Geriatric-assessment-guided Interventions to Address Functional Deficits in Older Adults Undergoing Treatment for Multiple Myeloma
Phase: NA
Conditions: Multiple Myeloma, Myeloma, Disability Physical, Disabilities Multiple
Sponsor: UNC Lineberger Comprehensive Cancer Center

LI N E B E R G E R C O M P R E H E N SI V E C A N C E R C E N T E R  
Healt h Ser vices Researc h  
C LI NI C A L O N C O L O G Y R E S E A R C H P R O G R A M  
Ma y 2 5 , 2 0 2 1 
U NI V E R SI T Y O F N O R T H C A R O LI N A A T C H A P E L HI L L  
L C C C 2 1 0 1:  G eri at ric-assess m e nt -g ui de d i nter ve nti o ns t o a d dress f u ncti o n al 
deficits i n ol der a d ults u n der g oi n g tre at me nt f or m ulti ple m yel o m a  
Pri nc i p al I n vesti g at or 
C hrist o p her Je nse n, M D 
1 7 0 Ma n ni n g Dri ve 
H o u pt B uil di n g, 3 r d Fl o or 
C B # 7 3 0 5 
P h o ne: 2 5 2- 9 0 8- 1 7 3 9 
Fa x: 9 1 9- 9 6 6- 6 7 3 5 
E mail:  c hrist o p her.je nse n @ u nc healt h. u nc. e d u  
Pri nci p al C o -I n vesti g at or  
Sasc ha A. T uc h m a n, M D M H S 
C o -I n vesti g at or(s) 
S ha kira Gra nt, M B B S  
H y ma n M uss, M D 
Kirste n N yr o p, P h D 
E be n Lic ht ma n, M D 
Sa m uel R u bi nstei n, M D 
Mart ha ( D ell) Stra y h or n, N P  
Bi ost a tistici a n  
Allis o n Deal, M. S. 
Li ne ber ger C o m pre he nsi ve Ca ncer Ce nter 
St u d y C o or di n at or 
Nic h olas Ma n gieri, M S 
S p o ns or :  L i ne ber ger C o m pre he nsi ve Ca ncer Ce nter 
F u n di n g S o ur ce: C o n q uer Ca ncer F o u n dati o n / A merica n S ociet y of Cli nical O nc ol o g y 
Y o u n g I n vesti gat or A w ar d ( 2 0 2 1 YI A- 7 3 1 6 1 1 8 9 3 3) 
Versi o n  D ate:  
Versi o n 1: 5/ 2 5/ 2 1 

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T A B L E O F C O N T E N T S  
1. 0  
B A C K G R O U N D A N D R A TI O N A L E  .................................................................. 1 
1. 1  
St u d y S y n o psis ...................................................................................................... 1 
1. 2  
Bac k gr o u n d ........................................................................................................... 1 
1. 3  
P ur p ose a n d Rati o nale ........................................................................................... 2 
2. 0  
S T U D Y O B J E C TI V E S A N D E N D P OI N T S  ......................................................... 3 
2. 1  
Pri mar y O bjecti ve  ................................................................................................. 3 
2. 2  
Sec o n dar y O bj ecti ves  ............................................................................................ 3 
3. 0  
P A TI E N T E LI GI BI LI T Y  ...................................................................................... 3 
3. 1  
I n cl usi o n Criteria ................................................................................................... 3 
3. 2  
E xcl usi o n Criteria  .................................................................................................. 4 
4. 0  
S T U D Y P L A N  ......................................................................................................... 4 
4. 1  
Sc he ma  .................................................................................................................. 4 
4. 2  
D urati o n of St u d y .................................................................................................. 4 
4. 3  
St u d y Details  ......................................................................................................... 4 
4. 4  
E x pecte d Ris ks ...................................................................................................... 8 
4. 5  
Re m o val of Patie nts fr o m Pr ot oc ol ....................................................................... 8 
5. 0  
TI M E A N D E V E N T S T A B L E  ............................................................................... 8 
6. 0  
U N A N TI CI P A T E D P R O B L E M S  ......................................................................... 8 
6. 1  
Defi niti o n  .............................................................................................................. 8 
6. 2  
Re p orti n g ............................................................................................................... 9 
7. 0  
S T A TI S TI C A L C O N SI D E R A TI O N S  .................................................................. 9 

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7. 1  
St u d y Desi g n ......................................................................................................... 9 
7. 2  
Sa m ple Size a n d Accr ual ....................................................................................... 9 
7. 3  
Data A nal ysis Pla ns  ............................................................................................... 9 
7. 4  
Data Ma na g e me nt/ A u dit  ..................................................................................... 1 0 
8. 0  
S T U D Y M A N A G E M E N T  .................................................................................... 1 0 
8. 1  
I nstit uti o nal Re vie w B oar d (I R B) A p pr o v al a n d C o nse nt .................................. 1 0 
8. 2  
Re q uire d D oc u me nt ati o n..................................................................................... 1 1  
8. 3  
Re gistrati o n Pr oce d ures....................................................................................... 1 1  
8. 4  
A d here n ce t o t he Pr ot oc ol  ................................................................................... 1 1 
8. 5  
A me n d me nts t o t he Pr ot oc ol ............................................................................... 1 3  
8. 6  
Rec or d Rete nti o n  ................................................................................................. 1 3 
8. 7  
O bli gati o ns of I n v esti gat ors ................................................................................ 1 3  
9. 0  
R E F E R E N C E S  ...................................................................................................... 1 4 
1 0. 0  A P P E N DI C E S  ....................................................................................................... 1 7 

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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  
We pr o p ose t o pil ot test a cli nic - bas e d i nter ve nti o n f or pr o m pt atte nti o n t o 
Geriatric Assess me nt ( G A) -i de ntifie d deficits i n patie nts 60 years or ol d er 
u n der g oi n g treat me nt f or m ulti ple m yel o ma . Vali date d meas ures will be use d t o 
i de ntif y pr o ble matic geri atric s y n dr o mes / i m pair me nts. I m pair m e nts t hat are 
re me dia ble will be mat c h e d wit h e vi de nce - bas e d i nter ve nti o ns, pri maril y referrals 
t o s pecialists. T he St u d y Tea m will ma ke referrals t o s pecialists or ser vices , a n d 
patie nt satisfacti o n wit h t he i nter ve nti o n(s) will be assesse d. O ur h y p ot h esis is 
t hat ti mel y i nter ve nti o ns t hat a d dress deficits el uci date d b y G A ca n be pla n ne d 
d uri n g a cli nic visit, a n d t hat ol der patie nts wit h m ulti ple m yel o ma  will  be 
i ntereste d i n a n d c o m pl y wit h i nter ve nti o n rec o m me n dati o ns. 
1. 2  
B ac k gr o u n d 
M ulti ple m yel o ma ( M M) is a cl o nal plas ma cell mali g na nc y ass oci ate d wit h 
si g nifica nt m or bi dit y a n d m ortalit y. I n t he U nite d States, it is t he sec o n d m ost 
c o m m o n he mat ol o gic mali g na nc y after n o n- H o d g ki n l y m p h o ma, acc o u nti n g f or 
a p pr o xi matel y 1 9 % of n e w dia g n oses a n d 2 1 % of deat hs relat e d t o he mat ol o gic 
mali g na ncies. 1 M M is dis pr o p orti o natel y a diseas e of ol der a d ults, wit h a m e dia n 
a ge at dia g n osis of 6 9 years a n d a p pr o xi matel y 4 0 % of ne w cases d e vel o pi n g i n 
a d ults o ver t he a g e of 7 5 years. 2, 3 C o nse q ue ntl y, t he care of p atie nts wit h M M is 
ofte n c halle n gi n g d ue t o t he hi g her pre vale n ce of v ul nera bilities o bser ve d wit h 
a d va nci n g a g e.  
H o we ver, c hr o n ol o gic a g e al o ne is n ot a c o m pre he nsi ve pre dict or of 
v ul nera bilities as t here is s u bsta ntial heter o ge neit y i n t he pr ocess of a gi n g, a n d 
c o nse q ue ntl y, m ore t h or o u g h assess me nt met h o d ol o gies are re q uire d. 4, 5 I n b ot h 
cli nical practice a n d r esearc h setti n gs, o ne a p pr oac h t o a d dress t his variati o n is t he 
use of G A  met h o d ol o gies.6 
A c o m pre he nsi v e geriatric assess me nt c o nsists of a m ulti di me nsi o nal e val uati o n 
of a n ol der p ers o n’s f u n cti o nal a bilit y, p h ysical perf or ma nce, n utriti o n, 
c o m or bi dities, c o g niti ve f u ncti o n, a n d ps yc h os oci al s u p p ort. 7 Tra diti o nal 
c o m pre he nsi ve g eriatri c assess me nt pr o gra ms ca n ta ke u p t o 2 h o urs t o c o m plete.  
T his d oes n ot i ncl u de t he ti me ta ke n t o re vie w t he data a n d t o f or m ulat e a pla n f or 
f urt her ma n a ge me nt.5 Alt h o u g h it pr o vi des usef ul i nf or mati o n, t he tra diti o nal 
m ulti -disci pli nar y geriatric assess me nt is c o nse q u e ntl y t o o ti me i nte nsi ve a n d 
i m practical t o perf or m i n a t y pical o nc ol o g y practice.8 F or t his reas o n, H urria et al 
c o n d ucte d a pil ot st u d y i n or der t o de v el o p a brief yet i ncl usi ve geriatric 
assess me nt t hat c o ul d be pri maril y self -a d mi nistere d, a n d t o esta blis h its 
feasi bilit y i n a n o nc ol o g y practice.  T he meas ures i ncl u de d i n t his a b bre viat e d 
assess me nt c o ver all of t he esse ntial d o mai ns i de ntifie d earlier a n d were c h ose n 
f or t heir r elia bilit y, vali dit y, bre vit y, a n d pr o g n ostic a bilit y t o deter mi ne ris k f or 
m or bi dit y or m ortalit y i n a n ol der patie nt. 4   

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T he mea n ti me t o c o m plete t he assess me nt i n H urria’s pil ot st u d y was 2 7 mi n utes, 
a n d 7 8 % c o m plete d t he s elf-a d mi nistere d p orti o n wit h o ut assista nce. T here was 
n o ass ociati o n bet wee n t he a bilit y t o c o m plete t he assess me nt i n de pe n de ntl y a n d 
a ge ( p = 0. 5 6) or e d ucati o nal le vel ( p = 0. 9 9). Ei g ht y- t hree p erce nt of patie nts state d 
t hat t he assess me nt was eas y t o u n dersta n d, a n d 1 0 0 % state d t hat n o ite ms were 
u psetti n g. Ni net y perce nt were s atisfie d wit h t he le n gt h of t he q uesti o n naire. 5 T he 
feasi bilit y of usi n g t he geriatric assess me nt i n an N CI -s p o ns ore d c o o p erati ve 
gr o u p setti n g was rece ntl y esta blis he d b y H urria a n d c ollea g ues f or t he Ca n cer 
a n d Le u ke mia Gr o u p B ( C A L G B) i n a m ulti-ce nter trial ( C A L G B 3 6 0 4 0 1). I n 
t his trial of 8 8 patie nts, 8 8 % were a ble t o c o m plet e t he assess me nt wit h o ut hel p 
wit h a me dia n ti me t o c o m pleti o n of 2 2 mi n utes .9 I n a st u d y of 1, 0 8 8 se ni ors 
recr uite d fr o m se ve n c o m m u nit y cli nics acr oss N ort h Car oli na, U N C res earc hers 
re p orte d mea n ti me t o c o m plete t he e ntire geriatri c assess me nt was 1 9 mi n utes i n 
t he aca d e mic me dical ce nter a n d 2 2 mi n utes i n c o m m u nit y setti n gs; stu d y 
partici pa nts re q uiri n g assista nce i n c o m pleti n g t he G A q uesti o n naires w as 1 4 % i n 
t he aca d e mic me dical ce nter c o m pare d t o 2 4 % i n t he c o m m u nit y setti n g.1 0  
Si milar a b bre viate d ass ess me nts ha ve bee n pre vi o usl y de pl o ye d i n st u dies of 
patie nts wit h M M.  T hese assess me nts ha ve b ee n d e m o nstrate d t o detect deficits 
a m o n g patie nts u n der g oi n g treat me nt f or M M t hat ma y g o misse d i n r o uti ne 
cli nical e val uati o n. 1 1 -1 4 M ore o ver, in p atie nts wit h M M , sc ori n g s yste ms 
i nc or p orati n g f u ncti o nal deficits ha ve b ee n f o u n d t o pre dict  treat me nt 
t olera nce,1 1, 1 5 -1 7 healt hcar e utilizati o n, 1 8 ca n di dac y  f or he mat o p oietic ste m cell 
tra ns pla ntati o n,1 2, 1 9 a n d s ur vi val.1 1, 1 5 -1 7, 2 0 -2 2 
T he pre v ale nce of geriatric i m pair me nt a m o n g patie nts wit h M M treate d at U N C 
has bee n e v al uate d usi n g o ne s uc h a b bre viate d G A as part of a n e xisti n g re gistr y 
of great er t ha n 1 5 0 patie nts wit h M M a n d ot her plas ma cell dis or ders  (L C C C 
1 7 2 8: Re gistr y f or A d ults wit h Plas ma Cell Dis or ders). A m o n g partici pa nts i n t his 
re gistr y, G A -i de ntifie d i m pair me nts were c o m m o n. S pecific i m pair me nts were 
see n i n a s u bsta ntial mi n orit y of patie nts , i ncl u di n g p o or perf or ma nce o n t he 
Ti me d U p a n d G o test (2 9. 8 % ), de pe n d e nce i n o ne or m ore i nstr u me ntal acti vities 
of dail y li vi n g ( 3 5. 6 %), a n d o ne or m ore falls i n t he pri or 6 m o nt hs ( 1 3. 5 %). 1 4 
M ore o ver, t he pres e nce of f u ncti o nal defi cits was ass ociate d wit h i nferi or p atie nt -
re p orte d q u alit y of life a m o n g affecte d i n di vi d uals.  
1. 3 
P ur p ose a n d R ati o n ale 
W hile t he pres e nce of G A -i de ntifie d defi cits has clear pr o g n ostic si g nifica nce f or 
patie nts wit h  M M, t he feasi bilit y a n d efficac y of cli nic - base d i nter ve nti o ns 
tar geti n g t hese deficits ha ve bee n less t h or o u g hl y e val uate d. I n t h e ge neral 
p o p ulati o n, s uc h tar gete d i nter ve nti o n has bee n s h o w n t o i m pr o ve s ur vi val a n d 
f u ncti o nal o utc o mes i n ol der a d ults.2 3 -2 6 T here is rece nt  dat a re g ar di n g t he 
efficac y of G A - g ui de d s u p p orti ve i nter ve nti o ns i n i m pr o vi n g cli nicall y rele va nt 
o utc o mes f or patie nts wit h s oli d t u m ors, b ot h i n t he peri o perati ve setti n g 2 7 a n d at 
ne w li nes of s yste mic t hera p y, 2 8 -3 1 t h o u g h si milar data f or p atie nts wit h 
he mat ol o gic mali g na ncies (i ncl u di n g M M) is lac ki n g.  Li ke wise, best practices 
f or i nte grati o n of g eriatri c assess me nts i nt o o nc ol o g y practice re mai n t o be 

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T uc h ma n) are c o -i n vesti gat ors o n t he L C C C 1 7 2 8 pr ot oc ol, a n d partici p a nts i n 
L C C C 1 7 2 8 ha ve a gree d t o be c o ntacte d f or p ote ntial f ut ure st u dies (as n ote d i n 
secti o n 5. 4 of t he L C C C 1 7 2 8 pr ot oc ol).   
 
As part of t he L C C C 1 7 2 8 pr ot oc ol, partici pa nts c o m plete i nter mitte nt 
assess me nts c o nsisti n g of a brief G A ( A p p e n di x I a n d II) a n d s u p ple me ntar y 
q ualit y of life q uesti o n naires: t he E ur o pea n Or ga nizati o n f or Researc h a n d 
Treat me nt of Ca n cer ( E O R T C) Q ualit y of Life of Ca ncer Patie nts C ore 3 0 ( Q L Q -
C 3 0) a n d M yel o ma M o d ule ( Q L Q- M Y 2 0). T hes e assess me nts are c o m plet e d at 
patie nt e nr oll me nt, at 3 a n d 6 m o nt hs after e nr oll me nt, e ver y 6 m o nt hs t hereaft er, 
a n d at a d diti o nal ti me of p oi nts of cli nical si g nifica nce.  
 
T he re gistr y’s d ata base will be q uerie d b y L C C C 1 7 2 8 data base a d mi nistrat or t o 
i de ntif y patie nts meeti n g t he i ncl usi o n criteria o utli ne d i n secti o n 3. 1. 1 ( dia g n osis 
of M M, a ge 6 0 or great er, a n d prese n ce of at least o ne of t he s pecifie d geriatric 
i m pair me nts). 
 
T he  res ear c h  tea m  will  c o ntact  t he  p atie nt’s  cli nicia n  f or  a p pr o priate n ess  f or  
partici pati o n i n L C C C 2 1 0 1 . T he researc h tea m will t he n a p pr oac h t he patie nt 
d uri n g a re g ularl y sc h e d ule d o ut patie nt cli nic a p p oi nt me nt t o descri be t he st u d y a n d 
assess t he patie nt’s i nterest i n partici pati n g.  F or patie nts bei n g see n re m otel y, t he 
researc h tea m will c o ntact t he patie nt b y p h o ne t o disc uss t he st u d y (see secti o n 
4. 3. 3 ). T he res ear c h tea m will a d mi nister t he Mai n C o nse nt a n d HI P P A C o nse nt t o 
i ntereste d patie nts. HI P A A c o nse nt will be re q u este d t o all o w t he st u d y t ea m access 
t o t heir me dical rec or ds t o descri be t he st u d y sa m ple a n d t o d oc u me nt f oll o w - u p t o 
i nter ve nti o n ref err als. 
4. 3. 2  I nter ve nti o n 
Patie nts will be matc he d t o a p pr o priate i nter v e nti o ns base d o n t he prese nce of 
geriatric i m pair me nts o n t heir m ost rece nt G eriatri c A ssess me nt, c o m plete d as 
part of L C C C 1 7 2 8 pri or t o e nr oll me nt o n L C C C 2 1 0 1. T hese i nter ve nti o ns 
lar gel y c o nsist of referrals t o rele va nt s peci alists a n d e xisti n g ser vices ( T a ble 1). 
I n t he e ve nt of c o m ple x or m ulti ple s y m pt o ms/ deficits, t he st u d y c o or di nat or will 
c o ns ult wit h t he St u d y I n vesti gat ors t o clarif y a n d pri oritize t he i nter ve nti o ns. All 
meas ures i ncl u de d i n t he asse ss me nt are s u m marize d i n secti o n 4. 3. 3. 
 
T he St u d y Tea m will t he n c o m m u nicate wit h t he st u d y partici pa nt a b o ut pr o p ose d 
i nter ve nti o ns i n or der t o r eac h a n a gree me nt o n t he patie nt’s prefere n ce f or 
s pecific i nter v e nti o n(s). T he St u d y I n v esti gat ors will or der a gree d -t o referrals. All 
of t hese referrals will be c o m plete d wit hi n t w o wee k s of t he patie nt’s recr uit me nt 
i nt o t he st u d y.  
 
