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Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy
This pilot randomized clinical trial studies how well a web-based decision aid works in improving informed decisions in patients with stage 0-IIIA breast cancer considering contralateral prophylactic mastectomy (CPM). A web-based decision aid (DA) may help doctors determine how patients make decisions about whether or not to have contralateral prophylactic mastectomy.
PRIMARY OBJECTIVES: I. To develop a feasible web-based decision aid (DA). SECONDARY OBJECTIVES: I. To provide preliminary data on the impact of the contralateral prophylactic mastectomy (CPM)-DA on preparedness to make the CPM decision, decisional conflict, CPM knowledge, psychosocial factors, perceived risk for cancer in the healthy/breast/metastatic disease, cancer recurrence/metastasis worry, cancer distress and intention to have CPM. OUTLINE: PHASE I (PROTOTYPE DEVELOPMENT AND TESTING): Patients attend an interview and are asked questions about experiences with CPM, reasons they chose and did not choose CPM, and CPM satisfaction for 60 minutes. Patients then receive access to web-based CPM-DA and attend an interview over 90 minutes to provide feedback on module and to complete a prototype evaluation. PHASE II (CPM-DA FEASIBILITY TRIAL): Patients are randomized to 1 of 2 arms. ARM I: Patients undergo usual care (UC) available to patients considering CPM and receive information from a medical oncologist about CPM. ARM II: Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. After completion of study treatment, patients are followed up at 2-4 weeks and 6 months.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
September 24, 2015
Primary Completion Date
April 11, 2018
Completion Date
April 11, 2018
Last Updated
April 20, 2021
94
ACTUAL participants
Internet-Based Intervention
OTHER
Survey Administration
OTHER
Lead Sponsor
Rutgers, The State University of New Jersey
Collaborators
NCT06401889
NCT05334069
Data Source & Attribution
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