Clinical trial NCT02342626: Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of Prostate
Keywords: Prostate
Cancer
Adenocarcinoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 140
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in KUJ score through education
timeFrame: 2 years
Secondary outcomes:
measure: Measure of overall quality and satisfaction with initial treatment decision.
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: James G Dolan
role: PRINCIPAL_INVESTIGATOR
References: