 2 0 1 9; 3 5( 3): 4 3 7- 4 4 5. 
8.  
A n ders o n R A, Baile y D E, Jr., W u B, et al. A da pti ve lea ders hi p fra me w or k f or c hr o nic 
ill ness: fra mi n g a researc h a ge n da f or tra nsf or mi n g care deli ver y. A N S A dv a nces i n 
n ursi n g scie nce. 2 0 1 5; 3 8( 2): 8 3- 9 5. 
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C orazzi ni K N, A n ders o n R A. A da pti ve lea ders hi p a n d pers o n-ce ntere d care: a ne w 
a p pr oac h t o s ol vi n g pr o ble ms. N ort h C ar oli n a me dic al j o ur n al. 2 0 1 4; 7 5( 5): 3 5 2- 3 5 4. 
1 0.  
Ferrell B R, Te mel J S, Te mi n S, et al. I nte grati o n of Palliati ve Care I nt o Sta n dar d 
O nc ol o g y Care: A merica n S ociet y of Cli ni cal O nc ol o g y Cli nical Practice G ui deli ne 
U p date. J o ur n al of cli nic al o nc ol o gy : offici al j o ur n al of t he A meric a n S ociety of Cli nic al 
O nc ol o gy. 2 0 1 7; 3 5( 1): 9 6- 1 1 2. 
1 1.  
Te mel J S, Greer J A, M uzi ka ns k y A, et al. Earl y palliati ve care f or patie nts wit h 
metastatic n o n-s mal l-cell l u n g ca ncer. T he Ne w E n gl a n d j o ur n al of me dici ne. 
2 0 1 0; 3 6 3( 8): 7 3 3- 7 4 2. 
1 2.  
El-Ja wa hri A, Trae ger L, Gr eer J A, et al. Effect of I n patie nt Palliati ve Care D uri n g 
He mat o p oietic Ste m- Cell Tr a ns pla nt o n Ps yc h ol o gical Distress 6 M o nt hs After 
Tra ns pla nt: Res ults of a Ra n d o mize d Cli nical Trial. J o ur n al of cli nic al o nc ol o gy : offici al 
j o ur n al of t he A meric a n S ociety of Cli nic al O nc ol o gy. 2 0 1 7; 3 5( 3 2): 3 7 1 4- 3 7 2 1. 
1 3.  
El-Ja wa hri A, Le Bla nc T, Va n D use n H, et  al. Effect of I n patie nt Palliati ve Care o n 
Q ualit y of Life 2 Wee ks After He mat o p oietic  Ste m Cell Tra ns pla ntati o n: A Ra n d o mize d 
Cli nical Trial. J a m a. 2 0 1 6; 3 1 6( 2 0): 2 0 9 4- 2 1 0 3. 
1 4.  
Pett y R E BJ, W heeler S C. . I n: Di Cle me nte RJ, Cr os by R A, Ke gler M C, e ds. E mer gi n g 
T he ories i n He alt h Pr o m oti o n Pr actice a n d Rese arc h.  2 n d e diti o n e d: J osse y- Bass; 2 0 0 9. 
1 5.  
Bats o n C D, P ol ycar p o u M P, Har m o n-J o nes E, et al. E m pat h y a n d attit u des: ca n feeli n g 
f or a me m ber of a sti g matize d gr o u p i m pr o ve feeli n gs t o war d t he gr o u p? J o ur n al of 
pers o n ality a n d s oci al psyc h ol o gy. 1 9 9 7; 7 2( 1): 1 0 5- 1 1 8. 
1 6.  
Mic hie S, Ric har ds o n M, J o h nst o n M, et al. T he be ha vi or c ha n ge tec h ni q ue ta x o n o m y 
( v 1) of 9 3 hierarc hicall y cl ustere d tec h ni q ues: b uil di n g a n i nter nati o nal c o nse ns us f or t he 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 0 
re p orti n g of be ha vi or c ha n ge i nter ve nti o ns. A n n als of be h avi or al me dici ne : a p u blic ati o n 
of t he S ociety of Be h avi or al Me dici ne. 2 0 1 3; 4 6( 1): 8 1- 9 5. 
1 7.  
Br ya nt A L, Deal, A., P hilli ps, B., Baile y, C ., Per g ol otti, M., Hac k ne y, A. C., Batta gli ni, 
C. Ca ncer relate d fati g ue, q ualit y of life a n d i nter ve nti o n a d here nce: E xercise a n d Q ualit y 
of Life trial preli mi nar y res ults Ger o n ot ol o gic al S ociety of A meric a. 2 0 1 5; 6 8t h A n n ual 
Scie ntific Meeti n g ( N o ve m ber 1 6- 2 0, 2 0 1 5). 
1 8.  
Marlatt G A D D. Rel a pse Preve nti o n 2 n d e diti o n e d: G uil f or d Press; 2 0 0 5. 
1 9.
 R M
 
S.
 
C o n q ueri n g t he C o nte nt: a Ste p- by- Ste p G ui de t o We b- B ase d C o urse 
Devel o p me nt.  Sa n Fra ncis o, C A: J osse y- Bass; 2 0 0 8. 
2 0.  
B o ve n d' Eer dt TJ, B otell R E, Wa de D T. Writi n g S M A R T re ha bilitati o n g oals a n d 
ac hie vi n g g oal attai n me nt sc ali n g: a practical g ui de. Cli nic al re h a bilit ati o n. 
2 0 0 9; 2 3( 4): 3 5 2- 3 6 1. 
2 1.  
Q uill T E, A ber net h y A P. Ge neralist pl us s pecialist palliati ve care--creati n g a m ore 
s ustai na ble m o del. T he Ne w E n gl a n d j o ur n al of me dici ne. 2 0 1 3; 3 6 8( 1 3): 1 1 7 3- 1 1 7 5. 
2 2.  
A n ders o n K H, Frie de ma n n M L, B ű sc her A, Sa ns o ni J, H o d nic ki D. I m mersi o n researc h 
e d ucati o n: st u de nts as catal ysts i n i nter nati o nal c ollab orati o n researc h. I nter n ati o n al 
N ursi n g Revie w. 2 0 1 2; 5 9( 4): 5 0 2- 5 1 0. 
2 3.  
Gils o n L L, Ma y nar d, T. M., J o nes Y o u n g N. C., Vartiai ne n, M., Ha k o ne n, M. Virt ual 
Tea ms Researc h: 1 0 Years, 1 0 T he mes, a n d 1 0 O p p ort u nities. J o ur n al of M a n a ge me nt 
2 0 1 5; 4 1( 5): 1 3 1 3- 1 3 3 7. 
2 4.  
Bell g AJ, B orrelli B, Res nic k B, et al. E n ha nci n g treat me nt fi delit y i n healt h be ha vi or 
c ha n ge st u dies: best prac tices a n d rec o m me n dati o ns fr o m t he NI H Be ha vi or C ha n ge 
C o ns orti u m. He alt h psyc h ol o gy : offici al j o ur n al of t he Divisi o n of He alt h Psyc h ol o gy, 
A meric a n Psyc h ol o gic al Ass oci ati o n. 2 0 0 4; 2 3( 5): 4 4 3- 4 5 1. 
2 5.  
Me nzi n J, La n g K, Earle C C, Ker ne y D, Mallic k R. T he o utc o mes a n d c osts of ac ute 
m yel oi d le u ke mia a m o n g t he el derl y. Arc hives of i nter n al me dici ne. 2 0 0 2; 1 6 2( 1 4): 1 5 9 7-
1 6 0 3. 
2 6.  
Br ya nt A L, C off ma n E M, B ullar d E, et al. E x perie nces of I n patie nt B o ne Marr o w 
Tra ns pla ntati o n N urses a n d Pr o vi ders  Usi n g Electr o nic S y m pt o m Re p orti n g. J o ur n al of 
o nc ol o gy pr actice. 2 0 1 8; 1 4( 8):e 4 9 6-e 5 0 4. 
2 7.  
Br ya nt A L, C off ma n E, P hilli ps B, et al. Pi l ot ra n d o mize d trial of a n electr o nic s y m pt o m 
m o nit ori n g a n d re p orti n g i nter ve nti o n f or h os pitalize d a d ults u n der g oi n g he mat o p oietic 
ste m cell tra ns pla ntati o n. S u p p ortive c are i n c a ncer  : offici al j o ur n al of t he M ulti n ati o n al 
Ass oci ati o n of S u p p ortive C are i n C a ncer. 2 0 1 9. 
2 8.  
Lea k Br ya nt A, C off ma n E M, P hilli ps B, et al. S y m pt o ms, M o b ilit y a n d F u ncti o n, a n d 
Q ualit y of Life i n A d ults Wit h Ac ut e Le u ke mia D uri n g I nitial H os pitalizati o n. O nc ol o gy 
n ursi n g f or u m. 2 0 1 8; 4 5( 5): 6 5 3- 6 6 4. 
2 9.  
Br ya nt A L, Deal A M, Batta gli ni C L, et al. T he Effects of E xercise o n Patie nt- Re p orte d 
O utc o mes a n d Perf or ma nce- Base d P h ysical F u ncti o n i n A d ults Wit h Ac ute Le u ke mia 
U n der g oi n g I n d ucti o n T hera p y:  E xercise a n d Q ualit y of Life i n Ac ute Le u ke mia 
( E Q U A L). I nte gr ative c a ncer t her a pies. 2 0 1 8; 1 7( 2): 2 6 3- 2 7 0. 
3 0.  
Aar o ns o n N K, A h me dzai S, Ber g ma n B, et al. T he E ur o pea n Or ga nizati o n f or Researc h 
a n d Treat me nt of Ca ncer Q L Q- C 3 0: a q ualit y- of-life i nstr u me nt f or use i n i nter nati o nal 
cli nical trials i n o nc ol o g y. J o ur n al of t he N ati o n al C a ncer I nstit ute. 1 9 9 3; 8 5( 5): 3 6 5- 3 7 6. 
3 1.
 G ui deli nes.
 
