NCT03061175

Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy

Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stage 0 Breast Cancer
• Stage I Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage IIIA Breast Cancer

Interventions

Type	Name	Description
OTHER	Internet-Based Intervention	Receive web-based CPM-DA
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2015-09-24
• Primary completion: 2018-04-11
• Completion: 2018-04-11
• First posted: 2017-02-23
• Last updated: 2021-04-20
• Results posted: 2020-07-20

Locations

3 sites across 1 country: United States