NCT00708968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2001

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
Last Updated

June 16, 2015

Status Verified

July 1, 2008

Enrollment Period

4.1 years

First QC Date

July 1, 2008

Last Update Submit

June 15, 2015

Conditions

Prostate CancerQuality of LifeCancer Survivorship

Keywords

randomized clinical trialcopingquality of lifefamilyfamily caregivercancer survivorshipcommunicationuncertaintysupportfamily educationCaregivers

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Baseline, 4, 8 and 12 months

Secondary Outcomes (6)

  • Threat appraisal

    Baseline, 4, 8 and 12 months

  • Uncertainty

    Baseline, 4, 8 and 12 months

  • Hopelessness

    Baseline, 4, 8 and 12 months

  • Coping

    Baseline, 4, 8 and 12 months

  • Family Communication

    Baseline, 4, 8 and 12 months

  • +1 more secondary outcomes

Study Arms (2)

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

Standard Care

NO INTERVENTION

Interventions

FOCUS ProgramBEHAVIORAL

Supportive, educative sessions with patients and spouses.

Also known as: Prostate Cancer Patient and Spouse Intervention, Family-based intervention
FOCUS Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Multiple primary cancers
  • Watchful waiting status
  • Spouse with cancer diagnosis in previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University-Karmanos Cancer Institute

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

Related Publications (7)

  • 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.

    PMID: 16676337BACKGROUND

  • 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.

    PMID: 19816159BACKGROUND

  • 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.

    PMID: 18830672BACKGROUND

  • 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.

    PMID: 20927648BACKGROUND

  • 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.

    PMID: 20967920BACKGROUND

  • 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.

    PMID: 17999405RESULT

  • 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.

    PMID: 17635953RESULT

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsCommunication

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Laurel L Northouse, PhD RN

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

September 1, 2001

Primary Completion

October 1, 2005

Study Completion

December 1, 2005

Last Updated

June 16, 2015

Record last verified: 2008-07

Locations

US(3)