Clinical trial NCT00828633: Health-Related Quality of Life in Gay Men With Localized Prostate Cancer
Official title: Patient-Reported Outcomes For Gay Men With Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage II prostate cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-01-26
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample contacted via Internet

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.

Eligibility 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

Primary outcomes:
measure: Effect of disease factors and treatment factors on subjective well-being
timeFrame: Cross-sectional retrospective study, one timepoint
measure: Effect of disease factors and treatment factors on illness intrusiveness
timeFrame: Cross-sectional retrospective study, one timepoint
measure: Effect of psychosocial factors on subjective well-being
timeFrame: Cross-sectional retrospective study, one timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dan L. Duncan Cancer Center at Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Veterans Affairs Medical Center - Houston
state: Texas
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Baylor College of Medicine
name: David M. Latini, PhD
role: PRINCIPAL_INVESTIGATOR
References: