Optimizing Surgical Decisions in Young Adults With Breast Cancer
NCT ID: NCT06275126
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2024-03-13
2027-08-31
Brief Summary
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Participants will complete surveys approximately within 1 week of the surgical consult and approximately 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.
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Detailed Description
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* To test the effectiveness of the CONSYDER decision support tool on reducing decisional conflict prior to breast cancer surgery.
* To evaluate the implementation of and mechanisms of use for CONSYDER.
Secondary Objectives:
* To determine the impact of CONSYDER on decision-making preferences, breast cancer knowledge, treatment goals and preferences, anxiety, decisional regret, and self-efficacy in communication.
Exploratory Objectives:
* To explore whether CONSYDER impacts surgical choice.
OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Approximately 800 women will be recruited at 4 study sites (Weill Cornell Medicine, Yale Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute), including network affiliate sites, over an approximate 30-month period. All sites will have a 6-month "run-in" period where patients will not be sent CONSYDER. The 6-month blocks may be extended if recruitment targets are not met. Sites will be randomized to begin delivery of CONSYDER to all newly diagnosed women, age ≤44, with Stage 0-III breast cancer as part of routine clinical care; young women will have access to the website whether or not they consent to research study participation.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual care
Prior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.
No interventions assigned to this group
CONSYDER decision aid
Web-based breast cancer surgery decision aid
CONSYDER decision aid
Web-based breast cancer surgery decision aid
Interventions
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CONSYDER decision aid
Web-based breast cancer surgery decision aid
Eligibility Criteria
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Inclusion Criteria
* New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer
* English or Spanish speaking
Exclusion Criteria
* Recurrent early-stage breast cancer
* Bilateral breast cancer
18 Years
44 Years
FEMALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Shoshana Rosenberg, ScD, MPH
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Rachel Greenup, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Weill Cornell Medicine
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-08026433
Identifier Type: -
Identifier Source: org_study_id
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