Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment preference based decision aid
Sponsor University of Pennsylvania
Collaborator Patient-Centered Outcomes Research Institute
Start date June 2013
End date December 2016
Trial size 800 participants
Trial identifier NCT02032550, PCC201

Summary

The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.
preference based decision aid
The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.
(No Intervention)
Participants randomized into this group will have usual care from their doctors without any intervention

Primary Outcomes

Measure
Satisfaction with treatment choice
time frame: 24 months

Secondary Outcomes

Measure
Generic and Prostate Specific Health Related Quality of Life
time frame: 24 months
Cancer Recurrence and complications
time frame: 24 months
Anxiety
time frame: 24 months
Urinary symptoms
time frame: 24 months
Treatment choice
time frame: 6 months
Depression
time frame: 24 months
Satisfaction with medical care
time frame: 24 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. Newly diagnosed with non-metastatic prostate cancer 2. Has not yet started radiation or surgery 3. Provide informed consent Exclusion Criteria: 1. Distant, metastatic prostate cancer at diagnosis 2. Has already begun treatment for prostate cancer 3. Unable to communicate in English

Additional Information

Official title Treatment Preference and Patient Centered Prostate Cancer Care
Principal investigator Ravishankar Jayadevappa, PhD
Description The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care. The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes. The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients. The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes. The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.