Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Decision Aid, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: 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. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Decision Making Tool for Contralateral Prophylactic Mastectomy
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.
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.
Interventions
- Other Decision Aid
Use decision making tool - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Acceptability of the decision support tool [Time frame: Up to 2 years]
- Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM) [Time frame: Baseline up to 2 years]
- Reductions in decisional conflict about CPM [Time frame: Baseline up to 2 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT02918474 · PA16-0469 · NCI-2018-02660 · PA16-0469