Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
Phase: NA
Conditions: Prostate Neoplasm, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasm, Prostate, Genital Diseases, Male, Prostatic Diseases
Sponsor: University of Miami

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Protocol #:20170656 (Version15
Long Protocol Title: Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) 
Intervention for Prostate Cancer
Short Protocol Title: Health Gatherings –For Your Health after Cancer ( Encuentros de Salud – Por tu Salud 
Después del Cáncer ) NCT#03344757
Principle Investigators:
Miami - Frank J. Penedo, PhD (PI)
Sylvester Professor of Psychology and Medicine
Associate Director for Cancer Survivorship & Translational Behavioral Research Sylvester Comprehensive Cancer 
Center
College of Arts and Sciences & Miller School of Medicine University of Miami
Frank.penedo@miami.edu
Miami - Michael Antoni, Ph.D. (MPI/Co-PI) Department of Psychology University of Miami
(305) 284-5466
mantoni@miami.edu
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Purpose of the Study:
This 5-year study evaluates the effects of a 10-week group-based linguistically translated and culturally adapted 
cognitive-behavioral stress and self-management (C-CBSM) intervention on symptom burden and health related 
quality of life (HRQoL) in Hispanic men treated for localized prostate cancer (PC). About 80% PC cases are 
diagnosed as early disease and have a 5- and 10-year survival rate of almost 100% and 99%, respectively.1 Most 
patients receive active treatment (~70%) leading to prolonged treatment-related side effects and dysfunction 
persisting well beyond primary treatment.2, 3, 4 Survival is offset by chronic side effects such as sexual and urinary 
dysfunction, pain and fatigue that can lead to poor psychosocial functioning, impaired intimacy and social 
functioning, and masculinity concerns. 5, 6, 7 Hispanic PC survivors report lower physical and social functioning, 
poorer emotional well-being and greater sexual and urinary dysfunction, even after accounting for SES and disease 
severity. These sequelae can lead to elevated glucocorticoid release and inflammatory cytokines that have a direct 
effect on these symptoms and can interfere with physiological pathways necessary for recovery of sexual and 
urinary functioning. We have shown that CBSM reduces symptom burden and improves HRQoL in bilingual 
Hispanic PC survivors. In a pilot we showed that a linguistic translation of CBSM with attention to sociocultural 
processes improved symptom burden and HRQoL in Spanish monolingual PC survivors. We have also shown that 
CBSM is associated with reduced glucocorticoid resistance and inflammatory gene expression pathways in 
circulating leukocytes among breast cancer survivors. We propose to (a) deliver a culturally adapted C-CBSM 
intervention in Spanish that places greater emphasis on salient sociocultural determinants of symptom burden and 
HRQoL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo), (b) 
incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of C-CBSM, 
relative to standard non-culturally adapted CBSM, in two diverse Hispanic communities (Chicago & Miami). We 
will test our aims in 200 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2 x 4 
randomized design with condition (C-CSBM vs. CBSM) as the between groups factors, and time (baseline, post-
intervention & 6- and 12-months post intervention) as the within groups factor.
Our Primary Aim is to determine whether randomization to C-CBSM, relative to standard CBSM, is associated 
with reduced symptom burden and improved HRQoL. Our Secondary Aims evaluate whether C-CBSM leads to 
greater improvements in the intervention targets (e.g., stress management, psychological distress & interpersonal 
disruption), and physiologic adaptation (i.e., glucocorticoid receptor sensitivity & inflammatory gene expression). 
We will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSM’s effects on our 
primary outcomes. We also explore several moderators (e.g., SES, acculturation, treatment, Hispanic origin) of C-
CBSM’s effect on primary outcomes and the effects of C-CBSM on cardiometabolic health (e.g., lipids, fasting 
glucose) via reduced inflammation.
Primary Aim:
Aim 1: Determine whether participation in C-CBSM is associated with significantly greater reductions in symptom 
burden and improvements in HRQoL relative to participation in CBSM.
Secondary Aims:
Aim 2: Determine whether participation in C-CBSM is associated with significantly greater improvements in 
intervention targets (i.e., improved stress management, and reduced psychological distress and interpersonal 
disruption) relative to participation in the CBSM condition.
Exploratory Aims:
Aim 3: Explore whether participation in C-CBSM is associated with significantly greater activation of leukocyte 
glucocorticoid receptor and less inflammatory gene expression profiles relative to CBSM.
Aim 4: Explore whether C-CBSM related improvements in symptom burden and HRQoL are mediated by 
improvements in intervention targets and gene expression profiles.
Aim 5:  Explore moderators of C-CBSM (e.g., SES, treatment type, acculturation, Hispanic ancestry) and C-
CBSM’s effects on cardiometabolic markers via reduced inflammation.
Integrated Model of Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) in PC: Our 
aims are guided by several theoretical frameworks.8,9,10,11,12,13,14,15,16,17 Our approach is based on three 
predominant models: (a) psychosocial interventions impact clinically relevant outcomes (e.g., symptoms & 
HRQoL); (b) effects of psychosocial interventions on clinical outcomes are mediated by improvement in 
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Protocol #:20170656 (Version 15
intervention targets (e.g., stress management skills) that impact psychosocial (e.g., mood, social relations) and 
physiological (e.g., glucocorticoid resistance & inflammation) adaptation; and (c) cultural adaptation of evidence-
based treatments (EBTs) to optimize the effectiveness in a specific population. We also draw from models in cancer 
survivorship18,19 suggesting that the influence of ethnicity on HRQoL is mediated by modifiable mechanisms (e.g., 
knowledge, attitudes), and that HRQoL outcomes must be considered within the cultural and social context. Our 
approach conceptualizes SES, culture, emotions, cognitions and biology as interrelated underlying mechanisms 
associated with race/ethnicity, and that individuals are embedded within systems at multiple levels (e.g., context, 
inter- and intra-personal factors) that impact and interact with these mechanisms to promote health 
outcomes.20,21,22,23,24Based on biobehavioral oncology models 25,108suggesting stress- induced psychosocial 
modulation of glucocorticoid receptor sensitivity favors pro-inflammatory states, we propose that stress-related 
inflammation worsens symptom burden and HRQoL, but that C-CBSM can buffer this pathway.
Model for Test of C-CBSM’s Effects on Symptom Burden and HRQoL. Based on our research in chronic 
disease interventions and health outcomes in PC,57, ,59,60,98,25 HIV,26 CFS27, we hypothesize that C-CBSM vs. 
a standard non-culturally adapted CBSM will have greater reductions in psychological distress and interpersonal 
disruption, increased stress management skills and parallel improvements in physiologic adaptation. Based on our 
CBSM work in BC, and localized and advanced PC59,60,28 and a C-CBSM pilot, we propose that due to the cultural 
specificity of C-CBSM based on our adaptation, C- CBSM leads to significantly greater (incremental efficacy) 
reductions in symptom burden and improvements in HRQoL via its improvements in psychosocial and physiologic 
targets. All proposed mechanisms are linked to our aims by our prior work or literature documenting such pathways.
First, we test a novel linguistic and culturally adapted, culture-specific CBT-based stress management intervention 
(C-CBSM) in Spanish bilingual and monolingual PC survivors diverse in regard to SES and Hispanic ancestry in 
two US cities with a large concentration of Hispanics-Chicago and Miami. Therefore, this study will inform the 
utility of culturally adapted interventions in diverse Hispanics and provide greater generalizability by surpassing 
prior limited intervention work with Hispanic cancer survivors, which typically involves homogenous, low SES 
participants specific to one geographic area with behavioral interventions that have limited or no cultural adaptation. 
Second, unlike prior work, we test the utility and incremental efficacy of such cultural adaptations by comparing C-
CBSM to a standard CBSM intervention that is only linguistically translated. This approach will allow us to address 
an important and emerging research question—Do culturally adapted interventions for cancer survivors have 
incremental efficacy over standard, non-adapted treatments? This approach addresses the gap in prior work where 
the few available RCTs involved limited adaptations and inert or inadequate comparison conditions with no 
opportunity to evaluate the incremental efficacy of the cultural adaptation. Third, we evaluate whether C-CBSM’s 
effects on symptom burden and HRQoL are explained via its effect on physiologic pathways. Evaluating leukocyte 
gene expression of glucocorticoid and inflammation pathways will elucidate novel molecular signaling pathways 
by which C-CBSM and culture impact symptom burden and HRQoL. Relating psychosocial modulation of 
inflammation to PC symptom burden (i.e., sexual & urinary dysfunction) is highly innovative.
Background and Significance:
Almost 2.8 million men are living with Prostate Cancer (PC) accounting for 40% of all male cancer survivors. 
About 80% of PC cases are diagnosed as non-metastatic and have a 5-year relative survival rate of 100%. Survival 
is offset by chronic and debilitating treatment side effects of sexual and urinary dysfunction, pain and fatigue. Side 
effects also lead to poor psychosocial functioning including mood disturbance, impaired intimacy and social 
functioning, and body image and masculinity concerns. As PC occurs primarily in men 55 or older, other age-related 
stressors such as retirement, isolation, loss of independence, sense of lack of productivity, caregiving burdens and 
comorbidities can exacerbate compromises in health related quality of life (HRQoL).29, 30 Below we summarize 
studies examining the role of sociocultural, psychosocial and biobehavioral processes in HRQoL and health 
outcomes in PC57,98,31,32,33,34,35,36,37,38,39 survivors based on 15 years of work in PC.
Disparities in Hispanic PC Survivorship. In 216 Hispanic and non-Hispanic White (NHW) PC survivors with 
localized disease, Hispanics showed poorer psychosocial functioning, greater treatment- related symptom burden 
and poorer HRQoL, controlling for relevant confounds (see Table C.1). Participants were evenly divided between 
surgery and radiation, and most completed treatment in the past 12 months. All were fluent in English and ethnicity 
did not vary by age, marital status or SES.
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Psychosocial & Behavioral Adaptation, Symptom Burden and HRQoL. Hispanics reported less optimism, 
poorer emotional regulation, less tangible support, and greater perceived stress. Hispanics also reported worse sleep, 
less physical activity and lower adherence to nutritional guidelines. In regard to symptom burden and HRQoL, 
Hispanics showed significantly greater sexual and urinary dysfunction, less sexual desire and greater difficulty in 
achieving climax, greater bother associated with urine leakage and greater problems with daily incontinence. 
General HRQoL as measured by the Functional Assessment of Cancer Therapy (FACT-G)40 and specific domains 
of HRQoL were also compromised.
Sociocultural Processes & HRQoL. In 108 Hispanics, closeness and familiarity with Hispanic culture (Hispanic 
Cultural Identity Index; unpublished) was associated with greater HRQoL (FACT total, r=.23 & functional well-
being, r=.26), as well as with ABS positive affect (r=.26), and was inversely related to negative affect (ABS anxiety, 
r= -27; ABS negative affect composite, r= -.24). Cultural Estrangement (alienation from majority) was negatively 
associated with poorer HRQoL (FACT physical, r=-.24; emotional, r = -.28; and functional, r = -.37 well-being) 
and FACT Total (r=-.33; all p’s <.05). Using the Multigroup Ethnic Identity Measure (MEIM)41 "ethnic 
affirmation, belonging and commitment" was positively correlated with FACT-G (r=.19), tangible social support 
(r=.17), ABS positive affect (r=.20) and use of active coping strategies (r= .15, all p’s <.05), and inversely associated 
with ABS depression (r=-.26), anger (r=-.15) and guilt (r=-.25). Similarly, “ethnic identity search” was positively 
correlated with emotional and tangible social support (r=.21 & r=.23), positive affect(r=.21), general FACT HRQoL 
(r=.20) and social/family well-being (r=.30), but inversely related to measures of negative affect, including ABS 
depression (r=-.21) and anger (r=-.16; all p’s <.05). We also found that perceived discrimination and medical 
mistrust were associated with poorer FACT general, functional and emotional well-being (FACT scales; all r’s >-
.32),42 CES-D depression (r=.45), and IES cancer distress (r=.25; all p’s <.01). Fatalism was associated with poorer 
FACT emotional and physical wellbeing (all p’s <.05).
Efficacy of CBSM in Reducing Symptom Burden and Improving HRQoL. Our prior CBSM work was 
conducted in 200 men treated for localized PC (51% surgery, 49% radiation), 18-months post- treatment with an 
average age of 65.4. About 41% were NHW, 27% Black/African-American (AA), and 32% bilingual Hispanics 
(H). CBSM relative to a one-day stress management control seminar improved general HRQoL (FACT-G). 
Perceived stress management skills (PSMS) mediated the relationship between group assignment and HRQoL (β = 
.27, p < .001).57 Using structural equation modeling (SEM) we also showed that CBSM significantly improved both 
HRQoL and benefit finding, with effects mediated by CBSM-associated changes in PSMS.57 In a model with 
baseline sexual functioning, age, comorbidities, and sexual aids, assignment to CBSM predicted post-intervention 
sexual functioning (β=.14, P<.05; see Figure 3). CBSM also improved FACT emotional well-being across the 12-
mos. follow-up. CBSM also improved perceived sexual dysfunction pre- to post-CBSM (p<.05), and thru the 12-
month follow-up (p>.05) (see Figure 4).43 and improved urinary functioning pre-post CBSM (R2 Δ=.03, p<.05) 
(see Figure 5).43
Pilot of a Linguistically Adapted CBSM Intervention with Limited Attention to Culture. We conducted a 
linguistic translation of CBSM for PC survivors treated for localized disease who were Spanish monolingual men. 
