Engaging and Activating Cancer Survivors in Genetic Services Study

NCT04455698 | Completed DMC

• 2 other identifiers: CIRB21-0176R01CA237369
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• Number of participants who received testing or genetic counseling

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

  6 Months status survey (ARM C)

• Genetic Knowledge Scale

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

  Baseline - Within 7 Days After Result Disclosure

• Impact of Events Scale (IES)

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

  Baseline - Within 7 Days After Result Disclosure

• Patient-Reported Outcomes Measurement Information System (PROMIS)

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

  Baseline - Within 7 Days After Result Disclosure

Secondary Outcomes (4)

• Uptake of genetic counseling, testing, and identification of genetic carriers

  6 month status survey (ARM C)

• Patient Reported Outcomes Measurement Information Systems (PROMIS)

  Baseline - Within 7 Days After Result Disclosure

• Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)

  Baseline - Within 7 Days After Result Disclosure

• Change in Health Behaviors (Selected from the Behavioral Risk Factor Surveillance System Questionnaire and the Health and Diet survey Dietary Guidelines Supplement)

  Baseline - 6 Months After Result Disclosure

Study Arms (3)

Remote Telegenetics: TELEPHONE (ARM A)

EXPERIMENTAL

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

Behavioral: Remote Telegenetic Counseling by Phone

Remote Telegenetics: VIDEOCONFERENCING (ARM B)

EXPERIMENTAL

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

Behavioral: Remote Telegenetic Counseling by Videoconferencing

USUAL CARE (ARM C)

EXPERIMENTAL

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.

Behavioral: Usual Care Arm

Interventions

Remote Telegenetic Counseling by Phone BEHAVIORAL

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

Remote Telegenetics: TELEPHONE (ARM A)

Remote Telegenetic Counseling by Videoconferencing BEHAVIORAL

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

Remote Telegenetics: VIDEOCONFERENCING (ARM B)

Usual Care Arm 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.

USUAL CARE (ARM C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• or more malignancies in childhood (age 18 or younger)
• A first degree relative (parent or sibling) with cancer aged 45 or younger
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: collaborator
• National Cancer Institute (NCI): collaborator
• University of Chicago: lead
• University of Pennsylvania: collaborator
• Fox Chase Cancer Center: collaborator

Study Sites (3)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

St Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States

Location

Related Publications (3)

• Henderson TO, Egleston B, Howe S, Allen MA, Mim R, Fleisher LG, Elkin EB, Oeffinger KC, Krull KR, Ofidis D, McLeod B, Griffin H, Wood EM, Cacioppo CN, Brown S, Perpich M, Armstrong GT, Bradbury AR. The ENGAGE study: a randomized trial optimizing uptake of germline cancer genetic services in childhood cancer survivors. Lancet Reg Health Am. 2026 Feb 13;55:101375. doi: 10.1016/j.lana.2026.101375. eCollection 2026 Mar.

  PMID: 41867409 DERIVED

• Henderson TO, Egleston B, Howe S, Allen MA, Mim R, Fleisher LG, Elkin EB, Oeffinger KC, Krull KR, Ofidis D, Mcleod B, Griffin H, Wood EM, Cacioppo CN, Brown S, Perpich M, Armstrong GT, Bradbury AR. The ENGAGE Study: A Randomized Trial Optimizing Uptake of Germline Cancer Genetic Services in Childhood Cancer Survivors. medRxiv [Preprint]. 2025 Oct 22:2025.10.20.25338173. doi: 10.1101/2025.10.20.25338173.

  PMID: 41282828 DERIVED

• 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.

  PMID: 38414045 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tara O Henderson, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Angela Bradbury, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 2, 2020
• Study Start: August 16, 2021
• Primary Completion: March 5, 2025
• Study Completion: December 31, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)