Clinical trial NCT06275126: Optimizing Surgical Decisions in Young Adults With Breast Cancer
Official title: Optimizing Surgical Decisions in Young Adults With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Stage 0
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-02-23
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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.

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.

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

Primary outcomes:
measure: Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS)
timeFrame: pre-surgery
measure: Use of CONSYDER pre-consult
timeFrame: pre-surgery
Secondary outcomes:
measure: Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI)
timeFrame: pre-surgery
measure: Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
timeFrame: pre-surgery
measure: Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form
timeFrame: pre-surgery and 6 months post-surgery
measure: Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI).
timeFrame: pre-surgery
measure: Decisional regret as measured by the Decision Regret Scale (DRS)
timeFrame: 6 months post-surgery
measure: Receipt of contralateral prophylactic mastectomy
timeFrame: 6 months post-surgery
measure: Fidelity of implementation of CONSYDER via patient portal email
timeFrame: pre-surgical consult
measure: Use of CONSYDER post-consult
timeFrame: up to 6 months post-surgical consult
measure: Frequency of CONSYDER use pre-consult
timeFrame: pre consult
measure: Frequency of CONSYDER use post-consult
timeFrame: up to 6 months post-surgical consult
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shoshana Rosenberg, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Rachel Greenup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: