Implementing BREASTChoice Into Practice

• ClinicalTrials.gov Identifier: NCT04491591
• Recruitment Status: Active, not recruiting
• First Posted: July 29, 2020
• Last Update Posted: May 31, 2023
• Sponsor: Washington University School of Medicine
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Washington University School of Medicine

Tracking Information

• First Submitted Date: July 24, 2020
• First Posted Date: July 29, 2020
• Last Update Posted Date: May 31, 2023
• Actual Study Start Date: November 4, 2020
• Actual Primary Completion Date: September 2, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 30, 2020)

• Knowledge as measured by Decision Quality Instrument [ Time Frame: After initial visit but before surgery, estimated to be before day 7 ]
  -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items. *For participant arms only
• Preference concordance as measured by the Decision Quality Instrument [ Time Frame: Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR ]
  -The investigators will first estimate the patient's preferred treatment (mastectomy alone versus mastectomy with reconstruction), by inputting her values (entered into BREASTChoice or control survey) into a previously developed statistical model to compute her preferred treatment. The investigators will compare her 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 the patient states an intention to have delayed reconstruction, as she might not have started this process during the study. *For participant arms only
• Decisional conflict as measured by the SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) scale for decisional conflict [ Time Frame: After initial visit but before surgery, estimated to be before day 7 ]
  -The validated, widely-used SURE 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. *For participant arms only

Original Primary Outcome Measures (submitted: July 24, 2020)

• Knowledge as measured by Decision Quality Instrument [ Time Frame: After initial visit but before surgery, estimated to be before day 7 ]
  -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items. *For participant arms only
• Preference concordance as measured by the Decision Quality Instrument [ Time Frame: Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR ]
  -The investigators will first estimate the patient's preferred treatment (mastectomy alone versus mastectomy with reconstruction), by inputting her values (entered into BREASTChoice or control survey) into a previously developed statistical model to compute her preferred treatment. The investigators will compare her 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 the patient states an intention to have delayed reconstruction, as she might not have started this process during the study. *For participant arms only
• Decisional conflict as measured by the SURE scale for decisional conflict [ Time Frame: After initial visit but before surgery, estimated to be before day 7 ]
  -The validated, widely-used SURE 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 answered on a Likert scale. *For participant arms only

Current Secondary Outcome Measures (submitted: May 26, 2022)

• Compare number of high-risk participants from each arm who chose breast reconstruction [ Time Frame: After patient participation (approximately 18 months) ]
  -Participants will be considered high-risk if their risk exceeds two times the population average
• Provider intention to engage in shared decision making as measured by the change in the mean CPD (Continuing Professional Development)-Reaction scale [ Time Frame: Assessed pre- and post-study (approximately 24 months) ]
  -CPD Reaction scale is a 12-item measure, each item with a scale of 1-7. Measure change in mean response. Higher change in mean indicates behavior change. Constructs assessed include Intention, Social Influence, Beliefs about capabilities, Moral norm, and beliefs about consequence. **For clinician arm only
• Knowledge as measured by knowledge questions developed in previous studies [ Time Frame: After initial visit but before surgery, estimated before day 7 ]
  -This is an 11-item measure. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items, using the approach described for the DQI
• Consult time as measured by time spent with clinician during the visit [ Time Frame: Initial visit (day 1) ]
  -Consult time using the BREASTChoice will be compared to consult using the attention control.
• Usability as measured by the system usability scale (SUS) [ Time Frame: After initial visit but before surgery, estimated to be before day 7 ]
  -The SUS is a 10-item measure of how easy a website is to use. A usability score is calculated by adding the item and multiplied the sum by 2.5. Scores can range from 0-100 with higher scores indicating greater usability.

Original Secondary Outcome Measures (submitted: July 24, 2020)

• Compare number of high-risk participants from each arm who chose breast reconstruction [ Time Frame: After patient participation (approximately 18 months) ]
  -Participants will be considered high-risk if their risk exceeds two times the population average
• Provider intention to engage in shared decision making as measured by the change in the mean CPD-Reaction scale [ Time Frame: Assessed pre- and post-study (approximately 18 months) ]
  -CPD Reaction scale is a 12-item measure, each item with a scale of 1-7. Measure change in mean response. **For clinician arm only
• Knowledge as measured by knowledge questions developed in previous studies [ Time Frame: After initial visit but before surgery, estimated before day 7 ]
  -This is an 11-item measure. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items, using the approach described for the DQI
• Consult time as measured by time spent with clinician during the visit [ Time Frame: Initial visit (day 1) ]
  -Consult time using the BREASTChoice will be compared to consult using the attention control.
• Usability as measured by the system usability scale (SUS) [ Time Frame: After initial visit but before surgery, estimated to be before day 7 ]
  -The SUS is a 10-item measure of how easy a website is to use. A usability score is calculated by adding the item and multiplied the sum by 2.5. Scores can range from 0-100 with higher scores indicating greater usability.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Implementing BREASTChoice Into Practice
• Official Title: Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings
• 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)

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Breast Reconstruction
• Breast Cancer

Intervention

• Other: 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
  Other Name: BREASTChoice
• Other: Attention Control Website
  -(https://www.cancer.gov/types/breast/reconstruction-fact-sheet)
• 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.

Study Arms

• Experimental: 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.
  Intervention: Other: Breast Reconstruction Education and Support Tool (BREASTChoice)
• Active Comparator: 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.
  Intervention: Other: Attention Control Website
• Experimental: 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
  Intervention: Other: Clinician Survey

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 21, 2022): 412
• Original Estimated Enrollment (submitted: July 24, 2020): 340
• Estimated Study Completion Date: June 30, 2023
• Actual Primary Completion Date: September 2, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Stage IV breast carcinoma
• Histology type besides ductal/obular 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

Inclusion Criteria for Clinicians:

-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 for Clinicians:

-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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04491591
• Other Study ID Numbers: 202005217; R18HS026699 ( U.S. AHRQ Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Washington University School of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Washington University School of Medicine
• Original Study Sponsor: Same as current
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Mary Politi, Ph.D.; Washington University School of Medicine
• Principal Investigator: Clara Lee, M.D., MPP; The Ohio State University Wexner Medical Center

• PRS Account: Washington University School of Medicine
• Verification Date: May 2023