Prostate NeoplasmNCT03344757
Health Gatherings - For Your Health After Cancer
A study testing Cultural CBSM and Standard CBSM in people with Prostate Neoplasm and Genital Neoplasms, Male, run by University of Miami at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasm, Genital Neoplasms, Male, Urogenital Neoplasms
- What is being tested?
- Cultural CBSM and Standard CBSM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2017to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age;
- Hispanic/Latino self-identification;
- Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
- Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
- Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-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 approximately12 months.
Who cannot join
- 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., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.
- Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.
- .
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
University of Miami
Miami, Florida, 33136
About this study
Official title: Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
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.
- Conditions
- Prostate Neoplasm, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasm, Prostate, Genital Diseases, Male, Prostatic Diseases
- Being tested
- Cultural CBSM, Standard CBSM
- Keywords
- prostate cancer, localized prostate cancer, spanish, latino, hispanic, stress management
- Medical subject headings
- Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultural CBSMBehavioural
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).
Standard CBSMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cultural-Cognitive Behavioral Stress Management (CCBSM) | Experimental | Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention. Receives: Behavioral: Cultural CBSM |
| Cognitive Behavioral Stress Management (CBSM) | Active comparator | Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. Receives: Behavioral: Standard CBSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
Secondary outcomes (6)
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
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.
Measured: Baseline, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start5 Oct 2017
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank Penedo, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344757
- Sponsor's protocol ID
- 20170656
- Other IDs
- STU00203197, 1R01CA206456-01A1
- Status last verified
- Aug 2025
- First submitted
- 27 Sep 2017
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
- ClinicalTrials.gov ID
- NCT03344757
- Acronym / sponsor ID
- 20170656
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Northwestern University, National Cancer Institute (NCI)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cultural-Cognitive Behavioral Stress Management (CCBSM) | Experimental | Behavioral: Cultural CBSMParticipants randomized to this arm will receive 10 weekly group-based C-CBSM intervention. |
| Cognitive Behavioral Stress Management (CBSM) | Active comparator | Behavioral: Standard CBSMParticipants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age;
- Hispanic/Latino self-identification;
- Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
- Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
- Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months;
Key exclusion criteria (7 listed)
- 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., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultural CBSMThe 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). | Behavioural | Cultural-Cognitive Behavioral Stress Management (CCBSM) |
| Standard CBSMThe 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. | Behavioural | Cognitive Behavioral Stress Management (CBSM) |
Primary outcome
Change in Symptom Burden as Measure by EPIC-S.
Time frame: Baseline, Month 3, Month 6, Month 12
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.
Change in HRQoL as Measured by the FACT Questionnaire.
Time frame: Baseline, Month 3, Month 6, Month 12
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.
Change in Symptom Burden as Measure by EPIC-UIN.
Time frame: Baseline, Month 3, Month 6, Month 12
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.
Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire
Time frame: Baseline, Month 3, Month 6, Month 12
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.
Change in HRQoL as Measured by the PROMIS Pain Questionnaire
Time frame: Baseline, Month 3, Month 6, Month 12
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.
6 secondary outcomes
Change in Stress Management Skills as Measured by MOCS-A
Time frame: Baseline, Month 3, Month 6, Month 12
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II
Time frame: Baseline, Month 3, Month 6, Month 12
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III
Time frame: Baseline, Month 3, Month 6, Month 12
Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire
Time frame: Baseline, Month 3, Month 6, Month 12
Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire
Time frame: Baseline, Month 3, Month 6, Month 12
Change in Interpersonal Function as Measured the SIP Questionnaire
Time frame: Baseline, Month 3, Month 6, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38429598Pedreira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Penedo, Ph.D. principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultural CBSM and Standard CBSM in people with Prostate Neoplasm and Genital Neoplasms, Male, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Burden as Measure by EPIC-S. (time frame: Baseline, Month 3, Month 6, Month 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.