Health Gatherings - For Your Health After Cancer

NCT03344757 | Completed Results DMC

• 3 other identifiers: 20170656STU002031971R01CA206456-01A1
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (5)

• Change in Symptom Burden as Measure by EPIC-S.

  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.

  Baseline, Month 3, Month 6, Month 12

• 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, Month 3, Month 6, Month 12

• Change in Symptom Burden as Measure by EPIC-UIN.

  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.

  Baseline, Month 3, Month 6, Month 12

• 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 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.

  Baseline, Month 3, Month 6, Month 12

• Change in HRQoL as Measured by the PROMIS Pain Questionnaire

  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.

  Baseline, Month 3, Month 6, Month 12

Secondary Outcomes (6)

• Change in Stress Management Skills as Measured by MOCS-A

  Baseline, Month 3, Month 6, Month 12

• Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II

  Baseline, Month 3, Month 6, Month 12

• Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III

  Baseline, Month 3, Month 6, Month 12

• Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire

  Baseline, Month 3, Month 6, Month 12

• Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire

  Baseline, Month 3, Month 6, Month 12

Study Arms (2)

Cultural-Cognitive Behavioral Stress Management (CCBSM)

EXPERIMENTAL

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

Behavioral: Cultural CBSM

Cognitive Behavioral Stress Management (CBSM)

ACTIVE COMPARATOR

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

Behavioral: Standard CBSM

Interventions

Cultural CBSM BEHAVIORAL

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).

Cultural-Cognitive Behavioral Stress Management (CCBSM)

Standard CBSM BEHAVIORAL

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.

Cognitive Behavioral Stress Management (CBSM)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• History of non-skin cancer within the last 2 years.
• 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.

Sponsors & Collaborators

• University of Miami: lead
• Northwestern University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Pedreira PB, Fleszar-Pavlovic SE, Walsh EA, Noriega Esquives B, Moreno PI, Perdomo D, Heller AS, Antoni MH, Penedo FJ. Familism, family cohesion, and health-related quality of life in Hispanic prostate cancer survivors. J Behav Med. 2024 Aug;47(4):595-608. doi: 10.1007/s10865-024-00479-1. Epub 2024 Mar 1.

  PMID: 38429598 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Prostatic Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: Dr. Frank Penedo
• Organization: University of Miami

fpenedo@miami.edu

305-284-4290

Study Officials

• Frank Penedo, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: November 17, 2017
• Study Start: October 5, 2017
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)