untitled h1
9. 8 . 3 a

T h e r el ati o ns hi p b et w e e n e a c h pr e-s el e ct e d S N P g e n ot y p e a n d t h e p er c e nt c h a n g e fr o m b as eli n e t o 1 2 m o nt hs o n-st u d y i n p er c e nt a g e b o d y f at, f asti n g pl as m a gl u c os e, b o d y m ass i n d e x, w aist cir c u mf er e n c e, a n d f asti n g i ns uli n a m o n g m e n u n d er g oi n g A D T will e a c h b e t est e d usi n g a t w o -  
s a m pl e t t est or Wil c o x o n -r a n k-s u m t est as a p pr o pri at e w h e n t h e S N Ps ar e i n d o mi n a nt or r e c essi v e f as hi o n. W h e n S N Ps ar e i n t h e a d diti v e m o d el, f or e a c h S N P, a g e n er ali z e d li n e ar m o d el wit h a n a p pr o pri at e li n k will b e us e d c o nsi d eri n g e a c h b as eli n e -1 2 m o nt h c h a n g e as t h e r es p o ns e v ari a bl e a n d S N P g e n ot y p e ( c o d e d as 0, 1, a n d 2 f or z er o, o n e a n d t w o c o pi es of mi n or all el e) as t h e pr e di ct or. A n al ysis will b e e xt e n d e d t o a dj ust f or p ossi bl e ris k f a ct ors b y fitti n g m ulti v ari at e g e n er ali z e d li n e ar m o d els f or e a c h b as eli n e -1 2 m o nt h c h a n g e a n d e a c h S N P.  
M ulti pl e t esti n g a dj ust m e nts will b e d o n e f or e a c h b as eli n e -1 2 m o nt h c h a n g e a cr oss all S N Ps b y c o ntr olli n g f or f als e dis c o v er y r at e.  
T h e m e a n p er c e nt c h a n g e fr o m b as eli n e i n tr a b e c ul ar b o n e mi cr o ar c hit e ct ur e p ar a m et ers i n cl u di n g tr a b e c ul ar b o n e n u m b er a n d tr a b e c ul ar b o n e v ol u m e ass ess e d b y hi g h r es ol uti o n q u a ntit ati v e p eri p h er al C T will b e d es cri pti v el y r e p ort e d f or t h e e ntir e st u d y p o p ul ati o n. I n a n e x pl or at or y f as hi o n, t h e m e a n p er c e nt c h a n g e b et w e e n t h os e r a n d o mi z e d t o t h e S T A N D v ers us us u al c ar e tr e at m e nt ar ms will b e c o m p ar e d usi n g M a n n -W hit n e y t est.  
T h e distri b uti o n of t h e 2 D: 4 D fi n g er l e n gt h r ati o will b e d et er mi n e d f or t h e e ntir e st u d y p o p ul ati o n. As t h e o pti m al c ut -off t o d efi n e s e nsiti vit y t o a n dr o g e n d e pri v ati o n t h er a p y is n ot k n o w n, t h e st u d y c o h ort will b e di c h ot o mi z e d i nt o t h os e wit h 2 D: 4 D r ati os a b o v e a n d b el o w t h e m e di a n r es p e cti v el y. T h e m e a n p er c e nt c h a n g e fr o m b as eli n e i n Q O L s c or es fr o m t h e c oll e ct e d q u esti o n n air es as w ell as t h e b as eli n e a n d m e a n p er c e nt c h a n g e fr o m b as eli n e i n e m p at h y s c or e will b e c o m p ar e d b et w e e n di c h ot o mi z e d s u b gr o u ps usi n g t h e M a n n- W hit n e y t est.  
N o a dj ust m e nt f or m ulti pl e c o m p aris o ns will b e m a d e f or t h e a n al ysis of t h e c orr el ati v e st u d y e n d p oi nts.
untitled h1
1 0 . st u

T his st u d y will b e c o n d u ct e d i n a c c or d a n c e wit h t h e et hi c al pri n ci pl es t h at h a v e t h eir ori gi n i n t h e D e cl ar ati o n of H elsi n ki as st at e d i n 2 1 C F R § 3 1 2. 1 2 0( c)( 4); c o nsist e nt wit h G C P a n d all a p pli c a bl e r e g ul at or y r e q uir e m e nts.  
B ef or e i niti ati n g t his tri al, t h e I n v esti g at or will h a v e writt e n a n d d at e d a p pr o v al fr o m t h e I nstit uti o n al R e vi e w B o ar d f or t h e pr ot o c ol, writt e n i nf or m e d c o ns e nt f or m, s u bj e ct r e cr uit m e nt pr o c e d ur es ( e. g., a d v ertis e m e nts), a n d a n y ot h er wr itt e n i nf or m ati o n t o b e pr o vi d e d t o s u bj e cts b ef or e a n y pr ot o c ol r el at e d pr o c e d ur es ar e p erf or m e d o n a n y s u bj e cts.  
T h e I n v esti g at or m ust c o m pl y wit h t h e a p pli c a bl e r e g ul ati o ns i n Titl e 2 1 of t h e C o d e of F e d er al R e g ul ati o ns ( 2 1 C F R) P arts § 5 0, § 5 4, a n d § 3 1 2, G C P/I C H g ui d eli n es, a n d all a p pli c a bl e r e g ul at or y r e q uir e m e nts. T h e I R B m ust c o m pl y wi t h t h e r e g ul ati o ns i n 2 1 C F R 5 6 a n d a p pli c a bl e r e g ul at or y r e q uir e m e nts.
untitled h1
1 0 . 2 i

T h e pr ot o c ol, t h e pr o p os e d i nf or m e d c o ns e nt f or m, a n d all f or ms of p arti ci p a nt i nf or m ati o n r el at e d t o t h e st u d y ( e. g. a d v ertis e m e nts us e d t o r e cr uit p arti ci p a nts) will b e r e vi e w e d a n d a p pr o v e d b y t h e C o m mitt e e o n H u m a n R es e ar c h ( U C S F's I R B). Pri or t o o bt ai ni n g C H R  
a p pr o v al, t h e pr ot o c ol m ust b e a p pr o v e d b y t h e H el e n Dill er F a mil y C o m pr e h e nsi v e C a n c er C e nt er Pr ot o c ol R e vi e w C o m mitt e e ( P R C). T h e i niti al pr ot o c ol a n d all pr ot o c ol a m e n d m e nts m ust b e a p pr o v e d b y t h e I R B pri or t o i m pl e m e nt ati o n.
untitled h1
1 0 . 3 i

All p arti ci p a nts m ust b e pr o vi d e d a c o ns e nt f or m d es cri bi n g t h e st u d y wit h s uffi ci e nt i nf or m ati o n f or p arti ci p a nts t o m a k e a n i nf or m e d d e cisi o n r e g ar di n g t h eir p arti ci p ati o n. P arti ci p a nts m ust si g n t h e I R B-a p pr o v e d i nf or m e d c o ns e nt f or m pri or t o p arti ci p ati o n i n a n y st u d y s p e cifi c pr o c e d ur e. T h e p arti ci p a nt m ust r e c ei v e a c o p y of t h e si g n e d a n d d at e d c o ns e nt d o c u m e nt. T h e ori gi n al si g n e d c o p y of t h e c o ns e nt d o c u m e nt m ust b e r et ai n e d i n t h e m e di c al r e c or d or r es e ar c h fil e.
untitled h1
1 0 . 4 c

O n c e t h e pr ot o c ol h as b e e n a p pr o v e d b y t h e U C S F C o m mitt e e o n H u m a n R es e ar c h ( C H R), a n y c h a n g es t o t h e pr ot o c ol m ust b e d o c u m e nt e d i n t h e f or m of a n a m e n d m e nt. T h e a m e n d m e nt m ust b e si g n e d b y t h e I n v esti g at or a n d a p pr o v e d b y P R C a n d t h e C H R pri or t o i m pl e m e nt ati o n.  
If it b e c om es n e c ess ar y t o alt er t h e pr ot o c ol t o eli mi n at e a n i m m e di at e h a z ar d t o p ati e nts, a n a m e n d m e nt m a y b e i m pl e m e nt e d pri or t o C H R a p pr o v al. I n t his cir c u mst a n c e, h o w e v er, t h e I n v esti g at or m ust t h e n n otif y t h e C H R i n writi n g wit hi n fi v e ( 5) w or ki n g d a ys aft er i m pl e m e nt ati o n.
untitled h1
1 0 . 5 c

T h e Pri n ci p al I n v esti g at or a n d/or his/ h er d esi g n e e will pr e p ar e a n d m ai nt ai n a d e q u at e a n d a c c ur at e p arti ci p a nt c as e hist ori es wit h o bs er v ati o ns a n d d at a p erti n e nt t o t h e st u d y. St u d y s p e cifi c C as e R e p ort F or ms ( C R Fs) will d o c u m e nt tr e at m e nt o ut c o m es f or d at a a n al ysis . st u d y d at a will b e e nt er e d i nt o O n C or e ® a n d R e d C A P, U C S F's Cli ni c al Tri al M a n a g e m e nt S yst e m  
( C T M S) vi a st a n d ar di z e d C R Fs i n a c c or d a n c e wit h t h e C T M S st u d y c al e n d ar, usi n g si n gl e d at a e ntr y wit h a s e c ur e a c c ess a c c o u nt. T h e Cli ni c al R es e ar c h C o or di n at or ( C R C) will c o m pl et e t h e C R Fs as s o o n as p ossi bl e u p o n c o m pl eti o n of t h e st u d y visit; t h e I n v esti g at or will r e vi e w a n d a p pr o v e t h e c o m pl et e d C R Fs.  
T h e i nf or m ati o n c oll e ct e d o n C R Fs s h all b e i d e nti c al t o t h at a p p e ari n g i n ori gi n al s o ur c e d o c u m e nts. S o ur c e d o c u m e nts will b e f o u n d i n t h e p ati e nt's m e di c al r e c or ds m ai nt ai n e d b y U C S F p ers o n n el. All s o ur c e d o c u m e nt ati o n s h o ul d b e k e pt i n s e p ar at e r es e ar c h f ol d ers f or e a c h p ati e nt.  
I n a c c or d a n c e wit h f e d er al r e g ul ati o ns, t h e I n v esti g at or is r es p o nsi bl e f or t h e a c c ur a c y a n d a ut h e nti cit y of all cli ni c al a n d l a b or at or y d at a e nt er e d o nt o C R Fs. E a c h C R F m ust b e r e vi e w e d f or a c c ur a c y b y t h e I n v esti g at or, c orr e ct e d as n e c ess ar y, a n d t h e n a p pr o v e d. Alt er n ati v el y, t h e I n v esti g at or m a y si g n i n di vi d u al, pri nt e d C R Fs. T h es e si g n at ur es att est t h at t h e i nf or m ati o n c o nt ai n e d o n t h e C R Fs is tr u e a n d a c c ur at e.  
All s o ur c e d o c u m e nt ati o n a n d C T M S d at a will b e a v ail a bl e f or r e vi e w/ m o nit ori n g b y t h e D at a a n d S af et y M o ni t ori n g C o m mitt e e ( D S M C) a n d r e g ul at or y a g e n ci es.  
T h e Pri n ci p al I n v esti g at or will b e r es p o nsi bl e f or e ns uri n g t h e a c c ur at e c a pt ur e of st u d y d at a. At st u d y c o m pl eti o n, w h e n t h e d at a b as e h as b e e n d e cl ar e d t o b e c o m pl et e a n d a c c ur at e, t h e d at a b as e will b e l o c k e d. A n y c h a n g es t o t h e d at a b as e aft er t h at ti m e c a n o nl y b e m a d e b y j oi nt writt e n a gr e e m e nt a m o n g t h e Pri n ci p al I n v esti g at or , t h e Tri al St atisti ci a n, a n d t h e Pr ot o c ol Proj e ct M a n a g er.
untitled h1
1 0 . 6 r

T h e I n v esti g at or a gr e es t o m ai nt ai n a c o m pl et e a n d c urr e nt r e c or d of all d o c u m e nt ati o n ass o ci at e d wit h t h e st u d y. All of t h e d o c u m e nts s h all b e k e pt t o g et h er. E a c h s h o ul d b e a v ail a bl e f or r e a d y r e vi e w. T h es e st ud y d o c u m e nts will i n cl u d e t h e:  
- pr ot o c ol  
- pr ot o c ol a m e n d m e nts, w h e n a p pli c a bl e  
- I n v esti g at or's c urr e nt c urri c ul u m vit a e  
- d o c u m e nt ati o n of C H R a p pr o v als f or t h e pr ot o c ol, a m e n d m e nts, i nf or m e d c o ns e nts a n d a d v ertis e m e nts us e d t o r e cr uit p ati e nts  
- sit e visit l o g  
- c orr es p o n d e n c e ( all "t o " a n d "fr o m " c orr es p o n d e n c e)  
- c as e r e p ort f or ms a n d i nf or m e d c o ns e nt d o c u m e nts f or i n di vi d u al p ati e nts  
- fi n al r e p ort f or t h e st u d y if a v ail a bl e.
untitled h1
1 1 . r ef

1. Br a g a - B as ari a M, D o bs A S, M ull er D C et al. M et a b oli c s y n dr o m e i n m e n wit h pr ost at e c a n c er u n d er g oi n g l o n g- t er m a n dr o g e n- d e pri v ati o n t h er a p y. J o ur n al Cli n O n c ol 2 0 0 6; 2 4( 2 4): 3 9 7 9- 3 9 8 3.  
2. B as ari a S, M ull er D C, C ar d u c ci M A, et al. H y p er gl y c e mi a a n d i ns uli n r esist a n c e i n m e n wit h pr ost at e c ar ci n o m a w h o r e c ei v e a n dr o g e n d e pri v ati o n t h er a p y. C a n c er 2 0 0 6; 1 0 6( 3): 5 8 1- 5 8 8.  
3. D o c k er y F, B ul pitt CJ, A g ar w al S, et al. T est ost er o n e s u p pr essi o n i n m e n wit h pr ost at e c a n c er l e a ds t o a n i n cr e as e i n art eri al stiff n ess a n d h y p eri ns uli n a e mi a. Cli n S ci ( L o n d) 2 0 0 3; 1 0 4: 1 9 5- 2 0 1.  
4. S mit h J C, B e n n ett S, E v a ns L M, et al. T h e eff e cts of i n d u c e d h y p o g o n a dis m o n art eri al stiff n ess, b o d y c o m p ositi o n, a n d m et a b oli c p ar a m et ers i n m al es wit h pr ost at e c a n c er. J Cli n E n d o cri n ol M et a b 2 0 0 1; 8 6( 9): 4 2 6 1- 4 2 6 7.  
5. S mit h M R, Fi n k elst ei n J S, M c G o v er n FJ, et al. C h a n g es i n b o d y c o m p ositi o n d uri n g a n dr o g e n d e pri v ati o n t h er a p y f or pr ost at e c a n c er. J Cli n E n d o cri n ol M et a b 2 0 0 2; 8 7( 2): 5 9 96 0 3.  
6. S mit h M R, L e e H, N at h a n D M. I ns uli n s e nsiti vit y d uri n g c o m bi n e d a n dr o g e n bl o c k a d e f or pr ost at e c a n c er. J Cli n E n d o cri n ol M et a b 2 0 0 6; 9 1( 4): 1 3 0 5- 1 3 0 8.  
7. K e ati n g N L, O' M all e y J, S mit h M R. Di a b et es a n d c ar di o v as c ul ar dis e as e d uri n g a n dr o g e n d e pri v ati o n t h er a p y f or pr ost at e c a n c er. J o ur n al of Cli ni c al O n c ol o g y 2 0 0 6; 2 4( 2 7): 4 4 4 84 4 5 6.  
8. L e br et T, C ol o b y P, D es c ot es J L, et al. E d u c ati o n al t o ol- kit o n di et a n d e x er cis e: s ur v e y of pr ost at e c a n c er p ati e nts a b o ut t o r e c ei v e a n dr o g e n d e pri v ati o n t h er a p y. J of Ur ol o g y 2 0 1 0; 7 6: 1 4 3 4- 1 4 3 9.  
9. K a h e n d e J W, L o o mis B R, A d hi k ari B, a n d M ars h all L. A r e vi e w of e c o n o mi c e v al u ati o ns of t o b a c c o c o ntr ol pr o gr a ms. I nt er n ati o n al J of E n vir o n m e nt al R es e ar c h a n d P u bli c H e alt h 2 0 0 9; 6: 5 1- 6 8.  
1 0. N o hl ert E, H el g as o n A R, Till gr e n P, et al. C o m p aris o n of t h e c ost- eff e cti v e n ess of a hi g h -  
a n d a l o w-i nt e nsit y s m o ki n g c ess ati o n i nt er v e nti o n i n S w e d e n: a r a n d o mi z e d tri al. Ni c oti n e a n d T o b a c c o R es e ar c h [ a c c e pt e d f or p u bli c ati o n 2 0 1 3].  
1 1. T at e D F, J a c k v o n y E H, Wi n g R R. A r a n d o mi z e d tri al c o m p ari n g h u m a n e- m ail c o u ns eli n g, c o m p ut er- a ut o m at e d t ail or e d c o u ns eli n g, a n d n o c o u ns eli n g i n a n i nt er n et w ei g ht l oss pr o gr a m. Ar c hi v es of I nt er n al M e di ci n e 2 0 0 6; 1 6 6( 1 5): 1 6 2 0- 2 5.  
1 2. C h e u n g A S, P attis o n D, Br et h ert o n I, et al. C ar di o v as c ul ar ris k a n d b o n e l oss i n m e n u n d er g oi n g a n dr o g e n d e pri v ati o n t h er a p y f or n o n- m et ast ati c pr ost at e c a n c er: i m pl e m e nt ati o n of st a n d ar di z e d m a n a g e m e nt g ui d eli n es. A n dr ol o g y 2 0 1 3; 1: 5 8 3- 5 8 9.  
1 3. S mit h M R. C h a n g es i n f at a n d l e a n b o d y m ass d uri n g a n dr o g e n- d e pri v ati o n t h er a p y f or pr ost at e c a n c er. J of Ur ol o g y 2 0 0 4; 6 3( 4): 7 4 2- 7 4 5.  
1 4. J e ns k y- S q uir es N E, Di eli- C o n wri g ht C M, R oss u ell o A, et al. V ali dit y a n d r eli a bilit y of b o d y c o m p ositi o n a n al ys ers i n c hil dr e n a n d a d ults. Br J of N utriti o n 2 0 0 8; 1 0 0( 4): 8 5 9- 8 6 5.  
1 5. S mit h M R, L e e H, M c G o v er n F, et al. M et a b oli c c h a n g es d uri n g g o n a d otr o pi n- r el e asi n g h or m o n e a g o nist t h er a p y f or pr ost at e c a n c er. C a n c er 2 0 0 8; 1 1 2: 2 1 8 8- 9 4.  
1 6. I nt e nsi v e bl o o d- gl u c os e c o ntr ol wit h s ul p h o n yl ur e as or i ns uli n c o m p ar e d wit h c o n v e nti o n al tr e at m e nt a n d ris k of c o m pli c ati o ns i n p ati e nts wit h t y p e 2 di a b et es ( U K P D S 3 3). U K  
Pr os p e cti v e Di a b et es St u d y ( U K P D S) Gr o u p. L a n c et 1 9 9 8; 3 5 2( 9 1 3 1): 8 3 7.  
1 7. B o n or a E, F or m e nti ni G, C al c at err a F, et al. H O M A- esti m at e d i ns uli n r esist a n c e is a n i n d e p e n d e nt pr e di ct or of c ar di o v as c ul ar dis e as e i n t y p e 2 di a b eti c s u bj e cts: pr os p e cti v e d at a fr o m t h e V er o n a Di a b et es C o m pli c ati o ns St u d y. Di a b et es C ar e 2 0 0 2; 2 5: 1 1 3 5- 1 1 4 1.  
1 8. S mit h M R, G o o d e M, Zi et m a n A L, et al. Bi c al ut a mi d e m o n ot h er a p y v ers us l e u pr oli d e m o n ot h er a p y f or pr ost at e c a n c er: eff e cts o n b o n e mi n er al d e nsit y a n d b o d y c o m p ositi o n. J  
Cli n O n c ol 2 0 0 4; 2 2( 1 3): 2 5 4 6- 2 5 5 3.  
1 9. S h a hi ni a n V B, K u o Y F, Fr e e m a n J L, a n d G o o d wi n J S. Ris k of fr a ct ur e aft er a n dr o g e n d e pri v ati o n f or pr ost at e c a n c er. N e w E n gl J of M e di ci n e 2 0 0 5; 3 5 2( 2): 1 5 4- 1 6 4.  
2 0. W ar e J E a n d S h er b o ur n e C D. T h e M O S 3 6- it e m s h ort-f or m h e alt h s ur v e y ( S F- 3 6). M e di c al C ar e 1 9 9 2; 3 0( 6): 4 7 3- 4 8 3.  
2 1. P ot os k y A L, K n o pf K, Cl e g g L X, et al. Q u alit y- of-lif e o ut c o m es aft er pri m ar y a n dr o g e n d e pri v ati o n t h er a p y: r es ults fr o m t h e Pr ost at e C a n c er O ut c o m es St u d y. J Cli n O n c ol 2 0 0 1; 1 9( 1 7): 3 7 5 0- 3 7 5 7.  
2 2. C ar p e nt er J S. T h e h ot fl as h r el at e d d ail y i nt erf er e n c e s c al e. J of P ai n a n d S y m pt o m M a n a g e m e nt 2 0 0 1; 2 2( 6): 9 7 9- 9 8 9.  
2 3. S z y m a ns ki K M, W ei J T, D u n n R L, a n d S a n d a M G. D e v el o p m e nt a n d v ali d ati o n of a n a b br e vi at e d v ersi o n of t h e E x p a n d e d Pr ost at e C a n c er I n d e x c o m p osit e i nstr u m e nt f or m e as uri n g h e alt h -r el at e d q u alit y of lif e a m o n g pr ost at e c a n c er s ur vi v ors. J Ur ol o g y 2 0 1 0; 7 6( 5): 1 2 4 5- 1 2 5 0.  
2 4. L e e K A, Hi c ks G, a n d Ni n o- M ur ci a G. V ali dit y a n d r eli a bilit y of a s c al e t o ass ess f ati g u e.  
Ps y c hi atr y R es e ar c h 1 9 9 1; 3 6: 2 9 1- 2 9 8.  
2 5. Pirl W F, Si e g el GI, G o o d e MJ, a n d S mit h M R. D e pr essi o n i n m e n r e c ei vi n g a n dr o g e n d e pri v ati o n t h er a p y f or pr ost at e c a n c er: a pil ot st u d y. Ps y c h o- O n c ol o g y 2 0 0 2; 1 1: 5 1 8- 5 2 3.  
2 6. Ji n Y, H a y es D F, Li L, et al. Estr o g e n r e c e pt or g e n ot y p es i nfl u e n c e h ot f l as h pr e v al e n c e a n d c o m p osit e s c or e b ef or e a n d a ft er t a m o xif e n th er a p y . J Cli n O n c ol 2 0 0 8; 2 6( 3 6): 5 8 4 9- 5 8 5 4.  
2 7. R oss R, O h W K, Xi e W, et al. I n h erit e d v ari ati o n i n t h e a n dr o g e n p at h w a y is a ss o ci at e d wit h t h e effi c a c y of a n dr o g e n d e pri v ati o n t h er a p y i n me n wit h pr ost at e c a n c er . J Cli n O n c ol 2 0 0 8; 2 6( 6): 8 4 2- 4 7.  
2 8. S a yl or PJ, K ar ol y E D, S mit h M R. Pr os p e cti v e st u d y of c h a n g es i n t h e m et a b ol o mi c pr ofil es of m e n d uri n g t h eir first t hr e e m o nt hs of a n dr o g e n d e pri v ati o n t h er a p y f or pr ost at e c a n c er.  
Cli n C a n c er R es 2 0 1 2; 1 8: 3 6 7 7- 8 5.  
2 9. M o a z z a mi A A, Z h a n g J X, K a m al -El di n A, et al. N u cl e ar m a g n eti c r es o n a n c e -b as e d m et a b ol o mi cs e n a bl e d et e cti o n of t h e eff e cts of a w h ol e gr ai n r y e a n d r y e br a n di et o n t h e m et a b oli c pr ofil e of pl as m a i n pr ost at e c a n c er p ati e nts. J N utr 2 0 1 1; 1 4 1: 2 1 2 6- 3 2.  
A p p e n di x 1. S el e ct e d G e n eti c P ol y m o r p hi s m s  
| G e n e                | P ol y m o r p his m     | L o c ati o n        | P r ot ei n                   | R ef e r e n c e                                     |                |
|------------------------|--------------------------|----------------------|-------------------------------|------------------------------------------------------|----------------|
| C Y P 1 9 A 1          | ( T T T A)               | I ntr o n 4          | Ar o m at as e                | Ts u c hi y a N, et al J of  Cli n O n c ol 2 0 0 6  |                |
| C Y P 1 9 A 1          | rs 1 8 7 0 0 5 0 A > C   | 5 k b u pstr e a m   | Ar o m at as e                | R oss R, et al J of Cli n  O n c ol 2 0 0 8          |                |
| H S D 3 B 1            | rs 1 8 5 6 8 8 8 A > G   | 1 3 k b u pstr e a m | H S D                         | R oss R, et al J of Cli n  O n c ol 2 0 0 8          |                |
| H S D 1 7 B 4          | rs 7 7 3 7 1 8 1 C > G   | I ntr o n            | H S D                         | R oss R, et al. J of  Cli n O n c ol 2 0 0 8         |                |
| S L C O 1 B 3          | 3 3 4 T > G              | E x o n 3            | O A T P                       | H a m a d a A, et al. Cli n  C a n c er R es 2 0 0 8 |                |
| S L C O 1 B 3          | 6 9 9 G > A              | E x o n 6            | O A T P                       | H a m a d a A, et al. Cli n  C a n c er R es 2 0 0 8 |                |
| S L C O 2 B 1          | rs 1 2 4 2 2 1 4 9 A > G | E x o n 7            | O A T P                       | Y a n g                                              | M, et al. J of |
| Cli n O n c ol 2 0 1 1 |                          |                      |                               |                                                      |                |
| S L C O 2 B 1          | rs 1 7 8 9 6 9 3         | I ntr o n 7          | O A T P                       | Y a n g                                              | M, et al. J of |
| Cli n O n c ol 2 0 1 1 |                          |                      |                               |                                                      |                |
| S L C O 2 B 1          | rs 1 0 7 7 8 5 8         | I ntr o n 8          | O A T P                       | Y a n g                                              | M, et al. J of |
| Cli n O n c ol 2 0 1 1 |                          |                      |                               |                                                      |                |
| A R                    | ( C A G)n                | E x o n 1 ( N T D)   | A n dr o g e n  R e c e pt or | St a nf or d J, et al.  C a n c er R es 1 9 9 7      |                |
| A R                    | ( G G C)                 | E x o n 1 ( N T D)   | A n dr o g e n  R e c e pt or | St a nf or d J, et al.  C a n c er R es 1 9 9 7      |                |
| A R                    | rs 1 7 3 0 2 0 9 0       | Pr o m ot er         | A n dr o g e n  R e c e pt or | Li n dstr o m et al Cli n  C a n c er R es 2 0 0 7   |                |  
A p p e n di x 2 . Q u alit y of Lif e Q u e sti o n n ai r e s S F - 1 2 ®:
untitled h1
epic-26

