Clinical trial NCT02783664: Evaluating the Effects of Genetic Testing on Patients' Stress Levels
Official title: Evaluating the Effects of Genetic Testing on Patients' Stress Levels
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
BRCA1
BRCA2
stress
gene testing
genetic screening
psychological support
State-Trait Anxiety Inventory
Cancer Worry Scale
Health Anxiety Inventory
gene mutations
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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.

Brief summary: This prospective Medical College of Wisconsin Cancer Center study will evaluate stress levels in breast cancer patients undergoing genetic testing. It aims to 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. This will help the clinical staff to provide better care for patients both medically and psychologically through potential interventions to decrease stress.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Measure anxiety at baseline using the State-Trait Anxiety Inventory.
timeFrame: Baseline
measure: Measure change in degree of health anxiety on the questionnaire Health Anxiety Inventory from baseline to six months.
timeFrame: Baseline, 1 Week following results disclosure, 5 Weeks, 3 Months, 6 Months
measure: Measure change in degree of health anxiety on the questionnaire Cancer Worry Scale from baseline to six months.
timeFrame: Baseline, 1 Week following results disclosure, 5 Weeks, 3 Months, 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Amanda Kong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Cancer Society (ACS). Surveillance and Health Services Research. 2013.
citation: Miki Y, Swensen J, Shattuck-Eidens D, Futreal PA, Harshman K, Tavtigian S, Liu Q, Cochran C, Bennett LM, Ding W, et al. A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science. 1994 Oct 7;266(5182):66-71. doi: 10.1126/science.7545954.
citation: Wooster R, Bignell G, Lancaster J, Swift S, Seal S, Mangion J, Collins N, Gregory S, Gumbs C, Micklem G. Identification of the breast cancer susceptibility gene BRCA2. Nature. 1995 Dec 21-28;378(6559):789-92. doi: 10.1038/378789a0.