Evaluating the Effects of Genetic Testing on Patients' Stress Levels
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Measure anxiety at baseline using the State-Trait Anxiety Inventory.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Measure anxiety at baseline using the State-Trait Anxiety Inventory.
时间窗: Baseline
The STAI assesses current and trait anxiety symptoms. The investigators use the STAI to measure anxiety at baseline.
Measure change in degree of health anxiety on the questionnaire Health Anxiety Inventory from baseline to six months.
时间窗: Baseline, 1 Week following results disclosure, 5 Weeks, 3 Months, 6 Months
Degree of health anxiety measured by the questionnaire Health Anxiety Inventory with 14 and 18-items (HAI). First survey taken at the appointment. Subsequent surveys given over the phone.
Measure change in degree of health anxiety on the questionnaire Cancer Worry Scale from baseline to six months.
时间窗: Baseline, 1 Week following results disclosure, 5 Weeks, 3 Months, 6 Months
CWS consists of 6 items and has been used in research to assess concerns about developing cancer or developing cancer again and the impact of these concerns on daily functioning among individuals at risk for hereditary cancer.
次要结局
未报告次要终点
研究者
Amanda Kong
Associate Professor, Department of Surgery, Division of Surgical Oncology
Medical College of Wisconsin