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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02918474
Other study ID # PA16-0469
Secondary ID NCI-2018-02660PA
Status Recruiting
Phase N/A
First received
Last updated
Start date April 28, 2017
Est. completion date September 30, 2026

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Abenaa M Brewster
Phone 713-745-4949
Email abrewster@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
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 Design


Related Conditions & MeSH terms

  • 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
  • Breast Carcinoma In Situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Ductal, Breast
  • Carcinoma, Intraductal, Noninfiltrating
  • 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

Intervention

Other:
Decision Aid
Use decision making tool
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 2 years
Primary 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. Baseline up to 2 years
Primary 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. Baseline up to 2 years
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