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Prostate Cancer: Family Care for Patients and Spouses

21 Years
Not Enrolling
Prostate Cancer, Quality of Life, Cancer Survivorship

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Trial Information

Prostate Cancer: Family Care for Patients and Spouses

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Quality of Life

Outcome Time Frame:

Baseline, 4, 8 and 12 months

Safety Issue:


Principal Investigator

Laurel L Northouse, PhD RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

R01 CA090739



Start Date:

September 2001

Completion Date:

December 2005

Related Keywords:

  • Prostate Cancer
  • Quality of Life
  • Cancer Survivorship
  • randomized clinical trial
  • coping
  • quality of life
  • family
  • family caregiver
  • cancer survivorship
  • communication
  • uncertainty
  • support
  • family education
  • Caregivers
  • Prostatic Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Wayne State University-Karmanos Cancer Institute Detroit, Michigan  48202
William Beaumont Hospitals Royal Oak, Michigan  48073