Optimizing Surgical Decisions in Young Adults With Breast Cancer
CONSYDER
2 other identifiers
interventional
800
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedStudy Start
First participant enrolled
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
September 9, 2025
September 1, 2025
3.1 years
February 6, 2024
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS)
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.
pre-surgery
Use of CONSYDER pre-consult
Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult
pre-surgery
Secondary Outcomes (10)
Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI)
pre-surgery
Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
pre-surgery
Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form
pre-surgery and 6 months post-surgery
Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI).
pre-surgery
Decisional regret as measured by the Decision Regret Scale (DRS)
6 months post-surgery
- +5 more secondary outcomes
Study Arms (2)
Usual care
NO INTERVENTIONPrior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.
CONSYDER decision aid
OTHERWeb-based breast cancer surgery decision aid
Interventions
Eligibility Criteria
You may qualify if:
- Female aged 18-44
- New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer
- English or Spanish speaking
You may not qualify if:
- Diagnosis of de novo Stage 4 breast cancer
- Recurrent early-stage breast cancer
- Bilateral breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shoshana Rosenberg, ScD, MPH
Weill Medical College of Cornell University
- PRINCIPAL INVESTIGATOR
Rachel Greenup, MD, MPH
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 23, 2024
Study Start
March 13, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available following publication of the primary endpoints of the study. No end date.
- Access Criteria
- Requests must be made in writing to the principal investigators. A data use agreement may be required with participating institutions to facilitate sharing of any data sets.
De-identified data sets will made available, by request, to outside researchers. A data use agreement may be required with participating institutions to facilitate sharing of any data sets. Data from qualitative interviews, focus groups, audio-recordings, and any data collected from clinicians/providers will not be made available due to concerns about potentially identifying information being shared.