Prostate Cancer: Family Care for Patients and Spouses

June 15, 2015 updated by: University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

263

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Experimental: FOCUS Intervention
Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.
Behavioral: FOCUS Program
Supportive, educative sessions with patients and spouses.
Other Names:
  • Prostate Cancer Patient and Spouse Intervention
  • Family-based intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: Baseline, 4, 8 and 12 months
Baseline, 4, 8 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Threat appraisal
Time Frame: Baseline, 4, 8 and 12 months
Baseline, 4, 8 and 12 months
Uncertainty
Time Frame: Baseline, 4, 8 and 12 months
Baseline, 4, 8 and 12 months
Hopelessness
Time Frame: Baseline, 4, 8 and 12 months
Baseline, 4, 8 and 12 months
Coping
Time Frame: Baseline, 4, 8 and 12 months
Baseline, 4, 8 and 12 months
Family Communication
Time Frame: Baseline, 4, 8 and 12 months
Baseline, 4, 8 and 12 months
Self-Efficacy
Time Frame: Baseline, 4, 8 and 12 months
Baseline, 4, 8 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Wayne State University

Investigators

  • Principal Investigator: Laurel L Northouse, PhD RN, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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