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Prostate Cancer: Family Care for Patients and Spouses

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Cancer Survivorship
Quality of Life
Prostate Cancer

Treatments

Behavioral: FOCUS Program

Study type

Interventional

Funder types

Other

Identifiers

NCT00708968
R01CA090739 (U.S. NIH Grant/Contract)
IRBMED 2001-0091
UMCC 0080

Details and patient eligibility

About

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.

Full 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.

Enrollment

263 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

263 participants in 2 patient groups

FOCUS Intervention
Experimental group
Description:
Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.
Treatment:
Behavioral: FOCUS Program
Standard Care
No Intervention group

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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