Implementing BREASTChoice Into Practice

NCT ID: NCT04491591

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2023-02-28

Brief 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.

Detailed 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)

Conditions

Breast Reconstruction; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

BREASTChoice

• After consent, the participant will be randomized
• Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message

• 1) prior to their visit with the surgeon;
• 2) at the time of their visit with the surgeon;
• 3) after the surgeon appointment
• Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
• Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.

Group Type: EXPERIMENTAL

Breast Reconstruction Education and Support Tool (BREASTChoice)

Intervention Type: OTHER

The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record

Attention Control Website

• After consent, the participant will be randomized
• Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message

• 1) prior to their visit with the surgeon;
• 2) at the time of their visit with the surgeon;
• 3) after the surgeon appointment
• Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
• Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.

Group Type: ACTIVE_COMPARATOR

Attention Control Website

Intervention Type: OTHER

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

Clinicians

• Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
• Will complete pre-post trial survey about shared decision making

Group Type: EXPERIMENTAL

Clinician Survey

Intervention Type: OTHER

-Questions regarding opinions on shared decision-making with answers ranging from 1-7 with 1=strongly disagree or harmful to 7=strongly agree or beneficial. The higher the score the more the physician agrees with shared decision making.

Interventions

Breast Reconstruction Education and Support Tool (BREASTChoice)

The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record

Intervention Type: OTHER

Attention Control Website

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

Intervention Type: OTHER

Clinician Survey

-Questions regarding opinions on shared decision-making with answers ranging from 1-7 with 1=strongly disagree or harmful to 7=strongly agree or beneficial. The higher the score the more the physician agrees with shared decision making.

Intervention Type: OTHER

Other Intervention Names

BREASTChoice

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Diagnosis of incident or recurrent stage 0-III breast carcinoma

-Clinicians who provide breast cancer care within the plastic and reconstructive surgery at Barnes Jewish Hospital, Siteman Cancer Center, Barnes Jewish West County, Christian Hospital North East, and the Stefanie Spielman Comprehensive Breast Center of OSU who provide care for patients considering breast reconstruction after mastectomy

Exclusion Criteria

• Stage IV breast carcinoma
• Histology type besides ductal/lobular carcinoma (e.g. phyllodes, sarcoma - these rare tumors differ in treatment and prognosis)
• Prior mastectomy and are seeking delayed breast reconstruction
• No malignancy (i.e., considering mastectomy for prophylaxis only)
• Cannot give informed consent or use provided study materials due to self-reported or observed cognitive, visual, or emotional barriers

-Plastic and reconstructive clinicians working at other breast clinic locations, and surgeons who do provider breast reconstruction care to patients who have undergone a mastectomy due to breast cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Politi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Clara Lee, M.D., MPP

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Washington University School of Medicine

St Louis, Missouri, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

R18HS026699

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

202005217

Identifier Type: -

Identifier Source: org_study_id