Prostate Cancer: Family Care for Patients and Spouses

Not Applicable

Completed

• Conditions: Prostate Cancer; Quality of Life; Cancer Survivorship
• Interventions: Behavioral: FOCUS Program

• Registration Number: NCT00708968
• Lead Sponsor: University of Michigan

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 Timeline

• Study Start: 2001-09
• Primary Completion: 2005-10
• Study Completion: 2005-12
• Status Verified: 2008-07
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOCUS Intervention	FOCUS Program	Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.

Primary Outcome Measures

Name	Time	Method
Quality of Life	Baseline, 4, 8 and 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

William Beaumont Hospitals; 🇺🇸 Royal Oak, Michigan, United States

Wayne State University-Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States