Health Gatherings - For Your Health After Cancer

Prostate Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03344757
• Other study ID #: 20170656
• Secondary ID: STU002031971R01C
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, Hispanic/Latino men diagnosed with Prostate Cancer (PC).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Cancer Institute (NCI), Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptom burden as measure by EPIC-S.	Symptom Burden will be measured using the Expanded Prostate Cancer Index Composite (EPIC) - Short Form Summary (EPIC-S). The EPIC-S is a 6-item questionnaire with a total score ranging from 6 - 29 with the lower score indicating greater symptom burden.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
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.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Primary	Change in symptom burden as measure by EPIC-UIN.	Symptom Burden will be measured using the EPIC-Short Form Urinary Domain (EPIC-UIN). The EPIC-UIN is a 5-item questionnaire with a total score ranging from 9-43 with the higher score indicating greater symptom burden.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Primary	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 total score ranges from 95-475 with the higher score indicating increased fatigue.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Primary	Change in HRQoL as measured by the PROMIS Pain questionnaire	HRQoL will be measured using PROMIS short form for Pain Questionnaire. The items are item banks and the scoring via a computer adaptive testes (CAT) which use item response theory (IRT) to calculate a score that is transformed to a T score. 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. The higher the score the greater pain symptom.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	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.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	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.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	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.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	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.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	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.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	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.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	Change in the activation of leukocyte glucocorticoid receptors expression	Leukocyte glucocorticoid receptor expression will be evaluated via blood serum	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary	Change in the inflammatory gene expression	Inflammatory gene expression will be evaluated via blood serum.	Baseline to Month 3, Baseline to Month 6, Baseline to Month 12