Remote Phone Telegenetics:

Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - TELEPHONE.

Remote Videoconferencing Telegenetics:

Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - VIDEOCONFERENCING.

Usual Care:

Participants will receive referrals to genetic counseling providers, initiating services on their own. At 6 months, if participants have not sought and received genetic counseling services, they will be offered randomization to ARM A/ARM B.

Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.

Remote Telegenetic Counseling by Phone

Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.

Remote Telegenetic Counseling by Videoconferencing

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.

Usual Care Arm

Tara Henderson, MD

Mary A Allen

Melissa Marx, MPH

Tara Henderson, MD, MPH

Angela Bradbury, MD

Beth Wood

Aaron McDonald, PhD

Shani Alston

Tara O Henderson, MD, MPH, FASCO

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.

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.

Engaging and Activating Cancer Survivors in Genetic Services Study

Primary composite outcome collected via remote services records-Yes/No (ARMS A/B)

Change in knowledge (ARMS A/B only). Increased change score indicates increase in knowledge (better).

Change in Cancer Specific Distress (ARMS A/B only). Score Range = 0-40. Decreased score change indicates a decrease in distress (better).

Change in Depression (ARMS A/B only). Score Range = 4-20. Decreased score change indicates a decrease in depression (better).

Collected via remote services records (ARMS A/B)

Change in Anxiety (ARMS A/B only). Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better).

Change in Uncertainty (ARMS A/B only). Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better).

Change in performance of risk reductive and screening behaviors and communication of results - Yes/No responses (ARMS A/B only).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Engaging and Activating Cancer Survivors in Genetic Services Study	NCT04455698	Cancer	Remote Telegene... Remote Telegene... Usual Care Arm	18 Years -	University of Chicago
Engaging and Activating Cancer Survivors in Genetic Services Study	NCT04455698	Cancer	Remote Telegene... Remote Telegene... Usual Care Arm	18 Years -	University of Chicago

Spots Global Cancer Trial Database for remote telegenetic counseling by phone