Adenocarcinoma of Prostate
Conditions
Keywords
Prostate, Cancer, Adenocarcinoma
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.
Interventions
BEHAVIORALDashboard
With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in KUJ score through education | 2 years | The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of overall quality and satisfaction with initial treatment decision. | 2 years | 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. |
Countries
United States
Outcome results
None listed