Clinical trial NCT03061175: Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
Official title: Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-02-23
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)
* PHASE I: Speaks and reads English
* PHASE I: Women with sporadic cancers (WSC) (does not have hereditary breast/ovarian cancer syndrome \[BReast CAncer gene (BRCA) carrier, strong family history\]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; the Tyrer-Cuzick model calculates a personal lifetime risk of breast cancer based on multiple factors; it has become the standard model because it incorporates not only factors such as estrogen exposure and first degree relatives, but also second degree relatives and paternal lineage; a lifetime risk of 20% or greater is considered high risk and would necessitate increased screening methods to the traditional annual mammogram; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation
* PHASE I: Able to provide meaningful informed consent
* PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy)
* PHASE II: Has home internet access
* PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer
* PHASE II: Speaks and reads English
* PHASE II: WSC (does not have hereditary breast/ovarian cancer syndrome \[BRCA carrier, strong family history\]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation
* PHASE II: Able to provide meaningful informed consent

Primary outcomes:
measure: Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants
timeFrame: 2-4 week follow up
measure: Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys
timeFrame: 2-4 week follow up
measure: Decisional Conflict Assessed by the Decisional Conflict Scale
timeFrame: 2-4 week follow up
Secondary outcomes:
measure: Self-Efficacy at 2-4 Week Follow up Survey
timeFrame: 2-4 week follow up
measure: Cancer Worry Assessed by 2-4 Week Follow-up Surveys
timeFrame: 2-4 week follow-up
measure: CPM Motivations Assessed by Surveys
timeFrame: 2-4 week follow up
measure: Perceived Risk of Recurrence Assessed by 2 Items on Surveys
timeFrame: 2-4 week follow-up
Other outcomes:
measure: User Interface Satisfaction Survey
timeFrame: 2-4 week follow up
measure: B-Sure Use- Time
timeFrame: 2-4 week follow up
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne
role: PRINCIPAL_INVESTIGATOR
References: