Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer

Phase

N/A

Condition

Ductal Carcinoma In Situ (Dcis)

Carcinoma

Precancerous Condition

Treatment

Questionnaire Administration

Decision Aid

Clinical Study ID

NCT02918474

PA16-0469

NCI-2018-02660

PA16-0469

Ages > 18
Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadicunilateral invasive breast cancer
Able to speak read or write English

Exclusion

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 ofbreast cancer (e.g. BRCA1/2) and/or they are considered at high risk forcontralateral breast cancer on the basis of a strong family history of cancer

Study Design

Questionnaire Administration

April 28, 2017

September 30, 2026

Study Description

PRIMARY OBJECTIVES:

I. An online decision support tool will be field tested that provides patients facing a decision about contralateral prophylactic breast cancer (CPM) with evidence-based information about the expected incidence of contralateral breast cancer and the life expectancy benefit of CPM. The tool will be designed for use in clinical settings and viewed jointly by the patient and physician as part of a shared decision making process around CPM.

OUTLINE:

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

Connect with a study center

M D Anderson Cancer Center
Houston, Texas 77030
United States
Active - Recruiting

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