Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool
Patients newly diagnosed with breast cancer face a series of complex decisions regarding
locoregional and systemic treatment. Currently many of these decisions do not meet the
definition of a high quality decision, defined as one that is both informed (i.e., based on
an accurate understanding of the treatment risks and benefits) and preference-concordant
(i.e., consistent with the patients' underlying preferences). Moreover, the introduction of
evaluative tests has made these decisions more complicated for many patients. There is a
need to improve the quality of locoregional and systemic treatment decisions for breast
cancer patients, and to help patients understand the role of evaluative tests in this
decision process. Ensuring patients can deliberate effectively about these decisions, assert
their views and communicate with their clinicians is likely to improve their overall
decision preparedness and satisfaction. This study will focus on the third pillar of
individualized care by evaluating the impact of an innovative decision tool on locoregional
and systemic therapy decision making for newly diagnosed breast cancer patients. The
innovative online decision tool has been developed and tested over the past two years by the
CanSORT team (R21 CA129859). Pilot data suggests that this tool has a positive impact on
patient knowledge and decision outcomes. The goal of this study is to evaluate the impact of
this tool, after it is enhanced in collaboration with our Communication and Dissemination
Core, on the quality of decision making for locoregional and systemic breast cancer
treatment decision making. We will conduct a randomized controlled trial (RCT) of 444 newly
diagnosed patients with invasive early stage breast cancer, seen by 28-30 surgeons in two
SEER catchment areas. Patients will be randomized to view our comprehensive decision tool or
a static version of the tool.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
High quality decisions about locoregional and systemic therapy
The primary outcomes will be the rate of high quality decisions about locoregional and systemic therapy for patients viewing the CanSORT tool vs. the existing website.
Up to 5 years
No
Sarah T. Hawley, PhD, MPH
Principal Investigator
University of Michigan
United States: Federal Government
P01CA163233
NCT01840163
September 2013
September 2017
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |