ClinicalTrials.gg
CompletedNCT03344757Updated Sep 11, 2025Results posted

Health Gatherings - For Your Health After Cancer

An interventional study of Cultural CBSM and Standard CBSM in Prostate Neoplasm, Genital Neoplasms, Male and Urogenital Neoplasms, sponsored by University of Miami. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by University of Miami · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Prostatic Neoplasms by University of Miami — 7 open to participants now, 12 under way, none of them phase 3. Prostatic Neoplasms · University of Miami.

Enrollment
3rd of 18
188 · median 44
Started
2017
the only one that year
No phase
12 of 21
3 open now
Registered
12th of 21
by date

Among the 21 studies in Prostatic Neoplasms by University of Miami, this one is the 3rd largest by enrollment of the 18 interventional ones, is the only one that started in 2017, is one of 12 with no phase, and was the 12th registered.

By phase

21 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 3 open
Phase 24 · 2 open
Observational3 · 1 open
Phase 1/21 · 0 open
Phase 41 · 1 open

By the year they started

First in 2007; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 44 across the 18 interventional studies, 144 across the 3 observational. Of the 8 that completed or were terminated, 7 (88%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 21 studies in Prostatic Neoplasms by University of Miami, or all of them as a file.
02

Study summary

The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).

Read the detailed description

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. 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. 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 CCBSM'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 CCBSM's effects on cardiometabolic markers via reduced inflammation.

03

Conditions studied

  • Prostate Neoplasm
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Neoplasm, Prostate
  • Genital Diseases, Male
  • Prostatic Diseases

Keywords

  • prostate cancer
  • localized prostate cancer
  • spanish
  • latino
  • hispanic
  • stress management
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ≥ 18 years of age;
  2. Hispanic/Latino self-identification;
  3. Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
  4. Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
  5. Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months;
  6. 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;
  7. Willingness to be randomized and followed for approximately12 months.

Exclusion criteria

Exclusion Criteria:

  1. History of non-skin cancer within the last 2 years.
  2. 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;
  3. Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;
  4. Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and
  5. Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, , or treatment requiring conditions), per PI discretion based on a case by case review.
  6. Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.

    .

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    Cultural-Cognitive Behavioral Stress Management (CCBSM)

    Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.

    Behavioral: Cultural CBSM

  • Active comparator
    Cognitive Behavioral Stress Management (CBSM)

    Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.

    Behavioral: Standard CBSM

Interventions

  • BehavioralCultural CBSM

    The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).

  • BehavioralStandard CBSM

    The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.

06

What researchers measure

Primary outcomes

  1. Change in Symptom Burden as Measure by EPIC-S.

    Symptom Burden will be measured using the 5-item sexual domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-S). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.

    Time frame: Baseline, Month 3, Month 6, Month 12

  2. Change in HRQoL as Measured by the FACT Questionnaire.

    HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function.

    Time frame: Baseline, Month 3, Month 6, Month 12

  3. Change in Symptom Burden as Measure by EPIC-UIN.

    Symptom Burden will be measured using the 9-item urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-UIN). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.

    Time frame: Baseline, Month 3, Month 6, Month 12

  4. Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire

    HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The PROMIS Fatigue measure generates t-scores with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Higher scores indicate greater fatigue.

    Time frame: Baseline, Month 3, Month 6, Month 12

  5. Change in HRQoL as Measured by the PROMIS Pain Questionnaire

    HRQoL will be measured using the PROMIS short form for Pain Interference Questionnaire. The items are item banks, and scoring is done via a computer adaptive test (CAT), which utilizes item response theory (IRT) to calculate a score that is then transformed into a T-score with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. Higher scores indicate greater pain interference.

    Time frame: Baseline, Month 3, Month 6, Month 12

Secondary outcomes

  1. Change in Stress Management Skills as Measured by MOCS-A

    Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills.

    Time frame: Baseline, Month 3, Month 6, Month 12

  2. Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II

    Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress.

    Time frame: Baseline, Month 3, Month 6, Month 12

  3. Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III

    Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress.

    Time frame: Baseline, Month 3, Month 6, Month 12

  4. Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire

    PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression.

    Time frame: Baseline, Month 3, Month 6, Month 12

  5. Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire

    PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety.

    Time frame: Baseline, Month 3, Month 6, Month 12

  6. Change in Interpersonal Function as Measured the SIP Questionnaire

    Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function.

    Time frame: Baseline, Month 3, Month 6, Month 12

07

Results

Posted Sep 11, 2025

Participant flow

Participant flow — Overall Study
MilestoneCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Started10088
Completed8270
Not completed1818
Withdrew: Withdrawal by subject1816
Withdrew: Lost to follow-up02

Outcome measures

PrimaryChange in Symptom Burden as Measure by EPIC-S.

Symptom Burden will be measured using the 5-item sexual domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-S). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Symptom Burden as Measure by EPIC-S.
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline30.1 ± 2.5332.1 ± 3.02
Month 334.7 ± 3.0135.8 ± 3.30
Month 635.9 ± 3.3938.0 ± 3.67
Month 1236.2 ± 3.2738.9 ± 3.50
PrimaryChange in HRQoL as Measured by the FACT Questionnaire.

HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in HRQoL as Measured by the FACT Questionnaire.
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline81.1 ± 1.1281.7 ± 1.70
Month 383.8 ± 1.3083.7 ± 1.45
Month 683.6 ± 1.5183.3 ± 1.74
Month 1282.6 ± 1.4183.0 ± 1.54
PrimaryChange in Symptom Burden as Measure by EPIC-UIN.

Symptom Burden will be measured using the 9-item urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-UIN). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Symptom Burden as Measure by EPIC-UIN.
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline73.5 ± 2.4578.8 ± 2.32
Month 377.4 ± 2.5082.2 ± 2.38
Month 679.5 ± 2.4784.6 ± 2.18
Month 1278.3 ± 2.4183.3 ± 2.31
PrimaryChange in HRQoL as Measured by the PROMIS Fatigue Questionnaire

HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The PROMIS Fatigue measure generates t-scores with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Higher scores indicate greater fatigue.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · T-score
Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire
T-scoreCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline43.2 ± 0.9043.5 ± 0.99
Month 343.3 ± 0.8842.8 ± 1.06
Month 643.9 ± 1.0943.1 ± 1.05
Month 1243.5 ± 0.9643.0 ± 0.99
PrimaryChange in HRQoL as Measured by the PROMIS Pain Questionnaire

HRQoL will be measured using the PROMIS short form for Pain Interference Questionnaire. The items are item banks, and scoring is done via a computer adaptive test (CAT), which utilizes item response theory (IRT) to calculate a score that is then transformed into a T-score with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. Higher scores indicate greater pain interference.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · T-score
Change in HRQoL as Measured by the PROMIS Pain Questionnaire
T-scoreCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline47.8 ± 0.9347.0 ± 0.97
Month 346.7 ± 0.9646.4 ± 1.08
Month 647.1 ± 1.2046.9 ± 1.06
Month 1248.3 ± 1.0746.2 ± 1.02
SecondaryChange in Stress Management Skills as Measured by MOCS-A

Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Stress Management Skills as Measured by MOCS-A
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline38.5 ± 0.8737.6 ± 1.09
Month 338.6 ± 0.9138.3 ± 1.09
Month 639.6 ± 0.9339.3 ± 1.23
Month 1239.2 ± 0.9038.0 ± 0.95
SecondaryChange in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II

Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline7.1 ± 0.9410.0 ± 1.20
Month 35.6 ± 0.986.2 ± 0.97
Month 65.01 ± 0.937.7 ± 1.24
Month 126.7 ± 1.086.1 ± 0.94
SecondaryChange in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III

Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline8.5 ± 0.288.1 ± 0.37
Month 38.9 ± 0.319.1 ± 0.33
Month 68.7 ± 0.298.3 ± 0.38
Month 129.1 ± 0.308.8 ± 0.35
SecondaryChange in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire

PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline44.8 ± 0.9145.9 ± 0.96
Month 343.8 ± 0.9444.7 ± 1.05
Month 644.8 ± 1.0545.4 ± 1.12
Month 1245.5 ± 0.9744.9 ± 1.10
SecondaryChange in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire

PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline49.5 ± 0.9850.0 ± 1.08
Month 350.4 ± 0.9649.1 ± 1.18
Month 651.0 ± 1.1649.8 ± 1.24
Month 1250.7 ± 0.9849.0 ± 1.15
SecondaryChange in Interpersonal Function as Measured the SIP Questionnaire

Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function.

Time frame:
Baseline, Month 3, Month 6, Month 12
Reported as:
Mean · score on a scale
Change in Interpersonal Function as Measured the SIP Questionnaire
score on a scaleCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
Baseline2.5 ± 0.283.1 ± 0.38
Month 32.6 ± 0.402.9 ± 0.45
Month 62.2 ± 0.302.5 ± 0.40
Month 122.6 ± 0.382.3 ± 0.36

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cultural-Cognitive Behavioral Stress Management (CCBSM)0/100 (0%)0/100 (0%)3/100 (3%)
Cognitive Behavioral Stress Management (CBSM)0/88 (0%)3/88 (3.4%)7/88 (8%)
Most frequent serious events
Most frequent serious events
EventCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
InjuryInjury, poisoning and procedural complications0/1001/88
InsomniaPsychiatric disorders0/1001/88
HypertensionCardiac disorders0/1001/88
Most frequent other events
Most frequent other events
EventCultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)
AnxietyPsychiatric disorders1/1002/88
DepressionPsychiatric disorders0/1002/88
Gastroesophageal reflux diseaseGastrointestinal disorders0/1001/88
FallInjury, poisoning and procedural complications1/1001/88
InjuryInjury, poisoning and procedural complications0/1001/88
COVID-19Infections and infestations1/1000/88

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)Total
Mean66.07 ± 7.6465.42 ± 8.4265.77 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)Cultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)Total
Female000
Male10088188
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)Total
Hispanic or Latino10088188
Not Hispanic or Latino000
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cultural-Cognitive Behavioral Stress Management (CCBSM)Cognitive Behavioral Stress Management (CBSM)Total
American Indian or Alaska Native011
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American426
White7572147
More than one race151025
Unknown or Not Reported628
08

Study locations

2 sites
  • University of Miami
    Miami, Florida 33136, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
09

References and documents

Publications

  • Pedreira PB, Fleszar-Pavlovic SE, Walsh EA, Noriega Esquives B, Moreno PI, Perdomo D, Heller AS, Antoni MH, Penedo FJ. Familism, family cohesion, and health-related quality of life in Hispanic prostate cancer survivors. J Behav Med. 2024 Aug;47(4):595-608. doi: 10.1007/s10865-024-00479-1. Epub 2024 Mar 1. PubMed 38429598 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03344757
Responsible party
Frank Penedo (Professor, University of Miami) — Principal investigator
First posted
Nov 17, 2017
Start date
Oct 5, 2017
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024
Results posted
Sep 11, 2025
Last update
Sep 11, 2025

Study contacts

Frank Penedo, Ph.D.
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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