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

January 18, 2018 updated by: David Latini, Baylor College of Medicine

Patient-Reported Outcomes For Gay Men With Localized Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Ryerson University
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, United States, 77030
        • Dan L. Duncan Cancer Center at Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Convenience sample contacted via Internet

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of disease factors and treatment factors on subjective well-being
Time Frame: Cross-sectional retrospective study, one timepoint
Cross-sectional retrospective study, one timepoint
Effect of disease factors and treatment factors on illness intrusiveness
Time Frame: Cross-sectional retrospective study, one timepoint
Cross-sectional retrospective study, one timepoint
Effect of psychosocial factors on subjective well-being
Time Frame: Cross-sectional retrospective study, one timepoint
Cross-sectional retrospective study, one timepoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000600597
  • BCM-H-21892 (Other Identifier: Baylor College of Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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