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

Prostate Cancer Clinical Trial

Official title:

Patient-Reported Outcomes For Gay Men With Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828633
• Other study ID #: CDR0000600597
• Secondary ID: BCM-H-21892
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: January 18, 2018
• Start date: August 2008
• Est. completion date: June 2015

Study information

• Verified date: January 2018
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Ryerson University	Toronto	Ontario
United States	Dan L. Duncan Cancer Center at Baylor College of Medicine	Houston	Texas
United States	Veterans Affairs Medical Center - Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of disease factors and treatment factors on subjective well-being		Cross-sectional retrospective study, one timepoint
Primary	Effect of disease factors and treatment factors on illness intrusiveness		Cross-sectional retrospective study, one timepoint
Primary	Effect of psychosocial factors on subjective well-being		Cross-sectional retrospective study, one timepoint