Clinical trial NCT03344757: Health Gatherings - For Your Health After Cancer
Official title: Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Cancer Institute (NCI)
First posted: 2017-11-17
Enrollment: 202
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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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Primary outcomes:
measure: Change in symptom burden as measure by EPIC-S.
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in HRQoL as measured by the FACT questionnaire.
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in symptom burden as measure by EPIC-UIN.
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in HRQoL as measured by the PROMIS Fatigue questionnaire
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in HRQoL as measured by the PROMIS Pain questionnaire
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary outcomes:
measure: Change in stress management skills as measured by MOCS-A
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section I-II
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section III
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in psychosocial distress as measured by the PROMIS Depression questionnaire
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in psychosocial distress as measured by the PROMIS Anxiety questionnaire
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in interpersonal function as measured the SIP questionnaire
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in the activation of leukocyte glucocorticoid receptors expression
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
measure: Change in the inflammatory gene expression
timeFrame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: University of Miami
name: Frank Penedo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: