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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00828633
First received: January 23, 2009
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: PATIENT-REPORTED OUTCOMES FOR GAY MEN WITH LOCALIZED PROSTATE CANCER

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Effect of disease factors and treatment factors on subjective well-being [ Time Frame: Cross-sectional retrospective study, one timepoint ] [ Designated as safety issue: No ]
  • Effect of disease factors and treatment factors on illness intrusiveness [ Time Frame: Cross-sectional retrospective study, one timepoint ] [ Designated as safety issue: No ]
  • Effect of psychosocial factors on subjective well-being [ Time Frame: Cross-sectional retrospective study, one timepoint ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Convenience sample contacted via Internet

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828633

Locations
United States, Arizona
Arizona State University - West Campus
Phoenix, Arizona, United States, 85069
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
Canada, Ontario
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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00828633     History of Changes
Other Study ID Numbers: CDR0000600597, BCM-H-21892
Study First Received: January 23, 2009
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013