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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer, measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process, the treatments selected, and 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.

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

Conditions
-----------------
Adenocarcinoma of Prostate

Intervention / Treatment
-----------------
* Behavioral: Dashboard


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No use of the decision aid dashboard before, during or after the treatment decision time period. | |
| Experimental: Dashboard<br>Use of the decision aid dashboard before, during and after the treatment decision time period. | Behavioral: Dashboard<br>* With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in KUJ score through education | The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of overall quality and satisfaction with initial treatment decision. | The use of the dashboard will improve the overall quality and satisfaction with initial treatment decisions as measured by a) decisional conflict, b) patient quality of life, and c) post-decision regret, using the PORPUS questionnaire and Decisional Regret questionnaire. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Cancer, Adenocarcinoma