Breast Cancer Clinical Trial
Optimizing Surgical Decisions in Young Adults With Breast Cancer
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.
Full 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 4 Locations for this study
New Haven Connecticut, 06510, United States More Info
Principal Investigator
Boston Massachusetts, 02215, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Durham North Carolina, 27710, United States More Info
Principal Investigator
How clear is this clinincal trial information?