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NCT02918474 | RECRUITING | Anatomic Stage I Breast Cancer AJCC v8

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

M.D. Anderson Cancer Center

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.

Condition or disease

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage Ia Breast Cancer Ajcc v8

Anatomic Stage Ib Breast Cancer Ajc V8

Anatomic Stage II Breast Cancer Ajc V8

Anatomic Stage Iia Breast Cancer Ajc 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 Ajc V8

Prognostic Stage Ib Breast Cancer Ajcc v8

Prognostic Stage II Breast Cancer Ajc V8

Prognostic Stage Iia Breast Cancer Ajcc v8

Prognostic Stage Iib Breast Cancer Ajcc v8

Prognostic Stage III Breast Cancer Ajcc v8

Prognostic Stage IIAia Breast Cancer Ajc V8

Prognostic Stage IIB Breast Cancer Ajc V8

Prognostic Stage IIIC BREAST CANCER AJCC V8

Sporadic Breast Carcinoma

Intervention/treatment

Decision Aid

Questionnaire Administration

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Decision Making Tool for Contralateral Prophylactic Mastectomy
Actual Study Start Date : 2017-04-28
Estimated Primary Completion Date : 2026-09-30
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer

Location Details

NCT02918474

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How to Participate

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Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030