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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828633
First Posted: January 26, 2009
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
  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:


Further study details as provided by David Latini, 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 ]
  • Effect of disease factors and treatment factors on illness intrusiveness [ Time Frame: Cross-sectional retrospective study, one timepoint ]
  • Effect of psychosocial factors on subjective well-being [ Time Frame: Cross-sectional retrospective study, one timepoint ]

Enrollment: 92
Study Start Date: August 2008
Study Completion Date: June 2015
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828633


Locations
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

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 ( Other Identifier: Baylor College of Medicine )
First Submitted: January 23, 2009
First Posted: January 26, 2009
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by David Latini, 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