Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer



Status:Completed
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 85
Updated:1/11/2018
Start Date:January 2015
End Date:December 2017

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CDC SIP: Rochester Prevention Research Center: Development and Evaluation of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer

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.

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.

Specifically, we propose to conduct a clinical trial to compare the effects of a prostate
decision dashboard versus usual care on:

1. patient knowledge regarding the treatment options available for low or intermediate risk
prostate cancer,

2. measures of the decision making process including decisional conflict and the extent to
which decisions were made via a shared decision making process,

3. the treatments selected, and

4. 3-6 and 9-12 month outcome assessments of clinical status, decision regret,
cancer-related quality of life including worry, functional status, and treatment side
effects.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-276-5161
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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