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

Adenocarcinoma of Prostate Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342626
• Other study ID #: UCCS14115
• Status: Completed
• Phase: N/A
• First received: January 15, 2015
• Last updated: January 5, 2018
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Prostate
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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