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NCT Number: NCT02918474

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

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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Adenocarcinoma 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 Breast Carcinoma In Situ Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial 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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Abenaa M. Brewster

CONTACT

713-745-4949

Abenaa M. Brewster

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Aid

Other

Use decision making tool

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Acceptability of the decision support tool

    Time frame: Up to 2 years

    Patients' rating of the acceptability of the decision support tool will be assessed using questions from the Ottawa Acceptability Measures, including the clarity, amount, and balance of the information provided by the tool. Acceptability data from patients enrolled in the field test will be reported descriptively.

  2. Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM)

    Time frame: Baseline up to 2 years

    Will test for change in knowledge from before to after administration of the decision support tool with a breast cancer surgeon using paired samples t-tests.

  3. Reductions in decisional conflict about CPM

    Time frame: Baseline up to 2 years

    Will be assessed using the Decisional Conflict Scale. Will test for reduction in decisional conflict from before to after administration of the decision support tool with a breast cancer surgeon using paired samples t-tests.

Study contacts

Contact information is provided by the study sponsor or research team.

Abenaa M Brewster

CONTACT

[email protected]

713-745-4949

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Decision Making Tool for Contralateral Prophylactic Mastectomy

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2016
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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