C T E P N C T Cf A E C v OIa.
 
Ca ncer
 
T hera p y E val uati o n Pr o gra m N CI. C o m m o n 
Ter mi n ol o g y Criteria f or A d verse E ve nts ( C T C A E) v 3. 0 O nli ne I nstr ucti o ns a n d 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 1 
G ui deli nes. 
htt ps:// we ba p ps.cte p. nci. ni h. g o v/ we b o bjs/ctc/ we b hel p/ welc o me _t o _ctcae. ht m . P u blis he d 
2 0 0 9. Accesse d. 
3 2.  
I nstit ute N C. Patie nt- Re p orte d O utc o mes versi o n of t he C o m m o n Ter mi n ol o g y Criteria 
f or A d verse E ve nts ( P R O- C T C A E™).  P u blis he d 2 0 1 7. Accesse d. 
3 3.  
Basc h E, Deal A M, Kris M G, et al. S y m pt o m M o nit ori n g Wit h Patie nt- Re p orte d 
O utc o mes D uri n g R o uti ne Ca ncer Treat me nt: A Ra n d o mize d C o ntr olle d Trial. J o ur n al of 
cli nic al o nc ol o gy : o ffici al j o ur n al of t he A meric a n S ociety of Cli nic al O nc ol o gy. 
2 0 1 6; 3 4( 6): 5 5 7- 5 6 5. 
3 4.  
Per g ol otti M, C utc hi n M P. T he P ossi bilities f or Acti vit y Scale ( P Act S): De vel o p me nt, 
vali dit y, a n d relia bilit y. C a n a di a n j o ur n al of occ u p ati o n al  t her a py Rev ue c a n a die n ne 
d'er g ot her a pie. 2 0 1 5; 8 2( 2): 8 5- 9 2. 
3 5.  
Hale y S M, C oster WJ, A n dres P L, et al. Acti vit y o utc o me meas ur e me nt f or p ostac ute 
care. Me dic al C are. 2 0 0 4:I 4 9-I 6 1. 
3 6.  
Cr o o ks V, Waller S, S mit h T, Ha h n TJ. T he use of t he Kar n ofs k y Perf or ma nce Scale i n 
deter mi ni n g o utc o mes a n d ris k i n geriatric o ut patie nts. J o ur n al of ger o nt ol o gy. 
1 9 9 1; 4 6( 4): M 1 3 9- 1 4 4. 
3 7.  
Sc ha g C C, Hei nric h R L, Ga nz P A. Kar n ofs k y perf or ma nce stat us re visite d: relia bilit y, 
vali dit y, a n d g ui deli nes. J o ur n al of cli nic al o nc ol o gy : of fici al j o ur n al of t he A meric a n 
S ociety of Cli nic al O nc ol o gy. 1 9 8 4; 2( 3): 1 8 7- 1 9 3. 
3 8.  
Ber g K, W o o d- Da u p hi ne S, Willia ms J, Ga yt o n D. Meas uri n g bala nce i n t he el derl y: 
preli mi nar y de vel o p me nt of a n i nstr u me nt. P hysi ot her a py C a n a d a. 1 9 8 9; 4 1( 6): 3 0 4- 3 1 1. 
3 9.  
La w M C, Ba ptiste S, Cars well A, Mc C oll M A, P olataj k o H, P oll oc k N. C a n a di a n 
occ u p ati o n al perf or m a nce me as ure: C O P M.  C A O T P u bl. A C E; 1 9 9 8. 
4 0.  
H ol m M B, R o gers J, He m p hill- Pears o n B. T he perf or ma nce assess me nt  of self-care s kills 
( P A S S). Assess me nts i n occ u p ati o n a l t her a py me nt al he alt h. 2 0 0 8; 2: 1 0 1- 1 1 0. 
4 1.  
A grell B, De hli n O. T he cl oc k- dra wi n g test. A ge a n d a gei n g. 1 9 9 8; 2 7( 3): 3 9 9- 4 0 3. 
4 2.  
Basc h E, Ree ve B B, Mitc hell S A, et al. De ve l o p me nt of t he Nati o nal Ca ncer I nstit ute's 
patie nt-re p orte d o utc o mes versi o n of t he c o m m o n ter mi n ol o g y criteria f or a d verse e ve nts 
( P R O- C T C A E). J o ur n al of t he N ati o n al C a ncer I nstit ute. 2 0 1 4; 1 0 6( 9). 
4 3.  
C ole ma n E A, S mit h J D, Fra n k J C, Eilertse n T B, T hiare J N, Kra mer A M. De vel o p me nt 
a n d testi n g of a meas ure desi g ne d t o a ssess t he q ualit y of care tra nsiti o ns. I nter n ati o n al 
j o ur n al of i nte gr ate d c are. 2 0 0 2; 2:e 0 2. 
4 4.  
Hi b bar d J H, St oc kar d J, Ma h o ne y E R, T usler  M. De vel o p me nt of t he Patie nt Acti vati o n 
Meas ure ( P A M): c o nce pt ualizi n g a n d meas uri n g acti vati o n i n patie nts a n d c o ns u mers. 
He alt h services rese arc h. 2 0 0 4; 3 9( 4 Pt 1): 1 0 0 5- 1 0 2 6. 
 
