Treatment Decision Analysis Model for Prostate Cancer: A Randomized Trial

Summary

This is a psychosocial/behavioral study and does not involve administration of any treatment or diagnostic procedures. We will use a randomized trial to test the hypothesis that a decision analysis model that provides individualized estimates of quality-adjusted disease-free survival for each of the treatment options for clinically localized prostate cancer will lead to higher quality treatment decisions congruent with a patient's values leading to improved decisional regret and treatment satisfaction. In this trial, all patients would be evaluated at baseline for their utilities for various clinically important health states. The control arm will receive counseling regarding treatment options using standard patient-physician interactions and nomogram-predicted probabilities of treatment outcome for the various treatment options and they will be unaware of the decision analysis recommendation. The treatment arm would be counseled using standard patient-physician interactions and they would also be provided with a personalized treatment recommendations based on the decision analysis model prior to treatment selection. The primary endpoint of this study will be regret-free survival at 2 years after treatment. There will be a 1:1 randomization. A random permuted design will be used to assure approximate balanced number of patients in the two groups over time.

Conditions

• Adenocarcinoma of Prostate
• Adenocarcinoma of the Prostate Stage I
• Adenocarcinoma of the Prostate Stage II
• Adenocarcinoma of the Prostate Stage III

Interventions

BEHAVIORAL

Personalized Treatment Recommendations

This is a psychosocial/behavioral study. It will use a randomized trial to test the hypothesis that a decision analysis model that provides individualized estimates of quality-adjusted disease-free survival for each of the treatment options for clinically localized prostate cancer will lead to higher quality treatment decisions congruent with a patient's values leading to improved decisional regret and treatment satisfaction. In this trial, all patients would be evaluated at baseline for their utilities for various clinically important health states. The primary endpoint of this study will be regret-free survival at 2 years after treatment. There will be a 1:1 randomization. A random permuted design will be used to assure approximate balanced number of patients in the two groups over time.

BEHAVIORAL

Standard patient-physician counseling interaction

Both patients and physicians will be unaware of the decision analysis recommendation and the patients will receive standard treatment counseling alone. After the patient has made a treatment decision he will be given a short questionnaire to assess decisional conflict. If after one month no treatment decision information is available, a letter and form requesting treatment information along with the decisional conflict questionnaire will be sent to patients.

Sponsors & Collaborators

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Andrew Stephenson, MD · Case Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• United States

Study Locations