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Clinical Trials/NCT00708968
NCT00708968
Completed
Not Applicable

Prostate Cancer: Family Care for Patients and Spouses

University of Michigan3 sites in 1 country263 target enrollmentSeptember 2001

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University of Michigan
Enrollment
263
Locations
3
Primary Endpoint
Quality of Life
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2001
End Date
December 2005
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of Life

Time Frame: Baseline, 4, 8 and 12 months

Secondary Outcomes

  • Threat appraisal(Baseline, 4, 8 and 12 months)
  • Family Communication(Baseline, 4, 8 and 12 months)
  • Uncertainty(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)

Study Sites (3)

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