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

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Ductal Breast Carcinoma In SituInvasive Breast CarcinomaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Sporadic Breast Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer

Able to speak read or write English

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Decision Aid

    Other intervention

    Use decision making tool

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Supportive care (decision making tool)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Acceptability of the decision support tool

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.

Time frame
Up to 2 years
2

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

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.

Time frame
Baseline up to 2 years
3

Reductions in decisional conflict about CPM

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.

Time frame
Baseline up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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