Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
Completed · Not applicable
Conditions studied: Adenocarcinoma of Prostate
In brief
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
Key facts
- Study ID
- NCT02342626
- Run by
- University of Rochester
- People needed
- 140
- Starts
- 2015-01-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-01-09
Who can join
Age: 40 and older, up to 85. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Age: 40 to 85 years
- Sex: male
- Race/ethnicity: no restrictions
- Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either:
- localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values < 10 ng/ml, OR
- Intermediate risk prostate cancer, defined as Gleason score = 7, T2b-T2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or PSA 10-20 ng/ml
- Willing to participate and able to give informed consent
- Able to adequately see the study intervention which is an interactive decision dashboard \& complete study-related questionnaires
- Able to understand English language adequately to use the decision dashboard and complete study-related questionnaires
You may not qualify if…
- Unable to complete study-related tasks due to cognitive deficits or English non-fluency
- Unwilling to participate.
- Deemed clinically unsuitable for active surveillance as a prostate cancer management option
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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