 

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Falls i n t he past 6 m o nt hs 
- 
N u m ber of me dicati o ns ta ke n o n a dail y basis ( prescri be d, o ver -t he-c o u nter, 
her bs, vita mi ns) 4 3 
- 
C o -m or bi dities 4 4 
- 
E yesi g ht, heari n g 
- 
S ocial Acti vities 4 5 
- 
Me ntal Healt h I n d e x - 1 74 6 -4 8 
- 
P R O MI S I nstr u me ntal S u p p ort 
- 
P R O MI S S ocial Is olati o n  
- 
Healt h Be ha vi ors Q u esti o n naire 4 9 
- 
Fee d b ac k o n t he q u esti o n naire 
 
P atie nt - Re p orte d S y m pt o m a n d Q u alit y of Life Me as ures ( A p pe n di x III): 
- 
E ur o pea n Or g a nizati o n  f or  Researc h  a n d  Treat me nt  of  Ca ncer ( E O R T C) 
Q ualit y of Life Q uesti o n naire ( Q L Q) C ore q u esti o n naire ( C 3 0) 
- 
E O R T C Q L Q M ulti ple M yel o ma s u p ple me nt ( M Y 2 0) 
( 2 5 mi n utes re q uire d f or c o m pleti o n) 
 
A d diti o nal meas ures: 
Pri or t o 3 m o nt h f oll o w u p assess me nt, st u d y i n vesti gat ors will re vie w E pi c @ U N C  
f or e vi de n ce of partici pa nt atte n da nce at sc h e d ule d referrals. Patie nts will be as ke d 
a b o ut  f oll o w  u p  a n d  barriers  t o  f oll o w  u p  at  t he  ti me  of  t he  first  f oll o w  u p  
assess me nt ( A p pe n di x I V). 
 
Patie nt satisfacti o n wit h t he i nter ve nti o n(s) will als o be e val uate d at t he 3 - m o nt h 
assess me nt  via a Li kert scale ( A p p e n di x I V).  ( 5 mi n utes re q uire d f or c o m pl eti o n) 
4. 3. 4  F ull y Re m ote O pti o n  
D ue t o t he C O VI D- 1 9 pa n de mic a n d eff orts t o mai ntai n s ocial dista nci n g, a f ull y 
re m ote o pti o n is a vaila ble f or partici pa nts w h o are u na ble t o c o me t o cli nic f or all 
or a p orti o n of t he st u d y. Partici pa nts will be c o ntacte d via p h o ne t o disc uss t he 
st u d y a n d re vie w t he c o nse nt f or ms. T he Mai n C o nse nt a n d HI P A A c o ns e nt 
f or ms will be pr o vi de d t o partici pa nts o nli ne a n d c o nse nt will be o btai ne d t hr o u g h 
Re d Ca p. F or p artici pa nts w h o c h o ose t he f ull y re m ote o pti o n, t he M O C A a n d 
T U G will be a d mi nistere d via a vi de o  visit , a n d t he BI A assess me nt will be 
o mitte d . If t he p artici pa nt d oes n ot ha ve access t o a s mart p h o ne or c o m p uter wit h 
vi de o ca mer a f or a vi de o visit, t he T U G a n d M O C A will be o mitte d.  T he 
re mai n der of t he self-re p ort q uesti o n naires will be c o m plete d eit her o nli ne 
t hr o u g h RE D Ca p or will be maile d t o t he partici pa nt f or c o m pleti o n. U p o n recei pt 
of t he c o m plete d q uesti o n naires, a st u d y tea m me m ber will c o ntact t he partici pa nt 
via tele p h o ne or e mail, per patie nt prefere nce, t o disc uss t he res ults a n d a n y 
rec o m me n de d i nter ve nti o ns. T he st u d y tea m me m ber will or der a n y acce pte d 
referrals a n d t h e patie nt will be n otif ie d via p h o ne or e mail. At t he ti me of 3-
m o nt h f oll o w u p, t he partici pa nt will be c o ntacte d via p h o ne or e mail t o dis c uss 
w het her t he y w o ul d li ke t o c o m plete t he assess me nt re m otel y or i n- pers o n. T he 

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•  
Is relate d or p ossi bl y relate d t o a s u bject’s partici pati o n i n t he researc h; 
a n d  
•  
S u g gests t hat t he researc h places s u bjects or ot h ers 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 mi c, or s ocial har m) rel ate d 
t o t he researc h t ha n w as pre vi o usl y k n o w n or rec o g nize d. 
6. 2  
Re p orti n g  
A n y U PI R S O  t hat occ urs d uri n g t he c o n d uct of t his st u d y a n d t hat meets all t hree 
criteria liste d i n 6. 1  m ust be re p ort e d t o t he U N C I R B usi n g t he I R B’s we b-base d 
re p orti n g s yste m.   
 
7. 0  
S T A TI S TI C A L C O N SI D E R A TI O N S  
7. 1  
St u d y Desi g n  
T his is a o ne-ar m o bser v ati o nal pil ot st u d y. 
7. 2  
S a m ple Size a n d Accr u al  
O ur o ne- y ear accr ual g oal is a mi ni m u m of 4 0 patie nts a ge 6 0 or ol der wit h 
m ulti ple m yel o ma w h o  are see n i n t he o ut p atie nt he mat ol o g y/ o nc ol o g y cli nic at 
U N C Ca ncer H os pital. Patie nts will be recr uite d fr o m a n e xisti n g re gistr y of 
patie nts wit h plas ma cell dis or ders treat e d at U N C ( L C C C 1 7 2 8).  
7. 3  
D at a A n al ysis Pl a ns  
7. 3. 1  Pl a n ne d A n al yses  
We  will  esti mate  per ce nta ges  a n d  perf or m  des cri pti ve  statistics  of  t he  patie nt  
p o p ulati o n . T hr o u g h electr o nic me dical rec or d c h art a bstracti o n a n d patie nt re p ort, 
we will meas ure t he rate of partici pa nts ’ atte n da nce of at least o ne a p p oi nt me nt 
f oll o wi n g  ref err als.  A d diti o nall y,  all  partici pa nts  will  c o m plete  a  s atisfacti o n  
s ur ve y t hat will be re vie we d f or q u alitati ve a nal ysis re gar di n g t he stre n gt hs a n d 
wea k ness of t he st u d y desi g n a n d i nter ve nti o ns.  
 
