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Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool

21 Years
84 Years
Not Enrolling
Breast Cancer

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Trial Information

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.

Inclusion Criteria:

- Stage 1-2 invasive breast cancer diagnosis,

- Ability to read English

Exclusion Criteria:

- Male,

- DCIS or late stage diagnosis

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Outcome Measure:

High quality decisions about locoregional and systemic therapy

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Sarah T. Hawley, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Federal Government

Study ID:




Start Date:

September 2013

Completion Date:

September 2017

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624