Prostate Cancer: Family Care for Patients and Spouses

NCT ID: NCT00708968

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Quality of Life Cancer Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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FOCUS Intervention

Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.

Group Type EXPERIMENTAL

FOCUS Program

Intervention Type BEHAVIORAL

Supportive, educative sessions with patients and spouses.

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FOCUS Program

Supportive, educative sessions with patients and spouses.

Intervention Type BEHAVIORAL

Other Intervention Names

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Prostate Cancer Patient and Spouse Intervention Family-based intervention

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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University of Michigan

Principal Investigators

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Laurel L Northouse, PhD RN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Wayne State University-Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

William Beaumont Hospitals

Royal Oak, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16676337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19816159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18830672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20927648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20967920 (View on PubMed)

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.

Reference Type RESULT
PMID: 17999405 (View on PubMed)

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.

Reference Type RESULT
PMID: 17635953 (View on PubMed)

Related Links

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http://www.cancer.med.umich.edu/

University of Michigan Comprehensive Cancer Center website

Other Identifiers

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R01CA090739

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 0080

Identifier Type: -

Identifier Source: secondary_id

IRBMED 2001-0091

Identifier Type: -

Identifier Source: secondary_id

R01CA090739

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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