Implementing BREASTChoice Into Practice

NCT04491591 | Completed Results DMC

• 2 other identifiers: 202005217R18HS026699
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Reconstruction; Breast Cancer

Keywords

Breast cancer; Breast Reconstruction; Breast Reconstruction Education; Breast Reconstruction Decision Tool

Outcome Measures

Primary Outcomes (3)

• Knowledge as Measured by Decision Quality Instrument

  -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A value of 1 is given for each correct answer and a value of 0 is given for each incorrect answer. An overall knowledge score is calculated for each patient by dividing the number of correct responses (range 0-9) by 9 to be re-scaled from 0-100. Higher values indicate higher knowledge.

  After initial visit but before surgery, estimated to be before day 7

• Preference Concordance

  * Investigators will estimate the patient's preferred treatment (mastectomy alone vs. mastectomy with reconstruction), by inputting values (entered into BREASTChoice or control survey) into a statistical model to compute preferred treatment. The investigators will compare preferred treatments to actual treatment received, with concordance determined by agreement between preferred and actual treatment received. The investigators will consider "actual treatment received" to be delayed reconstruction, if she states an intention to have delayed reconstruction, as she might not have started this process during the study. * Reconstruction vs no reconstruction excluded includes those who did not have a mastectomy, unsure or no preference, or received lumpectomy. * Immediate vs delayed reconstruction excluded includes those with unsure preference or no preference. * Flap vs implant reconstruction excluded includes those unsure of final reconstruction type, unsure preference, or no preference.

  Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR

• Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict

  -The validated, widely-used SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) Measure of Decisional Conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict; the outcome is binary indicating a score of 4 (no decisional conflict) vs. ≤3 (presence of decisional conflict).

  After initial visit but before surgery, estimated to be before day 7

Secondary Outcomes (8)

• Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction

  After patient participation (approximately 18 months)

• Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale

  Assessed pre- and post-study (approximately 24 months)

• Knowledge as Measured by Knowledge Questions Developed in Previous Studies

  After initial visit but before surgery, estimated before day 7

• Consult Time as Measured by Time Spent With Clinician During the Visit

  Initial visit (day 1)

• Usability as Measured by the System Usability Scale (SUS)

  After initial visit but before surgery, estimated to be before day 7

Study Arms (3)

BREASTChoice

EXPERIMENTAL

* 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.

Other: Breast Reconstruction Education and Support Tool (BREASTChoice)

Attention Control Website

ACTIVE COMPARATOR

* 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.

Other: Attention Control Website

Clinicians

EXPERIMENTAL

* 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

Other: Clinician Survey

Interventions

Breast Reconstruction Education and Support Tool (BREASTChoice) OTHER

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

Also known as: BREASTChoice

BREASTChoice

Attention Control Website OTHER

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

Attention Control Website

Clinician Survey 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.

Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Mary Politi, Ph.D.
• Organization: Washington University School of Medicine

mpoliti@wustl.edu

314-747-1967

Study Officials

• Mary Politi, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Clara Lee, M.D., MPP

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: November 4, 2020
• Primary Completion: July 22, 2022
• Study Completion: February 28, 2023
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)