Optimizing Surgical Decisions in Young Adults With Breast Cancer

This study aims to improve how young women with newly diagnosed breast cancer (Stage 0, 1, 2, or 3) make decisions about surgery. It's testing a web-based tool called CONSYDER, which provides information and helps you talk with your surgeon. Researchers want to see if CONSYDER reduces confusion or difficulty in making surgical choices before your operation. The study is open to women aged 18-44 who speak English or Spanish. This study is currently unclear on its recruitment status, but plans to enroll about 800 participants.

Study design
This study is a multi-site cluster randomized trial involving approximately 800 women. It uses a stepped wedge design where sites will gradually begin using the CONSYDER tool.
What's involved
You would complete surveys approximately one week before your surgical consultation and again about six months after surgery. If you receive chemotherapy before surgery, you'll also complete a survey after that treatment but before surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be surveyed approximately six months after surgery.

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NCT06275126

Optimizing Surgical Decisions in Young Adults With Breast Cancer

Recruiting
NAAges 18–44InterventionalHealth services
Weill Medical College of Cornell University
~800 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:CONSYDER decision aid

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS)
Measured over pre-surgery
+1 more outcome measured
Breast Cancer Stage 0
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
4 sites across 4 states
Connecticut1
Massachusetts1
New York1
North Carolina1
  • Shoshana Rosenberg, ScD, MPH · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
  • Rachel Greenup, MD, MPH · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

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

Exclusion

Diagnosis of de novo Stage 4 breast cancer
Recurrent early-stage breast cancer
Bilateral breast cancer
  • Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS)pre-surgery

    The Decisional Conflict Scale (DCS) includes 5 subscales (uncertainty, informed, values clarity, support, effective decision). Each item is rated on a scale of 0 (strongly agree)-4 (strongly disagree). Scores range from 0-100 with higher scores indicating more decisional conflict.

  • Use of CONSYDER pre-consultpre-surgery

    Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult