Engaging and Activating Cancer Survivors in Genetic Services Study

NCT ID: NCT04455698

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 391 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Remote Telegenetics: TELEPHONE (ARM A)

Remote Phone Telegenetics:

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

Group Type: EXPERIMENTAL

Remote Telegenetic Counseling by Phone

Intervention Type: BEHAVIORAL

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

Remote Telegenetics: VIDEOCONFERENCING (ARM B)

Remote Videoconferencing Telegenetics:

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

Group Type: EXPERIMENTAL

Remote Telegenetic Counseling by Videoconferencing

Intervention Type: BEHAVIORAL

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

USUAL CARE (ARM C)

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.

Group Type: EXPERIMENTAL

Usual Care Arm

Intervention Type: BEHAVIORAL

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.

Interventions

Remote Telegenetic Counseling by Phone

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Able to understand and communicate in English or Spanish
• Currently residing in the US
• Childhood Cancer Survivor Study Participant survivors of the following primary cancers:

• CNS tumor
• Sarcoma (except Ewing sarcoma)
• Hepatoblastoma
• Leukemia
• Childhood Cancer Survivor Study Participant with a family history of a child with cancer:

• 2 or more malignancies in childhood (age 18 or younger)
• A first degree relative (parent or sibling) with cancer aged 45 or younger
• 2 or more second degree relatives with cancer aged 45 or younger (same side of family)
• Parents of the child with cancer are related (consanguinity)
• Other family history that meets NCCN criteria
• Able to communicate remotely through remote telegenetic platforms (phone or videoconference) with genetic counselors

Exclusion Criteria

• Uncorrected or uncompensated speech defects that would lead to the participant being unable to communicate effectively with genetic counselor
• Currently residing in a US state or territory where genetic counselors are not licensed to provide care
• Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and task
• Participants who have already completed and received a clinically appropriate multi-gene panel genetic testing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara O Henderson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Angela Bradbury, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

St Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

References

Henderson TO, Allen MA, Mim R, Egleston B, Fleisher L, Elkin E, Oeffinger K, Krull K, Ofidis D, Mcleod B, Griffin H, Wood E, Cacioppo C, Weinberg M, Brown S, Howe S, McDonald A, Vukadinovich C, Alston S, Rinehart D, Armstrong GT, Bradbury AR. The ENGAGE study: a 3-arm randomized hybrid type 1 effectiveness and implementation study of an in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic services in childhood cancer survivors. BMC Health Serv Res. 2024 Feb 28;24(1):253. doi: 10.1186/s12913-024-10586-z.

Reference Type: DERIVED

PMID: 38414045 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01CA237369

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CIRB21-0176

Identifier Type: -

Identifier Source: org_study_id