Based on this preliminary work and literature describing shared cultural processes that may interact with chronic 
disease management,75,34 we translated the intervention using a professional company and internal verification 
and conducted some minor adaptations of the C- CBSM intervention to address how factors such as allocentrism 
and fatalism impact distress, interpersonal relations, self-management and health behaviors. We then conducted 12 
focus group sessions following an iterative approach where we first presented the adapted C-CBSM to 
interventionists (n=4) and health care providers (n=8; Sessions 1-4) and incorporated revisions, then presented the 
revised CBSM to ten Hispanic PC survivors (Sessions 5-8) and added further revisions based on their feedback. 
Finally, we presented the further revised CBSM to interventionists, providers and patients combined (Sessions 9-
12) and subsequently derived the final version. The vast majority (85-90%) of interventionists, providers and 
patients rated the final revision of C-CBSM “highly acceptable” and “highly relevant” to the needs of Hispanic PC 
survivors. Based on this qualitative work, we conducted a pilot study (N=71; surgery n=32; radiation n=39; all 
localized PC),98of this version of CBSM developed following standard adaptation procedures (e.g., information 
gathering, focus groups, expert & patient review).75,44 Acceptance rate for fully eligible participants was 42% and 
attendance was 80%. Assignment to C-CBSM, relative to controls (one-day seminar), showed significant 
improvements in FACT total, physical and emotional well-being, and EPIC sexual functioning, provided 
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Pa ge 5 of 3 4
--
Pr ot oc ol #: 2 0 1 7 0 6 5 6 ( Versi o n 1 5
preli mi nar y data o n t he feasi bilit y a n d acce pta bilit y ( 8 0 % atte n da nce), as well as s o me preli mi nar y efficac y o n 
i m pr o vi n g s y m pt o m b ur de n a n d H R Q o L f or His pa nic P C s ur vi v ors.
C B S M 
& P h ysi ol o gic al 
A d a pt ati o n. 
We d oc u me nte d 
C B S M’s effects o n di ur nal c ortis ol, circ ulati n g 
i nfla m mat or y mar kers a n d pr o-i nfla m mat or y ge ne e x pressi o n i n circ ulati n g le u k oc ytes.1 2 4 I n 8 4 P C s ur vi v ors 
a b o ut 1 0. 3 m o nt hs p ost s ur gical or ra diati o n treat me nt u n der g oi n g h or m o nal t hera p y, pr o- i nfla m mat or y c yt o ki nes 
were ass ociate d greater s y m pt o m b ur de n. Better uri nar y f u ncti o n pre- t o p ost- C B S M was ass ociate d wit h decreases 
i n b ot h I L- 1 ￿ (r =-. 5 5) a n d I L- 6 (r =-. 4 0). Si milarl y, decreases i n fati g ue acr oss t he i nter ve nti o n peri o d were 
ass ociate d wit h decreases i n I L- 1 ￿ (r =. 4 1) a n d I L- 6 (r =. 3 5). We als o f o u n d t hat decreases i n I L- 6 were ass ociate d 
wit h i ncreases i n b ot h p h ysical (r =-. 3 8) a n d s ocial (r =-. 3 7) f u ncti o ni n g, a n d decreases i n a n xiet y (r =. 4 0), w hile 
decreases i n I L- 1 ￿ were ass ociate d wit h decreases i n b ot h C E S- D de pressi o n (r =. 4 0) a n d a n A B S ne gati ve m o o d 
c o m p osite (r =. 4 1; all p’s <. 0 5). I n sta ge 0-III breast ca ncer ( B C) s ur vi v ors, C B S M re d uce d c ortis ol, c ha n ge d 
circ ulati n g n u m bers of s pecific le u k oc yte s u bsets a n d c yt o ki ne pr o d ucti o n b y T l y m p h oc ytes. 1 2 1, 1 2 3 ,1 2 4 ,1 2 5 
C B S M-treate d B C s ur vi v ors als o s h o we d re d ucti o ns i n e x pressi o n of le u k oc yte pr o-i nfla m mat or y ge ne pat h wa ys 
a n d e n ha nce d e x pressi o n of i n nate a nti viral ge ne pat h wa ys . Ge n o me- wi de tra nscri pti o nal pr ofili n g a n d 
bi oi nf or matics a nal yses were c o n d ucte d at baseli ne a n d 6- a n d 1 2- m o nt hs p ost- C B S M i n 7 9 B C s ur vi v ors 
ra n d o mize d t o C B S M or healt h pr o m oti o n. At baseli ne, ne gati ve affect was ass ociate d wit h a > 5 0 % differe ntial 
e x pressi o n of 2 0 1 le u k oc yte tra nscri pts. T his i ncl u de d u pre g ulate d e x pressi o n of pr o-i nfla m mat or y a n d metastasis-
relate d ge nes. C B S M altere d le u k oc yte e x pressi o n of 9 1 ge nes b y > 5 0 % at f oll o w- u p. Effects i ncl u de d 
d o w nre g ulati o n of pr o-i nfla m mat or y (e. g., I L- 1 A, I L 6, T N F A) a n d 
metastasis-relate d ( M M P 9) ge nes a n d 
u pre g ulati o n of T y pe I i nterfer o n (I F N) res p o nse ge nes. Pr o m oter- base d bi oi nf or matic a nal yses s h o we d a decrease d 
acti vit y of N F- ka p pa B/ Rel a n d G A T A fa mil y tra nscri pti o n fact ors a n d i ncrease d acti vit y of I F N res p o nse fact ors 
a n d t he gl uc oc ortic oi d rece pt or, s u g gesti n g t hese as me diat ors of C B S M-i n d uce d re versal of u pre g ulate d 
i nfla m mat or y ge ne e x pressi o n.1 2 4  Alt h o u g h hi g hl y efficaci o us, acti ve treat me nt (e. g., s ur ger y & ra diati o n; ~ 7 0 % 
of cases) f or l ocalize d pr ostate ca ncer ( P C) ca n lea d t o si g nifica nt s y m pt o m b ur de n (i.e., se x ual & uri nar y 
d ysf u ncti o n) a n d c o m pr o mises i n m ulti ple facets of healt h relate d q ualit y of life ( H R Q o L). His pa nic P C s ur vi v ors 
are at a p h ysical a n d ps yc h os ocial disa d va nta ge, yet e vi de nce base d treat me nts ( E B Ts) s uc h as c o g niti ve be ha vi oral 
stress ma na ge me nt ( C B S M) t hat ha ve pr o ve n effecti ve i n re d uci n g s y m pt o m b ur de n a n d i m pr o vi n g H R Q o L i n 
ca ncer s ur vi v ors ha ve rarel y tar gete d His pa nics or deli vere d c ult urall y a da pte d C B S M i n S pa nis h t o di verse 
His pa nics i n t he c o nte xt of a ra n d o mize d be ha vi oral cli nical trial wit h a n a de q uate sa m ple size a n d l o n g-ter m f oll o w-
u p. T his st u d y will fill se veral critical ga ps i n o ur k n o wle d ge o n t he i ncre me ntal efficac y of c ult urall y a da pte d 
E B Ts, relati ve t o sta n dar d li n g uistic tra nslati o ns, o n i m pr o vi n g s y m pt o m b ur de n a n d H R Q o L i n His pa nic me n wit h 
l ocalize d P C, a n d ma p s oci oc ult ural, ps yc h os ocial a n d m olec ular mec ha nis ms i n v ol ve d i n t he efficac y of C B S M, 
a n d t heref ore hel p g ui de tar gete d treat me nts f or t his criticall y u n derst u die d p o p ulati o n a n d ot her S pa nis h s pea ki n g 
ca ncer s ur vi v ors.
Acti ve tre at me nts are c o m m o n a n d a si g nific a nt s o urce of s y m pt o m b ur de n a n d p o or H R Q o L. Des pite t he 
utilit y of acti ve s ur veilla nce ( A S) i n l o w ris k P C, A S re mai ns u n der use d (i.e., ~ 1 2 % of eli gi ble patie nts). 4 5, 4 6 
I n de pe n de nt of P C ris k, use of acti ve treat me nt i ncrease d a b o ut 1 0 % fr o m 2 0 0 4- 2 0 1 2 ( ~ 7 0 % of l ocalize d cases 
recei ve acti ve treat me nt).4 7 , 4 8 Treat me nt relate d s y m pt o m b ur de n (i.e., se x ual & uri nar y d ysf u ncti o n), pai n, 
fati g ue a n d c o m pr o mise d H R Q o L (e. g., p h ysical, s ocial/fa mil y, e m oti o nal & f u ncti o nal well bei n g) are a 
persiste nt s o urce of c o ncer n a n d b ot her. 3, 4, 4 9 Years after treat me nt, 8 2 % of s ur ger y patie nts a n d 5 0 % of 
ra diati o n patie nts re mai n i m p ote nt ( E D), a n d 6 8 % re p ort p o or uri nar y c o ntr ol.5 0, 5 1 T he i m pact of E D o n H R Q o L 
is si g nifica nt, affecti n g se x ual i nterest a n d desire, relati o ns hi p q ualit y, b o d y i ma ge, a n d masc uli nit y a n d self-
estee m, wit h u p t o 8 5 % of me n wit h E D re p orti n g si g nifica nt le vels of ps yc h ol o gical distress. 5 2, 5 3, 5 4, 5 5, 5 6
Ps yc h os oci al i nter ve nti o ns re d uce s y m pt o m b ur de n a n d i m pr o ve H R Q o L i n c a ncer s ur vi v ors. Ps yc h os ocial 
i nter ve nti o ns facilitate a da ptati o n a n d fa v ora bl y i m pact mec ha nis ms k n o w n t o re d uce s y m pt o m b ur de n a n d 
i m pr o ve H R Q o L i n ca ncer s ur vi v ors.5 7- 5 8 I n B C a n d P C, we ha ve s h o w n t hat a c o g niti ve be ha vi oral t hera p y 
( C B T) gr o u p- base d stress a n d self- ma na ge me nt ps yc h os ocial i nter ve nti o n ( C B S M)5 9, 6 0 re d uce d s y m pt o m 
b ur de n, a n d i m pr o ve d H R Q o L, wit h stress ma na ge me nt s kills me diati n g t hese effects. 5 7 H o we ver, m ost of t his 
w or k has f oc use d o n n o n- His pa nic w hites ( N H Ws), wit h s o me atte nti o n t o His pa nics b ut wit h e xtre mel y li mite d 
c o nsi derati o n of S pa nis h s pea kers or His pa nic c ult ural pr ocesses.
P C S ur vi v ors hi p Dis p arities. Africa n A merica ns ( A As) a n d His pa nic/ Lati n os ( His pa nics hereafter) treate d f or 
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localized PC report significantly lower HRQoL relative to non-Hispanic whites even after controlling for SES and 
disease related factors.61,62 AAs are also more likely to be diagnosed with PC at a younger age, and are 2.4 more 
times likely to die of PC relative to NHWs.63 Hispanics, in contrast, generally have lower incidence and mortality 
for most cancers including PC64; however, they experience poorer quality of care, 65,66 which may account for 
greater recurrence, poorer HRQoL, shorter survival and higher mortality for some cancer sites.64 Relative to 
NHWs, Hispanic cancer survivors also report greater supportive needs with respect to connecting with other 
patients, stress management, coping with sadness, sharing thoughts/feelings, worries about their families and 
overcoming fears.67 This is not surprising as they also report greater distress and worse HRQoL compared to 
NHWs.68 In PC, Hispanics are more likely to present with advanced disease69,70 and report poorer physical 
functioning and emotional well-being, less treatment satisfaction, greater sexual and urinary dysfunction, and poorer 
recovery post-treatment relative to NHWs.67,68,69,70They are also more likely to be poorer, have less education, 
and have no health insurance or source of primary care.71,72,73,74 Despite this disadvantage, few evidence-based 
treatments (EBTs) target Hispanics or address Hispanic cultural processes.
Shared Hispanic sociocultural factors can impact health. Hispanics share sociocultural patterns with 
implications for disease management and health outcomes.75 However, very few have addressed these processes 
in cancer survivors and their implications for the effectiveness of EBTs such as CBSM.59,60 Family 
interdependence (allocentrism, familism) is associated with seeking medical care76 and better health behaviors but 
can also compromise HRQoL for men who place family needs before their own.77 Family support (familism) 
promotes emotional well-being in cohesive families, whereas family conflict is related to psychological distress.78 
Masculinity (gender roles) can heighten health maintenance but also contribute to negative health behaviors.79 
Lack of control about health (fatalism)80 can inhibit positive behavior change.81 Further, health care providers 
perceived as authority figures (power distance) and the need for harmonious interactions (simpatía) inhibit assertive 
and proactive communication/behaviors. In Hispanic breast cancer (BC) survivors, emotional and informational 
support is generally sought from the family82 and both BC and PC survivors are more likely to use religion or 
spirituality to cope with cancer.83,84,85 Such strategies are associated with less distress.83 Also, treatment 
symptoms such as fatigue and hair loss not only compromises HRQoL but are also stigmatized and associated with 
low self-esteem86,87 further compromising HRQoL.88 In our own work we found that multiple sociocultural 
factors impact symptom burden and HRQoL in PC.
