Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2
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| First Received Date ICMJE | November 15, 2010 | ||||||||
| Last Updated Date | March 29, 2012 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months [ Time Frame: 3 and 6 month follow-up ] [ Designated as safety issue: No ] Men who review a DESI before making a treatment decision will be more likely to choose active surveillance/watchful waiting and will have better decision-specific knowledge. |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01244568 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2 | ||||||||
| Official Title ICMJE | Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2 | ||||||||
| Brief Summary | Researchers in this study will determine whether providing decision support interventions (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and alters their treatment decisions. |
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| Detailed Description | Potentially eligible men (age 45 and older who have localized prostate cancer with a Gleason score of 6 or less) will be identified and recruited to participate in the study before their next office visit. Patients who are interested and provide informed consent will be asked to complete a brief survey about background, medical history, knowledge of prostate cancer and health-related quality of life. Once the survey is completed the patient will be randomly assigned to one of 2 groups. Those assigned to the "Usual Care" group will not receive any additional information materials as part of their participation in the study. Those assigned to the "Patient Decision Support" group will receive a DVD program that contains information about treatment choices for prostate cancer. Participants will be asked to answer a brief telephone survey at 3 and 6 months from the day of their last office visit. Survey questions will ask about knowledge about prostate cancer, health-related quality of life, whether or not the DVD was viewed and what treatment decision was made. Research staff will also review medical records 6 months after enrollment to determine which treatment was received for prostate cancer, how many visits with health care providers were completed since enrollment and which medical services and procedures were received. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE | Behavioral: Prostate cancer treatment DESI
DESI is a 50 minute program on treatment choices for prostate cancer that will be given out to the experimental group. The program explains several treatment options including surgery (radical prostatectomy), radiation therapy (external beam and/or brachytherapy), hormone therapy, and active surveillance and watchful waiting. The program's intended audience is men with early state prostate cancer who are trying to make a treatment decision.
Other Name: Decision Support Intervention |
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| 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 | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 240 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Age 45 or older Localized prostate cancer with a Gleason score of 6 or less Exclusion Criteria: Women |
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| Gender | Male | ||||||||
| Ages | 45 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 | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01244568 | ||||||||
| Other Study ID Numbers ICMJE | 10-1318, 1R18AE000023 - 01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill | ||||||||
| Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||||||
| Verification Date | March 2012 | ||||||||
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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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