Clinical trial · Interventional
Health Gatherings - For Your Health After Cancer
Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
NCT03344757CI-TRIAL-00094925completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Diseases, Male | — | UNRESOLVED | — |
| Genital Neoplasms, Male | — | UNRESOLVED | — |
| Neoplasm, Prostate | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Prostatic Diseases | — | UNRESOLVED | — |
| Urogenital Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cultural CBSM | Behavioral | — | UNRESOLVED |
| Standard CBSM | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cultural-Cognitive Behavioral Stress Management (CCBSM)
- description
- Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
- interventionNames
- Behavioral: Cultural CBSM
- type
- ACTIVE_COMPARATOR
- label
- Cognitive Behavioral Stress Management (CBSM)
- description
- Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
- interventionNames
- Behavioral: Standard CBSM
Primary outcomes (5)
- measure
- Change in Symptom Burden as Measure by EPIC-S.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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. .
References
Publications (1)
- DERIVEDPedreira 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