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

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT02342626

Collaborator

(none)

140

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of Prostate	Behavioral: Dashboard	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Control

No use of the decision aid dashboard before, during or after the treatment decision time period.

Experimental: Dashboard

Use of the decision aid dashboard before, during and after the treatment decision time period.

Behavioral: Dashboard

With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator: James G Dolan, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James Dolan, Associate Professor, University of Rochester

ClinicalTrials.gov Identifier:

NCT02342626

Other Study ID Numbers:

UCCS14115

First Posted:

Jan 21, 2015

Last Update Posted:

Jan 9, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by James Dolan, Associate Professor, University of Rochester

Prostate

Cancer

Adenocarcinoma

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Jan 9, 2018