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

NCT02342626 | Completed

• 1 other identifier: UCCS14115
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of Prostate

Keywords

Prostate; Cancer; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure of overall quality and satisfaction with initial treatment decision.

  2 years

Study Arms (2)

Control

NO INTERVENTION

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

Dashboard

EXPERIMENTAL

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

Behavioral: Dashboard

Interventions

Dashboard BEHAVIORAL

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

Dashboard

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms; Adenocarcinoma

Interventions

Dashboard Systems

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Database Management Systems; Management Information Systems; Organization and Administration; Health Services Administration

Study Officials

• James G Dolan

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)