 
 

L C C C 1 8 4 8 
 
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U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 2 
1 3. 0  A P P E N DI C E S 
1 3. 1  A p pe n di x I – I nter vie w G ui de  
 
1 3. 1. 1 F or patie nt (c o ntr ol gr o u p) 
1 3. 1. 2 F or care gi ver (c o ntr ol gr o u p) 
1 3. 1. 3 F or patie nt (i nter ve nti o n gr o u p) 
1 3. 1. 4 F or care gi ver (i nter ve nti o n gr o u p) 
 
 

L C C C 1 8 4 8 
 
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U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 3 
1 3. 1. 1 F or p atie nt (c o ntr ol gr o u p) 
 
Greeti n g  
T ha n k y o u f or bei n g here t o da y. We reall y a p precia te y o u ta ki n g t he ti me t o partici pate i n t his 
disc ussi o n. M y na me is _ _ _ _ _ _ _ a n d w ill lea d t he disc ussi o n t o da y. 
 
R ole 
M y r ole t o da y will be t o as k s o me s pecific q ue sti o ns a n d t o kee p t he c o n versati o n g oi n g.  We 
ha ve a l ot t o c o ver, s o I ma y nee d t o c ha n ge t he s u bject or m o ve a hea d wit h t he disc ussi o n.  
H o we ver, please st o p me if y o u wa nt  t o a d d a n yt hi n g or if y o u have a n y q uesti o ns. T he i nter vie w 
t o da y will last a b o ut 2 0- 3 0 mi n utes. 
 
P ur p ose 
T he mai n t hi n g we are i ntereste d i n t o da y is heari n g  fr o m y o u, t he e x pert. We wa nt t o hear y o ur 
e x perie nces a b o ut bei n g dia g n ose d wit h ac ute le u ke mia a n d t he i nitiati o n of c he m ot hera p y. Y o ur 
e x perie nces will hel p us gai n val ua ble i nsi g ht o n c halle n ges t hat patie nts wit h A M L face d uri n g 
c he m ot hera p y. T his i nf or mati o n will g ui de us t o f urt her de vel o p i nter ve nti o ns t o ma na ge t hese 
c halle n ges i n t he ac ute le u ke mia p o p ulati o n. 
 
I w o ul d li ke t o state t hat o ur c o n versati o n is bei n g a u di ota pe d t o hel p us re me m ber w hat is sai d. 
Y o u ma y as k me t o t ur n off t he rec or der at a n y ti me or si m pl y sa y y o u d o n ot wa nt t o a ns wer a 
q uesti o n.  E ver yt hi n g sai d here t o da y will be c o nfi de ntial. N ot hi n g y o u sa y will be c o n necte d 
wit h y o ur na me.  
 
A n y q uesti o ns bef ore we be gi n? 
 
T his secti o n will be c o n d ucte d at disc h ar ge assess me nt of cycle 1 a n d cycle 2.  
 
1.  H o w w o ul d y o u descri be y o ur m o bi lit y bef ore y o ur dia g n osis? 
2.  H o w w o ul d y o u descri be y o ur m o bili t y bef ore y o ur dia g n osis n o w? 
3.  W hat d o y o u t hi n k will hel p y o u c o nti n ue t o sta y acti ve? 
4.  H o w w o ul d y o u descri be y o ur ( p h ysi cal/ ps yc h ol o gical) s y m pt o ms?  
5.  W hat has y o ur e x perie nce bee n w hile bei n g h o me?  
 
 
Cl osi n g ( 5 mi n utes)  
Is t here a n yt hi n g else we ha ve n ot yet disc ussed t hat y o u w o ul d li ke t o me nti o n relate d t o w hat 
we’ ve bee n tal ki n g a b o ut?  
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
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U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 4 
1 3. 1. 2 F or c are gi ver (c o ntr ol gr o u p) 
Greeti n g  
T ha n k y o u f or bei n g here t o da y. We reall y a p precia te y o u ta ki n g t he ti me t o partici pate i n t his 
disc ussi o n. M y na me is  
 a n d w ill lea d t he disc ussi o n t o da y. 
 
R ole 
M y r ole t o da y will be t o as k s o me s pecific q ue sti o ns a n d t o kee p t he c o n versati o n g oi n g.  We 
ha ve a l ot t o c o ver, s o I ma y nee d t o c ha n ge t he s u bject or m o ve a hea d wit h t he disc ussi o n.  
H o we ver, please st o p me if y o u wa nt  t o a d d a n yt hi n g or if y o u have a n y q uesti o ns. T he i nter vie w 
t o da y will last a b o ut 2 0- 3 0 mi n utes. 
 
P ur p ose 
T he mai n t hi n g we are i ntereste d i n t o da y is heari n g  fr o m y o u, t he e x perts. We wa nt t o hear y o ur 
e x perie nces a b o ut n otici n g [ patie nt’s na me] c o g niti ve c ha n ges afte r bei n g dia g n ose d wit h ac ute 
le u ke mia a n d recei vi n g c he m ot hera p y. T hese c ha n ges ma y i ncl u de diffic ulties t hi n ki n g a n d 
pr ocessi n g, c o nce ntrati n g, me m o rizi n g or a n y c ha n ges y o u n otice ma y be relate d. Y o ur 
e x perie nces will hel p us gai n val ua ble i nsi g ht o n c halle n ges t hat patie nts wit h A L a n d care gi vers 
face d uri n g c he m ot hera p y. T his i nf or mati o n will g uide us t o ha ve a n i n- de pt h u n dersta n di n g of 
c o g niti ve i m pair me nt a n d t o f urt her de vel o p i nte r ve nti o n t o ma na ge t hese c halle n ges i n ac ute 
le u ke mia p o p ulati o n a n d care gi vers. 
 
I w o ul d li ke t o state t hat o ur c o n versati o n is bei n g a u di ota pe d t o hel p us re me m ber w hat is sai d. 
Y o u ma y as k me t o t ur n off t he rec or der at a n y ti me or si m pl y sa y y o u d o n ot wa nt t o a ns wer a 
q uesti o n.  E ver yt hi n g sai d here t o da y will be c o nfi de ntial. N ot hi n g y o u sa y will be c o n necte d 
wit h y o ur na me.  
 
A n y q uesti o ns bef ore we be gi n? 
 
T his secti o n will be c o n d ucte d at disc h ar ge assess me nt of cycle 1 a n d cycle 2.  
 
1.  
W hat w o ul d y o u ha ve wis he d y o u ha d k n o w n a b o ut [ patie nt’s na me] ac ute le u ke mia? 
2.  
W hat else mi g ht we ha ve d o ne t o be hel p f ul t o y o u d uri n g t he [h os pitalizati o n/cli nic 
visit]? 
 
Cl osi n g ( 5 mi n utes)  
Is t here a n yt hi n g else we ha ve n ot yet disc usse d t hat y o u w o ul d li ke t o me nti o n relate d t o 
w hat we’ ve bee n tal ki n g a b o ut?  
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 5 
1 3. 1. 3 F or p atie nt (I nter ve nti o n gr o u p) 
Greeti n g  
T ha n k y o u f or bei n g here t o da y. We reall y a p precia te y o u ta ki n g t he ti me t o partici pate i n t his 
disc ussi o n. M y na me is _ _ _ _ _ _ _ a n d w ill lea d t he disc ussi o n t o da y. 
 
R ole 
M y r ole t o da y will be t o as k s o me s pecific q ue sti o ns a n d t o kee p t he c o n versati o n g oi n g.  We 
ha ve a l ot t o c o ver, s o I ma y nee d t o c ha n ge t he s u bject or m o ve a hea d wit h t he disc ussi o n.  
H o we ver, please st o p me if y o u wa nt  t o a d d a n yt hi n g or if y o u have a n y q uesti o ns. T he i nter vie w 
t o da y will last a b o ut 2 0- 3 0 mi n utes. 
 
P ur p ose 
T he mai n t hi n g we are i ntereste d i n t o da y is heari n g  fr o m y o u, t he e x perts. We wa nt t o hear y o ur 
e x perie nces a b o ut n otici n g [ patie nt’s na me] c o g niti ve c ha n ges afte r bei n g dia g n ose d wit h Ac ute 
Le u ke mia a n d recei vi n g c he m ot hera p y. T hese c ha n ges ma y i ncl u de diffic ulties t hi n ki n g a n d 
pr ocessi n g, c o nce ntrati n g, me m o rizi n g or a n y c ha n ges y o u n otice ma y be relate d. Y o ur 
e x perie nces will hel p us gai n val ua ble i nsi g ht o n c halle n ges t hat patie nts wit h ac ute le u ke mia 
a n d care gi vers face d uri n g c he m ot hera p y. T his i nf o r mati o n will g ui de us t o ha ve a n i n- de pt h 
u n dersta n di n g of c o g niti ve i m pair me nt a n d t o f u rt her de vel o p i nter ve nti o ns t o ma na ge t hese 
c halle n ges i n t he ac ute le u ke mia p o p ul ati o n a n d wit h t heir care gi vers. 
. 
I w o ul d li ke t o state t hat o ur c o n versati o n is bei n g a u di ota pe d t o hel p us re me m ber w hat is sai d. 
Y o u ma y as k me t o t ur n off t he rec or der at a n y ti me or si m pl y sa y y o u d o n ot wa nt t o a ns wer a 
q uesti o n.  E ver yt hi n g sai d here t o da y will be c o nfi de ntial. N ot hi n g y o u sa y will be c o n necte d 
wit h y o ur na me.  
 
A n y q uesti o ns bef ore we be gi n? 
 
I nter ve nti o n Fee d b ac k ( 1 5- 2 0 mi n utes) 
T his secti o n will be c o n d ucte d d uri n g cycles 1 a n d 2 ( d ays 6 or 7). We will ask q uesti o ns wit hi n 
3 0 d ays of cycle 3.  
 
 
1.  H o w w o ul d y o u descri be y o ur m o bilit y bef ore y o ur dia g n osis a n d n o w? 
2.  W hat was it li ke f or y o u t o ha ve y o ur R N tal k wit h y o u dail y a b o ut y o ur s y m pt o ms? 
3.  W hat was it li ke f or y o u t o ha ve y o ur O T a n d P T visit wit h y o u d uri n g y o ur h os pital sta y? 
4.  Descri be y o ur e x perie nce i n t he j oi nt m eeti n gs t o hel p y o u de vel o p y o ur S M A R T g oals. 
5.  W hat d o y o u t hi n k will hel p y o u c o nti n ue t o sta y acti ve? 
6.  W hat di d y o u fi n d t he m ost be neficial a b o ut w or ki n g wit h y o ur st u d y tea m d uri n g y o ur 
h os pital sta y? 
7.  D o y o u ha ve ge neral s u g gesti o ns f or i m pr o ve me nt of t he i nter ve nti o n? 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 6 
 
1 3. 1. 4 F or c are gi ver (I nter ve nti o n gr o u p) 
Greeti n g  
T ha n k y o u f or bei n g here t o da y. We reall y a p precia te y o u ta ki n g t he ti me t o partici pate i n t his 
disc ussi o n. M y na me is Ya- Ni n g C ha n. I a m a 3 r d year P h D st u de nt i n n ursi n g a n d als o t he 
researc h assista nt of t he st u d y. 
 
R ole 
M y r ole t o da y will be t o as k s o me s pecific q ue sti o ns a n d t o kee p t he c o n versati o n g oi n g.  We 
ha ve a l ot t o c o ver, s o I ma y nee d t o c ha n ge t he s u bject or m o ve a hea d wit h t he disc ussi o n.  
H o we ver, please st o p me if y o u wa nt  t o a d d a n yt hi n g or if y o u have a n y q uesti o ns. T he i nter vie w 
t o da y will last a b o ut 3 0- 4 5 mi n utes. 
 
P ur p ose 
T he mai n t hi n g we are i ntereste d i n t o da y is heari n g  fr o m y o u, t he e x perts. We wa nt t o hear y o ur 
fee d bac k a b o ut t he i nter ve nti o n a n d e x perie nces a b o ut n otici n g [ patie nt’s na me’s] c o g niti ve 
c ha n ges after bei n g dia g n ose d wit h A M L a n d r ecei vi n g c he m ot hera p y. Y o ur  fee d bac ks will hel p 
us gai n val ua ble i nsi g ht o n c halle n ges t hat pa tie nts wit h A M L face d uri n g c he m ot hera p y. T his 
i nf or mati o n will g ui de o ur f urt her i nter ve ntio n de vel o p me nt t o ma na ge s y m pt o ms i n A M L 
p o p ulati o n. 
 
I w o ul d li ke t o state t hat o ur c o n versati o n is bei n g a u di ota pe d t o hel p us re me m ber w hat is sai d. 
Y o u ma y as k me t o t ur n off t he rec or der at a n y ti me or si m pl y sa y y o u d o n ot wa nt t o a ns wer a 
q uesti o n.  E ver yt hi n g sai d here t o da y will be c o nfi de ntial. N ot hi n g y o u sa y will be c o n necte d 
wit h y o ur na me.  
 
A n y q uesti o ns bef ore we be gi n? 
 
I nter ve nti o n Fee d b ac k ( 3 0 mi n utes) 
T his secti o n will be c o n d ucte d d uri n g cycles 1 a n d 2 ( d ays 6 or 7). We will ask q uesti o ns wit hi n 
3 0 d ays of cycle 3.  
 
1.  
W hat w o ul d y o u ha ve wis he d y o u ha d k n o w n a b o ut [ patie nt’s na me] ac ute le u ke mia? 
2.  
W hat di d y o u fi n d m ost hel p f ul a b o ut t he i nter ve nti o n? 
3.  
W hat di d y o u fi n d least hel p f ul a b o ut t he i nter ve nti o n? 
4.  
W hat else mi g ht we ha ve d o ne t o be hel pf ul t o y o u d uri n g t he h os pitalizati o n? 
5.  
D o y o u ha ve ge neral s u g gesti o ns f o r i m pr o ve me nt of t he i nter ve nti o n? 
 
Cl osi n g ( 5 mi n utes)  
Is t here a n yt hi n g else we ha ve n ot yet disc usse d t hat y o u w o ul d li ke t o me nti o n relate d t o 
w hat we’ ve bee n tal ki n g a b o ut? 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 7 
1 3. 2  Me as ures  
 
1 3. 2. 1  E O R T C  Q L Q- C 3 0  
1 3. 2. 2  P R O- C T C A E  
1 3. 2. 3  Acti vit y Meas ure f or P ost- Ac ute  Care ( A M- P A C) “ 6 clic ks” 
1 3. 2. 4   Patie nt a n d cli nicia n re p orte d  Kar n ofs k y Perf or ma nce Scale ( K P S) 
1 3. 2. 5   P ossi bilities f or Acti vit y Scale ( P A C T S) 
1 3. 2. 6   Ti me d U p a n d G o  
1 3. 2. 7   P A S S- Perf or ma nce Assess me nt of Self- Care S kills ( P A S S) 
1 3. 2. 8   B E R G Bala nce Scale 
1 3. 2. 9   M uscle Stre n gt h  
1 3. 2. 1 0 M o difie d Ca na dia n Occ u pati o nal Perf or ma nce M eas ure ( C O P M) 
1 3. 2. 1 1 Baseli ne assess me nt of de m o gra p hic a n d cli nical c haracteristic 
1 3. 2. 1 2 C o m or bi dit y Assess me nt 
1 3. 2. 1 3 Cl oc k Dra wi n g 
1 3. 2. 1 4 Care Tra nsiti o ns Meas ure 
1 3. 2. 1 5 Patie nt Acti vati o n Meas ure 
1 3. 2. 1 6 Pre pare d ness f or Care gi vi n g Scale 
1 3. 2. 1 7 Fall a n d Healt h Care utilizati o n 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 8 
1 3. 2. 1  E O R T C  Q L Q- C 3 0  
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
3 9 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 0 
1 3. 2. 2  P R O- C T C A E  
 