P R O meas ures will be s c ore d t o pr o vi d e a rati n g f or eac h s y m pt o m wit h hi g her 
sc ores  i n dicati n g  hi g her  se verit y  a n d  great er  i nterfere nce  wit h  dail y  acti vities. 
Paire d t tests  will  be  use d  t o  c o m pare  eac h  s y m pt o m  sc ore  bef ore  a n d  after  
i nter ve nti o n. T his will be c o nsi dere d a n e x pl orat or y a nal ysis gi ve n t he s mall sa m ple 
size. 
7. 3. 2  P o wer / Precisi o n C o nsi der ati o ns  
We a ntici pate a n acce pt a nce rat e f or i nter ve nti o n referral  (as meas ure d b y 
atte n da nce of at least o ne a p p oi nt me nt) of at least 7 5 %, t h us t he pr ojecte d 
precisi o n of a 9 5 % e xact bi n o mial c o nfi de nce i nter val is ( 5 8. 8 %,  8 7. 3%). 
A d diti o nall y, all partici pa nts will c o m plete a s ur v e y c o ncer ni n g t he i nter v e nti o n 
st u d y, i ncl u di n g a 5-p oi nt Li kert scale re gar di n g t heir satisfacti o n. T he p erce nta ge 

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of patie nts w h o re p ort a 4 or 5 (i n dicati n g a gree or str o n gl y a gree wit h t he 
satisfacti o n state me nt) will be re p orte d, wit h a 9 5 % CI n o l ar ger t ha n +/- 1 6. 2%. 
T he satisfacti o n s ur v e ys will a d diti o nall y ser ve as t he basis f or a n a nal ysis 
re gar di n g t he str e n gt hs a n d wea k ness es of t he st u d y desi g n a n d i nter ve nti o ns. 
7. 4  
D at a M a n a ge m e nt / A u dit 
All data will be c ollecte d a n d ma na g e d b y Dr. Je ns e n a n d his d esi g nate d staff. Data 
will i ncl u de c o nse nt f or ms, c o ntact a n d s cree ni n g i nf or mati o n, a n d res p o nses t o 
pri nte d a n d electr o nic q u esti o n naires. Dr. Je ns e n a n d his desi g nate d staff will be 
res p o nsi ble f or re vie wi n g q uesti o n naire res p o nses f or c o m plete n ess a n d l o gical 
c o nsiste nc y. Desi g nat e d staff will e nter all q uesti o n naire dat a i nt o a R E D Ca p ™ 
data base.  T he y  will  be  res p o nsi ble  f or  pr ocessi n g  all  st ore d  d ata  usi n g  well -
de vel o pe d  pr o ce d ur es  f or  pre -co de d  f or ms  desi g n,  e nc o di n g,  data  e ntr y,  data  
e diti n g, a n d file ma na ge me nt. All pr oce d ures will be I R B a n d HI P A A c o m plia nt. 
C o m plete d  q uesti o n naires,  c o nse nt  f or ms,  c o ntact  i nf or mati o n,  a n d  ot her  
d oc u me nts will be k e pt b y Dr. Je ns e n or his desi g nees i n a l oc ke d file ca bi net u ntil 
t he basic re vie ws are c o m plete d, s o t hat p ossi ble err ors ca n be c hec k e d a gai nst t he 
ori gi nal f or ms.  
 
As a n i n vesti gat or-i nitiate d st u d y, t his trial will als o be a u dite d b y t he Li ne ber ger 
Ca ncer Ce nter a u dit c o m mittee e ver y si x or t wel v e m o nt hs.  
 
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 U N C Li ne ber ger Data a n d Safet y 
M o nit ori n g C o m mittee ( D S M C) as re q uire d. 
  
Meeti n gs/telec o nfere n ces will be hel d at a fre q ue n c y de pe n d e 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 v a nt t o st u d y pr o gress, i ncl u di n g e nr oll me nt, 
safet y, re gul at or y, data c ollecti o n, etc. a n d t he tea m will pr o d uce s u m maries or 
mi n utes of t hese meeti n gs. 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 r e g ulat or y b o dies c h ar 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 mite d t o, t he o versi g ht 
( Office of H u ma n R esear c 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 C ar oli na Tra C S I nstit ute D ata 
a n d Safet y M o nit ori n g B oar d ( D S M B). 
8. 0  
S T U D Y M A N A G E M E N T  
8. 1  
I nstit uti o n al Re vie w B o ar d (I R B) A p pr o v al a n d C o nse nt 
It is e x p ecte d t hat t he I R B will ha ve t he pr o per re prese ntati o n a n d f u n cti o n i n 
acc or d a nce wit h fe d erall y ma n date d re g ul ati o ns.  T he I R B s h o ul d 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 o c u me nti n g i nf or me d c o nse nt, t he i n vesti gat or s h o ul d c o m pl y 
wit h t he a p plica ble r e 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 

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Practice ( G C P) a n d t o et hical pri nci ples t hat ha ve t heir ori gi n i n t he Declarati o n 
of Helsi n ki. 
  
  
 
Bef ore r ecr 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 v a nt ele me nts c urre ntl y re q uire d 
b y t he F D A Re g ul ati 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 pate i n t he st u d y b y si g ni n g a n 
I R B-a p pr o ve d c o nse nt f or m. 
 
Pri or t o a patie nt’s partici pati o n i n t he trial, t he writte n i nf or me d c o nse nt f or m 
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 he pers o n w h o 
c o n d ucte d t he i nf or me d c o nse nt disc ussi o n. 
8. 2  
Re q uire d D oc u m e 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 ntati o n m ust be 
pr o vi de d t o t he Cli nical Pr ot oc ol Office ( C P O) at t he U ni versit y of N ort h 
Car oli na.  
•  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 
•  C Vs a n d me dical lice ns ure f or t he pri nci pal i n vesti gat or a n d a n y 
ass ociate i n vesti gat ors w h o will be i n v ol ve d i n t he st u d y 
•  A c o p y of t he I R B-a p pr o ve d c o nse nt f or m 
8. 3  
Re gistr ati o n Pr o ce d ures  
All partici pa nts will be re gistere d a n d e nt ere d i nt o t he we b- bas e d cli nical researc h 
platf or m O nc or e ®. 
8. 4  
A d here nce t o t he Pr ot o c ol  
E xce pt f or a n e mer ge nc y sit uati o n i n w hic h pr o per care f or t h e pr otecti o n, safet y, 
a n d well -bei n g of t h e st u d y patie nt re q uires alter n ati ve treat me 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.   
8. 4. 1  E m er ge nc y M o dific ati o ns  
U N C i n vesti gat ors ma y i m ple me nt a de viati o n fr o m, or a c ha n g e of, t he pr ot oc ol 
t o eli mi nate a n i m me diate hazar d(s) t o trial s u bjects wit h o ut pri or U N C I R B 
a p pr o val.  
 
F or a n y s u c h e mer ge nc y m o dificati o n i m ple me nte d, a U N C I R B m o dificati o n 
f or m m ust be c o m plete d b y U N C Researc h Pers o n nel  wit hi n fi ve ( 5) b usi n ess 
da ys of ma ki n g t he c h a n ge.   

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8. 4. 2  Si n gle P atie nt/ S u bject E xce pti o ns  
Eli gi bilit y si n gle s u bject e xce pti o ns are n ot per mitte d f or Li ne ber ger 
C o m pre he nsi ve Ca ncer Ce nter I n vesti gat or I nitiate d Trials u n der a n y 
circ u msta nces. Ot her t y p es of si n gle s u bject e x ce pti o ns ma y be all o we d if pr o per 
re g ulat or y r e vie w has b ee n c o m plete d i n acc or d a nce wit h Li ne ber ger 
C o m pre he nsi ve Ca ncer Ce nter’s Si n gle S u bject E xce pti o ns P olic y. 
8. 4. 3  Ot her Pr ot o c 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 v e d pr ot oc ol t hat:  
•  Is g e ner all y n ote d or rec o g nize d after it occ urs 
•  Ha s n o s u bsta nti ve effect o n t he ris ks t o researc h p artici pa nts  
•  Has n o s u bsta nti ve effect o n t he scie ntific i nte grit y of t he researc h pla n 
or t he val ue of t h e data c ollecte d  
•  Di d n ot res ult fr o m willf ul or k n o wi n g misc o n d uct o n t he part of t he 
i n vesti gat or(s).  
 
A n u n pla n ne d pr ot oc ol v aria nce is c o nsi dere d a vi olati o n if t he varia nce meets 
a n y of t he f oll o wi n g criteria:  
•  Has har me d or i ncrease d t he ris k of har m t o o ne or m ore researc h 
par tici pa nts. 
•  Has da ma ge d t h e scie ntific i nte grit y of t he data c ollecte d f or t he st u d y. 
•  Res ults fr o m willf ul or k n o wi n g misc o n d uct o n t he part of t he 
i n 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 vi ati 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 D e vi ati o ns: U N C pers o n nel will rec or d t he de viati o n i n O n C ore ®  ( or 
ot her a p pr o pri ate data b as e set u p f or t he st u d y), a n d re p ort t o a n y s p o ns or or data 
a n d safet y m o nit ori n g c o m mittee i n acc or da n ce wit h t heir p olicies.  De viati o ns 
s h o ul d be s u m marize d a n d re p orte d t o t he I R B at t he ti me of c o nti n ui n g re vie w. 
 
