A tool to help patients decide on contralateral prophylactic mastectomy for breast cancer
Decision Making Tool for Contralateral Prophylactic Mastectomy
NA · M.D. Anderson Cancer Center · NCT02918474
This study tests if an online tool can help women newly diagnosed with breast cancer make better choices about having a preventive mastectomy on the other breast.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02918474 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of an online decision support tool designed to assist patients with newly diagnosed breast cancer in making informed choices about contralateral prophylactic mastectomy (CPM). The tool provides evidence-based information regarding the risk of contralateral breast cancer and the potential life expectancy benefits of undergoing CPM. Patients will use this tool during consultations with their breast cancer surgeon and will complete questionnaires before and after the consultation to assess its impact on their decision-making process.
Who should consider this trial
Good fit: Ideal candidates are patients newly diagnosed with ductal breast carcinoma in situ or stage I-III sporadic unilateral invasive breast cancer who can communicate in English.
Not a fit: Patients with a history of breast cancer, prior bilateral prophylactic mastectomy, or known genetic predispositions to breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could empower patients to make more informed decisions regarding their surgical options, potentially improving their satisfaction and outcomes.
How similar studies have performed: Other studies have shown that decision support tools can significantly improve patient decision-making in cancer care, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer * Able to speak read or write English Exclusion Criteria: * Patients with previous breast cancer * Prior history of bilateral prophylactic mastectomy * Known to have a germline mutation that predisposes them to an increased risk of breast cancer (e.g. BRCA1/2) and/or they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Abenaa M Brewster — M.D. Anderson Cancer Center
- Study coordinator: Abenaa M Brewster
- Email: abrewster@mdanderson.org
- Phone: 713-745-4949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8