T he f oll o wi n g 1 9 s y m pt o ms will be assesse d dail y b y b ot h t he c o ntr ol a n d i nter ve nti o n patie nts:  
 
diarr hea, c hills, heart b ur n, na us ea, a p petite, m o ut h s ores, v o miti n g, c o nsti pati o n, c o u g h, ras h, 
s h ort ness of breat h, fati g ue, a n xiet y, sa d ness, n ot hi n g will c heer me u p, pai n, i ns o m nia, 
c o nce ntrati o n, a n d me m or y  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 1 
1 3. 2. 3 Acti vit y Me as ure f or P ost Ac ute C are ( A M- P A C) “ 6 clic ks ” 
 
 
 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 2 
1 3. 2. 4 P atie nt a n d cli nici a n re p orte d K ar n ofs k y Perf or m a nce Sc ale ( K P S) 
 
 
 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 3 
1 3. 2. 5. P ossi bilities f or Acti vit y Sc ale ( P A C T S) 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 4 
1 3. 2. 6  Ti me d U p a n d G o 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 5 
1 3. 2. 7  P A S S- Perf or m a nce Assess me nt of  Self- C are S kills ( P A S S)  
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 6 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 7 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
4 9 
 
Ber g B al a nce Sc ale 
 
 
Na me: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
L ocati o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  Rater: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
I T E M
 
D E S C RI P TI O N
 
 
 
 
 
 S C O R E
 
( 0- 4)
 
 
1.  Sitti n g
 
t o
 
sta n di n g
 
 
 
 
 
 _ _ _ _ _ _ _ _
 
2.  Sta n di n g
 
u ns u p p orte d
  
 
 
 
 _ _ _ _ _ _ _ _
 
3.  Sitti n g
 
u ns u p p orte d
 
 
 
 
 
 _ _ _ _ _ _ _ _
 
4.  Sta n di n g
 
t o
 
sitti n g
 
 
 
 
 
 _ _ _ _ _ _ _ _
 
5.  Tra nsfers
 
 
 
 
 
 
 _ _ _ _ _ _ _ _
 
6.  Sta n di n g
 
wit h
 
e yes
 
cl ose d
 
 
 
 
 _ _ _ _ _ _ _ _
 
7.  Sta n di n g
 
wit h
 
feet
 
t o get her
 
 
 
 
 _ _ _ _ _ _ _ _
 
8.  Reac hi n g f or war d wit h o utstretc he d ar m  
  
  
_ _ _ _ _ _ _ _ 
9.  Retrie vi n g
 
o bject
 
fr o m
 
fl o or
  
 
 
 _ _ _ _ _ _ _ _
 
1 0.  T ur ni n g
 
t o
 
l o o k
 
be hi n d
 
 
 
 
 _ _ _ _ _ _ _ _
 
1 1.  T ur ni n g
 
3 6 0
 
de grees
  
 
 
 
 _ _ _ _ _ _ _ _
 
1 2.  Placi n g
 
alter nate
 
f o ot
 
o n
 
st o ol
 
 
 
 _ _ _ _ _ _ _ _
 
1 3.  Sta n di n g wit h o ne f o ot i n fr o nt  
  
  
  
_ _ _ _ _ _ _ _ 
1 4.  Sta n di n g
 
o n
 
o ne
 
f o ot
  
 
 
 
 _ _ _ _ _ _ _ _
 
 
T otal    
_ _ _ _ _ _ _ _  
 
 
G E N E R A L I N S T R U C TI O N S 
Please d oc u me nt eac h tas k a n d/ or gi ve i nst r ucti o ns as writte n. W he n sc ori n g, please 
rec or d t he l o west res p o nse categ or y t hat a p plies f or eac h ite m. 
 
I n m ost ite ms, t he s u bject is as ke d t o mai ntai n a gi ve n p ositi o n f or a s pecific ti me. 
Pr o gressi vel y m ore p oi nts are de d ucte d if: 
 t he ti me or dista nce re q uire me nts are n ot met 
 t he s u bject’s perf or ma nce warra nts s u per visi o n 
 t he s u bject t o uc hes a n e xter nal s u p p ort or recei ves assista nce fr o m t he e xa mi ner  
S u bject s h o ul d u n dersta n d t hat t he y m ust ma i ntai n t heir bala nce w hile atte m pti n g t he 
tas ks. T he c h oices of w hic h leg t o sta n d o n or h o w far t o r eac h are left t o t he s u bject. 
P o or j u d g me nt will a d versel y i nfl ue nce t he perf or ma nc e a n d t he sc ori n g. 
 
E q ui p me nt re q uire d f or testi n g is a st o p watc h or watc h wit h a sec o n d ha n d, a n d a r uler or 
ot her i n dicat or of 2, 5, a n d 1 0 i nc hes. C hairs use d d uri n g testi n g s h o ul d be a reas o na ble 
hei g ht. Eit her a ste p or a st o ol of a vera ge ste p hei g ht ma y be use d f or ite m # 1 2. 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 0 
Ber g B al a nce Sc ale 
 
1. SI T TI N G T O S T A N DI N G 
I N S T R U C TI O N S: Please sta n d u p. Tr y n ot t o use y o ur ha n d f or s u p p ort. 
(    ) 4  
a ble t o sta n d wit h o ut usi n g ha n ds a n d sta bilize i n de pe n de ntl y 
(    ) 3  
a ble t o sta n d i n de pe n de ntl y usi n g ha n ds 
(    ) 2  
a ble t o sta n d usi n g ha n ds after se veral tries 
(    ) 1  
nee ds mi ni mal ai d t o sta n d or sta bilize 
(    ) 0  
nee ds m o derate or ma xi mal assist t o sta n d 
 
2.  S T A N DI N G U N S U P P O R T E D 
I N S T R U C TI O N S: Please sta n d f or t w o mi n utes wit h o ut h ol di n g o n. 
(    ) 4  
a ble t o sta n d safel y f or 2 mi n utes 
(    ) 3  
a ble t o sta n d 2 mi n utes wit h s u per visi o n 
(    ) 2  
a ble t o sta n d 3 0 sec o n ds u ns u p p orte d 
(    ) 1  
nee ds se veral tries t o sta n d 3 0 sec o n ds u ns u p p orte d 
(    ) 0  
u na ble t o sta n d 3 0 sec o n ds u ns u p p orte d 
 
If a s u bject is a ble t o sta n d 2 mi n utes u ns u p p orte d, sc ore f ull p oi nts f or sitti n g u ns up p orte d. Pr ocee d t o ite m # 4. 
 
