Implementing BREASTChoice Into Practice

Breast Cancer Clinical Trial

Official title: Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings

Status Active, not recruiting

Clinical Trial Summary

Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure. The risk of complications exceeds that of most elective procedures. In past work, a clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. It was modified with extensive stakeholder input and built to be incorporated into electronic health records and patient portals. This randomized control trial will evaluate whether the implementation of BREASTChoice into routine care delivery is more effective than a control website, at improving the quality of reconstruction decisions.

Clinical Trial Description

Prior to the beginning of the Randomized Control Trial (RCT), a pilot phase will be launched to test the workflow and procedures. The investigators plan to recruit up to 20 patients, continuing until procedures are smooth and ready for the randomized trial. The investigators will follow these same procedures as the trial, other than randomization, to test the workflow and tool use programming.

For the RCT, patients considering mastectomy at academic and community practices (n=340) will be randomized over 18 months to use BREASTChoice or a control website.

After the patient participant consents to be in the study, they will be randomized (using computer random assignment) participants to view the clinical decision support tool, BREASTChoice or the attention control website, using block randomization (block size of 2 and 4). Depending on the clinic work-flow, the patients may be sent the link to the tool or control website: 1) by email or MyChart message, prior to their visit with the plastic or reconstruction surgeon, for them to complete from home or in the waiting room (ideal and preferred approach); 2) by email or MyChart, in person or virtually at the time of their plastic or reconstruction visit, for patients that have same-day breast surgeon and plastic reconstruction surgeon visits, with time to wait in between appointments; or 3) by email or MyChart, after the plastic surgery appointment, if they have not yet made a decision about reconstruction after mastectomy (e.g., if they are undergoing neoadjuvant chemotherapy, or they want or need more time to decide on their surgery choices). Participants will be sent the link via MyChart unless they do not have a MyChart account. In that case, they will be sent the link via email. Study staff will be available to answer questions about MyChart via phone or email.

BREASTChoice is interactive with multiple modules. It starts with facts about breast reconstruction. Modules describe pros and cons of reconstruction, reconstruction timing, and reconstruction types. When discussing reconstruction timing, a risk prediction model pulls health data from the EHR (asking patients information in the model that is missing) to personalize risk of complications from immediate breast reconstruction. It also shows average risks for mastectomy alone and mastectomy plus immediate breast reconstruction so women can compare their personalized risk to average risks. Each module contains real patient quotes, a section called "Let's review" which checks patients' understanding, and "What matters to you", which elicits patients' preferences. Diverse patient photos and outcomes are provided. It is written at a 7th grade reading level. Data on patients' risks and a summary of her preferences are sent to their plastic/reconstructive surgeon to view in the electronic health record. The tool takes the patient about 20minutes to complete.

Control Website: The investigators chose an attention control, rather than usual care, to reduce differences between arms in participant expectation of benefit. Those in the control arm will get a link to an NCI website about breast reconstruction. That website includes 10 sections with information about types of breast reconstruction, timing, recovery, risks, cancer surveillance and additional resources. The website provides information, but does not include values clarification or tailored risk information. It is not interactive and does not include photos..

(https://www.cancer.gov/types/breast/reconstruction-fact-sheet) ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Reconstruction

• NCT number: NCT04491591
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2020
• Completion date: June 30, 2023