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

Tracking Information

First Received Date ^ICMJE

January 23, 2009

Last Updated Date

July 8, 2009

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00828633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

PATIENT-REPORTED OUTCOMES FOR GAY MEN WITH LOCALIZED PROSTATE CANCER

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.

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Other: internet-based intervention
Other: survey administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00828633

Responsible Party

David M. Latini, Dan L. Duncan Cancer Center at Baylor College of Medicine

Study ID Numbers ^ICMJE

CDR0000600597, BCM-H-21892

Study Sponsor ^ICMJE

Baylor College of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David M. Latini, PhD

Baylor College of Medicine

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP