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

Not Applicable

Completed

• Conditions: Adenocarcinoma of Prostate
• Interventions: Behavioral: Dashboard

• Registration Number: NCT02342626
• Lead Sponsor: University of Rochester

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:

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 140

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dashboard	Dashboard	Use of the decision aid dashboard before, during and after the treatment decision time period.

Primary Outcome Measures

Name	Time	Method
Increase in KUJ score through education	2 years	The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.

Secondary Outcome Measures

Name	Time	Method
Measure of overall quality and satisfaction with initial treatment decision.	2 years	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States