3.  SI T TI N G WI T H B A C K U N S U P P O R T E D B U T F E E T S U P P O R T E D O N F L O O R O R O N A S T O O L 
I N S T R U C TI O N S: Please sit wit h ar ms f ol de d f or 2 mi n utes. 
(    ) 4  
a ble t o sit safel y a n d sec urel y f or 2 mi n utes 
(    ) 3  
a ble t o sit 2 mi n utes u n der s u per visi o n 
(    ) 2  
a ble t o a ble t o sit 3 0 sec o n ds 
(    ) 1  
a ble t o sit 1 0 sec o n ds 
(    ) 0  
u na ble t o sit  wit h o ut s u p p ort 1 0 sec o n ds 
 
4.  S T A N DI N G T O SI T TI N G 
I N S T R U C TI O N S: Please sit d o w n. 
(    ) 4  
sits safel y wit h mi ni mal use of ha n ds 
(    ) 3  
c o ntr ols desce nt b y usi n g ha n ds 
(    ) 2  
uses bac k of le gs a gai nst c hair t o c o ntr ol desce nt 
(    ) 1  
sits i n de pe n de ntl y b ut has u nc o ntr olle d desce nt 
(    ) 0  
nee ds assist t o sit 
 
5.  T R A N S F E R S 
I N S T R U C TI O N S: Arra n ge c hair(s) f or pi v ot tra nsfer. As k s u bject t o tra nsfer o ne wa y t o war d a seat wit h ar mrests a n d o ne wa y 
t o war d a seat wit h o ut ar mrests. Y o u ma y use t w o c hairs (o ne wit h a n d o ne wit h o ut ar mrests) or a be d a n d a c h air. 
(    ) 4  
a ble t o tra nsfer safel y wit h mi n or use of ha n ds 
(    ) 3  
a ble t o tra nsfer safel y defi nite nee d of ha n ds 
(    ) 2  
a ble t o tra nsfer wit h ver bal c ui n g a n d/ or s u per visi o n 
(    ) 1  
nee ds o ne pers o n t o assist 
(    ) 0  
nee ds t w o pe o ple t o assist or s u per vise t o be safe 
 
6.  S T A N DI N G U N S U P P O R T E D WI T H E Y E S C L O S E D 
I N S T R U C TI O N S: Please cl ose y o ur e yes a n d sta n d still f or 1 0 sec o n ds. 
(    ) 4  
a ble t o sta n d 1 0 sec o n ds safel y 
(    ) 3  
a ble t o sta n d 1 0 sec o n ds wit h s u per visi o n  
(    ) 2  
a ble t o sta n d 3 sec o n ds 
(    ) 1  
u na ble t o kee p e yes cl ose d 3 sec o n ds b ut sta ys safel y 
(    ) 0  
nee ds hel p t o kee p fr o m falli n g 
 
7.  S T A N DI N G U N S U P P O R T E D WI T H F E E T T O G E T H E R 
I N S T R U C TI O N S: Place y o ur feet t o get her a n d sta n d wit h o ut h ol di n g o n. 
(    ) 4  
a ble t o place feet t o get her i n de pe n de ntl y a n d sta n d 1 mi n ute safel y 
(    ) 3  
a ble t o place feet t o get her i n depe n de ntl y a n d sta n d 1 mi n ute wit h s u per visi o n 
(    ) 2  
a ble t o place feet t o get her in de pe n de ntl y b ut u na ble t o h ol d f or 3 0 sec o n ds 
(    ) 1  
nee ds hel p t o attai n p ositi o n b ut a ble t o sta n d 1 5 sec o n ds feet t o get her 
(    ) 0  
nee ds hel p t o attai n p ositi o n a n d u na ble t o h ol d f or 1 5 sec o n ds 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 1 
Ber g B al a nce Sc ale  c o nti n ue d ….. 
 
8.  R E A C HI N G F O R W A R D WI T H O U T S T R E T C H E D A R M W HI L E S T A N DI N G 
I N S T R U C TI O N S: Lift ar m t o 9 0 de grees. Stretc h o ut y o ur fi n gers a n d reac h f or war d as far as y o u ca n. ( E xa mi ner places a r uler at  t he 
e n d of fi n gerti ps w he n ar m is at 9 0 de grees . Fi n gers s h o ul d n ot t o uc h t he r uler w hile reac hi n g f or war d. T he rec or de d meas ure is t he 
dista nce f or war d t hat t he fi n gers reac h w hile  t he s u bject is i n t he m ost f or war d lea n p ositi o n. W he n p ossi ble, as k s u bject t o use b ot h 
ar ms w he n reac hi n g t o a v oi d r otati o n of t he tr u n k.) 
(    ) 4  
ca n reac h f or war d c o nfi de ntl y 2 5 c m ( 1 0 i nc hes) 
(    ) 3  
ca n reac h f or war d  1 2 c m ( 5 i nc hes) 
(    ) 2  
ca n reac h f or war d 5 c m ( 2 i nc hes) 
(    ) 1  
reac hes f or ward b ut nee ds s u per visi o n 
(    ) 0  
l oses bala nce w hile tr yi n g/re q uires e xter nal s u p p ort 
 
9.  PI C K U P O BJ E C T F R O M T H E F L O O R F R O M A S T A N DI N G P O SI TI O N 
I N S T R U C TI O N S: Pic k u p t he s h oe/sli p per, w hic h is place i n fr o nt of y o ur feet. 
(    ) 4  
a ble t o pic k u p sli p per safel y a n d easil y 
(    ) 3  
a ble t o pic k u p sli p per b ut nee ds s u per visi o n  
(    ) 2  
u na ble t o pic k u p b ut reac hes 2- 5 c m( 1- 2 i nc hes) fr o m sli p per a n d kee ps bala nce i n de pe n de ntl y 
(    ) 1  
u na ble t o pic k u p a n d nee ds s u per visi o n w hile tr yi n g 
(    ) 0  
u na ble t o tr y/ nee ds assist t o kee p fr o m l osi n g bala nce or falli n g 
 
1 0.  T U R NI N G T O L O O K B E HI N D O V E R L E F T A N D RI G H T S H O U L D E R S W HI L E S T A N DI N G 
I N S T R U C TI O N S: T ur n t o l o o k directl y be hi n d y o u o ver t o war d t he left s h o ul der. Re peat t o t he ri g ht. E xa mi ner ma y pic k a n o bject t o 
l o o k at directl y be hi n d t he s u bject t o e nc o ura ge a better t wist t ur n. 
(    ) 4  
l o o ks be hi n d fr o m b ot h si des a n d wei g ht s hifts well 
(    ) 3  
l o o ks be hi n d o ne si de o nl y ot her si de s h o ws less wei g ht s hift 
(    ) 2  
t ur ns si de wa ys o nl y b ut mai ntai ns bala nce 
(    ) 1  
nee ds s u per visi o n w he n t ur ni n g 
(    ) 0  
nee ds assist t o kee p fr o m l osi n g bala nce or falli n g 
 
1 1.  T U R N 3 6 0 D E G R E E S 
I N S T R U C TI O N S: T ur n c o m pletel y ar o u n d i n a f ull circle. Pa use. T he n t ur n a f ull circle  i n t h e ot her directi o n. 
(    ) 4  
a ble t o t ur n 3 6 0 de grees safel y i n 4 sec o n ds or less 
(    ) 3  
a ble t o t ur n 3 6 0 de grees safel y o ne si de o nl y 4 sec o n ds or less 
(    ) 2  
a ble t o t ur n 3 6 0 de grees safel y b ut sl o wl y 
(    ) 1  
nee ds cl ose s u per visi o n or ver bal c ui n g 
(    ) 0  
nee ds assista nce w hile t ur ni n g 
 
