Clinical trial · Observational
Evaluating the Effects of Genetic Testing on Patients' Stress Levels
NCT02783664CI-TRIAL-00096458active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires to Evaluate Anxiety Related to Genetic Testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Questionnaires to Evaluate Patient Stress Levels
- interventionNames
- Other: Questionnaires to Evaluate Anxiety Related to Genetic Testing
Primary outcomes (3)
- measure
- Measure anxiety at baseline using the State-Trait Anxiety Inventory.
- timeFrame
- Baseline
- description
- The STAI assesses current and trait anxiety symptoms. The investigators use the STAI to measure anxiety at 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDAmerican Cancer Society (ACS). Surveillance and Health Services Research. 2013.
- BACKGROUNDMiki 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. PMID 7545954
- BACKGROUNDWooster 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. PMID 8524414