Actively Recruiting
Decision Making Tool for Contralateral Prophylactic Mastectomy in Women with Newly Diagnosed Breast Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a decision support tool designed to help women newly diagnosed with early stage breast cancer make informed choices about contralateral prophylactic mastectomy (CPM). This tool provides evidence-based information on the risk of developing cancer in the opposite breast and the potential life expectancy benefits of CPM. The study is sponsored by M.D. Anderson Cancer Center and aims to assess how acceptable and helpful this tool is during clinical consultations. Participants use the decision making tool during their consultation with a breast cancer surgeon. They complete questionnaires before and after the consultation to measure their understanding and feelings about CPM. The tool is intended to be used jointly by patients and physicians as part of shared decision making, supporting discussions about surgical options. Throughout the study, researchers will evaluate how well the decision support tool is accepted by patients and whether it improves their knowledge about CPM. They will also measure changes in decisional conflict related to the choice of CPM from baseline up to two years. Participants engage in questionnaires and consults as part of the study, which may last up to two years for outcome assessments.
CONDITIONS
Brief Title
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer
- Able to speak, read, or write English
- Female
- Age 18 years or older
You will not qualify if you...
- Previous breast cancer diagnosis
- Prior history of bilateral prophylactic mastectomy
- Known genetic mutation increasing breast cancer risk (e.g., BRCA1/2) or high risk due to strong family history of cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants use an online decision making tool during consultation with their breast cancer surgeon and complete questionnaires before and after the consultation.
1 consultation visit with questionnaires before and after
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Abenaa M Brewster
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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