A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 84 |
| Updated: | 11/10/2018 |
| Start Date: | February 2014 |
| End Date: | September 1, 2017 |
Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool
This study examines the impact of an online decision tool for patients with early stage
invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly
diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas.
Participants will be randomized to receive either a basic version of a decision tool (similar
to existing website with breast cancer information) or an enhanced version (featuring a
knowledge building component, a values clarification exercise, and a patient activation
module). Our hypothesis is that patients who use the enhanced version of the tool will have
greater knowledge of their test and treatment options, have a higher rate of high quality
(i.e., informed, preference-concordant) decisions, and report more positive appraisal of the
decision-making process.
invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly
diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas.
Participants will be randomized to receive either a basic version of a decision tool (similar
to existing website with breast cancer information) or an enhanced version (featuring a
knowledge building component, a values clarification exercise, and a patient activation
module). Our hypothesis is that patients who use the enhanced version of the tool will have
greater knowledge of their test and treatment options, have a higher rate of high quality
(i.e., informed, preference-concordant) decisions, and report more positive appraisal of the
decision-making process.
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.
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.
Inclusion Criteria:
- Stage 1-2 invasive breast cancer diagnosis,
- DCIS
- Ability to read English
Exclusion Criteria:
- Male
We found this trial at
1
site
Ann Arbor, Michigan 48109
Principal Investigator: Sarah T Hawley, PhD, MPH
Phone: 734-615-3952
Click here to add this to my saved trials