The need for a culturally adapted psychosocial intervention for Hispanic PC survivors. Available evidence 
suggests that culturally adapted psychological interventions and treatments are valuable and needed.89 Integrating 
sociocultural components into EBTs can help achieve desired outcomes in specific populations.90,91 In conditions 
such as asthma, diabetes, and HIV/AIDS,92,93,94 culturally adapted EBTs have proven to be effective, and in 
depression, culturally adapted CBT programs show superior effects relative to standard treatment.95,96,97 
However, there are very few culturally adapted EBTs for cancer survivors.98,99,100,101 In Hispanic BC survivors, 
linguistically translated and community-engaged stress management and peer-support interventions have shown 
feasibility and some preliminary efficacy.102,103 In Hispanic BC survivors, physical activity interventions 
delivered in a culturally sensitive manner reduce distress, while adapted psychoeducational interventions decrease 
depressive symptoms.104,105 Although promising, available studies have multiple conceptual and methodological 
limitations, and the vast majority only have involved a linguistic translation. A linguistic translation is limited in 
that language does not fully address cultural patterns, behaviors, frames of reference/world view, belief systems 
and other factors, does not imply cultural competence and therefore limits the potential of therapeutic gains. 89,106 
In fact, in culturally competent care, by definition, a cultural adaptation involves “adaptation of interventions to 
meet culturally unique needs”.107 Consequently, there are significant gaps in understanding the efficacy of 
culturally adapted treatments: (a) cultural adaptation has generally involved a linguistic translation, or racial/ethnic 
pairing of interventionist, with no or very limited attention to cultural and social norms; (b) rarely have studies 
addressed how culture impacts provision and acquisition of EBT skills; (c) the vast majority of culturally adapted 
treatments have been paired against usual care, wait-list or other inert conditions thus limiting our knowledge on 
whether the cultural adaptation or the standard EBT mechanisms impacted observed outcomes; and (d) the utility 
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Protocol #:20170656 (Version 15
and incremental efficacy of adapted interventions, relative to standard EBTs, remains unknown.89
Why a focus on physiologic adaptation in Localized PC? Among cancer survivors, psychosocial processes (e.g., 
stress, anxiety, isolation) coupled with ongoing monitoring and symptom burden can promote dysregulation of 
neuroendocrine (e.g., cortisol) and immune (e.g., pro-inflammatory response) mechanisms, psychological and 
physical symptoms (e.g., pain, fatigue) and disease activity.108 For example, low social support, repressive coping 
and anxiety are associated with disruptions in diurnal cortisol output and reduced glucocorticoid receptor 
sensitivity.109,110 Cancer-related stress is also associated with cortisol dysregulation, and stress-modulated 
alterations 
in 
cortisol 
are 
related 
to 
disruption 
in 
immune 
function 
and 
cancer 
progression.111,112,113,114,115,116,117,118 BC patients with altered cortisol patterns show greater inflammatory 
cytokine responses.108,82,112 Stress-related disruptions in glucocorticoid sensitivity promote a shift from a Th1 
to a Th2 pro-inflammatory response108,113 that can promote or exacerbate symptom burden and negatively impact 
HRQoL.114,115 Although limited to BC survivors, stress management interventions that improve psychosocial 
adjustment impact physiological mechanisms (e.g., cortisol, inflammatory markers) with salutary effects on 
physical symptoms (e.g., fatigue, pain), HRQoL and disease activity.119,120,121,122,123,124,125,126,127 Very 
limited work has assessed these patterns in PC survivors.
What is the link between inflammation, symptom burden, HRQoL and overall health in PC survivors? 
Psychosocial stress can impact symptom burden and HRQoL via neuroendocrine and pro- inflammatory 
mechanisms.128 In PC, higher C-reactive protein (CRP), IL-6, IL-8 and TNF-α are associated with ED129,130,131 
independent of risk factors. Inflammatory states can influence recovery from PC treatment by interfering with the 
recovery of pathways and tissue necessary for adequate sexual and urinary functioning.132,133 For example, TNF-
α reduces endothelial nitric oxide (NO) synthase thus interfering with erectile function. Inflammatory cytokines are 
also implicated in fatigue and in turn, fatigue is associated with distress and depression, and poor HRQoL.134,135 
In PC, avoidant coping is associated with disrupted diurnal cortisol,132 while inflammation is related to greater 
fatigue.136 Further, inflammation has also been implicated in bladder dysfunction.137 In our preliminary work, we 
found that (a) CBSM improved diurnal cortisol regulation, and (b) improvements in cortisol regulation were 
associated with reductions in pain and better physical functioning. We have documented strong associations 
between inflammatory cytokines (IL-1, IL-6 & TNF) and sexual and urinary dysfunction, depression, pain and 
fatigue in PC.138 Thus, regulation of glucocorticoid receptor sensitivity and inflammatory pathways via 
psychosocial mechanisms (e.g., stress reduction, mood) may provide one of several biological mechanisms of how 
stress, anxiety and other emotional/cognitive processes affect symptom burden and HRQoL. Furthermore, 
cardiovascular disease (CVD; e.g., heart attacks, congestive heart failure, vascular disease, stroke) is among the 
leading causes of death in localized PC. 139 Inflammation is a significant contributor to heart disease, and it is well 
established that inflammatory responses can exacerbate atherosclerotic processes.140,141,142,143 As we expect 
that stress management will reduce inflammation, we will have the unique opportunity to evaluate how such changes 
in inflammatory responses are favorably associated with markers of cardiometabolic health including blood pressure 
and fasting glucose. 144,145,146
Design and Procedures:
Participants:
This project will involve voluntary participation of approximately 200 men treated for a primary diagnosis of 
localized prostate cancer (PC; Stages1-3, NO, MO) within minimum of 1 month and maximum of -96 months with 
no evidence of disease recurrence. All participants will be self-identified Hispanics/Latinos (hereafter referred to as 
Hispanic) of any racial category who speak Spanish or are bilingual but express interest in a Spanish intervention 
program. We anticipate that about 50% of the population in our target communities is Spanish monolingual or is 
not proficient in English as these communities have large concentrations of foreign-born Hispanics. Nonetheless, 
we will also involve participants who are bilingual and agree to participate in a Spanish psychosocial intervention.
Inclusion Criteria:
•
≥ 18 years of age;
•
Hispanic/Latino self-identification;
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Protocol #:20170656 (Version 15
•
Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
•
Primary diagnosis of localized Prostate Cancer (Stages 1-3, N0, M0);
•
Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 1 month and 
maximum of 96-months;
•
Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe 
psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review;
•
Willingness to be randomized and followed for approximately 12 months.
Exclusion Criteria:
•
History of non-skin cancer within the last 2 years
•
Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., 
psychosis) within the past six months, as these conditions can interfere with adequate participation in our 
experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review;
•
Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a 
case-by-case review;
•
Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a 
case-by-case review; and
•
Acute or chronic immune system medical conditions, medications or conditions that impact immune and 
endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment 
requiring conditions), per P.I discretion, based on a case-by-case review.
•
Individuals scoring >3 on the SPMSQ will be excluded, or per P.I. discretion, based on a case- by-case 
review.
This study will not include any of the following special populations: a) adults unable to consent; b) individuals who 
are not yet adults (minors): i.e. infants, children, or teenagers; c) pregnant women; or d) prisoners or other detained 
individuals.
Data Collection and Assessment Measures:
A Pre-Screening and Screening protocol will be followed to determine eligibility to the study. This study requested a 
partial HIPAA waver to conduct chart reviews using the Electronic Medical Integrated (EMR) system within the 
Cancer Center for pre-screening purposes to determine possible eligibility to the study. A partial waiver is requested 
to access the medical record prior to subjects’ informed consent to enroll in the research. Any identifiers obtained in 
this process will be destroyed once the patient is deemed ineligible or consents or refuses to be involved in the 
research. Any documents containing identifying information generated in the process of recruitment will be 
concealed from non-research and healthcare individuals and will be stored in a secure location. We requested a partial 
waiver because it is not possible to identify the patients who are eligible without first accessing their medical record 
and specifically looking for eligibility and exclusion criteria. It is not practical for the potential subjects care provider 
to do this because assessing these criteria is not part of routine follow-up for these patients. Furthermore, not all of 
the care providers for potential subjects are investigators on this study. All personnel are trained in human subjects’ 
research and the importance of patient confidentiality. These trained personnel will only use medical records to 
identify subjects who are eligible for research. These procedures are further described in the recruitment section of 
this protocol.
Pre-Screening: Preliminary eligibility to the study will be determined by conducting a chart review using the study 
inclusion and exclusion criteria (see exclusion and inclusion criterial section). For example if the potential 
participant is a male, is ≥18 years old, Hispanic, has a diagnosis of PC, and has undergone treatment in the past 96 
months. If the potential participant meets the basic criteria to the study a formal screening protocol will be 
conducted. Individuals contacting us from the community will be asked to give us permission to contact their 
treating physician to determine basic eligibility by completing an Authorization for 3
rd Party Disclosure form. Upon 
confirming basic eligibility the community participant will be contacted to proceed with the telephone screening. 
Individuals who are identified through Uchart review as meeting basic eligibility and have signed the consent to 
contact form will be contacted using the UHealth Consent to Contact script to confirm patient’s identity and interest 
in the study. Individuals who express an interest will proceed to complete a phone screening to determine final 
eligibility. Individuals who are identified through UChart review but have not signed the consent to contact form 
will be approached through their treating physician and/or oncologist. We will advise their treating oncologist or 
physician, and direct medical staff of the possible eligibility to our study, and further request for them to introduce 
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Protocol #:20170656 (Version 15
our study to the patient and if the patient is interested to please call us.
Screening: Individuals who contact us or agree to be contacted to hear about the study will be provided with 
information on the study. Individuals who are identified as potentially eligible through UChart review and have 
signed a consent to contact will be contacted using the UHealth Consent to Contact Phone Script to confirm the 
patient’s identity and interest in the study. After confirming the patient’s identity and if they have expressed an 
interest, they will be asked for verbal permission to do a formal telephone screening interview. Full eligibility will 
be determined after completion of the study formal telephone screening interview is completed and reviewed by 
PIs or designated Co- Investigator through RedCap.
Baseline and Follow-up Assessment: After meeting full criteria and consenting to participate in the study 
participants will be asked to complete 4 psychosocial interviews, T1 (baseline), T2-T4 (follow- ups). The interviews 
may vary in length and may take up to 2.5 hours to complete, depending on the  ability of the participants to answer 
each question. The following information will be collected:
Primary Outcomes: PC Symptom Burden and HRQoL.
Symptom burden is assessed using the EPIC-Short Form Sexual Summary (EPIC-S) score and the EPIC-Short Form 
urinary domain score (EPIC-UIN).168,170,147 HRQoL will be measured with the Functional Assessment of Cancer 
Therapy-Prostate (FACT-P including 4 domains of the FACT-G)40 and PROMIS short forms for pain and 
fatigue.148 The FACT-P and PROMIS measures have been used to assess functioning (e.g., nausea, pain, fatigue, 
life engagement, work and/or daily activities) in cancer survivors and are available in Spanish.148,149
Possible Moderators of C-CBSM’s Effects on our Primary Outcomes.
Socioeconomic Status (SES): We will collect SES by gathering information on household income.
Treatment Type: We will assess treatment type as surgery (e.g., radical retropubic, radical perineal, laparoscopic, 
robotic assisted), radiation (e.g., external beam radiation therapy; 3- dimensional conformal radiation; intensity 
modulated; proton beam; brachytherapy), and/ or hormone therapy (e.g., LHRH analogs & antagonists; anti-
androgens). We will assess whether SES, and/or type of treatment modify the effects of C-CBSM. We will also 
explore whether major Hispanic origin categories (e.g., Mexican, Cuban, Puerto Rican, Central & South American) 
and acculturation moderate the effects of CBSM.
COVID-19 Impact: We will use the COVID-19: Impact of the Pandemic and HRQOL in Cancer Patients and 
Survivors moderate the effects of the interventions.
Intervention Targets: Stress Management Skills, Psychosocial Distress & Interpersonal Function. C-CBSM 
intervention targets including stress awareness, cognitive appraisals, relaxation skills, coping and communication 
skills, and interpersonal skills will be assessed using the Measure of Current States (MOCS).150 This instrument was 
designed to specifically evaluate efficacy of CBSM. For distress, we will administer the Memorial Anxiety Scale 
for Prostate Cancer patients (MAX-PC). The MAX-PC is an 18-item scale that detects symptoms of anxiety in PC 
patients. It evaluates three aspects of PC specific anxiety on 3 subscales: anxiety related to PC in general (PC anxiety 
subscale), anxiety specifically centered around prostate specific antigen (PSA) testing (PSA anxiety subscale) and 
fears of cancer recurrence (fear of recurrence subscale). The MAX-PC demonstrated high internal reliability and is 
well validated in PC patient samples.151 The PROMIS- Depression and Anxiety, and the Sickness Impact Profile 
(SIP) will be used to assess psychosocial distress and interpersonal function.
Participant Feedback:
We will also obtain information on each participant’s impression of our study and technology comfort level via the 
Feedback Form questionnaire and Technology Survey. The Feedback Form questionnaire is 5-item self-
administered questionnaire that will help us capture the participant’s impression of how much they liked the 
intervention and information provided during the group sessions. The Technology Survey is an 18-item 
questionnaire that will be administered by a study assessor at one of the study time-points. This questionnaire will 
help us assess usage of technology and comfort level to be considered as possible intervention delivery strategies.
Supplementary Questionnaires:
The study battery will consist of two supplementary questionnaires, the Acceptance & Action Questionnaire, and 
the Meaningful & Purpose Questionnaire. The Acceptance & Action Questionnaire is a 10-item questionnaire that 
measures the degree of experiential avoidance in our participants. The Meaningful & Purpose Questionnaire is a 7-
item measure that assesses the meaning in life for our participants.
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Protocol #:20170656 (Version 15
Medical & Disease Characteristics.
Study staff will collect medical treatment and disease characteristics (e.g. type of treatment, disease status markers 
such as Gleason score, PSA, TNM staging, time of diagnosis, etc.) via EMR review after written consent has been 
obtained by the participant. Free testosterone will be measured via ELISA. Study staff will enter a participant’s 
medical chart after the T1-baseline assessment and screen for the aforementioned characteristics. Study staff will 
collect this information from participant’s medical charts after each in-person assessment. Study staff will also 
collect these variables relevant to the time when participants were diagnosed with prostate cancer. All medical chart 
data collected will be used for study data analysis as outlined in the Informed Consent Form (ICF). Any medical 
conditions other than PC will be evaluated individually to form a comorbidity index using the Charlson comorbidity 
scale.152
Sociodemographic Characteristics.
