Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Primary Purpose
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8
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
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (decision making tool)
Arm Description
Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02918474
First Posted
September 27, 2016
Last Updated
September 12, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02918474
Brief Title
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Official Title
Decision Making Tool for Contralateral Prophylactic Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, 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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (decision making tool)
Arm Type
Experimental
Arm Description
Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
Use decision making tool
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Acceptability of the decision support tool
Description
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
Title
Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM)
Description
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
Title
Reductions in decisional conflict about CPM
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abenaa M Brewster
Phone
713-745-4949
Email
abrewster@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abenaa M Brewster
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abenaa M. Brewster
Phone
713-745-4949
First Name & Middle Initial & Last Name & Degree
Abenaa M. Brewster
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
Learn more about this trial
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
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