Optimizing Surgical Decisions in Young Adults With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CONSYDER decision aid.
- Who it may be relevant to
- Registry conditions: Breast Cancer Stage 0, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other CONSYDER decision aid
Web-based breast cancer surgery decision aid
Primary outcome measures
- Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) [Time frame: pre-surgery]
- Use of CONSYDER pre-consult [Time frame: pre-surgery]
Secondary outcome measures (10)
- Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI) [Time frame: pre-surgery]
- Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) [Time frame: pre-surgery]
- Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form [Time frame: pre-surgery and 6 months post-surgery]
- Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI). [Time frame: pre-surgery]
- Decisional regret as measured by the Decision Regret Scale (DRS) [Time frame: 6 months post-surgery]
- Receipt of contralateral prophylactic mastectomy [Time frame: 6 months post-surgery]
- Fidelity of implementation of CONSYDER via patient portal email [Time frame: pre-surgical consult]
- Use of CONSYDER post-consult [Time frame: up to 6 months post-surgical consult]
- Frequency of CONSYDER use pre-consult [Time frame: pre consult]
- Frequency of CONSYDER use post-consult [Time frame: up to 6 months post-surgical consult]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 4 centers
- Yale Cancer Center — New Haven
- Dana-Farber Cancer Institute — Boston
- Weill Cornell Medicine — New York
- Duke Cancer Institute — Durham
Identifiers
NCT: NCT06275126 · 23-08026433 · R01CA256877-01A1