Improving surgical decisions for young women with breast cancer
Optimizing Surgical Decisions in Young Adults With Breast Cancer
This study is testing a new online tool to help young women with breast cancer make better surgical decisions and communicate more effectively with their doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT06275126 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the surgical decision-making process for young women diagnosed with breast cancer by utilizing a web-based tool called CONSYDER. Participants will complete surveys before and after their surgical consultations to assess the tool's effectiveness in reducing decisional conflict and improving communication with surgeons. The study will involve approximately 800 women across four major cancer centers over a 30-month period, employing a multi-site cluster randomized design. The primary focus is to evaluate how CONSYDER impacts decision-making preferences, knowledge, anxiety, and self-efficacy in communication.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-44 with a new diagnosis of Stage 0 to Stage III unilateral breast cancer.
Not a fit: Patients with de novo Stage 4 breast cancer or recurrent early-stage breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower young breast cancer patients to make more informed and confident surgical decisions.
How similar studies have performed: Other studies have shown success with decision support tools in cancer care, indicating a promising approach for this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut and 3 other locations
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- Duke Cancer Institute — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Shoshana Rosenberg, ScD, MPH — Weill Medical College of Cornell University
- Study coordinator: Shoshana Rosenberg, ScD, MPH
- Email: shr4009@med.cornell.edu
- Phone: 646-962-8041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.