We will also collect age, education, employment, relationship status, nativity or years in the US, race, and years of 
education in the US. Participants will also complete the Abbreviated Multidimensional Acculturation Scale 
(AMS).153 Items are rated on a Likert-type scale ranging from 1 to 4 and assess multiple cultural domains. The 
AMSA has been widely used in research with diverse Hispanics.
Health Information and Biospecimens Collected: 
After a participant consents to participate in the study additional health and treatment information will be obtained 
from their electronic chart. These include: Gleason Score, Prostate Specific Antigen (PSA) results, staging (TNM), 
time since diagnosis, type of treatments, HIV/AIDS status, Sexually Transmitted Diseases (STD’s), Mental Health 
treatment, Substance Abuse and treatment, Sexual Assault information, Hospitalizations, Cardiovascular 
conditions, Gastrointestinal conditions, Hepatitis C, Behavioral & Cerebrovascular conditions, Hematology & 
Oncology, Nephrology and Genitourinary conditions, Respiratory conditions, Rheumatology conditions, other 
conditions (i.e. Bacteremia, Lupus, Sjorgren’s Syndrome). Participants that are enrolled from the community will 
be asked to sign a medical release form to request this information from their treating physicians. In addition, each 
participant will be asked to provide a blood sample either in-person via intravenous blood draw (approximately 2 
table spoons) or remotely via blood spot collection during each timepoint (T1-T4). Blood samples that are not able 
to be collected at the scheduled time-point through either of these two methods we will attempt to collect lab data at 
the next scheduled time-point or not collect them at all. The following are the health information and biospecimens 
that will be collected and analyzed for exploratory purposes:
Cardiometabolic Health.
For blood samples that are collected in-person via a blood draw procedure we will measure a panel of 
cardiometabolic risk markers including triglycerides, HDL-cholesterol, blood pressure (SBP/DBP), high sensitivity 
C-reactive protein (CRP) and fasting glucose following standard procedures used in prior work by the study PI. 
154,155 For samples that are collected using a remote Blood Spot procedure we will measure CRP only.
Anthropometric Measurements. For lab samples that are collected in-person at one of our lab locations we will 
measure height, weight, and waist circumference. These measurements, along with blood pressure, may be used for 
further data analysis. For samples that are collected remotely we will obtain the height and weight from the 
participant.
Inflammation.
C-CBSM will ameliorate the pro-inflammatory phenotype that underlies symptom burden in PC. These effects will 
be evident at systemic, cellular and functional genomic levels of analysis. For participants who visit our lab location 
and provide us with an in-person blood sample we will measure IL-1b, TNF- a, IL-6 and IL-10 as markers of 
systemic inflammation. Among participants who provide us with a blood spot sample we will measure IL-6 and IL-
10.
Systemic Level.
For in-person blood collection 8.5-ml of blood are drawn into BD Serum-Separator Tubes and serum harvested via 
manufacturer’s instructions. Aliquots are frozen at -80° C until the study ends. Serum is assayed in a single batch 
for C-reactive protein (CRP) and interleukin-6 (IL-6)-widely utilized markers of inflammation. Assays are 
conducted with commercially available Quantikine immunoassays (R&D Systems), with detection thresholds of 
0.02 ng/ml (IL-6) and 0.04 pg/ml (CRP). In our work, these kits show intra- and inter- assay CVs< 8%.
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Pa ge 1 1 of 3 4
--
Pr ot oc ol #: 2 0 1 7 0 6 5 6 ( Versi o n 1 5
Cell ul ar Le vel.
We acti vate cells e x vi v o wit h li ga n ds t hat e n ga ge t oll-li ke rece pt ors ( T L Rs), a n d m o nit or pr o d ucti o n of 
i nfla m mat or y c yt o ki nes. T his assa y sti m ulates cells wit h 9 li ga n ds, eac h o pti mize d t o i nterr o gate a s pecific T L R.1 5 6 
F or i n- pers o n bl o o d c ollecti o n 1 0- ml of bl o o d will be dra w n i nt o B D Cell- Se parat or T u bes. P B M Cs are is olate d 
t hr o u g h ce ntrif u gati o n a n d res us pe n de d i n R 1 0 ( Si g ma). 6 x 1 05 P B M Cs per well are plate d wit h o ne of t he T L R 
li ga n ds (I n vi v o ge n). Plates are i nc u bate d f or 2 4 h o urs u n der sta n dar d c o n diti o ns, after w hic h s u per nata nts are 
har veste d a n d fr oze n at - 8 0° C. T ha we d sa m ples are assa ye d i n si n gle batc h b y electr oc he mil u mi nesce nce i n Dr. 
Miller’s la b o n a S E C T O R I ma ger 2 4 0 0 A, usi n g m ulti ple x kits fr o m Mes o Scale Disc o ver y. T hese kits ha ve a 5-l o g 
d y na mic ra n ge, a n d res ults are hi g hl y acc urate a n d re pr o d uci ble. I n past w or k, o ur C Vs < 7 %. We will meas ure f o ur 
c yt o ki nes i m plicate d i n s y m pt o m b ur de n a n d H R Q o L: I L- 1 b, I L- 6, I L- 1 0 a n d T N F-a a n d sta n dar dize d val ues will 
be a vera ge d i nt o a n u n wei g hte d li near c o m p osite reflecti n g t he ma g nit u de of i nfla m mat or y res p o nse, as Miller’s 
tea m has s uccessf ull y i m ple me nte d i n m ulti ple st u dies. 1 5 7, 1 5 8, 1 5 9 F or re m ote bl o o d s p ot c ollecti o n we will n ot 
ha ve t he ca pacit y t o assess cell ular pr o d ucti o n of i nfla m mat or y c yt o ki nes.
Ge n o mic Le vel:
We c o n d uct ge n o me- wi de tra nscri pti o nal pr ofili n g of m o n oc ytes, t he cells t hat i nitiate a n d mai ntai n m ost 
i nfla m mat or y res p o nses.1 6 0, 1 6 1 F or i n- pers o n bl o o d c ollecti o n 1 0- ml of bl o o d are dra w n i nt o B D Cell- Se parat or 
T u bes. After P B M Cs ha ve bee n is olate d t hr o u g h ce ntrif u gati o n, t he y are la bele d wit h i m m u n o ma g netic bea ds 
a gai nst C D 1 4, 1 6 2 a s urface mar ker s pecific t o m o n oc ytes. B y passi n g t he la bele d cell s us pe nsi o ns t hr o u g h 
Mite n yi’s a ut o M A C S i nstr u me nt, we ca n ac q uire a relati vel y p ure ( ~ 9 0 %) p o p ulati o n of m o n oc ytes t hr o u g h 
p ositi ve selecti o n. T he ac q uire d cells will t he n be l yse d a n d sta bilize d ( R Neas y Mi ni- Kits), 1 6 3 a n d fr oze n at - 8 0° C 
u ntil s hi p me nt t o U C L A f or tra nscri pt o me pr ofili n g assa y. A gai n, b ot h Miller a n d Bl o m ber g’s la b ha ve s uccessf ull y 
i m ple me nte d t his pr ot oc ol i n pre vi o us c olla b orati o ns wit h C ole. 1 5 7 Dr. Ste ve C ole’s la b at U C L A will e xtract t otal 
R N A usi n g P C R-clea n a n d R N Ase-free tec h ni q ues, a n d c hec k sa m ple q ua ntit y a n d q ualit y wit h Na n o Dr o p 1 0 0 0 
a n d A gile nt Bi oa nal yzer 2 1 0 0 i nstr u me nts. 1 5 0 n g of t he R N A will be tra nsf or me d t o fl u oresce nt c R N A, h y bri dize d 
t o Ill u mi na H u ma n H T- 1 2 bea d arra ys, a n d sca n ne d o n a Ill u mi na i Sca n rea der. Ra w e x pressi o n val ues will be 
q ua ntile- n or malize d a n d l o g- 2 tra nsf or me d f or statistical a nal ysis, a n d t he p o ol of differe ntiall y e x presse d ge nes 
will be i de ntifie d b y Li near Mi xe d M o dels t hat c o m pare C B S M a n d C- C B S M gr o u ps, net of de m o gra p hic a n d 
bi o be ha vi oral c o nf o u n ders (e. g. a ge, B MI, c o- m or bi dities a n d disease-rele va nt c o nf o u n ders s uc h as ti me of 
treat me nt, ti me si nce treat me nt). Differe ntiall y e x presse d ge nes are defi ne d as t h ose s h o wi n g ≥1. 5-f ol d  differe nce 
bet wee n gr o u ps a n d a tra nscri pt-le vel false disc o ver y rate of < 5 % ( usi n g sta n dar d Be nja mi ni & H oc h ber g ste p-
d o w n a nal ysis. 1 6 4 U p t o 1 0 differe ntiall y e x presse d ge nes will be re- verifie d usi n g q ua ntitati ve R T- P C R wit h 
Ta q Ma n ge ne e x pressi o n assa ys ( A p plie d Bi os yste ms I nc.), a o ne-ste p e nz y me s yste m, 1 6 5 a n d ma n ufact urer’s 
s pecifie d t her mal c ycli n g pr ot oc ol o n a i C ycler real-ti me P C R i nstr u me nt ( Bi o Ra d I nc.). T o i de ntif y tra nscri pti o n 
c o ntr ol pat h wa ys u n derl yi n g differe ntial ge ne e x pressi o n, we use a 2-sa m ple varia nt of t he Tra nscri pti o n Ele me nt 
Liste ni n g S yste m ( T E Li S). 1 6 6 T E Li S q ua ntifies t he pre vale nce of tra nscri pti o n fact or- bi n di n g m otifs wit hi n 
pr o m oters of differe ntiall y e x presse d ge nes. A nal yses f oc us o n 3 tra nscri pti o n fact ors ( T Fs) b y w hic h C- C B S M 
c o ul d affect m o n oc yte i nfla m mat or y acti vit y: N F ￿B,  t he maj or pr o- i nfla m mat or y T F; C R E B, a T F t hat c o n ve ys 
a dre ner gic si g nals t o m o n oc ytes, a n d w h ose acti vit y reflects t he a m o u nt of S N S si g nal reac hi n g t hese cells’ ge n o me; 
a n d gl uc oc ortic oi d rece pt or, a T F t hat pr o pa gates c ortis ol’s a nti-i nfla m mat or y si g nals wit hi n m o n oc ytes a n d, li ke 
C R E B, i n de xes h o w m uc h h or m o ne si g nal t hese cells are re gisteri n g. F or t he re m ote bl o o d c ollecti o n t hat is 
c ollecte d via drie d bl o o d sa m ples ( D B S) we will use sta n dar d D B S c ollecti o n pr oce d ures t hat ha ve bee n well 
vali date d a n d use d b y o ur researc h tea m (i.e., Miller). 2 0 0, 2 0 1 Briefl y, t he sa m ples are c ollecte d b y pric ki n g t he 
ti p of t he mi d dle di git wit h a sterile dis p osa ble la ncet, a n d t he n all o wi n g dr o ps of bl o o d t o wic k o nt o filter pa per 
car ds T otal R N A will be e xtracte d fr o m D B S sa m ples b y c utti n g 2 – 4 bl o o d s p ots fr o m t he 5-s p ot filter pa per f or 
eac h sa m ple ( usi n g a se parate raz or bla de f or eac h sa m ple t o pre ve nt c o nta mi nati o n), de p ositi n g all filter pa per 
s p ots fr o m eac h sa m ple i nt o 3 7 0 μ L  of R L T i n a n R N Ase-free sterile 1. 5 ml micr oce ntrif u ge t u be, i nc u bati n g t he 
t u be f or 3 0 mi n at 3 7° C wit h a gitati o n ( 1 0 0 0 r p m), tra nsferri n g t u be c o nte nts (i ncl u di n g filter pa per) i nt o a 
QI As hre d der c ol u m n f or 6 0 sec micr oce ntrif u gati o n at ma xi m u m s pee d, after w hic h t he 3 6 0 μ L  of re mai ni n g R L T 
was pr ocesse d t hr o u g h t he QI Ac u be n ucleic aci d e xtracti o n s yste m usi n g R Neas y 
Micr o Kit rea ge nts, t he 
ma n ufact urer’s sta n dar d o perati n g pr ot oc ol (i ncl u di n g D N Ase treat me nt), a n d a 2 0 μ L  el uti o n v ol u me. D B S 
sa m ples are hi g hl y sta ble, ca n sit o ver ni g ht at r o o m te m perat ure a n d ca n be maile d f or s u bse q ue nt st ora ge i n a - 8 0 
freezer. Sa m ples will be st ore d/ batc he d at Dr. Bl o o m ber g’s la b a n d maile d t o C o-I Miller’s la b at N ort h wester n 
-       St u d y #: 2 0 1 7 0 6 5 6        Eff e cti v e D at e: 8/ 1 4/ 2 0 2 5

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Protocol #:20170656 (Version 15
University for analyses.
Procedures Involved:
Locations of Research and Recruitment:
The study will take place in two diverse communities in the US: Chicago and Miami. Miami will be the main site 
for this study. Miami-Dade County, Florida and Cook County, Illinois, represent the 3
rd and 4th largest concentrations 
of Hispanics in the US. Therefore, our participants are from communities diverse in regard to Hispanic ancestry, 
SES and acculturation addressing limitations of prior survivorship studies that have focused on homogeneous 
Hispanic communities not representative of Hispanics in the US. Miami-Dade County is the largest county in the 
South Florida region and is home to about 1.75 million Hispanics that comprise 65% of the total population in this 
county. About 53% of Hispanics in this region are of Cuban origin (~856,000), while the rest are of other descent 
representing 15 distinct Hispanic countries of origin and a population of about 768,000. The majority of the “other” 
Hispanic ancestry is represented by individuals from Colombia, Venezuela and Argentina in South America, 
Honduras, Nicaragua and El Salvador in Central America and the Dominican Republic and Puerto Rico in the 
Caribbean. About 60% of Hispanics in Miami-Dade county are foreign born, over 50% are primarily Spanish 
speakers and 73% of households speak primarily Spanish at home.167 Therefore, Miami-Dade County represents 
a very diverse community in regard to Hispanic ancestry. From 2004-2010, there were 13,500 new cases of PC in 
Miami-Dade and 40% of these cases (~5,400) were Hispanic.
Recruitment:
Our primary sources of referral will be our affiliated hospitals and clinics. In Miami, recruitment will take place at 
the University of Miami (UM) Sylvester Comprehensive Cancer Center (SCCC) and their satellite clinics and 
surgical oncology practices in Miami-Dade, Broward, Palm Beach and Collier counties in South Florida. 
Recruitment procedures follow similar approaches that we have used in our prior and current work with Hispanics 
and encompass highly integrated recruitment relationship between the research staff and the medical professionals 
at each location. Patients will be informed of the study via their physician, clinic staff or other personnel in their 
treatment settings or by obtaining recruitment flyers at various community-based clinics/organizations not directly 
affiliated with UM/SCCC (e.g. La Ligua Contra el Cancer). We also plan to participate in different local Spanish 
speaking radio and TV shows in order to inform the Hispanic community of our study. Information about the study 
will also be presented at different health fair venues and activities in order to raise community awareness about the 
study. Further, research staff will have IRB/HIPAA compliant approval to access electronic medical records (EMR) 
systems to pre-screen prospective participants. The University of Miami (UM) Sylvester Comprehensive Cancer 
Center (SCCC) has an electronic medical records (EMR) management systems that will be accessed by our staff 
consistent with IRB/HIPAA guidelines as we have in our prior studies. The study now available on 
Clinicaltrials.gov (study number NCT03344757) for potential participants to access. Additionally, we will work 
with the Florida Cancer Data System (FCDS) to obtain a list of potential participants meeting our study criteria. 
Identified participants from the FCDS will be mailed a packet including a patient contact letter and a patient 
response form and a letter from the Department of Health. If after 3 weeks from sending the initial packet there is 
no patient response, a second mailing will be sent with the addition of the telephone opt-out card. The telephone 
opt-out card explains to the patient if no response is received, the study investigator and/or a member of the study 
team will attempt to contact them via a telephone call, text, or email to introduce the study. If there is not response 
to the second mailing and the telephone opt-out card after 3 weeks, a telephone call will be attempted by the study 
staff. We will continue to use the established pre-screening and consent protocol for those participants who express 
an interest in our study (see below). For FCDS subjects we will use a Question and Answer Script (provided by the 
FCDS) that explains “how our study received their name”. Information obtained from the FCDS registry will be 
treated with the utmost security, all data will be stored in our UM secure servers and only study personnel will have 
access to this information. Please refer to Privacy and Data Storage & Confidentiality section below for more 
information on data storage protocol.
Pre-Screening Protocol:
We will implement a pre-screening protocol by which chart reviews will be conducted to identify potential 
participants that meet the study’s basic inclusion and exclusion criteria (example: male, ≥ 18, Hispanic/Latino, 
diagnosed with localized PC Stages 1-3,N0,M0, and had received surgical or radiation treatment within the last 96 
months). We will attempt to contact individuals that meet the study’s basic criteria by contacting those who have 
expressed an interest in our study or have signed a Consent to Contact form (UM SCCC patients are asked at each 
medical appointment if they would like to be contacted for research studies. Individuals who meet the study basic 
inclusion criteria as per Uchart review and have signed a Consent to Contact form will be contacted using the 
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Consent to Contact Script and will be asked verbal consent to proceed with the telephone screening questionnaire 
to determine full eligibility. Individuals who are identified through UChart review but have not signed the Consent 
to Contact form will be approached through their treating physician and/or oncologist. We will advise their treating 
oncologist or physician, and direct medical staff of the possible eligibility to our study, and further request for them 
to introduce our study to the patient and if the patient is interested to please call us. Individuals who express an 
interest in our study will be provided with information and will be asked their verbal consent to complete a telephone 
screening questionnaire . Any participants from non-affiliated sites/clinics and FCDS will also be asked to sign an 
Authorization for 3
rd Party Disclosure form to obtain their medical records and determine basic eligibility. Once 
basic eligibility is confirmed the community potential participant will be called and asked their verbal permission to 
proceed with the telephone screening questionnaire and determine final eligibility.
Formal Screening Protocol. 
Because the inclusion criteria for this study requires that the participants be Spanish speakers, all participants will 
be screened in Spanish by Spanish speaking research staff. Upon meeting initial eligibility via EMRs (see protocol 
section Recruitment), research staff will conduct phone screening to assess symptom burden using the EPIC-
S168,169 and -UIN170,169 for sexual and urinary function and Short Portable Mental Status Questionnaire 
(SPMSQ) to assess cognitive function and detect impairment. We anticipate that ~70% of participants score in this 
range based on our prior work in PC. The Short Portable Mental Status Questionnaire (SPMSQ) will measure 
orientation, memory, attention, naming, comprehension capabilities and is sensitive to Hispanic populations; 
accounting for higher illiteracy rates in this community. The Short Portable Mental Status Questionnaire (SPMSQ) 
will be used as a screening instrument for dementia.171 The SPMSQ is a 10- item test that assesses orientation, 
concentration, immediate and delayed verbal memory, language, 3-  step praxis and constructional apraxia. Literate 
individuals scoring >3 on the SPMSQ will be excluded, or as per PI discretion based on a case by case review. 
SPMSQ is also calibrated to take into illiteracy into account, for illiterate individuals scoring >4 they will be 
excluded or as per PI discretion based on a case by case review. The screening process will take approximately 15-
20 minutes (please refer to the screening form).
Per PI discretion – participants with a history of, or current, psychosis, current dependence disorders, organic mental 
disorder, or active suicidal ideation or panic disorders may be excluded because these are likely interfere with 
adequate participation in the group sessions. We will also assess other exclusion criteria (e.g., suicidality). 
Participants who meet full eligibility (see protocol section Inclusion and Exclusion Criteria and section Recruitment) 
are asked to come in-person to sign the study’s Informed Consent (IC). Individuals that are not able to come in-
person to sign the IC form will be consented remotely via Electronic-Consent (E-Consent via RedCap link sent to 
their email) or for those individuals that do not have a computer we will mailed two copies of the IC form to sign 
one copy and mail back to us. All individuals who will be consented remotely will be called to review the consent 
form and answer any questions they may have. We will use an IC check-list during the phone call to make sure the 
participant understands the informed consent document and all components of the study. As part of the consent 
process, participants will also be asked to opt-in into being audio or video recorded to aid with clinical supervision 
purposes. This will allow the P.I. and Co-I to evaluate the quality of the group sessions andhow they are facilitated 
by the group therapist. As this is an optional element, participants may still enroll in the study if they decline to be 
audio or video recorded (see protocol section Consent Process).If there is a participant who does not wish to be 
audio or video recorded, none of the participants will be audio or video recorded. All participants who do not meet 
eligibility criteria per the completed the formal screen will be thanked and provided with printed Spanish materials 
relevant to PC from the NCI, and ACS, as well as be referred to appropriate and relevant services. Over the past 
several years, both the Chicago and Miami sites have identified an extensive list of community referrals that include 
physicians, psychologists, social workers, community-based clinics and centers, etc. that are known to provide 
services to Hispanic men.
Consent Process:
The informed consent process will occur after eligibility has been fully established by the PI and/or Co-PI. The 
potential participant may be consented at the beginning of the first in-person assessment meeting or if he is not able 
to come in person to a scheduled assessment consent will be obtained remotely via E-Consent (RedCap link sent to 
the individual’s email) or through Zoom. If the individual does not have a computer to provide consent via E-consent 
or Zoom, he will be mailed 2 copies of the consent form. All remote consents through Zoom or US mail will involve 
a 3-party telephone call with the potential participant, the person obtaining the consent, and a witness to review the 
consent documents and answer any questions the potential participant may have. We will use an IC Review 
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Checklist to ensure that all sections of the consent form are thoroughly reviewed and that individuals will be given 
ample time to ask any questions about the study. The IC Review Checklist will also have a statement describing the 
consent process, including the return method after signing the consent form or if the participant has difficulties in 
sending us their signed consent form. Participants in this study will be consented using IRB approved informed 
consent form (ICF) documents in Spanish or if they prefer in English as long as the participant agrees to participate 
in groups in Spanish. Research staff will review the ICF with the participant and assure that participants have a full 
understanding of the informed consent by asking them several questions to ascertain comprehension before having 
them sign. Participants will also be asked to consent to videotaping of sessions for clinical supervision purposes 
and informed that all videos are held in the highest regard of confidentiality and destroyed upon completion of the 
study. If participant decline to sign the consent to video, they will not be excluded from the study and no videos 
will be done where the individual declining to be videotaped is present. A copy of the consent form will be provided 
to the participant for their record.
Assessment and Data collection:
After meeting full criteria and consenting to participate in the study participants will be asked to complete 4 
psychosocial interviews. Because the inclusion criteria for this study requires that the participants be Spanish 
speakers, all participants will be assessed in Spanish by Spanish speaking research staff. Participants complete in-
person assessments at baseline (T1) and at approximately (plus or minus 2 months) 3-months (T2), 6- (T3) & 12-
months (T4) post baseline. The interviews may vary in length and may take up to 2.5 hours to complete, depending 
on the ability of the participants to answer each question. Participants will have the choice of visiting our study 
office or conduct the interview at their home or via Zoom or phone if they are not able to meet us in-person. 
Participants will also be asked at baseline to complete a technology-based questionnaire; this questionnaire will 
allow research staff to determine the best method to deliver study-related material related to the group sessions. The 
study-related material will consist of audio files covering relaxation techniques reviewed throughout their 10-week 
participation. All assessments are completed and scored via RedCap, an online research management tool that 
enables researchers to create study websites for securely capturing data. RedCap is a web-based system led by the 
Department of Medical Social Sciences. Dr. Penedo the PI has extensive experience working with this system. All 
screening and assessment instruments are guided by our conceptual model for managing PC, have excellent 
psychometric properties (e.g., Cronbach’s α ≥. 70) and have been translated and validated in Spanish speaking 
populations.
Blood collection: Participants will also be asked to provide a sample of blood via an intravenous blood draw 
(approximately 2 table spoons) or a remote home-based blood spot collection. All in- person blood samples will be 
drawn at one of the Sylvester laboratory locations (Miami, Lennar, Plantation and Kendall) by a licensed 
phlebotomist. The blood draw will be scheduled by a member of our study team and who will then meet the 
participant at the preferred lab. A member of our team will take with them appropriate study labels (participant 
corresponding ID, date, time and timepoint of blood draw). Blood samples will be transported after collection by a 
member of our study team to Dr. Blomberg’s laboratory (1600 NW 10th Ave. #3146A, Miami, Fl 33136) and the 
Department of Pathology, UMHC & Sylvester Cancer Center Lab (1475 N.W 12th Ave, Miami FL, 33136) the 
same day of the blood draw. At the time of the blood draw we will also collect Cardiometabolic and Anthropometric 
measures (please see Data Collection and Assessment Measure). Remote dried blood spot (DBS) sample collection 
will be done by using a protein saver card to collect a total of 5 drops of blood. Participants will be mailed a blood 
spot packet consisting of a set of 2 protein saver cards, lancets, a desiccant, plastic bags, alcohol swabs, and gloves. 
Participants will also receive hard copy instructions on how to collect and ship samples. Participants will be 
instructed to collect the blood samples in the afternoon or evening and to send samples to Dr. Blomberg’s laboratory 
via FedEx or equivalent for storing. Samples will be stored in a -80 freezer and stored until the end of the study or 
batched as per PI’s discretion and sent to Dr. Miller’s lab for analysis.
Randomization Protocol:
Participants will be randomized by cluster randomization (C-CBSM or CBSM) to balance treatment type across 
conditions. We project to retain 140 participants at our 12-months post-intervention assessment visit (T4). All 
participants will be asked to participate in 10-weekly 90-minute in person sessions targeting CBT based skills for 
managing stress and self-management in one of two experimental conditions—a linguistically translated (Spanish) 
and culturally adapted cognitive behavioral stress and self-management (CBSM) condition (i.e., C-CBSM) or in a 
standard version of CBSM that is only linguistically translated (CBSM). Following the baseline visit (T1, pre C-
CBSM or CBSM), participants are randomly assigned into one of our experimental or control condition groups. 
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Randomization will be group type (C-CBSM vs. CBSM) to assure balanced representation at the end of the study. 
The dose of both our conditions is based on our prior work documenting the efficacy of 10-week group-based 
programs in improving multiple psychosocial, physiological and health outcomes across multiple chronic diseases 
including breast cancer, HIV, CFS, CVD and localized PC (including bilingual and Spanish monolingual Hispanics) 
and advanced PC. Thus we feel that a 10-week involvement in our CBSM intervention balanced against the possible 
benefits of engaging in a supportive group environment and acquiring stress and self-management skills is 
reasonable for our participants. We considered a health promotion or inert usual care condition but felt that for 
ethical considerations, offering an inert usual care condition was not ethical. Furthermore, the conceptual approach 
that we are following addresses whether culturally adapted evidence-based treatments provide an added benefit with 
respect to improving HRQoL and reducing symptom burden, relative to standard and non-adapted programs. 
