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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    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
    Anatomic Stage IIIB Breast Cancer AJCC v8
    Anatomic Stage IIIC Breast Cancer AJCC v8
    Ductal Breast Carcinoma In Situ
    Invasive Breast Carcinoma
    Prognostic Stage I Breast Cancer AJCC v8
    Prognostic Stage IA Breast Cancer AJCC v8
    Prognostic Stage IB Breast Cancer AJCC v8
    Prognostic Stage II Breast Cancer AJCC v8
    Prognostic Stage IIA Breast Cancer AJCC v8
    Prognostic Stage IIB Breast Cancer AJCC v8
    Prognostic Stage III Breast Cancer AJCC v8
    Prognostic Stage IIIA Breast Cancer AJCC v8
    Prognostic Stage IIIB Breast Cancer AJCC v8
    Prognostic Stage IIIC Breast Cancer AJCC v8
    Sporadic Breast Carcinoma

NCT02918474

M.D. Anderson Cancer Center

18 May 2024

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