Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06275126

Conditions

Breast Cancer Stage 0

Breast Cancer Stage I

Breast Cancer Stage II

Breast Cancer Stage III

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

CONSYDER decision aid

Study Details

Brief summary:

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.

Conditions

Breast Cancer Stage 0

Breast Cancer Stage I

Breast Cancer Stage II

Breast Cancer Stage III

Study ID

NCT06275126

Start date

Mar 13, 2024

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female aged 18-44
  • New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer
  • English or Spanish speaking

Exclusion Criteria:

  • Diagnosis of de novo Stage 4 breast cancer
  • Recurrent early-stage breast cancer
  • Bilateral breast cancer

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

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 ]
  • Use of CONSYDER pre-consult [ Time Frame: pre-surgery ]

Central Contacts and Locations

Central contacts

Locations

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Principal Investigator:

Rachel Greenup, MD, MPH

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Ann Partridge, MD, MPH

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Shoshana Rosenberg, ScD, MPH

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Jennifer Plichta, MD, MS

9196819156jennifer.plichta@duke.edu

Principal Investigator:

Jennifer Plichta, MD, MS

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-19.