1 2.  P L A C E A L T E R N A T E F O O T O N S T E P O R S T O O L W HI L E S T A N DI N G U N S U P P O R T E D 
I N S T R U C TI O N S: Place eac h f o ot alt er natel y o n t he ste p/st o ol. C o nti n ue u ntil eac h f o ot has t o uc h t he ste p/st o ol f o ur ti mes. 
(    ) 4  
a ble t o sta n d i n de pe n de ntl y a n d safel y a n d c o m plete 8 ste ps i n 2 0 sec o n ds 
(    ) 3  
a ble t o sta n d i n de pe n de ntl y a n d c o m plete 8 ste ps i n > 2 0 sec o n ds 
(    ) 2  
a ble t o c o m plete 4 ste ps wit h o ut ai d wit h s u per visi o n 
(    ) 1  
a ble t o c o m plete > 2 ste ps nee ds mi ni mal assist 
(    ) 0  
nee ds assista nce t o kee p fr o m falli n g/ u na ble t o tr y 
 
1 3.  S T A N DI N G U N S U P P O R T E D O N E F O O T I N F R O N T 
I N S T R U C TI O N S: ( D E M O N S T R A T E T O S U BJ E C T) Place o ne f o ot directl y i n fr o nt of t he ot her. If y o u feel t hat y o u ca n n ot place 
y o ur f o ot directl y i n fr o nt, tr y t o ste p far e n o u g h a hea d t hat t he heel of y o ur f or war d f o ot is a hea d of t he t oes of t he ot her f o ot. ( T o 
sc ore 3 p oi nts, t he le n gt h of t he ste p sh o ul d e xcee d t he le n gt h of t he ot her f o ot a n d t he wi dt h of t he sta nce s h o ul d a p pr o xi mat e t he 
s u bject’s n or mal stri de wi dt h.)  
(    ) 4  
a ble t o place f o ot t a n de m i n de pe n de ntl y a n d h ol d 3 0 sec o n ds 
(    ) 3  
a ble t o place f o ot a hea d i n de pe n de ntl y a n d h ol d 3 0 sec o n ds 
(    ) 2  
a ble t o ta ke s mall ste p i n de pe n de ntl y a n d h ol d 3 0 sec o n ds 
(    ) 1  
nee ds hel p t o ste p b ut ca n h ol d 1 5 sec o n ds 
(    ) 0  
l oses bala nce w hile ste p pi n g or sta n di n g 
 
1 4.  S T A N DI N G O N O N E L E G 
I N S T R U C TI O N S: Sta n d o n o ne le g as l o n g as y o u ca n wit h o ut h ol di n g o n. 
(    ) 4  
a ble t o lift le g i n de pe n de ntl y a n d h ol d > 1 0 sec o n ds 
(    ) 3  
a ble t o lift le g i n de pe n de ntl y a n d h ol d  5- 1 0 sec o n ds 
(    ) 2  
a ble t o lift l e g i n de pe n de ntl y a n d h ol d ≥ 3 sec o n ds 
(    ) 1  
tries t o lift le g u na ble t o h ol d 3 sec o n ds b ut re mai ns sta n di n g i n de pe n de ntl y. 
(    ) 0  
u na ble t o tr y of nee ds assist t o pre ve nt fall 
 
 
(    )   T O T A L S C O R E ( Ma xi m u m = 5 6) 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 2 
1 3. 2. 9 M uscle Stre n gt h  
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 3 
1 3. 2. 1 0 M o difie d Ca na dia n Occ u pati o na l Perf or ma nce Meas ure ( C O P M) 
 
 
 
 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 4 
1 3. 2. 1 1 Baseli ne assess me nt of de m o gra p hic a n d cli nical c haracteristic   
 
 
L C C C 1 8 4 8  –  PI:  Dr.  As hl e y  L e a k Bry a nt   
 
  V ersi o n  –  0 1. 2 8. 2 0 2 0  
S u bj ect I D: _ _ _ _ _ _ _ _ D at e: __ __ _ _ _ _  
 
 
T h e f oll o wi n g qu esti o ns ai m t o b ett er u n d erst a n d y o ur b ack gr o u n d, q u ality of lif e a n d sy m pt o m 
b ur de n. Y o ur a ns w ers t o all f oll o wi n g q u esti o ns ar e i m p ort ant a n d m ay h av e a f ut ur e i m p act o n t he 
c ar e of p ati e nts i n t his p o p ul ati on. 
 
1.  H o w ol d ar e y o u ?  - _ _ _ _ _ _ 
 
2.  W h at i s y o ur g e n d er ? 
 Male      F e m al e        Pr ef er n ot t o a ns w er     I i d e ntify i n a n oth er w ay 
 
3.  W h ic h c at e g or y b e st d e s cri b e s y o ur r a c e ( s el e ct all t h at a p pl y) 
 W hit e    Bl ack or Afric a n A m eric a n    Asi a n    N ativ e H a waii a n or oth er Pacific Isl a n d er 
 N ativ e I n di a n or Al ask a n N ativ e           Oth er: _ _ _ _ _ _ _ _ _ _ _ __ _ _ _     Pr ef er n ot t o a ns w er 
 
4.  W it h w hi c h et h nicit y d o y o u i d e ntif y ?  -   His p a nic or L ati n o      N o n- His p a nic  Pr ef er n ot to a ns w er 
 
5.  W h at i s t h e hi g h e st l e v el of s c h o ol c o m pl et e d or t h e hi g he st de gr e e y o u h a v e r e c ei v e d ? 
 1st- 8t h gr a d es    
 9t h- 1 1t h gr ad es 
 Hi g h sc h ool gr a d u at e/ G E D 
 C oll e g e D e gre e ( Associ at es; B. A./ B. S.) 
 Adv a nc e d D egr e e ( M A, Ph D, etc.) 
 Pr ef er n ot t o a ns w er
  
6.  W h ic h of t h e f oll o wi n g c at e g ori e s b e st d e s cri b e s y o ur t ot al h o u s e h ol d i n c o me, b ef or e t a x e s, i n t h e 
y e ar pri or t o y o ur c urr e nt h o s pit al a d mis si o n? 
 < $ 2 0, 0 0 0 a n n u ally    
 $ 2 0, 0 0 1 – 4 0, 0 0 0 
 $ 4 0, 0 0 1 – 6 0, 0 0 0 
 $ 6 0, 0 0 1 – 8 0, 0 0 0 
 $ 80, 0 0 1 – 1 00, 0 0 0      
 > $ 1 00, 0 0 1    
Pr ef er n ot t o a ns w er 
7.  W hic h of t h e f oll o w b e st d e s cri b e s y o ur c urr e nt marit al st at u s ? 
 Si n gle, n ev er m arri e d    
 Marri e d/p art n ere d 
 Se p ar at e d 
 Div orce d 
 Wi d o w e d 
 Pr ef er n ot t o a ns w er
8.  W e re y o u li vi n g wit h a n ot h er p er s o n pri or t o y o ur c urr e nt h o s pit al a d mis si o n ?  
 Yes    N o    Pr efer n ot t o s ay 
 
9.  W h at i s y o ur zi p c o d e of r e si d e n c e ?  - _ _ _ _ _ _ 
 
1 0.  W er e y o u e m pl o y e d pri or t o y o ur c urr e nt h o s pit al a d mi s si o n ?
 Yes    N o    Pr efer n ot t o s ay 
 
1 1.  D o  y o u C U R R E N T L Y ha v e i ns ur a n c e c o v er a ge, s u c h a s Me dic ai d, M e dic ar e, or priv at e i n s ur a n c e ?
 Yes    N o    Pr efer n ot t o s ay 
 
1 2.  H o w m a n y f all s a p pr o xi m at el y ha v e y o u ha d i n t he l a st 6 m o nt hs ?  - _ _ _ _ _ _  
B a s eli n e P ati e nt A s s e s s m e nt  
L C C C 1 8 4 8  –  PI:  Dr.  As hl e y  L e a k Bry a nt   
 
  V ersi o n  –  0 1. 2 8. 2 0 2 0  
If y o u h av e fall e n, ple as e d escri be e ac h fall b el o w (i.e., w h e n, w h ere, w hy, a n d if it le d to a ny di ag n os es) 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 5 
 
 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 6 
 
 
 
L C C C 1 8 4 8  –  PI:  Dr.  As hl e y  L e a k Bry a nt   
 
  V ersi o n  –  0 1. 2 8. 2 0 2 0  
S u bj ect I D: _ _ _ _ _ _ _ _ D ate: __ __ _ _ _ _  
 
 
T h e f oll o wi n g qu esti o ns ai m t o b etter u n d erst a n d y o ur b ack gr o u n d a nd c ar e of y o ur l ov e d on e wit h 
c a nc er. Y o ur a ns w ers t o all f oll o wi ng q u esti o ns ar e i m p ort a nt an d m ay h av e a f ut ur e i m p act o n t h e 
c ar e of p ati e nts i n t his p o p ul ati on. 
 
