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Completed

NCT Number: NCT00708968

Prostate Cancer: Family Care for Patients and Spouses

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.

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Key information

Conditions

Prostate Cancer Behavior Cancer Survivorship Communication Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Quality of Life Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOCUS Program

Behavioral

Supportive, educative sessions with patients and spouses.

Other names: Prostate Cancer Patient and Spouse Intervention, Family-based intervention

Primary outcomes

  1. Quality of Life

    Time frame: Baseline, 4, 8 and 12 months

Secondary outcomes

  1. Threat appraisal

    Time frame: Baseline, 4, 8 and 12 months

  2. Uncertainty

    Time frame: Baseline, 4, 8 and 12 months

  3. Hopelessness

    Time frame: Baseline, 4, 8 and 12 months

  4. Coping

    Time frame: Baseline, 4, 8 and 12 months

  5. Family Communication

    Time frame: Baseline, 4, 8 and 12 months

  6. Self-Efficacy

    Time frame: Baseline, 4, 8 and 12 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Wayne State University

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Jul 3, 2008
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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