Therefore, because our interest is to determine whether cultural adaptation matters, we chose a comparison 
condition that delivers the “ingredients” of our CBT-based CBSM, but does not consider the cultural context. This 
approach provides a methodologically sound test of our randomized trial and the extent to which the adaptation of 
CBSM (C-CBSM) exerts a greater impact on our study outcomes relative to standard CBSM treatment. In our 
preliminary work in CBSM interventions in localized PC, our attendance at weekly sessions have been over 80%. 
These rates suggest that our experimental conditions delivered once a week over a 10-week period for 90 minutes 
per session are well accepted and tolerated in our target population.
Intervention:
Experimental Design. Our primary aim is to examine the effectiveness and incremental efficacy of a 10-week 
group-based, linguistically and culturally adapted cognitive behavioral stress and self- management intervention 
(C-CBSM) vs. a linguistically translated standard CBSM (no cultural adaptation) on symptom burden and HRQOL 
in Hispanic men treated for localized PC. This is randomized control trial (RCT) with a 2x4 design with group 
assignment (C-CBSM vs. CBSM) as the between-group factor and time (baseline [T1], post-intervention [T2], 6-
mos. [T3] & 12-mos [T4]. Post intervention [T4]) as the within-group factor. Primary outcomes are symptom burden 
(i.e., urinary & sexual function) and HRQoL (e.g., physical, social, emotional & functional). We will make every 
effort to engage and promote participation in all 10 sessions however we anticipate that some cases will not be able 
to attend all sessions due to multiple circumstances, such as change in employment or work schedule, health issues, 
relocation, unforeseen transportation difficulties, family crisis, social/environmental/health crisis (COVID-19), etc. 
This study uses an intent to treat intervention design model thus participation in all sessions may differ for some 
individuals. We estimate attrition at ~22% over the study although our prior rate is closer to 10%. Cluster 
randomization will occur by group type (C-CBSM vs. CBSM).
Experimental Conditions:
CBSM. The standard English language59,60 intervention was developed for stress management, risk reduction, 
health maintenance and self-management by providing relaxation training and CBT-based strategies to improve 
symptom management, interpersonal adjustment and HRQoL, and reduce arousal and negative mood in men treated 
for PC. This standard, not culturally-adapted CBSM underwent forward and backward translation by Action 
Translation Services172 with internal verification.
Stress management targets reducing arousal and anxiety, and symptom management (e.g., progressive muscle 
relaxation, imagery), changing negative stressor appraisals (e.g., cognitive restructuring), coping skills training 
(e.g., enhancing adaptive skills, accurate matching of coping & stressor, acceptance of uncontrollable stressors, 
spirituality), interpersonal skills training (e.g., anger management, communication) and building, enhancing and/or 
expanding social networks. The stress associated with having received treatment for PC and symptoms are used as 
catalysts for discussing strategies and as material used for in-session discussions. 
Risk reduction & health maintenance strategies include: (a) increasing self-efficacy/self–management to promote 
positive health behaviors; (b) use of coping strategies to promote health maintenance; (c) increasing assertiveness 
and communication skills to improve physician-patient transactions (e.g., clarifying treatment & follow-up care 
instructions) and enhancing use of efficacious social networks to maintain positive health changes, (d) learning self-
management (e.g., problem solving for obstacles to compliance, awareness of physical symptoms/limitations); and 
(e) preventing negative health behaviors such as alcohol, tobacco/ illicit substance use. All content in CBSM is 
linked to salient PC concerns and CBT-based skills provision to specifically target issues faced by PC survivors.
CBSM and CCBSM Format and Goals. CBSM and CCBSM interventions are delivered face-to- face or via a 
conference feature platform (phone or a tablet with video conferencing capabilities). Groups that will be conducted 
face to face will be held at one of our designated office locations (CRB). Groups that are run using a telephone 
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conference platform will use a private phone line where participants are called to join the group meeting. Groups 
that are conducted via a video conferencing format will be provided with a study tablet that connects to a secure 
conference network (Vidyo). The tablets connect to an AES encrypted channel which allows participants to access 
a secured video conferencing room (secured with pin) with the ability for the therapist to lock the room further after 
all the participants have entered before start of any group session. Each tablet will have a personalized pin number 
for participants to access its features. The pin numbers are reset upon completion of the intervention period and 
return of the tablet to our technical team. The delivery modality (face-to face, phone or through video conferencing) 
will be at the discretion of the PI and Co-PIs.
CBSM and CCBSM intervention groups are composed of 4-8 participants lasting 90 minutes/session. In the first 30 
minutes, participants are taught/discuss a new anxiety/arousal reduction technique whereas the latter 60 minutes 
focus on stress- and self-management. Disease course, symptom burden, communication with intimate partner 
and/or family members and health care provider, impact of stress on physical and mental health and symptoms, and 
management of symptom burden and decrements in HRQoL are used for educational purposes and as catalysts for 
CBSM techniques. Participants describe stressors with an emphasis on symptoms and disruption, HRQoL and their 
coping responses for in- session role-plays. Participants receive a participant workbook with all the relaxation and 
stress management didactics, homework, self-monitoring tools and exercises to implement skills learned in the 
CBSM sessions in their own “real world” settings. Homework assignments are considered a practice activity to be 
reviewed in group discussions, these are voluntary and not mandatory.
C-CBSM Intervention Cultural Adaptation. We followed a systematic approach to culturally adapt CBSM that 
considered language, culture and context (e.g., symptom burden) to develop a linguistically and culturally adapted 
CBSM (C-CBSM) intervention compatible with our participants’ cultural patterns and belief systems, meanings, 
values and social context.89,173,174 Our goals were not to promote change in culturally held beliefs, but rather 
ensure that Hispanic values and context were grounded in each of our CBSM components designed to improve our 
outcomes. We were guided by theory to make cultural adaptations of evidence-based treatments (EBTs).89,175,176 
These models involve a “top-down”/“bottom-up” approach where theoretical frameworks and intervention 
procedures from EBTs are used as starting point components of an EBT. These components are subjected to scrutiny 
by members of the target culture who provide recommendations to shape the adapted version of the intervention to 
be developed and evaluated.177 This occurs in four stages: (a) information gathering (e.g., differences in modifiable 
risk, outcomes & cultural influences on core intervention components); (b) preliminary adaptation design (e.g., 
integrate input of key stakeholders); (c) preliminary adaptation tests (e.g., train facilitators, pilot adapted 
intervention); and (d) adaptation refinement (e.g., feedback from pilot to revise the EBT). The final step involves 
testing the adapted treatment in a full scale RCT. Our C- CBSM intervention underwent all preliminary stages and 
is now ready for a full-scale RCT.
Our cultural adaptation process involved: (a) forward/back translation of CBSM; (b) review of literature on 
Hispanic cultural values and evidence of disparities in Hispanic PC survivors; (c) review of metaphors (e.g., 
concepts shared in PC), content (e.g., cultural values & traditions), illness perceptions (e.g., controllability, fatalistic 
themes) and context (e.g., acculturative stress, social support & ties to country of origin); (d) review of equivalence 
criteria of core components of the adapted EBT; (e) expert and patient review of the protocol (e.g., session by session 
changes); (f) focus groups; and (g) a pilot trial.173,175,178 Based on this process and feedback from our pilot, and 
additional data relating sociocultural processes to symptom burden and HRQoL, we have made further modifications 
to our C- CBSM intervention. The full scope of adaptations to CBSM based on Hispanic cultural factors, their 
implications for uptake and implementation of CBSM mechanisms, and how cultural factors based on literature and 
expert/participant feedback are integrated in C-CBSM sessions.
Training, Intervention Fidelity & Evaluation. The MPIs and co-PIs oversee all training for recruitment and 
assessment staff. We have a vast pool of CBT trained facilitators, several of whom have been trained in CBSM. C-
CBSM training is based on Hispanic sociocultural processes and how they interact with CBT-based programs. All 
group leaders will have completed a 20-hr. training seminar based on our Therapist Training Manual for C-CBSM 
or CBSM comprised of the following: intensive in-class training in relaxation techniques, cognitive restructuring, 
and assertiveness training; role-playing exercises with other staff and trained therapists with attention to adherence 
to protocol; and readings on group therapy/process in cancer populations. Using a standardized checklist, data is 
collected to document protocol adherence, identify problems at each session, and record attendance to ensure 
conditions are administered in the manner prescribed.179 State of the art video-conferencing platform (WebEx)180 
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is available to the PIs and also used for clinical supervision.
Cultural Awareness & Sensitivity Training. We will provide a 2-day training seminar on cultural sensitivity and 
awareness for all personnel involved in recruitment and assessment, and interventionists leading the C-CBSM 
condition only. To reduce contamination, interventionists in the CBSM condition do not undergo this training. To 
maximize participant accrual, retention and comfort with all procedures, emphasis will be on Hispanic PC survivors 
and involve thorough training on multicultural awareness that incorporate cultural attentiveness and sensitivity 
including cultural awareness (commonly held beliefs & practices by a culture), appreciation (respecting cultural 
differences specific to the delivery to therapeutic targets; e.g., collectivistic & familial frames of reference), and 
respect.181,182,183 Dr. Penedo has successfully implemented these training models in CBT-based interventions, 
and he is fully Spanish bilingual and has extensive experience working with Hispanics and particularly Hispanic 
cancer survivors.
Preventing Attrition and Reducing Burden. We will use strategies for enhancing retention184 such as meeting 
with participants to discuss the study and answer any questions (e.g., implications of randomization, roles of C-
CBSM & CBSM, nature of intervention, psychosocial & biological assessments, homework assignments, study 
benefits & risk, etc.). To prevent participant drop-out and reduce burden, we will use recommendations for 
enhancing clinical trial retention184 such as meeting with the participants in individual sessions at our recruitment 
sites during scheduled visits or speaking with them via telephone as requested to discuss study participation and 
answer any questions (e.g., implications of random assignment, roles of C-CBSM & CBSM, duration & nature of 
intervention, rationale for the psychosocial & biological assessments, homework assignments, study benefits & risk, 
etc.). We have found that regular contact with participants improves retention rates. We also have multiple strategies 
to prevent attrition and reduce participant burden. Understanding that this is an older, co-morbid population facing 
multiple contextual barriers, we have taken steps to address the multiple challenges and barriers that may lead to 
participant burden, prevent participation or promote attrition. These strategies include providing transportation for 
assessment or intervention visits for up to 30% of the sample. This will provide us with the flexibility to offer 
participants the option of receiving transportation services to attend our clinic or intervention visits. In our past 
work we have found that about 30% of all PC survivors make such requests; however, we will actively promote 
such accommodations to ease participation burden and reduce attrition. In addition to these accommodations, we 
follow procedures as we have in all our prior cancer survivorship studies where we provide snacks, refreshments 
and breaks during our assessments and intervention sessions, and provide flexible appointment schedules (e.g., 
weekends) to maximize participation, reduce burden and prevent attrition. We will also offer participants the option 
of completing a shorter version of the study assessment in person or by telephone. Telephone assessments will be 
determined on a case by case basis by the PI or Co -PIs who will assess the level of difficulty the participant has in 
completing the entire assessment face to face, for example unforeseen changes in employment and/ work schedule, 
health issues, relocation, unforeseen transportation difficulties, family crisis, social/environmental/health crisis 
(COVID-19), etc. Group facilitators will also reach out to participants via “booster” telephone calls in between 
participants’ T-2 through T-3 in person interview and T-3 through T-4 in person interview. The “booster” calls will 
serve as a mini-review session with participants to discuss content covered in the group sessions. Phone scripts for 
the booster calls are in the development by study staff and will be sent to PMRC and UM IRB in the next 
modification for approval. Study staff will also conduct two check-in calls to discuss general comments and/or 
concerns a participant may have; these check-in calls will also serve to remind participants of their next in-person 
assessment. The first check-in call will take place four weeks after the completion of the 10-week group sessions, 
while the second check-in call will take place four weeks after the second phone booster call. We will make every 
effort for participants to complete their follow-up assessments within their expected timeline (see Assessment and 
Data Collection section), however we anticipate that some participants will require additional 2 months to 
accommodate for life changes. If a participant’s follow-up assessment passes the extra 2 months period we will 
attempt to collect the next timepoint assessment. We will also encourage participants to complete all follow-up 
assessments however we anticipate that some participants may encounter difficulties in completing an assessment 
at the scheduled timepoint due to multiple circumstances, such as unforeseen changes in employment and/ work 
schedule, health issues, relocation, unforeseen transportation difficulties, family crisis, social/environmental/health 
crisis (COVID-19). . We will make sure that these participants are still willing to continue participating in the study 
and review their assessment timeline regularly. We will continue to assess the participant’s interest in continuing in 
our study via check-in calls and booster calls . Collectively, these strategies are designed to address the multiple 
medical and contextual challenges that our targeted sample is likely to be facing and thus promote study 
participation with minimal burden to the participant.
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Additional Retention Strategies: Participants who may be experiencing multiple challenges (e.g., financial, access 
to care, comorbid illness, etc.) present special problems for which alternative procedures are required in order to 
maximize retention. As mentioned above we will be compensating participants for their assessment visits, and 
mailing them follow-up reminder cards two to three weeks before their subsequent appointments. If a participant 
does not call to make an appointment for re- assessment, the contact staff will call on the individual indicated as 
primary contact by the participant. This contact may take place through telephone or face-to-face. The staff person 
making the call will attempt to collect information that will lead to location of the participant. Secondary and tertiary 
contacts named in the participant’s locator files will also be part of the contact staff’s repertoire for finding a 
seemingly lost participant. In the event that cancer or other medical condition hinders a participant’s ability to attend 
an assessment visit, we will offer them the option of home visits for data collection. In all such cases, we will respect 
the participants’ right to refuse this option and will be acutely sensitive to their desire to maintain their privacy 
during these difficult times. If the participant does consent to home visits, we will furnish the personnel to visit them. 
