Active Studies

Health-Related Quality of Life in Gay Men With Localized Prostate Cancer
This study is currently recruiting participants. It is lead by David Latini, PhD, group leader from the national Gay and Bisexual men’s cancer survivor support and advocacy nonprofit, Malecare .
Verified by National Cancer Institute (NCI), July 2009
First Received: January 23, 2009 Last Updated: July 8, 2009 History of Changes
Sponsor: Baylor College of Medicine
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00828633
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 Intervention
Prostate Cancer
Other: internet-based intervention
Other: survey administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Observational
Official Title: PATIENT-REPORTED OUTCOMES FOR GAY MEN WITH LOCALIZED PROSTATE CANCER

Resource links provided by NLM:

MedlinePlus related topics: Cancer Gay, Lesbian and Transgender Health Prostate Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

* Effect of disease factors and treatment factors on subjective well-being [ Designated as safety issue: No ]
* Effect of disease factors and treatment factors on illness intrusiveness [ Designated as safety issue: No ]
* Effect of psychosocial factors on subjective well-being [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Primary Completion Date: June 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
Criteria

DISEASE CHARACTERISTICS:

*

Diagnosis of localized prostate cancer
o 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 Recruiting
Phoenix, Arizona, United States, 85069
Contact: David Coon, PhD 602-543-6064 david.w.coon@asu.edu
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office – Dan L. Duncan Cancer Center at Baylor 713-798-1297
Veterans Affairs Medical Center – Houston Recruiting
Houston, Texas, United States, 77030
Contact: David M. Latini, PhD 713-794-8546
Canada, Ontario
Ryerson University Recruiting
Toronto, Ontario, Canada, M5B 2K3
Contact: Stacey Hart 416-979-5000, ext. 4247 Stacey.hart@psych.ryerson.ca
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: Dan L. Duncan Cancer Center at Baylor College of Medicine ( David M. Latini )
Study ID Numbers: CDR0000600597, BCM-H-21892
Study First Received: January 23, 2009
Last Updated: July 8, 2009
ClinicalTrials.gov Identifier: NCT00828633 History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage II prostate cancer

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