Problem Solving Therapy for Prostate Cancer Spousal Caregivers

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Problem-Solving Therapy

• Registration Number: NCT02085096
• Lead Sponsor: University of California, San Diego

Brief Summary

Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.

Detailed Description

Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.

Participants were randomly assigned to an experimental group which received problem-solving therapy, or to a control group which relied on their standard methods of coping (e.g. their normal therapist, family and friends).

Participants completed baseline surveys regarding their distress and coping prior to randomization. They then completed these surveys again at post-intervention (approximately 2-3 months post-baseline) and 6 months post-baseline to determine lasting effects of the intervention.

Study Timeline

• Study Start: 1997-07
• Primary Completion: 2002-12
• Study Completion: 2005-09
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• Diagnosed with prostate cancer within 18 months of study enrollment.
• The patient and significant other cohabited
• Couples resided in San Diego County
• Both patient and significant other were sufficiently proficient in English

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard Supportive Care	Problem-Solving Therapy	Participants who are randomized to this arm will be encouraged to use whatever supporting care is recommended to them by their health provider.
Problem-Solving Therapy	Problem-Solving Therapy	A problem-solving therapy training program will be provided to the spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.

Primary Outcome Measures

Name	Time	Method
Change from Baseline of Effects of Stress and Coping to Follow-ups	From baseline to follow-ups at post-intervention (2-3 months post-baseline) and 6-months post-baseline

Trial Locations

Locations (1)

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States