Optimizing Surgical Decisions in Young Adults With Breast Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06275126
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Stage 0
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • CONSYDER decision aid — OTHER
    Web-based breast cancer surgery decision aid

Study Details

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 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.

Key Dates

Start date
Mar 13, 2024
Status verified
Sep 2025
Primary completion
May 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual care
    Prior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.
  • Other: CONSYDER decision aid
    Web-based breast cancer surgery decision aid

Primary Outcome Measure

Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) [ Time Frame: pre-surgery ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06510
Rachel Greenup, MD, MPH
[email protected]
203-737-2966
Rachel Greenup, MD, MPH (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Ann Partridge, MD, MPH
[email protected]
617-632-3800
Ann Partridge, MD, MPH (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Shoshana Rosenberg, ScD, MPH
[email protected]
646-962-8041
Darima Dorzhieva
[email protected]
646-962-8666
Shoshana Rosenberg, ScD, MPH (PRINCIPAL_INVESTIGATOR)
Duke Cancer InstituteDurhamNorth Carolina27710
Jennifer Plichta, MD, MS
[email protected]
919-681-9156
Jennifer Plichta, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale Cancer Center· New Haven, CTDana-Farber Cancer Institute· Boston, MAWeill Cornell Medicine· New York, NYDuke Cancer Institute· Durham, NC

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