1. Over the past 4 weeks, how often have you leaked urine?  
| More than once a day....................... 1        |
|------------------------------------------------------|
| About once a day.................................. 2 |
| More than once a week...................... 3        |
| About once a week.............................4      |
| Rarely or never.                                     |  
(Circle one number)
2. Which of the following best describes your urinary control during the last 4 weeks?  
| No urinary control whatsoever.......... .................................1                      |
|-------------------------------------------------------------------------------------------------|
| Frequent dribbling........................................................................... 2 |
| Occasional dribbling                                                                            |
| Total control.                                                                                  |  
(Circle one number)
3. How many pads or adult diapers per day did you usually use to control leakage during the last 4 weeks?  
| None .                 | 0   |
|------------------------|-----|
| 1 pad per day.         | 1   |
| 2 pads per day         | 2   |
| 3 or more pads per day | 3   |  
(Circle one number)
4. How big a problem, if any, has each of the following been for you during the last 4 weeks?  
(Circle one number on each line)  
| No                                     | Very Small                        | Small   | Moderate   | Big     |    |    |
|----------------------------------------|-----------------------------------|---------|------------|---------|----|----|
| Problem                                | Problem                           | Problem | Problem    | Problem |    |    |
| a. Dripping or leaking urine ......... | 0                                 | 1       | 2          | 3       | 4  |    |
| b.                                     | Pain or burning on urination..... | 0       | 1          | 2       | 3  | 4  |
| Bleeding with urination............    | 2                                 | 3       |            |         |    |    |
| C                                      | 0                                 | 1       | 4          |         |    |    |
| d.                                     | Weak urine stream                 |         |            |         |    |    |
| or incomplete emptying .............   | 0                                 | 1       | 2          | 3       | 4  |    |
| e.                                     | Need to urinate frequently during | 2       |            |         |    |    |
| the day.                               | 0                                 | 1       | 3          | 4       |    |    |  
5. Overall, how big a problem has your urinary function been for you during the last 4 weeks?  
| No problem................................................. 1   |
|-----------------------------------------------------------------|
| Very small problem................................ 2            |
| Small problem.                                                  |
| Moderate problem                                                |
| Big problem.                                                    |  
(Circle one number)  
| 6. How big a problem, if any, has each of the following been for you? (Circle one number on each line)   |                                     |         |          |         |    |    |
|----------------------------------------------------------------------------------------------------------|-------------------------------------|---------|----------|---------|----|----|
| No                                                                                                       | Very Small                          | Small   | Moderate | Big     |    |    |
| Problem                                                                                                  | Problem                             | Problem | Problem  | Problem |    |    |
| a.                                                                                                       | Urgency to have                     |         |          |         |    |    |
| a bowel movement  .....................                                                                  | 0                                   | 1       | 2        | 3       | 4  |    |
| b.                                                                                                       | Increased frequency of              |         |          |         |    |    |
| bowel movements........................                                                                  | 0                                   | 1       | 2        | 3       | 4  |    |
| C                                                                                                        | Losing control of your stools...... | 0       | 1        | 2       | 3  | 4  |
| d.                                                                                                       | Bloody stools                       | 0       | 1        | 2       | 3  | 4  |
| e.                                                                                                       | Abdominal/ Pelvic/Rectal pain...    | 0       | 1        | 2       | 3  | 4  |  
7. Overall, how big a problem have your bowel habits been for you during the last 4 weeks?  
| No problem............................................. 1   |
|-------------------------------------------------------------|
| Very small problem.............................. 2          |
| Small problem............................................3  |
| Moderate problem................................... 4       |
| Big problem.                                                |  
(Circle one number)
8. How would you rate each of the following during the last 4 weeks? (Circle one number on each line)
Very Poor to None Poor Very Good Fair Good Your ability to have an erection?.  
a.  
1 2 3 4 5 Your ability to reach orgasm (climax)?.........................  
b.  
1 2 3 5 4 9. How would you describe the usual QUALITY of your erections during the last 4 weeks?  
| None at all.                                                                         | 1   |
|--------------------------------------------------------------------------------------|-----|
| Not firm enough for any sexual activity                                              | 2   |
| Firm enough for masturbation and foreplay only.................................... 3 |     |
| Firm enough for intercourse                                                          |     |  
(Circle one number)
10. How would you describe the FREQUENCY of your erections during the last 4 weeks?  
I NEVER had an erection when I wanted one.  
1  
| I had an erection LESS THAN HALF the time I wanted one.............      | 2   |
|--------------------------------------------------------------------------|-----|
| I had an erection ABOUT HALF the time I wanted one ..................... | 3   |
| I had an erection MORE THAN HALF the time I wanted one.............      | 4   |
| I had an erection WHENEVER I wanted one.                                 | 5   |  
(Circle one number)
1. Overall, how would you rate your ability to function sexually during the last 4 weeks?  
| Very poor.   | 1   |
|--------------|-----|
| Poor.        | 2   |
| Fair         | 3   |
| Good         | 4   |
| Very good.   | 5   |  
(Circle one number)
12. Overall, how big a problem has your sexual function or lack of sexual function been for you during the last 4 weeks?  
| No problem         | 1   |
|--------------------|-----|
| Very small problem | 2   |
| Small problem.     | 3   |
| Moderate problem   | 4   |
| Big problem.       | 5   |  
(Circle one number)
13. How big a problem during the last 4 weeks, if any, has each of the following been for you?  
(Circle one number on each line)  
| No                 | Very Small                           | Small   | Moderate   | Big     |    |    |
|--------------------|--------------------------------------|---------|------------|---------|----|----|
| Problem            | Problem                              | Problem | Problem    | Problem |    |    |
| a.                 | Hot flashes.                         | 0       | 1          | 2       | 3  | 4  |
| b.                 | Breast tenderness/enlargement.       | o       | 1          | 2       | 3  | 4  |
| Feeling depressed. |                                      |         |            |         |    |    |
| C                  | o                                    | 1       | 2          | 3       | 4  |    |
| Lack of energy     | 1                                    | 2       | 3          |         |    |    |
| d.                 | 0                                    | 4       |            |         |    |    |
| e.                 | Change in body weight............... | o       | 1          | 2       | 3  | 4  |
untitled h1
lee fatigue scale

