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OpenTrials
Completed

NCT Number: NCT04491591

Implementing BREASTChoice Into Practice

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.

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Key information

Conditions

Breast Reconstruction Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine, St Louis, Missouri, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/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

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

Treatment and study plan

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

Other names: BREASTChoice

Attention Control Website

Other

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

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.

Primary outcomes

  1. 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 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.

  2. Preference Concordance

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

    • 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.

  3. 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 (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).

Secondary outcomes

  1. 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

  2. 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)

    -The Continuing Professional Development (CPD) Reaction scale is a 12-item measure with each item having a scale of 1-7. These 12 items correspond to the following 5 constructs (2-3 items per construct) are assessed: intention (2 items), social influence (3 items), beliefs about capabilities (3 items), moral norm (2 items), and beliefs about consequence (2 items). The possible scale range is 1-7. Higher values or a positive change indicates higher intention, social influence, beliefs about capabilities, moral norm, or beliefs about consequences of engaging in shared decision making. Each scale is reported as an average.

    **For clinician arm only

  3. Knowledge as Measured by Knowledge Questions Developed in Previous Studies

    Time frame: After initial visit but before surgery, estimated before day 7

    -This is a an 11-item measure using true/false/unsure response options. A knowledge score is calculated by dividing the number of correct responses (each scored 1 if correct, 0 if incorrect, unsure, or blank) by the number of knowledge items (11), to be re-scaled to 0-100. Higher values indicate higher knowledge.

  4. 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.

  5. Usability as Measured by the System Usability Scale (SUS)

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

    -The System Usability Index (SUS) is a 10-item measure (each scaled 1-5) of how easy a website is to use. It is asked of only those in the BreastChoice group to assess the usability of tool. A usability score is calculated by adding the items and multiplying the sum by 2.5. Usability scores can range from 0-100 with higher scores indicating greater usability. A score greater than 68 indicates adequate usability.

  6. 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. Value of 1 given for each correct answer and value of 0 for each incorrect answer. Overall knowledge score range is 0-9 re-scaled from 0-100.

  7. 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 estimate the patient's preferred treatment (mastectomy alone versus 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, 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2020
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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