Prostate Cancer: Family Care for Patients and Spouses - Full Text View

Sponsors and Collaborators:	University of Michigan Wayne State University
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00708968

Purpose

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.

Condition	Intervention
Prostate Cancer Quality of Life Cancer Survivorship	Behavioral: FOCUS Program Other: Control Condition

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Prostate Cancer: Family Care for Patients and Spouses

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Quality of Life [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Threat appraisal [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]
Uncertainty [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]
Hopelessness [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]
Coping [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]
Family Communication [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]
Self-Efficacy [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]

Enrollment:	263
Study Start Date:	September 2001
Study Completion Date:	December 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
FOCUS Intervention: Experimental 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.
Standard Care: No Intervention Dyads randomized to this arm continued with their standard course of care at the cancer clinic.	Other: Control Condition Standard Clinical Care

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708968

Locations

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

Sponsors and Collaborators

University of Michigan

Wayne State University

Investigators

Principal Investigator:

Laurel L Northouse, PhD RN

University of Michigan

More Information

Principal Investigator's Faculty website This link exits the ClinicalTrials.gov site

University of Michigan Comprehensive Cancer Center website This link exits the ClinicalTrials.gov site

Publications of Results:

Northouse LL, Mood DW, Schafenacker A, Montie JE, Sandler HM, Forman JD, Hussain M, Pienta KJ, Smith DC, Kershaw T. Randomized clinical trial of a family intervention for prostate cancer patients and their spouses. Cancer. 2007 Dec 15;110(12):2809-18.

Northouse LL, Mood DW, Montie JE, Sandler HM, Forman JD, Hussain M, Pienta KJ, Smith DC, Sanda MG, Kershaw T. Living with prostate cancer: patients' and spouses' psychosocial status and quality of life. J Clin Oncol. 2007 Sep 20;25(27):4171-7. Epub 2007 Jul 16.

Other Publications:

Northouse LL, Rosset T, Phillips L, Mood D, Schafenacker A, Kershaw T. Research with families facing cancer: the challenges of accrual and retention. Res Nurs Health. 2006 Jun;29(3):199-211.

Responsible Party:	University of Michigan ( Laurel L. Northouse PhD/ Professor of Nursing )
Study ID Numbers:	R01 CA090739, R01 CA090739, UMCC 0080, IRBMED 2001-0091
Study First Received:	July 1, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00708968
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

randomized clinical trial
coping
quality of life
family
family caregiver
cancer survivorship

communication
uncertainty
support
family education
Caregivers

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Quality of Life

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009