Active — Not RecruitingNot Applicable

Evaluating the Effects of Genetic Testing on Patients' Stress Levels

United States164 participantsStarted 2016-07

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Measure anxiety at baseline using the State-Trait Anxiety Inventory.

Timeframe: Baseline

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 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

Trial details

NCT IDNCT02783664

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measure anxiety at baseline using the State-Trait Anxiety Inventory.

Timeframe: Baseline

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 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