Health Gatherings - For Your Health After Cancer

Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03344757

Enrollment

188

Registered

2017-11-17

Start date

2017-10-05

Completion date

2024-08-01

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

prostate cancer, localized prostate cancer, spanish, latino, hispanic, stress management

Brief 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).

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

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, Hepatitis C, or immunosuppressive 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. .

Design outcomes

Primary

Measure	Time frame	Description
Change in Symptom Burden as Measure by EPIC-S.	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.	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.	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	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	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.

Secondary

Measure	Time frame	Description
Change in Stress Management Skills as Measured by MOCS-A	Baseline, Month 3, Month 6, Month 12	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.
Change in Interpersonal Function as Measured the SIP Questionnaire	Baseline, Month 3, Month 6, Month 12	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.
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II	Baseline, Month 3, Month 6, Month 12	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.
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III	Baseline, Month 3, Month 6, Month 12	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.
Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire	Baseline, Month 3, Month 6, Month 12	PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression.
Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire	Baseline, Month 3, Month 6, Month 12	PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Cultural-Cognitive Behavioral Stress Management (CCBSM) Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention. Cultural 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).	100
Cognitive Behavioral Stress Management (CBSM) Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. Standard 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.	88
Total	188

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	2
Overall Study	Withdrawal by Subject	18	16

Baseline characteristics

Characteristic	Cognitive Behavioral Stress Management (CBSM)	Total	Cultural-Cognitive Behavioral Stress Management (CCBSM)
Age, Continuous	65.42 years STANDARD_DEVIATION 8.42	65.77 years STANDARD_DEVIATION 8	66.07 years STANDARD_DEVIATION 7.64
Ethnicity (NIH/OMB) Hispanic or Latino	88 Participants	188 Participants	100 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	2 Participants	6 Participants	4 Participants
Race (NIH/OMB) More than one race	10 Participants	25 Participants	15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	8 Participants	6 Participants
Race (NIH/OMB) White	72 Participants	147 Participants	75 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	88 Participants	188 Participants	100 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 100	0 / 88
other Total, other adverse events	3 / 100	7 / 88
serious Total, serious adverse events	0 / 100	3 / 88

Outcome results

Primary

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