Ignite Creation Date:
2024-05-06 @ 8:37 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02783664
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-17
First Post:
2016-05-24
Brief Title:
Evaluating the Effects of Genetic Testing on Patients Stress Levels
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Evaluating the Effects of Genetic Testing on Patients Stress Levels
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BRCA12 genesMiki 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None