Evaluating the Effects of Genetic Testing on Patients' Stress Levels

BACKGROUND: Breast cancer is the second leading cause of cancer death in women (ACS, 2013).
Genetic screening has also become increasingly important in treating breast cancer patients,
with 5-10% of breast cancers linked to mutations in BRCA1/2 genes(Miki, 1994) (Wooster,
1995). As the field of genetic testing has rapidly expanded and multigene panels are now
available, it is unclear what psychological consequences have resulted from the knowledge
gained from these tests.

RATIONALE: Breast cancer clinicians frequently employ genetic testing with breast cancer
patients. It is unclear what psychological consequences have resulted from the knowledge
gained from these tests. A literature review reveals that results are contradictory in terms
of determining stress levels related to test results. This is due to different study
methodologies. The Medical College of Wisconsin Cancer Center researchers will generate more
definitive answers through a prospective study that will establish baseline stress levels,
evaluate pre- and post- test stress levels at multiple time points, focus on the changes in
stress levels for the different resulting subgroups. Evaluating the impact of genetic testing
on stress levels will help health care professionals to better understand the consequences of
genetic testing, and thus, provide better care for patients both medically and
psychologically through potential interventions to decrease stress.

STUDY PROCEDURES: Patients will be contacted by phone after their genetic counseling
appointment is made, prior to their visit by a member of the research team. After giving
informed consent, patients will be provided with the State-Trait Anxiety Inventory (STAI) for
Adults handout to measure their baseline anxiety, as well as the Health Anxiety Inventory and
the Cancer Worry Scale to measure their baseline health anxiety and several additional
demographic questions. Subjects will complete the validated questionnaires privately and then
return them to the genetic counselor. The data collected at this time point will measure
their stress levels before genetic counseling and testing. Patients will be contacted by
phone four more times to take the HAI and CWS survey over the phone (one week after receiving
genetic testing results, which is three weeks after the consult; at five weeks; three months
and six months).

Inclusion Criteria:

- Females 18 years or older.

- Identified as currently diagnosed with breast cancer within the past six months or are
classified as being at high risk for developing breast cancer (i.e., they have a
family history of cancer that puts them at risk for breast cancer) by the Froedtert
Hospital & Medical College of Wisconsin Cancer Genetics Screening Program.

Exclusion Criteria:

- Prior genetic testing for breast cancer.

- Patient is a referral for genetic testing from an outside hospital system for whom
there is no access to outside medical records.

- Past medical history of breast cancer (not including a current diagnosis of breast
cancer within the past six months).

- Current or past history of ovarian cancer.

- Known family history of a BRCA1/2 mutation or cancer susceptibility genetic mutation.

- Patients who are seen in the day hospital for genetic counseling while they are being
administered chemotherapy.