Prostate CancerNCT00828633
Health-Related Quality of Life in Gay Men With Localized Prostate Cancer
An observational study of Prostate Cancer, run by Baylor College of Medicine at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 92 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2008to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Convenience sample contacted via Internet
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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
About this study
Official title: Patient-Reported Outcomes For Gay Men With Localized Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of disease factors and treatment factors on subjective well-being
Measured: Cross-sectional retrospective study, one timepoint
Effect of disease factors and treatment factors on illness intrusiveness
Measured: Cross-sectional retrospective study, one timepoint
Effect of psychosocial factors on subjective well-being
Measured: Cross-sectional retrospective study, one timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2010
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Latini, Baylor College of Medicine
- Investigators
- David M. Latini, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828633
- Sponsor's protocol ID
- CDR0000600597
- Other IDs
- BCM-H-21892
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2009
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes For Gay Men With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00828633
- Acronym / sponsor ID
- CDR0000600597
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample contacted via Internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of disease factors and treatment factors on subjective well-being
Time frame: Cross-sectional retrospective study, one timepoint
Effect of disease factors and treatment factors on illness intrusiveness
Time frame: Cross-sectional retrospective study, one timepoint
Effect of psychosocial factors on subjective well-being
Time frame: Cross-sectional retrospective study, one timepoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Latini, PhD principal investigator
Baylor College of Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Baylor College of Medicine at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of disease factors and treatment factors on subjective well-being (time frame: Cross-sectional retrospective study, one timepoint). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.