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Health-Related Quality of Life in Gay Men With Localized Prostate Cancer

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00828633
Collaborator
(none)
92
Enrollment
3
Locations
82
Duration (Months)
30.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Gathering information about prostate cancer, treatment, and quality of life from gay men with prostate cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is collecting information about health-related quality of life from gay men with localized prostate cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    OBJECTIVES:

    • To enroll 200 gay men with localized prostate cancer in a cross-sectional study of prostate cancer outcomes.

    • To complete an R01 application using pilot data collected from these patients.

    • To complete manuscripts describing the factors that influence quality of life and treatment satisfaction in these patients.

    OUTLINE: Patients complete a web-based survey about their disease (biopsy Gleason score, PSA at diagnosis, and T-stage), treatment (treatment type, time since treatment, and use of healthcare services [e.g., oral medications for erectile dysfunction]), symptom distress, and psychosocial factors (ethnicity, health literacy, level of social support, communication with provider, relationship status, and communication with partner) that affect their health-related quality of life. The data will be used to provide the information necessary to tailor an existing prostate cancer survivorship intervention to address the specific needs of gay men with prostate cancer.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    92 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Patient-Reported Outcomes For Gay Men With Localized Prostate Cancer
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Jun 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Effect of disease factors and treatment factors on subjective well-being [Cross-sectional retrospective study, one timepoint]

    2. Effect of disease factors and treatment factors on illness intrusiveness [Cross-sectional retrospective study, one timepoint]

    3. Effect of psychosocial factors on subjective well-being [Cross-sectional retrospective study, one timepoint]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Diagnosis of localized prostate cancer

    • No advanced disease

    • Self-identified as gay

    PATIENT CHARACTERISTICS:

    • Able to complete an online questionnaire

    • Able to speak and understand English

    PRIOR CONCURRENT THERAPY:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dan L. Duncan Cancer Center at Baylor College of Medicine Houston Texas United States 77030
    2 Veterans Affairs Medical Center - Houston Houston Texas United States 77030
    3 Ryerson University Toronto Ontario Canada M5B 2K3

    Sponsors and Collaborators

    • Baylor College of Medicine

    Investigators

    • Principal Investigator: David M. Latini, PhD, Baylor College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine
    ClinicalTrials.gov Identifier:
    NCT00828633
    Other Study ID Numbers:
    • CDR0000600597
    • BCM-H-21892
    First Posted:
    Jan 26, 2009
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine
    stage I prostate cancer
    stage II prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jan 23, 2018