Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2
Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2
2 other identifiers
interventional
218
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Dec 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedDecember 23, 2014
August 1, 2014
2.1 years
November 15, 2010
December 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
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.
3 and 6 month follow-up
Secondary Outcomes (2)
DESI viewing
3 month follow-up (phone survey)
Healthcare utilization
6 month follow-up
Study Arms (2)
Usual care
NO INTERVENTIONProstate cancer treatment DESI
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Age 45 or older Localized prostate cancer with a Gleason score of 6 or less
You may not qualify if:
- Women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen L Lewis, MD, MPH
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Ming Tai-Seale, Ph.D, MPH
Palo Alto Medical Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 19, 2010
Study Start
December 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
December 23, 2014
Record last verified: 2014-08