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Prostate CancerNCT00708968

Prostate Cancer: Family Care for Patients and Spouses

A study testing FOCUS Program in people with Prostate Cancer and Quality of Life, run by University of Michigan at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
FOCUS Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
263 participants
Where
3 sitesUnited States
Study dates
Sep 2001to Dec 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Wayne State University-Karmanos Cancer Institute

    Detroit, Michigan, 48202

  • William Beaumont Hospitals

    Royal Oak, Michigan, 48073

Other trials in United States

About this study

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.

Read the 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.

Being tested
FOCUS Program
Keywords
randomized clinical trial, coping, quality of life, family, family caregiver, cancer survivorship, communication, uncertainty, support, family education, Caregivers
Medical subject headings
Prostatic Neoplasms, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOCUS ProgramBehavioural

    Also called Prostate Cancer Patient and Spouse Intervention, Family-based intervention

    Supportive, educative sessions with patients and spouses.

Study groups in NCT00708968
Study groupRoleWhat they receive
FOCUS InterventionExperimentalDyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.
Receives: Behavioral: FOCUS Program
Standard CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

    Measured: Baseline, 4, 8 and 12 months

Secondary outcomes (6)

  1. Threat appraisal

    Measured: Baseline, 4, 8 and 12 months

  2. Uncertainty

    Measured: Baseline, 4, 8 and 12 months

  3. Hopelessness

    Measured: Baseline, 4, 8 and 12 months

  4. Coping

    Measured: Baseline, 4, 8 and 12 months

  5. Family Communication

    Measured: Baseline, 4, 8 and 12 months

  6. Self-Efficacy

    Measured: Baseline, 4, 8 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2008 (estimated)
  2. Study startSep 2001
  3. Primary completionOct 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00708968
Sponsor's protocol ID
R01CA090739
Other IDs
R01CA090739, UMCC 0080, IRBMED 2001-0091
Status last verified
Jul 2008
First submitted
1 Jul 2008
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16676337

  • 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.

    PubMed 19816159

  • 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.

    PubMed 18830672

  • 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.

    PubMed 20927648

  • 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.

    PubMed 20967920

  • 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.

    PubMed 17999405

  • 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.

    PubMed 17635953

Questions about this trial

What is this clinical trial studying?

A study testing FOCUS Program in people with Prostate Cancer and Quality of Life, run by University of Michigan at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (time frame: Baseline, 4, 8 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00708968, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.

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