Clinical trial NCT00708968: Prostate Cancer: Family Care for Patients and Spouses
Official title: Prostate Cancer: Family Care for Patients and Spouses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Quality of Life
Cancer Survivorship
Keywords: randomized clinical trial
coping
quality of life
family
family caregiver
cancer survivorship
communication
uncertainty
support
family education
Caregivers
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2008-07-03
Enrollment: 263
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Quality of Life
timeFrame: Baseline, 4, 8 and 12 months
Secondary outcomes:
measure: Threat appraisal
timeFrame: Baseline, 4, 8 and 12 months
measure: Uncertainty
timeFrame: Baseline, 4, 8 and 12 months
measure: Hopelessness
timeFrame: Baseline, 4, 8 and 12 months
measure: Coping
timeFrame: Baseline, 4, 8 and 12 months
measure: Family Communication
timeFrame: Baseline, 4, 8 and 12 months
measure: Self-Efficacy
timeFrame: Baseline, 4, 8 and 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University-Karmanos Cancer Institute
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospitals
state: Michigan
Study officials:
affiliation: University of Michigan
name: Laurel L Northouse, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/nur.20128.
citation: 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.
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.
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.
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.
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. doi: 10.1002/cncr.23114.
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. doi: 10.1200/JCO.2006.09.6503. Epub 2007 Jul 16.