Status:
COMPLETED
Health Gatherings - For Your Health After Cancer
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Northwestern University
National Cancer Institute (NCI)
Conditions:
Prostate Neoplasm
Genital Neoplasms, Male
Eligibility:
MALE
18+ years
Phase:
NA
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 relaxatio...
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 burde...
Eligibility Criteria
Inclusion
- ≥ 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
- History of non-skin cancer within the last 2 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.
- .
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT03344757
Start Date
October 5 2017
End Date
August 1 2024
Last Update
September 11 2025
Active Locations (2)
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1
University of Miami
Miami, Florida, United States, 33136
2
Northwestern University
Chicago, Illinois, United States, 60611