Back to resultsDevel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
Primary Purpose
Adenocarcinoma of Prostate
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dashboard
Sponsored by
About this trial
This is an interventional supportive care trial for Adenocarcinoma of Prostate focused on measuring Prostate, Cancer, Adenocarcinoma
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
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Dashboard
Arm Description
No use of the decision aid dashboard before, during or after the treatment decision time period.
Use of the decision aid dashboard before, during and after the treatment decision time period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02342626
First Posted
January 15, 2015
Last Updated
January 5, 2018
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02342626
Brief Title
Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Prostate
Keywords
Prostate, Cancer, Adenocarcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No use of the decision aid dashboard before, during or after the treatment decision time period.
Arm Title
Dashboard
Arm Type
Experimental
Arm Description
Use of the decision aid dashboard before, during and after the treatment decision time period.
Intervention Type
Behavioral
Intervention Name(s)
Dashboard
Intervention Description
With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.
Primary Outcome Measure Information:
Title
Increase in KUJ score through education
Description
The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Measure of overall quality and satisfaction with initial treatment decision.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Dolan
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
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