Clinical trial · Interventional
Engaging and Activating Cancer Survivors in Genetic Services Study
NCT04455698CI-TRIAL-00121748ENGAGEcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remote Telegenetic Counseling by Phone | Behavioral | — | UNRESOLVED |
| Remote Telegenetic Counseling by Videoconferencing | Behavioral | — | UNRESOLVED |
| Usual Care Arm | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Remote Telegenetics: TELEPHONE (ARM A)
- description
- Remote Phone Telegenetics: Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - TELEPHONE.
- interventionNames
- Behavioral: Remote Telegenetic Counseling by Phone
- type
- EXPERIMENTAL
- label
- Remote Telegenetics: VIDEOCONFERENCING (ARM B)
- description
- Remote Videoconferencing Telegenetics: Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - VIDEOCONFERENCING.
- interventionNames
- Behavioral: Remote Telegenetic Counseling by Videoconferencing
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDHenderson 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
- DERIVEDHenderson 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
- DERIVEDHenderson 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