Implementing BREASTChoice Into Practice
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|ClinicalTrials.gov Identifier: NCT04491591|
Recruitment Status : Active, not recruiting
First Posted : July 29, 2020
Last Update Posted : March 14, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Breast Reconstruction Breast Cancer||Other: Breast Reconstruction Education and Support Tool (BREASTChoice) Other: Attention Control Website Other: Clinician Survey||Not Applicable|
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..
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||412 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings|
|Actual Study Start Date :||November 4, 2020|
|Actual Primary Completion Date :||September 2, 2022|
|Estimated Study Completion Date :||April 30, 2023|
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
Active Comparator: Attention Control Website
Other: Attention Control Website
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.
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 18 years of age or older
- Diagnosis of incident or recurrent stage 0-III breast carcinoma
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491591
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|The Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43210|
|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|
|Responsible Party:||Washington University School of Medicine|
|Other Study ID Numbers:||
R18HS026699 ( U.S. AHRQ Grant/Contract )
|First Posted:||July 29, 2020 Key Record Dates|
|Last Update Posted:||March 14, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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