protocolSection identificationModule nctId: NCT06275126, orgStudyIdInfo id: 23-08026433, secondaryIdInfos id: R01CA256877-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA256877-01A1, briefTitle: Optimizing Surgical Decisions in Young Adults With Breast Cancer, acronym: CONSYDER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.Participants will complete surveys within 1 week of the surgical consult and 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded., conditionsModule conditions: Breast Cancer Stage 0, conditions: Breast Cancer Stage I, conditions: Breast Cancer Stage II, conditions: Breast Cancer Stage III, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study is a pragmatic, Type II hybrid effectiveness-implementation, stepped-wedge design that will incorporate a mixed-methods approach to test the efficacy and evaluate the implementation of the CONSYDER intervention, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: CONSYDER decision aid, outcomesModule primaryOutcomes measure: Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS), primaryOutcomes measure: Use of CONSYDER pre-consult, secondaryOutcomes measure: Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI), secondaryOutcomes measure: Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI), secondaryOutcomes measure: Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form, secondaryOutcomes measure: Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI)., secondaryOutcomes measure: Decisional regret as measured by the Decision Regret Scale (DRS), secondaryOutcomes measure: Receipt of contralateral prophylactic mastectomy, secondaryOutcomes measure: Fidelity of implementation of CONSYDER via patient portal email, secondaryOutcomes measure: Use of CONSYDER post-consult, secondaryOutcomes measure: Frequency of CONSYDER use pre-consult, secondaryOutcomes measure: Frequency of CONSYDER use post-consult, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yale Cancer Center, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Rachel Greenup, MD, MPH, role: CONTACT, phone: 203-737-2966, email: rachel.greenup@yale.edu, contacts name: Rachel Greenup, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Dana-Farber Cancer Institute, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Ann Partridge, MD, MPH, role: CONTACT, phone: 617-632-3800, email: ann_partridge@dfci.harvard.edu, contacts name: Ann Partridge, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Weill Cornell Medicine, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Shoshana Rosenberg, ScD, MPH, role: CONTACT, phone: 646-962-8041, email: shr4009@med.cornell.edu, contacts name: Darima Dorzhieva, role: CONTACT, phone: 646-962-8666, email: dad4011@med.cornell.edu, contacts name: Shoshana Rosenberg, ScD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Duke Cancer Institute, status: RECRUITING, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Jennifer Plichta, MD, MS, role: CONTACT, phone: 919-681-9156, email: jennifer.plichta@duke.edu, contacts name: Jennifer Plichta, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False