If the full battery of tests is too burdensome, we will use an abbreviated battery consisting of our primary outcome 
measures. For participants who refuse to return for assessments or who have dropped out of the study, we will offer 
them the opportunity to schedule their assessment at any time of day at the most convenient location and will offer 
them the opportunity to complete only the abbreviated form of the battery should they so request. We will also 
respect a participant’s refusal to undergo blood draws. Repeated failure to locate a participant for follow-up will 
lead to our contacting the Florida Departments of Health to learn of death certificates issued in the period since the 
missed assessment.
Data Analysis Plan including Statistical Procedures
Study Hypotheses:
Hypothesis 1 (Aim 1): C-CBSM will show significantly greater reduced symptom burden and improved HRQoL 
from baseline (T1) to 3-, 6- and 12-month follow-ups (T2-T4) relative to CBSM.
Hypothesis 2 (Aim 2): C-CBSM will show significantly greater improvements in intervention targets (i.e., 
improved stress management, and reduced psychological distress and interpersonal disruption) from baseline (T1) 
to 3-, 6- and 12-month follow-ups (T2-T4) relative to CBSM.
Test of Study Hypotheses. All analyses will be intent-to-treat analyses198 and linear mixed models will be used to 
test Hypotheses 1-2. These models classify time of measurement as a categorical variable in order to give full 
flexibility to different mean time courses in the two randomized groups. Latent growth modeling (LGM)185 with 
relevant covariates is used to test the three sub-hypotheses of Aim 4. Advances in LGM and structural equations 
modeling (SEM)186 allow us to blend these methods to test complex models of change187 as latent growth models. 
LGM allows for missing data, as well as irregularly spaced measurements across time, time-varying and invariant 
covariates, accommodation of individual-specific deviations from the mean time trend and estimation of population 
variance associated with individual effects. Analyses of the first 3 hypotheses inform the functional form of the 
LGM time course. Software to implement these analyses is available (e.g. Mplus).188,189 The software permits the 
blending of continuous and categorical data, the specification of linear and nonlinear models of change, and the 
specification of longitudinal structural models. Adequate model fit will be established by several fit indicators 
(Comparative Fit Index [CFI] > .95, Root-Mean-Square Error of Approximation [RMSEA] ≤ .05, Standardized 
Root-Mean-Square Residual [SRMR] < .08).190
Exploratory Hypotheses:
Hypothesis 3 (Aim 3): C-CBSM will show significantly greater activation of leukocyte glucocorticoid receptor 
(i.e., greater sensitivity) and lower inflammatory gene expression (i.e., less activation) pathways from baseline (T1) 
to 3-, 6- and 12-month follow-ups (T2-T4) relative to CBSM.
Hypotheses 4a-4c (Aim 4): 4a: Relationship between group assignment (C-CBSM vs. CBSM) and reduced 
symptom burden, and improved HRQOL from baseline (T1) to 3-, 6- and 12-month follow-ups (T2- T4) is mediated 
by improvements in intervention targets; 4b: Relationship between group assignment and greater activation of 
glucocorticoid leukocyte receptor and lower inflammatory gene expression pathways from baseline (T1) to 3-, 6- 
and 12-month follow-ups (T2-T4) is mediated by improvements in intervention targets; 4c: Relationship between 
group assignment and reduced symptom burden, and improved HRQOL from baseline (T1) to 3-, 6- and 12-month 
follow-ups (T2-T4) is mediated by greater activation of glucocorticoid receptor and lower activation of 
inflammatory gene pathways.
Hypothesis 5 (Aim 5): 5a: SES, acculturation, Hispanic ancestry and treatment type moderate C-CBSM’s effect; 
5b: C-CBSM improves cardiometabolic markers (e.g., lipids, fasting glucose) via reduced inflammation.
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To Test Exploratory Hypotheses. Aim 3: For Hypotheses 3, the linear mixed model will include fixed effects for 
the experimental group (C-CBSM vs. CBSM) and observation time (T1–T4), and random effect for person with a 
compound symmetry covariance structure for the repeated residuals within person. A group by time interaction and 
post-hoc tests on this model effect will indicate whether and how the time course of the dependent variable differs 
between the groups. Hypotheses 1-3 will all be analyzed in a similar manner using the outcome measures described 
in sections C.6.c (Primary Outcomes), C.6.d (Intervention Targets) and C.6.e (Inflammation) respectively. These 
measures include markers of symptom burden, systemic inflammation, and cytokine production following cellular 
activation with TLR ligands. Data from gene expression profiling are analyzed using advanced bioinformatics 
techniques, and described in C.6.e, and as reported previously by Antoni et al.124 As each outcome across the 
different study hypotheses have been carefully selected to address a priori hypotheses, no adjustment for testing of 
multiple outcomes will be made. However, within the analysis of a specific outcome, Tukey or Bonferroni 
adjustment will be made for the multiple tests across different time points. The power calculation below adjusts for 
this multiplicity. Aims 4a-4c: These hypotheses involve tests of proposed mediators of C-CBSM’s effect on our 
primary outcomes. To test mediation with LGM, individual change trajectory (in each outcome of interest) is 
characterized by an intercept and a slope factor. The overall pattern of change (e.g., linear, quadratic, etc., as 
informed by analyses for Aims 1-3) for the whole group can be specified by a particular set of coefficients associated 
with the slope factor. First, we will specify a growth curve model for all participants with an intercept factor 
representing our outcome of interest at baseline, and the slope factor reflecting the change trajectory in our outcome 
measure from T1 to T4. For example, to test that increased stress management skills (e.g., MOCS) in the C-CBSM 
group accounts for reductions in symptom burden (e.g., EPIC-S), we will first test a LGM model without the stress 
management skills (the mediator) and then test the model with change in stress management skills from T1 to T4. 
In the model without the stress management skills, we expect that group assignment is not related to baseline 
symptom burden, but that group assignment will be related to a greater negative change (reduction) in symptom 
burden scores. In the next step, we will add stress management skills and expect that after adding this mediator in 
the model, the path between group assignment and symptom burden slope will become non- significant, while the 
path between the mediator and symptom burden slope is significant thus suggesting mediation. This approach will 
be applied to test all mediation models in hypotheses 4a-4c.191,192  Aim 5a-5b: To evaluate moderators and 
mechanistic pathways of C-CBSM’s effects, we will use LMM and latent variable mediation models. For 
Hypothesis 5a, we will test moderation by including interaction terms between group assignment (C-CBSM vs. 
CBSM) and each moderator of interest (e.g., SES, acculturation, Hispanic ancestry, treatment type) within the LMM 
framework. These models will include fixed effects for group, time (T1–T4), the moderator, and the group × 
moderator and group × time × moderator interactions. A significant three-way interaction (group × time × 
moderator) will indicate that change in the outcome (e.g., inflammation, symptom burden, HRQoL) over time 
differs by both treatment group and the level of the moderator. Post-hoc comparisons will clarify the nature of the 
moderation effects across timepoints. For Hypothesis 5b, we will test whether improvements in cardiometabolic 
markers (e.g., lipids, fasting glucose, blood pressure) in the C-CBSM group are mediated by reductions in 
inflammation using SEM. Parallel process LGMs will estimate trajectories for inflammatory markers and 
cardiometabolic outcomes across time. The indirect effect from group assignment to cardiometabolic outcome slope 
via inflammation slope will be tested. This approach allows for simultaneous modeling of changes over time, 
capturing both within- and between-subject effects. Model fit will be evaluated using standard criteria (CFI > .95, 
RMSEA ≤ .05, SRMR < .08), and significance of indirect effects will be tested using bias-corrected bootstrapped 
confidence intervals.
Preliminary Analyses and other Statistical Considerations. Descriptive statistics will be computed to ensure 
values are within expected ranges and to eliminate any errors. We will use PRELIS2193,194 to examine multivariate 
normality. Non-normally distributed variables will be transformed using log transformations. We will compute 
estimates of internal consistency (Chronbach’s α) for all scales and composite scores. If reliability is <.70, we will 
evaluate the internal consistency of the measure and delete items or subscales as needed.195
Power Analyses. The primary aim compares pre-post change in symptom burden scores between the randomized 
arms. A sample of 100 per arm is assumed, although T1-T3 time points will have larger samples. Power is based 
on the effect size defined as the group difference in the mean change divided by the standard deviation of the change. 
Power calculations are based on effects of the C-CBSM pilot study.98 With 100 per arm, there is 80% power to 
detect an effect size of 0.40 assuming a two-tailed test and a Type I error rate of 5%. Since multiple tests look at 
change in various post-intervention time points, using a Type I error rate of 1% results in a detectable effect size of 
0.49. If effect sizes are calculated from Figure 6 from our preliminary work, then the observed effect sizes as defined 
above are 0.52 for FACT-G and 0.40 for EPIC-S. Effect sizes for subscales FACT-PWB and FACT-EWB are
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0.81 and 0.42 respectively. With greater effect sizes anticipated in the proposed study, the sample size of at least 
100 per arm has sufficient power to detect differences even after adjusting for the analysis of change from baseline 
to post-intervention time points. Power for C-CBSM’s effect on down regulation of inflammatory genes are based 
on Antoni et al.124 study which indicated that the observed effect size was one standard deviation in a sample size 
of 45 in the experimental condition. Glucocorticoid receptor sensitivity demonstrated similar effects. With a T4 
sample size of 100 in the C-CBSM group, effect sizes of 0.48 standard deviations are detectable with 80% power at 
a 2-tailed Type I error rate of 1%, so that expected effects will be detectable with sufficient power. While pilot data 
are not available for all outcome measures, the constant in the power calculation regardless of the outcome is the 
effect size expressed in terms of standard deviations, which is 0.40 or 0.49 depending on whether the Type I error 
rate is 5% or 1%.
Covariates, Cohort Effects, Intent to Treat & Missing Data. A number of variables (e.g., SES, disease factors) 
will be considered as possible covariates. These putative confounds will be entered as covariates if correlated with 
our outcomes (at p<.10). Random assignment should render groups equivalent on covariates and this will be verified 
post-hoc. We will test differences among cohorts who have completed our conditions by doing an ANOVA within 
each condition with k levels of cohort. If we find a cohort with differential outcomes (significant Condition x Cohort 
x Time interaction), we will conduct a Group x Time interaction tested within each cohort, and a Cohort x Time 
interaction tested within assignment. We have never observed a significant cohort effect in prior CBSM work. We 
will also use an intent-to-treat approach in that all participants will be retained in the analysis, including those with 
missing data at time points by using full information maximum likelihood (FIML) estimation. FIML, a 
recommended state-of-the-art method,197,198 uses all available data for each participant and provides unbiased 
estimates of parameters when the data are missing at random.
Cost to the Participants:
There will be no cost to the participants for taking part in this study. All expenses related to the study activities, 
including laboratory tests done and lab materials.
Risk and Benefits:
Risks: Though we regard the risks of participating in this study as relatively low, we will take every measure to 
ensure that every recruiter, interviewer or project personnel, is trained to handle situations sensitively and with 
empathy. All research staff are required to complete site mandated training on the Protection of Human Research 
Participants, and this training experience must be renewed on a yearly basis. Certificates for all research staff will 
be kept on file in the Project Manager or PI’s office at each respective site. As risks are relatively low and easily 
managed, and because benefits for participants are potentially substantial, the balance of risks-to-benefits are 
reasonable. 
In both experimental conditions, participants will be given specific Spanish PC-related information, as well as be 
asked to participate in the assessment of sensitive topics that may lead some to experience transient and mild 
anxiety. In addition, some participants are likely to manifest signs of severe symptoms, and in rare cases, disease 
progression, throughout the longitudinal component of the study, and they are likely to experience affective distress. 
There is also a slight possibility that participants may experience discomfort at the site of venipuncture as we are 
obtaining venous blood or during the remote blood spot collection in which the participant is instructed to use a 
lancet to obtain 5 drops of blood. In these cases, every attempt will be made to provide relief and to ameliorate the 
source of the discomfort. Participants will be mailed a set of instructions that include safety procedures in collecting 
blood drops. Should participants experience extreme acute or persisting affective reactions at any point during the 
study period, they will be referred to a psychiatrist or clinical psychologist associated with the site for care.
In the event that a participant reports symptoms or concerns of extreme distress (e.g., severe symptoms of depression 
and/or anxiety suggesting clinical concerns, suicidality, etc.), our interventionists will directly target such symptoms 
and assess the severity of such distress within the group context while maintaining the group process and eliciting 
support from other participants. Subsequent to the intervention session, the participant will be contacted individually 
by one of the interventionists for a more comprehensive assessment of distress. If it is determined at that point that 
the participant needs individual care, our interventionists and research staff will be prepared to refer the patient to 
a source of clinical intervention other than our C-CBSM or CBSM intervention (a list of referrals is available for 
each community). Similarly, should participants experience extreme, acute or persisting affective reactions at any 
other point during the study period (e.g., assessment, individual contact), they will be referred to the appropriate 
channels within the UM Departments of Psychiatry or Psychology, the UM/JMH and/or the Courtelis Center for 
Psychosocial Oncology at the UM/SCCC. Alliance and other community participants will be referred to a vast 
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network of community resources (e.g. Liga Contra el Cancer) known to treat Hispanic cancer survivors. They will 
also be provided a list of community resources/catchment sites in the South Florida area prepared to deliver 
resources to deal with extreme distress. As we will collect information on several cardiometabolic markers including 
blood pressure, fasting glucose, triglycerides, and HDL-cholesterol, participants with clinically elevated values will 
be alerted and results will be mailed, with participant consent, to primary care providers. For participants who report 
lack of a primary care provider, we will facilitate referral and access within our medical networks and community 
hospitals and clinics at each study site.
