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

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 [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