Health-Related Quality of Life in Gay Men With Localized Prostate Cancer
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| First Received Date ICMJE | January 23, 2009 | ||||
| Last Updated Date | November 7, 2011 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00828633 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Convenience sample contacted via Internet |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2012 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00828633 | ||||
| Other Study ID Numbers ICMJE | CDR0000600597, BCM-H-21892 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David Latini, Baylor College of Medicine | ||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Baylor College of Medicine | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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