| DIRECTIONS: You are asked to place an "X" through these lines to indicate how you are feeling RIGHT NOW.   |                                                                                  |
|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| For example, suppose you have not eaten since yesterday. Where would you put the "X" on the line below?    |                                                                                  |
| not at all                                                                                                 | extremely                                                                        |
| hungry                                                                                                     |                                                                                  |
| hungry                                                                                                     | You would probably put the "X" closer to the "extremely hungry" end of the line. |
| This is where I pul it                                                                                     |                                                                                  |
| not at all                                                                                                 | extromely                                                                        |
| hungry                                                                                                     | hungy                                                                            |
| NOW PLEASE COMPLETE THE FOLLOWING ITEMS.                                                                   |                                                                                  |
| not at all                                                                                                 | ectremely                                                                        |
| tired                                                                                                      | tired                                                                            |
| not at all                                                                                                 | extremely                                                                        |
| sleepy                                                                                                     |                                                                                  |
| sleepy                                                                                                     |                                                                                  |
| not at all                                                                                                 | arrrrrrrrrrrrrrr                                                                 |
| drowsy                                                                                                     | drowsy                                                                           |
| not at all                                                                                                 | extremely                                                                        |
| fatigued                                                                                                   | fatigued                                                                         |
| not all                                                                                                    | extremely                                                                        |
| worn out                                                                                                   | wom out                                                                          |
| not at al                                                                                                  | extremely                                                                        |
| energetic                                                                                                  | energet c                                                                        |
| not at all                                                                                                 | extremely                                                                        |
| active                                                                                                     | active                                                                           |
| not at all                                                                                                 | extremely                                                                        |
| vigorous                                                                                                   | vigorous                                                                         |
| not at al                                                                                                  | extromely                                                                        |
| efficient                                                                                                  | eficient                                                                         |
| not at all                                                                                                 | extremely                                                                        |
| lively                                                                                                     | lively                                                                           |
| not at all                                                                                                 | totaly                                                                           |
| bushed                                                                                                     |                                                                                  |
| bushed                                                                                                     |                                                                                  |
| not at all                                                                                                 | totally                                                                          |
| exhausted                                                                                                  | exhausted                                                                        |
| keeping my                                                                                                 | keeping my                                                                       |
| eyes open                                                                                                  | eyes open                                                                        |
| is a tremendous                                                                                            |                                                                                  |
| is no effort                                                                                               |                                                                                  |
| at all                                                                                                     | chore                                                                            |
| moving my                                                                                                  | moving my body                                                                   |
| is a tremendous                                                                                            |                                                                                  |
| body is no                                                                                                 |                                                                                  |
| effort at all                                                                                              | chore                                                                            |
| concentrating                                                                                              | concentrating                                                                    |
| is no offort                                                                                               | is a tremendous                                                                  |
| chore                                                                                                      |                                                                                  |
| at al                                                                                                      |                                                                                  |
| carrying on                                                                                                | carrying on                                                                      |
| a conversation                                                                                             | a conversation                                                                   |
| is no effort                                                                                               | is a tremendous                                                                  |
| chore                                                                                                      |                                                                                  |
| at all                                                                                                     | l have a                                                                         |
| I have                                                                                                     |                                                                                  |
| absolutely no                                                                                              | tremendous                                                                       |
| desire to close                                                                                            | desire to                                                                        |
| close my eyes                                                                                              |                                                                                  |
| my eyes                                                                                                    |                                                                                  |
| l have                                                                                                     | l have a                                                                         |
| tremendous                                                                                                 |                                                                                  |
| absolutely no                                                                                              |                                                                                  |
| desire lo                                                                                                  | desire to                                                                        |
| lie down                                                                                                   | le down                                                                          |  
l
untitled h1
hot flash related daily interference

