RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: 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

Phases

Therapies

Drugs

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

Secondary Trial ID Number

PA19-0403

Keywords

Retrospective

More Information

clinicaltrials.gov

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