Who To Contact
Baptist MD Anderson
Cancer Center
1301 Palm Avenue
Jacksonville, FL 32207
Poonam K. Neki, MBBS,DA, CCRP
Research Director
Baptist MD Anderson Clinical Trials
904.202.7468
poonam.neki@bmcjax.com
Clinical Trial ID: NCT99999999
Genomics in Oncology: Clinical Outcomes and Determinants
Status
Open
Description
The primary outcomes of the survey are to describe providers practices surrounding VUS reclassification for: test ordering, pre-test counseling, result interpretation, post-test counseling and long-term-follow up. Online survey responses will be analyzed in R. Univariate analysis will be conducted to characterize respondents; and their responses to survey items. Distribution of responses will be assessed between provider types and their cancer specialties to determine if stratified analysis is needed. Bivariate analysis will be conducted to characterize and explore attitudes toward VUS reclassification and demographic variables such as provider type and study site. Association testing will be done by chi-squared or other comparable test, but as a cross sectional survey, power will be limited to infer associations.
Objective
Aim 1a: Describe patients adherence to pathogenic genetic test results; and health behavior in response to VUS results derived from gene panel testing in breast, ovarian, and colorectal cancers. Aim1b; Evaluate the clinical utility of VUS reclassification (proportion in whom medical or surgical management was changed) among patients. Aim 2: Understand how family testing recommendations are communicated to patients and their family members through patient summary reports written for pathogenic genetic test results. Aim 3: Understand how oncologists and genetic counselors consider the possibility of VUS reclassification in genetic testing, pre- and post-test counseling, and long term follow-up decisions.
Treatment
Aim 1a. Describe patients’ adherence to pathogenic genetic test results; and health behavior in response to VUS results derived from gene panel testing in breast, ovarian, and colorectal cancers. Aim 1b. Evaluate the clinical utility of VUS reclassification (proportion in whom medical or surgical management was changed) among patients. Aim 2: Understand how family testing recommendations are communicated to patients and their family members through patient summary reports written for pathogenic genetic test results. Aim 3. Understand how oncologists and genetic counselors consider the possibility of VUS reclassification in genetic testing, pre- and post-test counseling, and long term follow-up decisions.
Conditions
Other
Age Group
Adult
Main Investiagtor
Samiian, Laila
Practice
Breast; GI; Gyn
Scope
National
Participating Institutions
Baptist MD Anderson Cancer Center
Eligibility
Invitations to participate in an anonymous online survey will be sent out through electronic mail to eligible genetic counselors and oncology physicians in the MDACC, and MDACC Network Sites. While MDACC is a large tertiary cancer center focusing on cancer diagnosis, treatment and research for patients from around the world, the MDA cancer network hospitals and health systems provide cancer diagnosis and treatment as a component of their health care system, and serve patients from their city and region. These health care environments differ in many ways from MD Anderson as well as from each other18. Estimated recruitment yields will vary based on the total number of eligible healthcare providers at each Network Site. All eligible healthcare providers will be invited to participate in the survey. The invitational email will contain a web link to a REDCap survey, supported by the MDACC Assessment, Intervention and Measurement (AIM) shared resource and used for research to survey activities via the Internet. Prior research has found that for individuals with email capability, which expectedly will be all providers, this works well to obtain relatively high survey completion rates. Following best practices, reminder emails will be sent out at 2, 4 and 6 weeks after initial survey deployment to encourage survey completion and to maximize response rates.
Nct ID Number
NCT99999999
Secondary Trial ID Number
PA19-0403
Keywords
Retrospective