Pr ot oc ol Vi ol ati o ns: Vi olati o ns s h o ul d be re p ort e d b y U N C pers o n n el wit hi n o ne 
( 1) wee k of t he i n vesti gat or bec o mi n g a w are 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 PI R S O .   
 
U n a ntici p ate d Pr o ble ms  I n v ol vi n g Ris ks t o S u bjects or Ot hers ( U PI R S O: 
A n y e ve nts t hat meet t he criteria f or “ U n a ntici pate d Pr o ble ms” as defi ne d b y 
U N C’s I R B (see secti o n 6. 1 ) m ust be re p orte d b y t he St u d y C o or di nat or usi n g t he 
I R B’s w e b- bas e d re p orti n g s yste m.   

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8. 5  
A m e n d m e nts t o t he Pr ot oc ol  
S h o ul d a me n d me nts t o t he pr ot oc ol be re q uire d, t h e a me n d me nts will be 
ori gi nate d a n d d oc u me nt e d b y t he Pri nci pal I n vesti gat or at U N C.  It s h o ul d als o 
be n ote d t hat w he n a n a me n d me nt t o t he pr ot oc ol s u bsta ntiall y alters t he st u d y 
desi g n 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 m e 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 v al pri or t o i m ple me ntati o n.   
8. 6  
Rec or d R ete nti o n  
St u d y d oc u me ntati o n i ncl u des all Case Re p ort F or ms, data c orrecti o n f or ms or 
q ueries, s o urce d oc u me nts, S p o ns or-I n v esti gat or c orres p o n de n ce, 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 d e nce a n d a p pr o val, si g ne d patie nt c o ns e nt f or ms). 
 
S o urce d oc u me nts i ncl u d e all rec or di n gs of o bser v ati 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 h e cli nical researc h st u d y. 
 
G o ver n me nt a g e nc y r e g ulati o ns a n d directi ves re q uire t hat all st u d y 
d oc u me ntati o n pertai ni n g t o t he c o n d uct of a cli nical trial m ust be retai n e 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 keti n g, t hese d o c 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 keti n g a p plicati o n i n a n I nter n ati o nal C o nfere n ce o n 
Har m o nizati o n (I C H) re gi o n.  I n all ot her cas es, 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 
i n vesti gati o nal st u d y. 
8. 7  
O bli g ati o ns of I n vesti g at ors 
T he Pri nci pal I n vesti gat or is res p o nsi ble f or t he c o n d uct of t he cli nical trial at t he 
site i n acc or d a 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 
Declar ati o n of Helsi n ki.  T he Pri nci pal I n vesti gat or is res p o nsi ble f or p ers o nall y 
o versee i n g t he tr eat me nt of all st u d y patie nts.  T he Pri nci pal I n v esti 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 her e t o t he st u d y pr ot oc ol 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 g ar 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 at eac h i nstit uti o n or site will be res p o nsi ble f or 
ass uri n g t hat all t he re q uire d data will be c ollecte d a n d e ntere d o nt o t he Cas e 
Re p ort F or ms. Peri o dicall y, m o nit ori n g visits will be c o n d ucte d a n d t he Pri nci pal 
I n v esti 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 d ata. At t he c o m pleti o n of t he st u d y, all case re p ort f or ms will 
be re vie w e d b y t he Pri nci pal I n v esti gat or a n d will re q uire his/ her fi nal si g nat ure 
t o verif y t he acc ur ac y of t he data.  

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9. 0  
R E F E R E N C E S  
             
1.  Sie gel R L, Miller K D, F uc hs H E, Je mal A. Ca n cer statistics, 2 0 2 1. C A Ca ncer 
J Cli n 2 0 2 1; 7 1: 7- 3 3. 
2.  Pal u m b o A, A n ders o n K. M ulti ple m yel o ma. N E n gl J Me d 2 0 1 1; 3 6 4: 1 0 4 6-
6 0. 
3. S E E R ca ncer stat facts: m yel o ma. Nati o nal Ca ncer I nstit ute, 2 0 2 0. ( Accesse d 
3 0 Dece m b er, 2 0 2 0, at htt ps://seer.ca ncer. g o v/statfacts/ ht ml/ m ul m y. ht ml .) 
4. H urria A, G u pt a S, Za u d erer M, et al. De v el o pi n g a ca n cer -s pecifi c geriatri c 
assess me nt: a feasi bilit y st u d y. Ca ncer 2 0 0 5; 1 0 4: 1 9 9 8- 2 0 0 5. 
5.  H urria A, L ac hs M S, C o he n HJ, M uss H B, K or n blit h A B. Geriatric 
assess me nt f or o nc ol o gists: rati o nale a n d f ut ure directi o ns. Crit Re v O nc ol 
He mat ol 2 0 0 6; 5 9: 2 1 1- 7. 
6. Wil diers H, Heere n P, P uts M, et al. I nter nati o nal S ociet y of Geriatri c 
O nc ol o g y c o nse ns us o n geriatric assess me nt i n ol der patie nts wit h ca n cer. J 
Cli n O nc ol 2 0 1 4; 3 2: 2 5 9 5- 6 0 3. 
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