Health Gatherings - For Your Health After Cancer

University of Miami

Status: Completed

Conditions: Prostate Neoplasm; Neoplasm, Prostate; Urogenital Neoplasms; Genital Neoplasms, Male; Prostatic Diseases; Genital Diseases, Male

Treatments: Behavioral: Cultural CBSM; Behavioral: Standard CBSM

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03344757

20170656

STU00203197 (Other Identifier)

1R01CA206456-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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 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 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.

Aim 3: Determine 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: Determine whether C-CBSM related improvements in symptom burden and HRQoL are mediated by improvements in intervention targets and gene expression profiles.

Enrollment: 202 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

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Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups

Cultural-Cognitive Behavioral Stress Management (CCBSM)

Experimental group

Description:

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

Treatment:

Behavioral: Cultural CBSM

Cognitive Behavioral Stress Management (CBSM)

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard CBSM