1.  H o w ol d ar e y o u ?  - _ _ _ __ _ 
 
2.  W h at i s y o ur g e n d er ? 
 Male      F e m al e       Pr efer n ot to a ns w er     I i d e ntify in a n oth er w ay 
 
3.  W h ic h c at e g or y b e st d e s cri b e s y o ur r a c e ( sele ct all t h at a p ply) 
 W hit e    Bl ack or Afric a n A m eric a n    Asi a n    N ativ e H a waiia n or oth er Pacific Isl a n d er 
 N ativ e In dia n or Al ask a n N ative           Oth er: _ _ _ _ _ _ _ _ _ _ _ __ _ _ _     Pr efer n ot to a ns w er 
 
4.  W it h w hi c h et h nicit y d o y o u i d e ntif y ?  -   His p a nic or L atin o      N o n- His p anic  Pr efer n ot to a ns w er 
 
5.  W h at i s t h e hi g h e st le v el of s c h o ol c o m pl et e d or t h e hi g he st de gr e e y o u h a v e r e c eiv e d ? 
 1st- 8t h gr a d es    
 9t h- 1 1t h gr ad es 
 Hi g h sc h ool gr a d u ate/ G E D 
 C olle g e D e gre e ( Associ ates; B. A./ B. S.) 
 Adv a nc e d D egr e e ( M A, Ph D, etc.) 
 Pr efer n ot to a ns w er
  
6.  W h ic h of t h e f oll o wi n g c at e g orie s b e st d e s cri b e s y o ur t ot al h o u s e h ol d i n c o me, b ef or e t a x e s, i n t h e 
ye ar pri or t o y o ur c urr e nt h o s pit al a d mis si o n? 
 < $ 20, 0 00 a n nu ally    
 $ 2 0, 0 0 1 – 4 0, 00 0 
 $ 40, 0 01 – 6 0,0 0 0 
 $ 60, 0 01 – 8 0,0 0 0 
 $ 80, 0 0 1 – 1 00,0 0 0      
 > $ 1 00, 0 0 1                
Pr ef er n ot t o a ns w er  
7.  W hic h of t h e f oll o w b e st d e s cri b es y o ur c urr e nt marit al st at u s ? 
 Si n gle, n ev er m arri e d    
 Marri e d/p artn ere d 
 Se p ar ate d 
 Div orce d 
 Wi d o w e d 
 Pr efer n ot to a ns w er 
 
8.  W h at i s y o ur zi p c o d e of r e si d e n ce ?  - _ _ __ _ _ 
 
 
C are giv er As ses s m e nt  

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 7 
1 3. 2. 1 2  C o m or bi dit y Assess me nt  
 
 
 
 
 
 
 I D _ _ _ _ _ _ _ _ _ _ _ _
 
C hr o ni c Ill n e s s A s s e s s m e nt 
1.  H a s p ati e nt h a d a hi st or y of art hriti s or c o n n e cti v e ti s s u e di s e a s e 
(r h e u m at oi d art hriti s, s e v er e o st e o art hriti s, d e g e n er ati v e j oi nt 
di s e a s e) ? 
 N o    Y es    
 
2 .  H a s p ati e nt h a d a hi st or y of l u n g di s e a s e ( a st h m a, e m p h y s e m a, 
c hr o ni c br o n c hiti s, or C O P D [ c hr o ni c o b str u cti v e p ul m o n ar y 
di s e a s e]) ? 
 N o    Y es    
 
3 .  H a s p ati e nt h a d a hi st or y of di a b et e s m ellit e s ? 
 N o    Y es    
 
4.  H a s p ati e nt h a d a hi st or y of c ar di o v a s c ul ar di s e a s e (i n cl u di n g 
hi st or y of h y p ert e n si o n, h y p er c h ol e st er ol e mi a/ h y p erli pi d e mi a, 
h e art att a c k, c o n g e sti v e h e art f ail ur e, p eri p h er al v a s c ul ar di s e a s e, 
or str o k e) ? 
 N o    Y es    
 
5 .  H a s p ati e nt h a d a hi st or y of c a n c er ? 
 N o    Y es , Pl e as e s p ecify l oc ati o n a n d y e ar __ __ _ __ __ _ __ _     
 
6 .  H a s p ati e nt h a d a hi st or y of r e n al di s e a s e ( di al y si s, s er u m 
cr e ati ni n e > 3 m g/ dl, r e n al tr a n s pl a nt, ur e mi a) ? 
 N o    Y es    
 
7 .  H a s p ati e nt h a d a hi st or y of m e nt al h e alt h i s s u e ( a n xi et y di s or d er 
or d e pr e s si o n) ? 
 N o    Y es    
 
8 .  H a s p ati e nt h a d a hi st or y of li v er di s e a s e ( h e p atiti s, or cirr h o si s) ? 
 N o    Y es   
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 8 
1 3. 2. 1 3  Cl oc k Dr a wi n g 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
5 9 
1 3. 2. 1 4 Care Tra nsiti o ns Meas ure 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
6 0 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
6 2 
1 3. 2. 1 5 Patie nt Acti vati o n Meas ure 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
6 3 
1 3. 2. 1 6 Pre pare d ness f or Care gi vi n g Scale 
 
 
 
 

L C C C 1 8 4 8 
 
C O N FI D E N TI A L 
PI: As hle y Le a k Br y a nt 
  
U NI V E R SI T Y O F N O R T H C A R O LI N A 
N o ve m ber 2 4, 2 0 2 0 
 
 
6 4 
1 3. 2. 1 7 Fall a n d Healt h Care utilizati o n 
 
 
 
 I D _ _ _ _ _ _ _ _ _ _ _ _
 
 
 
H e alt h c ar e a n d F all F oll o w- u p 
1.  Si n c e l e a vi n g t h e h o s pit al, h a v e y o u u s e d a n y h e alt h c ar e s er vi c e s ?  
 N o  
 Y e s    
 
1 a. I f y e s, pl e a s e s p e cif y w h at s er vi c e s h a v e y o u u s e d ? 
 h o s pit al    
 ur g e nt c ar e 
 e m er g e n c y d e p art m e nt  
 
1 b . Pl e a s e s p e cif y t h e r e a s o n( s) f or t h e s e s er vi c e s ? 
( a s e cti o n f or o p e n- e n d e d a n s w er) 
 
 
2.  H o w m a n y f all s h a v e y o u h a d wit hi n t h e l a st 3 0 d a y s ? 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
2 a. Pl e a s e s p e cif y a n y i nj uri e s a s a r e s ult of t h e f all. 
( a s e cti o n f or o p e n- e n d e d a n s w er)