Breast ReconstructionNCT04491591
Implementing BREASTChoice Into Practice
A study testing Breast Reconstruction Education and Support Tool (BREASTChoice) and Clinician Survey in people with Breast Reconstruction and Breast Cancer, run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Breast Cancer
- What is being tested?
- Breast Reconstruction Education and Support Tool (BREASTChoice) and Clinician Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2020to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings
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.
Read the 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
- Being tested
- Breast Reconstruction Education and Support Tool (BREASTChoice), Attention Control Website, Clinician Survey
- Keywords
- Breast cancer, Breast Reconstruction, Breast Reconstruction Education, Breast Reconstruction Decision Tool
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Reconstruction Education and Support Tool (BREASTChoice)Other
Also called BREASTChoice
The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record
Attention Control WebsiteOther
-(https://www.cancer.gov/types/breast/reconstruction-fact-sheet)
Clinician SurveyOther
-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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Clinician Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
-Participants will be considered high-risk if their risk exceeds two times the population average
Measured: 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
-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
Measured: Assessed pre- and post-study (approximately 24 months)
Knowledge as Measured by Knowledge Questions Developed in Previous Studies
-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.
Measured: After initial visit but before surgery, estimated before day 7
Consult Time as Measured by Time Spent With Clinician During the Visit
-Consult time using the BREASTChoice will be compared to consult using the attention control.
Measured: Initial visit (day 1)
Usability as Measured by the System Usability Scale (SUS)
-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.
Measured: After initial visit but before surgery, estimated to be before day 7
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 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.
Measured: After initial visit but before surgery, estimated to be before day 7
Preference Concordance as Measured by the Decision Quality Instrument
- 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.
Measured: 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 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.
Measured: After initial visit but before surgery, estimated to be before day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start4 Nov 2020
- Primary completion22 Jul 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Mary Politi, Ph.D., Principal investigator, Washington University School of MedicineClara Lee, M.D., MPP, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491591
- Sponsor's protocol ID
- 202005217
- Other IDs
- R18HS026699
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2020
- Last updated
- 12 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings
- ClinicalTrials.gov ID
- NCT04491591
- Acronym / sponsor ID
- 202005217
- Conditions
- Breast Reconstruction, Breast Cancer
- Keywords
- Breast cancer, Breast Reconstruction, Breast Reconstruction Education, Breast Reconstruction Decision Tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BREASTChoice | Experimental | Other: Breast Reconstruction Education and Support Tool (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. |
| Attention Control Website | Active comparator | Other: 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. |
| Clinicians | Experimental | Other: Clinician Survey* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Reconstruction Education and Support Tool (BREASTChoice)Also: BREASTChoiceThe tool is an interactive website and can be sent through My Chart and integrated into the electronic health record | Other | BREASTChoice |
| Attention Control Website-(https://www.cancer.gov/types/breast/reconstruction-fact-sheet) | Other | Attention Control Website |
| 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. | Other | Clinicians |
Primary outcome
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.
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.
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).
8 secondary outcomes
Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction
Time frame: 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
Time frame: Assessed pre- and post-study (approximately 24 months)
Knowledge as Measured by Knowledge Questions Developed in Previous Studies
Time frame: After initial visit but before surgery, estimated before day 7
Consult Time as Measured by Time Spent With Clinician During the Visit
Time frame: Initial visit (day 1)
Usability as Measured by the System Usability Scale (SUS)
Time frame: After initial visit but before surgery, estimated to be before day 7
Knowledge as Measured by Decision Quality Instrument
Time frame: After initial visit but before surgery, estimated to be before day 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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Politi, Ph.D. principal investigator
Washington University School of Medicine
Clara Lee, M.D., MPP principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Reconstruction Education and Support Tool (BREASTChoice) and Clinician Survey in people with Breast Reconstruction and Breast Cancer, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge as Measured by Decision Quality Instrument (time frame: After initial visit but before surgery, estimated to be before day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.