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

University of Rochester

Status: Completed

Conditions: Adenocarcinoma of Prostate

Treatments: Behavioral: Dashboard

Study type: Interventional

Funder types: Other

Identifiers

NCT02342626

UCCS14115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Control

No Intervention group

Description:

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

Dashboard

Experimental group

Description:

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

Treatment:

Behavioral: Dashboard