Clinical trial NCT01840163: A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool
Official title: Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2013-04-25
Enrollment: 537
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Stage 1-2 invasive breast cancer diagnosis,
* DCIS
* Ability to read English

Exclusion Criteria:

* Male

Primary outcomes:
measure: Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.
timeFrame: 4-5 weeks from date of enrollment
measure: Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant
timeFrame: 4-5 weeks from date of enrollment
Secondary outcomes:
measure: Patient Preparedness Decision Making for Locoregional Treatment.
timeFrame: 4-5 weeks from date of enrollment
measure: Patient Deliberation for Locoregional Breast Cancer Treatment.
timeFrame: 4-5 weeks from date of enrollment
measure: Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment
timeFrame: 4-5 weeks from date of enrollment
measure: Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer
timeFrame: 9 months after enrollment
measure: Patient Preparedness Decision Making for Systemic Treatment
timeFrame: 9 months after enrollment
measure: Patient Subjective Decision Quality for Systemic Breast Cancer Treatment
timeFrame: 9 months after enrollment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sarah T. Hawley, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hawley ST, Li Y, Jeanpierre LA, Goodell S, Jagsi R, Ward KC, Sabel MS, Katz SJ. Study protocol: A Randomized Controlled Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool (iCanDecide). Contemp Clin Trials Commun. 2017 Mar;5:123-132. doi: 10.1016/j.conctc.2017.02.001. Epub 2017 Feb 3.
citation: Hawley ST, Li Y, An LC, Resnicow K, Janz NK, Sabel MS, Ward KC, Fagerlin A, Morrow M, Jagsi R, Hofer TP, Katz SJ. Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial. J Clin Oncol. 2018 Mar 1;36(7):659-666. doi: 10.1200/JCO.2017.74.8442. Epub 2018 Jan 24.