Prostate Cancer: Family Care for Patients and Spouses

Prostate Cancer Clinical Trial

Official title:

Prostate Cancer: Family Care for Patients and Spouses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708968
• Other study ID #: R01CA090739
• Secondary ID: R01CA090739UMCC
• Status: Completed
• Phase: N/A
• First received: July 1, 2008
• Last updated: June 15, 2015
• Start date: September 2001
• Est. completion date: December 2005

Study information

• Verified date: July 2008
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: December 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer Survivorship
• Prostate Cancer
• Prostatic Neoplasms
• Quality of Life

Intervention

Behavioral:
• FOCUS Program
Supportive, educative sessions with patients and spouses.

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Wayne State University-Karmanos Cancer Institute	Detroit	Michigan
United States	William Beaumont Hospitals	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Harden J, Falahee M, Bickes J, Schafenacker A, Walker J, Mood D, Northouse L. Factors associated with prostate cancer patients' and their spouses' satisfaction with a family-based intervention. Cancer Nurs. 2009 Nov-Dec;32(6):482-92. doi: 10.1097/NCC.0b013e3181b311e9. — View Citation

Kershaw TS, Mood DW, Newth G, Ronis DL, Sanda MG, Vaishampayan U, Northouse LL. Longitudinal analysis of a model to predict quality of life in prostate cancer patients and their spouses. Ann Behav Med. 2008 Oct;36(2):117-28. doi: 10.1007/s12160-008-9058-3. Epub 2008 Sep 16. — View Citation

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 J — View Citation

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. — View Citation

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. — View Citation

Song L, Northouse LL, Braun TM, Zhang L, Cimprich B, Ronis DL, Mood DW. Assessing longitudinal quality of life in prostate cancer patients and their spouses: a multilevel modeling approach. Qual Life Res. 2011 Apr;20(3):371-81. doi: 10.1007/s11136-010-9753-y. Epub 2010 Oct 8. — View Citation

Song L, Northouse LL, Zhang L, Braun TM, Cimprich B, Ronis DL, Mood DW. Study of dyadic communication in couples managing prostate cancer: a longitudinal perspective. Psychooncology. 2012 Jan;21(1):72-81. doi: 10.1002/pon.1861. Epub 2010 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		Baseline, 4, 8 and 12 months	No
Secondary	Threat appraisal		Baseline, 4, 8 and 12 months	No
Secondary	Uncertainty		Baseline, 4, 8 and 12 months	No
Secondary	Hopelessness		Baseline, 4, 8 and 12 months	No
Secondary	Coping		Baseline, 4, 8 and 12 months	No
Secondary	Family Communication		Baseline, 4, 8 and 12 months	No
Secondary	Self-Efficacy		Baseline, 4, 8 and 12 months	No

External Links

•   Principal Investigator's Faculty website
•   University of Michigan Comprehensive Cancer Center website