Please circle one number to the right of each phrase to describe how much DURING THE PAST WEEK hot flashes have INTERFERED with each aspect of your life. Higher numbers indicate more interference with your life. If you are not experiencing  
| hot flashes or if hot flashes do not interfere with these aspects of your life, please mark zero to the right of each question.   |            |    |    |    |    |    |    |    |    |    |    |
|-----------------------------------------------------------------------------------------------------------------------------------|------------|----|----|----|----|----|----|----|----|----|----|
| Do not                                                                                                                            | Completely |    |    |    |    |    |    |    |    |    |    |
| interfere                                                                                                                         | interfere  |    |    |    |    |    |    |    |    |    |    |
| 2                                                                                                                                 | 3          | 6  | 7  | 9  |    |    |    |    |    |    |    |
| 1. Work (work outside the home and housework)                                                                                     | 0          | l  | 9  | 4  | 8  | 10 |    |    |    |    |    |
| 2. Social activities (time spent with family, friends, etc.)                                                                      | 0          | 2  | 3  | 3  | 6  | 7  | 8  | 9  | 10 |    |    |
| l                                                                                                                                 | 4          |    |    |    |    |    |    |    |    |    |    |
| 3. Leisure activities (time spent relaxing, doing hobbies, etc.)                                                                  | (          | l  | 2  | 3  | 4  | 3  | 6  | 7  | 8  | 9  | 10 |
| 4. Sleep                                                                                                                          | (          | l  | 2  | 3  | 4  | 5  | 6  | 7  | 8  | 9  | 10 |
| 5. Mood                                                                                                                           | 0          | l  | 2  | 3  | 4  | 5  | 6  | 7  | 8  | 9  | 10 |
| 6. Concentration                                                                                                                  | 2          | 5  | 6  | 7  | 9  |    |    |    |    |    |    |
| 0                                                                                                                                 | l          | 3  | 4  | 8  | 10 |    |    |    |    |    |    |
| 7. Relations with others                                                                                                          | (          | y  | 3  | 4  | 5  | b  | 7  | 8  | g  | 10 |    |
| l                                                                                                                                 |            |    |    |    |    |    |    |    |    |    |    |
| 8. Sexuality                                                                                                                      | 0          | l  | 2  | 3  | 4  | 5  | 6  | 7  | 8  | 9  | 10 |
| 9. Enjoyment of life                                                                                                              | (          | l  | 2  | 20 | 4  | 5  | 6  | 7  | 8  | 9  | 10 |
| 10. Overall quality of life                                                                                                       | 0          | l  | 2  | 2  | 4  | 5  | 6  | 7  | 8  | 9  | 10 |
patient health questionnaire (phq-9)
hot flash related daily interference

| NAME:                                                      | DATE:                |        |    |    |
|------------------------------------------------------------|----------------------|--------|----|----|
| Over the last 2 weeks, how often have you been             |                      |        |    |    |
| bothered by any of the following problems?                 | More than            |        |    |    |
| (use "✓" to indicate your answer)                          | Several              | Nearly |    |    |
| Not at all                                                 | half the             |        |    |    |
| dys                                                        | every day            |        |    |    |
| dys                                                        |                      |        |    |    |
| 0                                                          | 1                    | 2      | 3  |    |
| 1. Little interest or pleasure in doing things             | 0                    | 1      | 2  | 3  |
| 2. Feeling down, depressed, or hopeless                    | o                    | 1      | 2  | 3  |
| 3. Trouble falling or staying asleep, or sleeping too much | 0                    | 1      | 2  | 3  |
| 4. Feeling tired or having little energy                   | 0                    | 1      | 2  | 3  |
| 5. Poor appetite or overeating                             |                      |        |    |    |
| 6. Feeling bad about yourself—or that you are a failure or | 0                    | 1      | 2  | 3  |
| have let yourself or your family down                      |                      |        |    |    |
| 7. Trouble concentrating on things, such as reading the    | 0                    | 1      | 2  | 3  |
| newspaper or watching television                           |                      |        |    |    |
| 8. Moving or speaking so slowly that other people could    |                      |        |    |    |
| have noticed. Or the opposite - being so figety or         | 0                    | 1      | 2  | 3  |
| restless that you have been moving around a lot more       |                      |        |    |    |
| than usual                                                 |                      |        |    |    |
| 9. Thoughts that you would be better off dead, or of       | 1                    | 2      |    |    |
| 0                                                          | 3                    |        |    |    |
| hurting yourself                                           | add columns          |        |    |    |
| (Healthcare professional: For interpretation of TOTAL,     | TOTAL:               |        |    |    |
| please refer to accompanying scoring card).                |                      |        |    |    |
| 10. If you checked off any problems, how difficult         | Not difficult at all |        |    |    |
| have these problems made it for you to do                  | Somewhat difficult   |        |    |    |
| your work, take care of things at home, or get             | Very difficult       |        |    |    |
| along with other people?                                   | Extremely difficult  |        |    |    |
patient health questionnaire (phq-9)
attentional functional index

I. At this time, how well do you feel you are functioning in each of the areas below?  
| Place a mark through the line at whatever point best describes how you are doing in each area at present.   |                                          |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 1. Getting started on activities (tasks, jobs) you intend to do.                                            |                                          |
| Not at all                                                                                                  | Extremely well                           |
| 2.                                                                                                          | Following through on your plans.         |
| Not at all                                                                                                  | Extremely well                           |
| 3.                                                                                                          | Doing things that take time and effort.  |
| Not at all                                                                                                  | Extremely well                           |
| 4.                                                                                                          | Making your mind up about things.        |
| Not at all                                                                                                  | Extromoly woll                           |
| 5.                                                                                                          | Keeping your mind on what you are doing. |
| Not at all                                                                                                  | Extremely well                           |
| 6. Remembering to do all the things you started out to do.                                                  |                                          |
| Not at all                                                                                                  | Extremely well                           |
| 7. Keeping your mind on what others are saying.                                                             |                                          |
| Not at all                                                                                                  | Extremely well                           |
| 8. Keeping yourself from saying or doing things you did not want to say or do.                              |                                          |
| Not at all                                                                                                  | __                                       |
| 9.  Being patient with others.                                                                              |                                          |
| Not at all                                                                                                  | __                                       |
| I. At this time, how would you rate yourself on:                                                            |                                          |
| 10. How hard you find it to concentrate on details.                                                         |                                          |
| Not at all                                                                                                  | A great deal                             |
| 1. How often you make mistakes on what you are doing.                                                       |                                          |
| Not at all                                                                                                  | A great deal                             |
| 12.  Forgetting to do important things.                                                                     |                                          |
| Not at all                                                                                                  | A great deal                             |
| 13. Getting easily annoyed or irritated.                                                                    |                                          |
| Not at all _                                                                                                | _ A great deal                           |
patient health questionnaire (phq-9)
exercise pattern assessment (baseline)

8. What is your usual walking pace outdoors?  
) Easy, casual (less than 2 mph)  
  
| Comments                                                                                                         |          |         |           |          |         |        |         |        |         |          |           |        |         |          |         |
|------------------------------------------------------------------------------------------------------------------|----------|---------|-----------|----------|---------|--------|---------|--------|---------|----------|-----------|--------|---------|----------|---------|
| Please record any exercise that you do for the seven consecutive days prior to your visit with exercise trainer. | Nausea/Fatigue
(1-10 with 10 feeling          | Nausea  | _ Fatigue | Nausea   | Fatigue | Nausea | Fatigue | Nausea | Fatigue | , Nausea | _ Fatigue | Nausea | Fatigue | , Nausea | Fatigue |
| Perceived
Intensity                                                                                                                  |          |         |           |          |         |        |         |        |         |          |           |        |         |          |         |
| Heart Rate                                                                                                       |          |         |           |          |         |        |         |        |         |          |           |        |         |          |         |
| (inutes)                                                                                                         |          |         |           |          |         |        |         |        |         |          |           |        |         |          |         |
| Type of
Activity                                                                                                                  |          |         |           |          |         |        |         |        |         |          |           |        |         |          |         |
| Time                                                                                                             | IONDAY   | TUESDAY | HURSDAY   | SATURDAY | SUNDAY  |        |         |        |         |          |           |        |         |          |         |
| Day of
Week                                                                                                                  | EDNESDAY | RIDAY   |           |          |         |        |         |        |         |          |           |        |         |          |         |
| Date                                                                                                             |          |         |           |          |         |        |         |        |         |          |           |        |         |          |         |  
is and Settings/clarkjan/DesktopiCMCCExercise DAL.doc F O O D A N D B E V E R A G E W O R K S H E E T  
N a m e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Bi rt h d at e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
D a y of t h e W e e k: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Pl e as e r e c or d all f o o ds & b e v er a g es c o ns u m e d f or t h e d a y - t h e m or e d et ail e d t h e r e c or d, t h e m or e a c c ur at e t h e a n al ysis will b e. F or e x a m pl e: t ur k e y s a n d wi c h ( 2 sli c es w h ol e w h e at br e a d, 3 o z t ur k e y, ½ c u p l ett u c e, ¼ c u p t o m at o, 1 t bs p m ust ar d). I n cl u d e t w o w e e k d a ys & o n e w e e k e n d d a y.  
Ti m e F o o d o r B e v e r a g e A m o u nt  
| d a y.  Ti m e                 | F o o d o r B e v e r a g e   | A m o u nt   |
|--------------------------------|-------------------------------|--------------|
| W as t his d a y t y pi c al ? |  Y es                         |  N o         |
| If n ot, h o w s o ?           |                               |              |
patient health questionnaire (phq-9)
e q - 8 q

Pl e as e a ns w e r o n a s c al e of 1 -5 ( 1 dis a g r e e st r o n gl y; 5 a g r e e c o m pl et el y) h o w w ell e a c h st at e m e nt m at c h es y o u r p e rs o n alit y:  
1. I fi n d it e as y t o p ut m ys elf i n s o m e b o d y els e's s h o es.  
2. I a m g o o d at pr e di cti n g h o w s o m e o n e will f e el.  
3. I a m q ui c k t o s p ot w h e n s o m e o n e i n a gr o u p is f e eli n g a w k w ar d or u n c o mf ort a bl e.  
4. Ot h er p e o pl e t ell m e I a m g o o d at u n d erst a n di n g h o w t h e y ar e f e eli n g a n d w h at t h e y ar e t hi n ki n g.  
5. I fi n d it h ar d t o k n o w w h at t o d o i n a s o ci al sit u ati o n.  
6. I oft e n fi n d it h ar d t o j u d g e if s o m et hi n g is r u d e or p olit e.  
7. It is h ar d f or m e t o s e e w h y s o m e t hi n gs u ps et p e o pl e s o m u c h.  
8. Ot h er p e o pl e oft e n s a y t h at I a m i ns e nsiti v e, t h o u g h I d o n't al w a ys s e e w h y.
patient health questionnaire (phq-9)
appendix 3. charlson co-morbidity index

Table 1.    Charlson Comorbidity Index Scoring System  
| Score   |
|---------|  
1  
| Condition   |
|-------------|  
| Myocardial infarction (history, not ECG changes only)   |
|---------------------------------------------------------|
| Congestive heart failure                                |  
Peripheral vascular disease (includes aortic aneurysm ≥ 6 cm)
Cerebrovascular disease: CVA with mild or no residua or TIA
Dementia Chronic pulmonary disease Connective tissue disease Peptic ulcer disease Mild liver disease (without portal hypertension, includes chronic hepatitis)
Diabetes without end-organ damage (excludes diet-controlled alone)
Hemiplegia Moderate or severe renal disease Diabetes with end-organ damage (retinopathy, neuropathy, nephropathy, or brittle diabetes)
Tumor without metastases (exclude if >5 y from diagnosis)
Leukemia (acute or chronic)
Lymphoma Moderate or severe liver disease Motastatic solid tumor AIDS (not just HIV positive)
NOTE. For each decade > 40 years of age, a score of 1 is added to the above score.  
A A Complete and the complete of the complete and the complete of the complete and the complete of the complete and the complete of the immunodeficiency syndrome; HIV, human immunodeficiency virus.  
2 3 8 A p p e n di x 4 : Bi o el e ct ri c al I m p e d a n c e D e vi c e f o r A s s e s s m e nt of P e r c e nt a g e B o d y F at
patient health questionnaire (phq-9)
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A c c el er o m et er P arti ci p a nt I nstr u cti o ns  
- Pl e as e w e ar t h e b elt wit h t h e a c c el er o m et er f or s e v e n d a ys, st arti n g t h e m or ni n g of  
_ _ _ _ _ _ _ _ _ _ _ a n d e n di n g t h e e v e ni n g of _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.  
- W e ar t h e b elt ar o u n d y o ur w aist wit h t h e a c c el er o m et er pl a c e d o n y o ur ri g ht si d e. T h e d e vi c e s h o ul d b e att a c h e d s e c ur el y t o y o ur b o d y s o it d o es n ot h a v e a n y e xtr a n e o us m o v e m e nt.  
- Pl e as e w e ar t h e b elt wit h t h e a c c el er o m et er at all ti m es w h e n a w a k e, fr o m risi n g i n t h e m or ni n g u ntil g oi n g t o sl e e p at ni g ht, f or s e v e n c o ns e c uti v e d a ys.  
- T h e d e vi c e is N O T w at er pr o of - r e m o v e t h e b elt w h e n b at hi n g or s wi m mi n g.  
- Pl e as e r et ur n t h e b elt wit h t h e a c c el er o m et er i n p ers o n, or vi a U S P S i n t h e pr o vi d e d a d dr ess e d st a m p e d e n v el o p e, as s o o n as p ossi bl e aft er c o m pl eti n g y o ur s e v e n d a ys.  
- If a n y q u esti o ns, pl e as e c o nt a ct us vi a e m ail or t el e p h o n e: E v el y n H a n g at H a n g E @ c c. u csf. e d u or 4 1 5- 8 8 5- 3 3 5 7.
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T h e U C S F H el e n Dill er F a mil y C o m pr e h e n si v e C a n c er C e nt er ( H D F C C C) D at a a n d S af et y M o nit ori n g C o m mitt e e ( D S M C) i s r e s p o n si bl e f or m o nit ori n g d at a q u alit y a n d s u bj e ct s af et y f or all H D F C C C i n stit uti o n al cli ni c al st u di e s. A s u m m ar y of D S M C a cti viti e s f or t hi s st u d y i n cl u d e:  
- R e vi e w of Gr a d e 2 a n d hi g h er a d v er s e e v e nt s.  
- R e vi e w of s u s p e ct e d a d v er s e r e a cti o n s c o n si d er e d " s eri o u s" .
a p p e n
m o nit ori n

I n v e sti g at or s will c o n d u ct c o nti n u o u s r e vi e w of d at a a n d s u bj e ct s af et y a n d di s c u s s e a c h s u bj e ct' s tr e at m e nt at m o nt hl y Sit e C o m mitt e e m e eti n g s. T h e s e di s c u s si o n s ar e d o c u m e nt e d i n t h e Sit e C o m mitt e e m e eti n g mi n ut e s. T h e di s c u s si o n will i n cl u d e t h e n u m b er of s u bj e ct s, si g nifi c a nt t o xi citi e s i n a c c or d a n c e wit h t h e pr ot o c ol, a n d o b s er v e d r e s p o n s e s.
a p p e n
a d v er s

All gr a d e( s) 3 -5 a d v er s e e v e nt s, w h et h er or n ot u n e x p e ct e d, a n d w h et h er or n ot c o n si d er e d t o b e a s s o ci at e d wit h t h e u s e of t h e st u d y tr e at m e nt, will b e e nt er e d i nt o O n C or e ®, U C S F' s Cli ni c al Tri al M a n a g e m e nt S y st e m.  
All gr a d e( s) 3 -5 a d v er s e e v e nt s e nt er e d i nt o O n C or e ® will b e r e vi e w e d o n a m o nt hl y b a si s at t h e Sit e C o m mitt e e m e eti n g s. T h e Sit e C o m mitt e e will r e vi e w a n d di s c u s s t h e s el e ct e d t o xi cit y, t h e t o xi cit y gr a d e, a n d t h e attri b uti o n of r el ati o n s hi p of t h e a d v er s e e v e nt t o t h e a d mi ni str ati o n of t h e st u d y tr e at m e nt.  
I n a d diti o n, all s u s p e ct e d a d v er s e r e a cti o n s c o n si d er e d " s eri o u s" e nt er e d i nt o O n C or e ®, will b e r e vi e w e d a n d m o nit or e d b y t h e D at a a n d S af et y M o nit ori n g C o m mitt e e o n a n o n g oi n g b a si s a n d di s c u s s e d at D S M C m e eti n g s, w hi c h t a k e pl a c e e v er y si x w e e k s.  
If a d e at h o c c ur s d uri n g t h e tr e at m e nt p h a s e of t h e st u d y or wit hi n 3 0 d a y s aft er t h e l a st a d mi ni str ati o n of t h e st u d y tr e at m e nt a n d it i s d et er mi n e d t o b e r el at e d eit h er t o t h e st u d y tr e at m e nt or t o a st u d y pr o c e d ur e, t h e I n v e sti g at or or hi s/ h er d e si g n e e m u st n otif y t h e D S M C  
C h air wit hi n 1 b u si n e s s d a y of k n o wl e d g e of t hi s e v e nt. T h e c o nt a ct m a y b e b y p h o n e or e -  
m ail.
a p p e n
i n cr e a

If a n i n cr e a s e i n t h e fr e q u e n c y of Gr a d e 3 or 4 a d v er s e e v e nt s ( a b o v e t h e r at e r e p ort e d i n t h e I n v e sti g at or Br o c h ur e or p a c k a g e i n s ert) i s n ot e d i n t h e st u d y, a r e p ort s h o ul d b e s u b mitt e d t o t h e D S M C at t h e ti m e t h e i n cr e a s e d r at e i s i d e ntifi e d. T h e r e p ort will i n di c at e if t h e i n ci d e n c e of a d v er s e e v e nt s o b s er v e d i n t h e st u d y i s a b o v e t h e r a n g e st at e d i n t h e I n v e sti g at or Br o c h ur e or p a c k a g e i n s ert.  
If at a n y ti m e t h e I n v e sti g at or st o p s e nr oll m e nt or st o p s t h e st u d y d u e t o s af et y i s s u e s, t h e D S M C C h air a n d D S M C M a n a g er m u st b e n otifi e d wit hi n 1 b u si n e s s d a y vi a e -m ail. T h e D S M C  
m u st r e c ei v e a f or m al l ett er wit hi n 1 0 b u si n e s s d a y s a n d t h e C H R m u st b e n otifi e d .  
D at a a n d S af et y M o nit ori n g C o m mitt e e C o nt a ct s:  
D S M C C h air: D S M C M o nit or s P h o n e:  
E m ail:  
A d dr e s s:  
U C S F H el e n Dill er F a mil y  
  
C o m pr e h e n si v e C a n c er C e nt er S a n Fr a n ci s c o, C A 9 4 1 1 5
a p p e n
a p p e n

At b as eli n e, f or p ati e nts w h o a gr e e t o p arti ci p at e i n t his o pti o n al c o m p o n e nt of t h e st u d y, a 1 2 -  
m L bl o o d s a m pl e i n t w o pl asti c E D T A t u b es will b e c oll e ct e d fr o m e a c h p arti ci p a nt. S a m pl es will b e st or e d i n a 8 0 d e gr e es b el o w C elsi us fr e e z er i n t h e U C S F H el e n Dill er F a mil y C o m pr e h e nsi v e C a n c er C e nt er . G e n o mi c D N A will b e e xtr a ct e d b y usi n g a QI A m p D N A Mi ni Kit ( ) a c c or di n g t o t h e U C S F D N A B a n k st a n d ar d o p er ati n g pr o c e d ur es .  
B at c h e d D N A s a m pl es will b e t a k e n t o t h e Kr o et z l a b or at or y at U C S F Missi o n B a y c a m p us f or p ol y m or p his m ass ess m e nt.  
I n a d diti o n, at b as eli n e a n d aft er e v er y 3 m o nt hs o n st u d y, a n d at 6 m o nt hs f oll o wi n g c o m pl eti o n of S T A N D cli ni c p arti ci p ati o n, 2 0 m L of w h ol e bl o o d will b e c oll e ct e d i n o n e ti g ert o p (s er u m)  
a n d o n e l a v e n d er t o p t u b e ( pl as m a) a n d c e ntrif u g e d at 3 0 0 0 r p m f or 1 0 mi n ut es. T h e s er u m a n d pl as m a will b e d e c a nt e d i nt o t w o 2 -m L p ol y pr o p yl e n e s cr e w c a p (l e a k -pr o of) vi als (f o ur t ot al vi als) t h at h a v e b e e n pr o p erl y l a b el e d wit h t h e u ni q u e s p e ci m e n l o g n u m b er a n d st or e d at - 8 0 d e gr e es C elsi us.  
S a m pl es will b e c at al o g u e d i n di vi d u all y i n p ass w or d pr ot e ct e d tiss u e d at a b as e. P ati e nt i d e ntifi ers will b e r e m o v e d fr o m t his d at a b as e a n d s u bstit ut e d wit h st u d y I D n u m b ers. A n n ot ati o ns f or i n di vi d u al tiss u e/ bl o o d s a m pl es will b e m a d e f or pr o c essi n g.