Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774445
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-02-18
Brief Title:
Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
MyCancerGene
Brief Summary:
This protocol aims to evaluate the efficacy of a theoretically and stakeholder informed patient-centered genetic Interactive Health Communication Application to increase patient understanding of and affective and behavioral responses to genetic testing The study investigators hypothesize that the intervention will be associated with increases in knowledge decreases in distress increases in communication with relatives and health care providers and increases in performance of risk reducing health behaviors
Detailed Description:
As clinical practice increasingly use multi-gene testing many patients are left with unknowns after genetic testing Many have results that are unclear and may or may not be associated with any risk for cancer Variants of Uncertain Significance or mutations in genes with very limited information about disease risk or the best medical management Importantly many of these uncertainties will be clarified over time but there is a need for effective ways of communicating these updates to patients who had testing months or years ago In some cases there may be multiple updates over time To address this this study will provide patients access using an Interactive Health Communication Application MyCancerGene to information about their genetic testing their specific results and the implications the ability to print reports and other materials for their relatives and other health care providers and to assess if there has been a change in the personal or family history Additionally patients can contact their genetic provider through MyCancerGene and the cancer genetics team can send out updates to patients about their individual results or about new information about risk estimates or screening recommendations The study investigators hypothesize that MyCancerGene will be associated with increases in knowledge decreases in distress increases in communication with relatives and health care providers and increases in cancer screening and risk reducing health behaviors After 12 months all patients will have access to MyCancerGene which will aid in understanding who benefits most and least from this intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 832628 | OTHER | University of Pennsylvania IRB | None |