Cancer Survivorship, Prostate Cancer, Quality of Life
Conditions
Keywords
randomized clinical trial, coping, quality of life, family, family caregiver, cancer survivorship, communication, uncertainty, support, family education, Caregivers
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.
Interventions
BEHAVIORALFOCUS Program
Supportive, educative sessions with patients and spouses.
Sponsors
Wayne State University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life | Baseline, 4, 8 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Uncertainty | Baseline, 4, 8 and 12 months |
| Hopelessness | Baseline, 4, 8 and 12 months |
| Threat appraisal | Baseline, 4, 8 and 12 months |
| Family Communication | Baseline, 4, 8 and 12 months |
| Self-Efficacy | Baseline, 4, 8 and 12 months |
| Coping | Baseline, 4, 8 and 12 months |
Countries
United States
Outcome results
None listed