Health Gatherings - For Your Health After Cancer

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT03344757

Collaborator

Northwestern University (Other), National Cancer Institute (NCI) (NIH)

260

Enrollment

Locations

Arms

63.9

Anticipated Duration (Months)

130

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Neoplasm Genital Neoplasms, Male Urogenital Neoplasms Neoplasm, Prostate Genital Diseases, Male Prostatic Diseases	Behavioral: Cultural CBSM Behavioral: Standard CBSM	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 5, 2017

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: C-CBSM Participants randomized to this arm will receive 10 weekly group-based C-CBSM 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).
Active Comparator: CBSM Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: C-CBSM

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

Active Comparator: CBSM

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Change in symptom burden as measure by EPIC-S. [Baseline to Month 3, Baseline to Month 6, Baseline to Month 12]
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.
Change in HRQoL as measured by the FACT questionnaire. [Baseline to Month 3, Baseline to Month 6, Baseline to 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 to Month 3, Baseline to Month 6, Baseline to Month 12]
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.
Change in HRQoL as measured by the PROMIS Fatigue questionnaire [Baseline to Month 3, Baseline to Month 6, Baseline to Month 12]
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.
Change in HRQoL as measured by the PROMIS Pain questionnaire [Baseline to Month 3, Baseline to Month 6, Baseline to Month 12]
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.

Secondary Outcome Measures

Change in stress management skills as measured by MOCS-A [Baseline to Month 3, Baseline to Month 6, Baseline to 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 prostate cancer-specific psychological distress as measured by MAX-PC - Section I-II [Baseline to Month 3, Baseline to Month 6, Baseline to 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 to Month 3, Baseline to Month 6, Baseline to 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 to Month 3, Baseline to Month 6, Baseline to 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 to Month 3, Baseline to Month 6, Baseline to 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.
Change in interpersonal function as measured the SIP questionnaire [Baseline to Month 3, Baseline to Month 6, Baseline to 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 the activation of leukocyte glucocorticoid receptors expression [Baseline to Month 3, Baseline to Month 6, Baseline to Month 12]
Leukocyte glucocorticoid receptor expression will be evaluated via blood serum
Change in the inflammatory gene expression [Baseline to Month 3, Baseline to Month 6, Baseline to Month 12]
Inflammatory gene expression will be evaluated via blood serum.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 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.

Exclusion Criteria:

History of non-skin cancer within the last 5 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.