Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02918474

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decision Aid

Questionnaire Administration

Study Details

Brief summary:

This trial studies the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer. Decision making tool may help patients with early stage breast cancer make decisions regarding their surgical options.

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

Study ID

NCT02918474

Start date

Apr 28, 2017

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (decision making tool)

Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.

Interventions

Decision Aid

Use decision making tool

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Acceptability of the decision support tool [ Time Frame: Up to 2 years ]
  • Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM) [ Time Frame: Baseline up to 2 years ]
  • Reductions in decisional conflict about CPM [ Time Frame: Baseline up to 2 years ]

Central Contacts and Locations

Central contacts

Abenaa M Brewster

713-745-4949abrewster@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Abenaa M. Brewster

713-745-4949

Principal Investigator:

Abenaa M. Brewster

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.