NCT04455698

Engaging and Activating Cancer Survivors in Genetic Services Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 391 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To address the gap in access to genetic services, this study will evaluate the effectiveness of an adapted model of remote delivery of genetic services to increase the uptake of recommended genetic assessment and testing in childhood cancer survivors.

Detailed description

As childhood cancer survivors receive care locally from PCPs, the in-home, collaborative PCP model is designed to increase access to genetic services and uptake of genetic testing in childhood cancer survivors. In this model, individual survivors can access remote telegenetic services and genetic counselors will partner with PCPs to order genetic testing. This study comprises of a 3-arm randomized Hybrid 1 Effectiveness and Implementation study in 360 CCSS survivors to evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer survivors compared to usual care options for genetic testing. Aims are as follows: To evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic services to increase uptake of genetic testing at 6 months as compared to usual care among childhood cancer survivors who meet criteria for cancer genetic testing. Our primary outcome will be a composite variable indicating whether a person had pre-test counseling or genetic testing. To evaluate the effectiveness of remote videoconferencing to provide greater increase in knowledge and decrease in distress and depression as compared to remote phone services, to examine the moderators of patient outcomes with remote telegenetic services, and to estimate intervention costs and incremental cost-effectiveness of the three study arms. To conduct a multi-stakeholder, mixed-methods process evaluation to understand patient, provider and system factors associated with uptake of counseling and testing in our adapted in-home, collaborative PCP model and facilitators and barriers to uptake to provide recommendations for future implementation.

Conditions

• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Remote Telegenetic Counseling by Phone	Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
BEHAVIORAL	Remote Telegenetic Counseling by Videoconferencing	Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.
BEHAVIORAL	Usual Care Arm	Participants in the usual care arm will receive usual care services depending on which referral method they choose and if they initiate services. After a 6 month status survey, if they have not had genetic services through usual care they will be offered services and re-randomized to ARM A/ARM B.

Timeline

• Start date: 2021-08-16
• Primary completion: 2025-03-05
• Completion: 2025-12-31
• First posted: 2020-07-02
• Last updated: 2026-02-10

Locations

3 sites across 1 country: United States