A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

NCT ID: NCT01840163

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 537 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-09-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

CanSORT Online Tool

Comprehensive decision tool

Group Type: OTHER

CanSORT Online Tool

Intervention Type: OTHER

Static version of CanSORT tool

Static version (non-interactive) version of CanSORT decision tool

Group Type: OTHER

Static version of CanSORT tool

Intervention Type: OTHER

Interventions

Static version of CanSORT tool

Intervention Type: OTHER

CanSORT Online Tool

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Male

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sarah T. Hawley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah T. Hawley, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Medical School

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29152598 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29364772 (View on PubMed)

Other Identifiers

P01CA163233

Identifier Type: NIH

Identifier Source: org_study_id

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