N/A
N=188
Health Gatherings - For Your Health After Cancer
Prostate Neoplasm · Genital Neoplasms, Male · Urogenital Neoplasms · Neoplasm, Prostate · Genital Diseases, Male
Bottom Line
View on ClinicalTrials.gov: NCT03344757 ↗Enrolled (actual)
188
Serious AEs
1.6%
Results posted
Sep 2025
Primary outcome: Primary: Change in Symptom Burden as Measure by EPIC-S. — 30.1; 32.1; 34.7; 35.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cultural CBSM (Behavioral); Standard CBSM (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Symptom Burden as Measure by EPIC-S. |
30.1; 32.1; 34.7; 35.8; 35.9; 38.0 | — |
| PRIMARY Change in HRQoL as Measured by the FACT Questionnaire. |
81.1; 81.7; 83.8; 83.7; 83.6; 83.3 | — |
| PRIMARY Change in Symptom Burden as Measure by EPIC-UIN. |
73.5; 78.8; 77.4; 82.2; 79.5; 84.6 | — |
| PRIMARY Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire |
43.2; 43.5; 43.3; 42.8; 43.9; 43.1 | — |
| PRIMARY Change in HRQoL as Measured by the PROMIS Pain Questionnaire |
47.8; 47.0; 46.7; 46.4; 47.1; 46.9 | — |
| SECONDARY Change in Stress Management Skills as Measured by MOCS-A |
38.5; 37.6; 38.6; 38.3; 39.6; 39.3 | — |
| SECONDARY Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II |
7.1; 10.0; 5.6; 6.2; 5.01; 7.7 | — |
| SECONDARY Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III |
8.5; 8.1; 8.9; 9.1; 8.7; 8.3 | — |
| SECONDARY Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire |
44.8; 45.9; 43.8; 44.7; 44.8; 45.4 | — |
| SECONDARY Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire |
49.5; 50.0; 50.4; 49.1; 51.0; 49.8 | — |
| SECONDARY Change in Interpersonal Function as Measured the SIP Questionnaire |
2.5; 3.1; 2.6; 2.9; 2.2; 2.5 | — |
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).
Eligibility Criteria
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 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.
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Data sourced from ClinicalTrials.gov (NCT03344757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.