If, for some unforeseen reason, a situation arises in which a participant experiences more harm than good during the 
study, the Principal Investigator may choose to withdraw this participant. Though highly unlikely, such situations 
could include excessive physical, psychological, or emotional suffering. When participants withdraw from the 
research, study staff will update their data set (i.e. tracking spreadsheets) to reflect this change. Study staff will no 
longer contact participants to  schedule groups or assessments, depending on the time point at which the participants 
withdraw. Unless a participant expressly requests the destruction of whatever data (biological or otherwise) that has 
already been collected, and unless a participant requests no further data be collected about him whatsoever, study 
staff may continue to gather certain information (i.e. medical chart data) at the other time points at which the 
participant would have been seen had he remained active in the study.
Benefits: Participants will benefit from a culturally adapted cognitive-behavioral stress and self- management 
intervention (C-CBSM) or a standard CBSM intervention. Participants will be experiencing a psychosocial 
intervention specifically adapted to address and consider Hispanic sociocultural values and beliefs that is designed 
to ameliorate the distress, symptom burden and health- related quality of life (HRQoL) challenges experienced in 
localized PC. In both conditions, participants will be receiving relevant PC information, and strategies to manage 
stress, reduce symptom burden and improve HRQoL. In the C-CBSM condition, these strategies are delivered in a 
culturally informed and targeted manner and are thus hypothesized to have greater efficacy on our study outcomes, 
relative to standard CBSM. Nonetheless, both conditions will provide benefits. Thus, participants should all be in a 
position in which they experience less distress, better symptom management and HRQoL. The findings of this study 
will inform future interventions for Hispanic Spanish speaking men living with localized PC who have undergone 
surgery or radiation treatment.  Further, should the C-CBSM intervention prove to be more effective, this research 
will benefit other Hispanic and Spanish speaking cancer survivors via its documentation of the incremental efficacy 
of a culturally targeted program.
Participant Compensation:
Given the time demands of this study, we will offer compensation of $75 at each assessment visit, for a total of $300 
for study participation. Participants who are able to complete the entire interview (blood work and questionnaire) 
will receive $75. Participants who complete 75% of the interview (blood work and the socio-demographic, health 
related, stress/distress questionnaires) will receive $50.  Participants who complete the other 25% of the interview 
(Interpersonal, Mechanics, Culture, and Other sections) will receive $25 upon completion. We will also provide 
parking or transportation for assessment or intervention visits for up to 30% of the sample. This will provide us with 
the flexibility to offer participants the option of receiving transportation services to attend our clinic or intervention 
visits. Participants will not be paid for those research activities that they do not complete. However, they will not 
incur any additional costs for being in our study.
Vulnerable Populations:
N/A
Withdrawal of Subjects:
Participation in study is completely voluntary where participants can elect not to answer any specific question on 
the questionnaire. It is also voluntary to complete the questionnaire/test/specimen banking and can elect to not 
participate at all in the study.
Data & Safety Monitoring:
The informed consent, all assessment measures, and intervention modules have been reviewed and approved by the 
UM Institutional Review Boards (IRB). In addition, the study will be closely monitored by the Sylvester 
Comprehensive Cancer Center (SCCC) Data and Safety Monitoring Committee (DSMC) in accordance to the 
Cancer Center's Data and Safety Monitoring Plan (DSMP) and a Community Advisory Board (CAB). In its 
oversight capacity, the DSMC bears responsibility for suspending or terminating this study. DSMC oversight of the 
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conduct of this trial includes ongoing review of adverse event data, and periodic review of the study’s aims (refer to 
Data Analysis section). The guidelines appearing in this section are offered for DSMC consideration in assessing 
adverse events and treatment response or other study endpoint. In addition, the DSMC will review reports from all 
audits, site visits, or study reviews pertaining to this clinical trial and take appropriate action. The SCCC DSMC to 
which this study is subject can be found at www.sccc.org.
Community Advisory Board (CAB): 
We will take a CBPR approach to engage key stakeholders.199 PC survivors and health care professionals review 
all study procedures to optimize sensitivity, appropriateness and cultural relevance. Our prior work developing C-
CBSM involved an iterative approach where health providers who treat our target population were involved in all 
steps of the development. We will establish a community advisory board (CAB) of community partners, health care 
and administrative professionals, and Hispanics treated for localized PC to optimize dissemination and 
sustainability. Two CAB meetings take place in Years 1 and 5, and one each year during Year 2-4. Meetings elicit 
input from patients, health care providers and administrators in our Hispanic communities (5 individuals from each 
city), which are stakeholders in the proposed aims of the project. These meetings will maximize implementation and 
plan for sustainability.
Trial Monitoring, Auditing, and Inspecting
The investigator will permit trial-related monitoring, quality audits, and inspections by, government regulatory 
authorities, of all trial-related documents (e.g., source documents, regulatory documents, data collection 
instruments, case report forms). The investigator will ensure the capability for inspections of applicable trial- related 
facilities. The investigator will ensure that the trial monitor or any other compliance or QA reviewer is given access 
to all trial-related documents and trial-related facilities. Participation as an investigator in this trial implies the 
acceptance of potential inspection by government regulatory authorities.
Quality Assurance and Quality Control
In addition to the Clinical Monitoring component of this protocol, Quality Assurance will be implemented (QA) to 
assess compliance with GCP and applicable regulatory requirements. Data or documentation audited shall be 
assessed for compliance to the protocol, accuracy in relation to source documents and compliance to applicable 
regulations.
Publication policy/Results Reporting/Progress and Final Reports:
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH- Funded Clinical 
Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial 
is registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In 
addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be 
requested from other researchers 7 years after the completion of the primary endpoint by contacting Dr. Frank 
Penedo or the University of Miami.
Privacy, Data Storage, & Confidentiality:
Privacy: All material will be obtained exclusively for research purposes and in full IRB and HIPAA compliance. 
All sources of information will be coded using a special participant number, which precludes it being matched with 
identifying information. Because all our participants will be men treated for PC, the issues surrounding 
confidentiality are of supreme importance. In all cases, highly personal and clinical information will be obtained. 
By signing the informed consent form, participants attest to their understanding that the information they provide 
will be held as personal and confidential to the extent permitted by law. Access to the computer data files will be by 
password codes. The list matching participant number to identifying information will be maintained in a locked 
drawer, in the PI’s office. Additionally, in order to be able to track participants across the longitudinal period of the 
project, we will keep a separate record of each participant’s address, telephone number and contact person 
information. This record will indicate whether or not a participant has completed an assessment but will not include 
information concerning their assessment or intervention performance. Participants will be made explicitly aware at 
the time of the informed consent of the nature of the two separate records that will be kept.
Confidentiality and Data Management: The sources of research material obtained from participants will be the 
participants themselves in the form of medical history and blood specimens. In addition, participants will furnish 
demographic, psychiatric and psychosocial information and self-reports of changes in symptoms. As previously 
noted, we will also collect medical treatment and disease characteristics (e.g., type of treatment, disease status 
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markers such as Gleason score, PSA, time since diagnosis, etc.). Medical treatment and disease characteristic 
information will be collected via chart review by our research team under procedures established in prior work with 
our Urologist Dr. Kava. The majority of self-report data obtained from participants will be stored via the secure 
website Redcap. Per IRB policy, study data collected will be stored for 7 years after the completion of the study.
Biological specimens (participant blood samples) will be labeled with a code that does not contain personal or 
identifying information. All lab results are kept confidential and under no circumstances will the information gained 
from blood samples be shared with anyone outside of the research team. All data is kept in encrypted and password 
protected files on a locked Northwestern University and the University of Miami network. Participant names and 
all other identifying information are kept in a separate, locked and protected location to ensure participant identity 
cannot be linked to the blood sample provided. Biological specimens, including participant blood samples, will 
either be processed by the Department of Pathology at the UMHC & Sylvester Cancer Center lab (PSA & A1c) or 
stored in a predestinated research laboratory space in Dr. Blomberg’s lab located in Rosenstiel Medical Science 
Building,1600 NW 10th Ave. #3146A, Miami, Fl 33136. Only the laboratory technician on staff and supervising 
immunologist will have access to blood samples. Biological specimens (i.e. blood) obtained from participants will 
be stored for the duration of the study (4 years) and then will be destroyed. Blood samples processed by the 
Department of Pathology at UMCH SCCC Lab will be destroyed by the lab upon completion of the lab PSA and 
A1c analysis. Blood samples will not be used for future research and will not be shared with other researchers.
The project’s benchwork will involve collaboration amongst four laboratories. Immediately following collection, 
the specimens will be transported by courier to Dr. Blomberg’s lab (Miami patients). Experience staff at these labs 
(Dr. Diaz) will harvest serum for measurements of systemic inflammation, culture leukocytes with TLR ligands to 
assess cytokine production, and isolate monocytes for genome-wide transcriptional profiling. At the conclusion of 
the study, culture supernatants will be transported to Dr. Miller’s laboratory for multiplex cytokine analysis on the 
MSD platform, and monocyte lysates will be shipped to Dr. Cole’s laboratory for genome-wide expression profiling. 
While this is admittedly a complex workflow, the participating laboratories have many years of experience working 
together, and as the publications cited above show, can successfully execute the specified protocols. Unless required 
by law, only the study investigator, members of the investigator’s staff, representatives of The National Cancer 
Institute (NCI), the respective site’s Institutional Review Boards (IRB), and representatives from the Office for 
Human Research Protections (OHRP) will have access to review study records. Research staff will complete 
HIPAA (CITI) training courses on the protection of human subjects in research in order to better understand the 
precautions they must take with sensitive participant data. Again, all participant data will be de-identified and stored 
in secure locations (i.e. locked offices or labs) for the duration of the study and electronic information will be 
password protected and stored on secure university machines or secure websites. Approximately every 6 months, 
research staff, will conduct a quality check of their medical chart review data. This quality check will help ensure 
that all research staff are using the same methodology when extracting information from charts. Research staff will 
also cross-check hand-entered data to ensure that information being collected on paper forms is transmitted 
accurately into study spreadsheets. In regard to the data analysis plan, descriptive statistics will be computed for all 
variables to ensure that values are within expected ranges and to eliminate any errors.
Data and if applicable, Specimen Banking:
All psychosocial data, participant tracking and flow, and intervention data will be collected via University of Miami 
Redcap (https://recap.miami.edu), including previously collected transferred data at Northwester University at 
Chicago Redcap (https://redcap.nubic.northwestern.edu/redcap/). EMR and physiologic data will also be entered in 
the Redcap platform. Redcap is securely stored at the Northwestern University (NU) and University of Miami 
Research Data Centers and available via the web. The data management environment meets the security 
requirements identified in the Agency Automated Information Systems Security Program (AISSP) Handbook. 
Redcap requires use of current passwords and log-on codes to protect sensitive AIS (Automated Information 
System) data from unauthorized access: All system access requires a user name and password. All users who require 
anything more than “internet user” security to the NU and University of Miami campus network must have a unique 
ID assigned. The NU and University of Miami ID is used to control access to data files and applications that reside 
on the network. Every NU and Miami ID is required to have a complex password assigned. Access to Redcap is 
restricted to participants by means of a username and password incorporated within the participant registration 
process. Because SQL Server 2008 R2 is integrated with Windows, SQL Server and Windows (MySQL at the 
University of Miami) authentication is used to prevent unauthorized access. Restriction to Redcap involves 
maintaining an encrypted list of current users and authorizations based on permissions and roles assigned to each 
user. NU and the University of Miami provides Redcap administrators with secure Virtual Private Network (VPN) 
access. Operating system and database based permissions are set by the Redcap administrators. User accounts have 
limited system resource access. The availability and flow of data is limited to the security access identified and 
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signed off by management, and is controlled by the database administrator who pre-defines security access levels. 
This ensures that only data necessary for that individual’s work function are viewable. All requests are validated 
before attempting to submit data to the database. Any internal or stored reference to a participant is accomplished 
through a unique identifier key. Data is stored and accessed in full compliance with institutional IRB and 
governmental regulations regarding privacy and security. NU and the University of Miami have a secure data center 
that houses all servers. This center is limited to authorized employees via the use of a card swiping system and 
biometric reader on the entrance doors. NU’s Department of Medical Social Sciences and the University of Miami 
IT Department have established standard operating procedures relevant to data retention and removal based on NIH 
data retention requirements. Sensitive participant identifiers of on-going studies are encrypted and kept confidential. 
This procedure was initially designed to comply with HIPAA requirements. Terminated studies have all participant 
identifiers removed from electronic media storage after the retention period. Hard copy documents with participant 
identifiers will be shredded in a timely manner. NU and the University of Miami provide comprehensive data 
backup. At NU all data is stored in a dedicated storage server on top of redundant disk array. A snapshot of the 
virtual machines is taken every night and stored on backup storage that is alternated every two weeks. A full backup 
of the database is taken every night with incremental backups taken every two hours. Communications lines 
terminate in locked PBX rooms and in the data center.
Contingency plan for disaster recovery is in place. The NU Research Data Center has two Uninterruptible Power 
Supplies and a Diesel generator in the event of a power shutdown. These units are tested on a routine basis. At the 
University of Miami data is encrypted at rest using AES 256 encryption, server is backed up daily. Systems updates 
are performed monthly and RedCap application upgrades are performed bi-annually. The University of Miami also 
has an Uninterruptible Power Supplies in the event of a power shutdown.
Miami Site Setting:
The study will housed at the Coral Gables campus, the office of Dr. Michael Antoni, Co-PI Department of 
Psychology (Flipse Building, 5665 Ponce De Leon Drive, Coral Gables, Fl 33146) and the medical campus, the 
office of Dr. Dolores Perdomo, Project Manager, at the Center on Aging, Department of Psychiatry (1695 NW 9th 
Avenue, Suite 3204L, Miami, Fl 33136).
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