Prostate Cancer: Family Care for Patients and Spouses
Primary Purpose
Prostate Cancer, Quality of Life, Cancer Survivorship
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FOCUS Program
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring randomized clinical trial, coping, quality of life, family, family caregiver, cancer survivorship, communication, uncertainty, support, family education, Caregivers
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
Sites / Locations
- University of Michigan Comprehensive Cancer Center
- Wayne State University-Karmanos Cancer Institute
- William Beaumont Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
FOCUS Intervention
Standard Care
Arm Description
Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.
Outcomes
Primary Outcome Measures
Quality of Life
Secondary Outcome Measures
Threat appraisal
Uncertainty
Hopelessness
Coping
Family Communication
Self-Efficacy
Full Information
NCT ID
NCT00708968
First Posted
July 1, 2008
Last Updated
June 15, 2015
Sponsor
University of Michigan
Collaborators
Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT00708968
Brief Title
Prostate Cancer: Family Care for Patients and Spouses
Official Title
Prostate Cancer: Family Care for Patients and Spouses
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Michigan
Collaborators
Wayne State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOCUS Intervention
Arm Type
Experimental
Arm Description
Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.
Arm Title
Standard Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
FOCUS Program
Other Intervention Name(s)
Prostate Cancer Patient and Spouse Intervention, Family-based intervention
Intervention Description
Supportive, educative sessions with patients and spouses.
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
Baseline, 4, 8 and 12 months
Secondary Outcome Measure Information:
Title
Threat appraisal
Time Frame
Baseline, 4, 8 and 12 months
Title
Uncertainty
Time Frame
Baseline, 4, 8 and 12 months
Title
Hopelessness
Time Frame
Baseline, 4, 8 and 12 months
Title
Coping
Time Frame
Baseline, 4, 8 and 12 months
Title
Family Communication
Time Frame
Baseline, 4, 8 and 12 months
Title
Self-Efficacy
Time Frame
Baseline, 4, 8 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurel L Northouse, PhD RN
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University-Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospitals
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16676337
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.
Results Reference
background
PubMed Identifier
19816159
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.
Results Reference
background
PubMed Identifier
18830672
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.
Results Reference
background
PubMed Identifier
20927648
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.
Results Reference
background
PubMed Identifier
20967920
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.
Results Reference
background
PubMed Identifier
17999405
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.
Results Reference
result
PubMed Identifier
17635953
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.
Results Reference
result
Links:
URL
http://www.cancer.med.umich.edu/
Description
University of Michigan Comprehensive Cancer Center website
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Prostate Cancer: Family Care for Patients and Spouses
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