Trial Title:
Optimizing Surgical Decisions in Young Adults With Breast Cancer
NCT ID:
NCT06275126
Condition:
Breast Cancer Stage 0
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Conditions: Official terms:
Breast Neoplasms
Breast Carcinoma In Situ
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
The study is a pragmatic, Type II hybrid effectiveness-implementation, stepped-wedge
design that will incorporate a mixed-methods approach to test the efficacy and evaluate
the implementation of the CONSYDER intervention
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
CONSYDER decision aid
Description:
Web-based breast cancer surgery decision aid
Arm group label:
CONSYDER decision aid
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 within 1 week of the surgical consult and 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.
Detailed description:
Primary objectives:
- To test the effectiveness of the CONSYDER decision support tool on reducing
decisional conflict prior to breast cancer surgery.
- To evaluate the implementation of and mechanisms of use for CONSYDER.
Secondary Objectives:
- To determine the impact of CONSYDER on decision-making preferences, breast cancer
knowledge, treatment goals and preferences, anxiety, decisional regret, and
self-efficacy in communication.
Exploratory Objectives:
- To explore whether CONSYDER impacts surgical choice.
OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design.
Approximately 800 women will be recruited at 4 study sites (Weill Cornell Medicine, Yale
Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute), including network
affiliate sites, over an approximate 30-month period. All sites will have a 6-month
"run-in" period where patients will not be sent CONSYDER. The 6-month blocks may be
extended if recruitment targets are not met. Sites will be randomized to begin delivery
of CONSYDER to all newly diagnosed women, age ≤44, with Stage 0-III breast cancer as part
of routine clinical care; young women will have access to the website whether or not they
consent to research study participation.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
44 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Greenup, MD, MPH
Phone:
203-737-2966
Email:
rachel.greenup@yale.edu
Investigator:
Last name:
Rachel Greenup, MD, MPH
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ann Partridge, MD, MPH
Phone:
617-632-3800
Email:
ann_partridge@dfci.harvard.edu
Investigator:
Last name:
Ann Partridge, MD, MPH
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medicine
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shoshana Rosenberg, ScD, MPH
Phone:
646-962-8041
Email:
shr4009@med.cornell.edu
Contact backup:
Last name:
Darima Dorzhieva
Phone:
646-962-8666
Email:
dad4011@med.cornell.edu
Investigator:
Last name:
Shoshana Rosenberg, ScD, MPH
Email:
Principal Investigator
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Plichta, MD, MS
Phone:
919-681-9156
Email:
jennifer.plichta@duke.edu
Investigator:
Last name:
Jennifer Plichta, MD, MS
Email:
Principal Investigator
Start date:
March 13, 2024
Completion date:
May 2027
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06275126
