Prostate Cancer: Family Care for Patients and Spouses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 263
- Locations
- 3
- Primary Endpoint
- Quality of Life
Study Overview
Brief Summary
The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouses.
Detailed Description
The purpose of this study was to determine if a family-based intervention (The FOCUS Program) could improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouse/partners. Aim 1. The first aim was to determine if the family intervention could improve several proximal clinical outcomes (less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, better family communication, higher self-efficacy, and more problem-focused coping) and improve the distal clinical outcome, quality of life, in a culturally and economically diverse sample of men with prostate cancer and their spouses. Aim 2. The second aim was to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at higher risk of poorer long-term quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of prostate cancer
- •Willing spousal partner
- •Speaks and understands English
- •Mentally and physically able to participate
- •Minimum life expectancy of 12 months
- •Lives within 70 miles
Exclusion Criteria
- •Multiple primary cancers
- •Watchful waiting status
- •Spouse with cancer diagnosis in previous year
Arms & Interventions
FOCUS Intervention
Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.
Intervention: FOCUS Program (Behavioral)
Standard Care
Outcomes
Primary Outcomes
Quality of Life
Time Frame: Baseline, 4, 8 and 12 months
Secondary Outcomes
- Threat appraisal(Baseline, 4, 8 and 12 months)
- Uncertainty(Baseline, 4, 8 and 12 months)
- Family Communication(Baseline, 4, 8 and 12 months)
- Coping(Baseline, 4, 8 and 12 months)
- Hopelessness(Baseline, 4, 8 and 12 months)
- Self-Efficacy(Baseline, 4, 8 and 12 months)