Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA237369 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| St. Jude Children's Research Hospital | OTHER |
| Fox Chase Cancer Center | OTHER |
| National Cancer Institute (NCI) |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Telegenetic Counseling by Phone | Behavioral | Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of genetic counseling, testing, and identification of genetic carriers | Collected via remote services records (ARMS A/B) | 6 month status survey (ARM C) |
| Patient Reported Outcomes Measurement Information Systems (PROMIS) |
Not provided
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:
Childhood Cancer Survivor Study Participant with a family history of a child with cancer:
Able to communicate remotely through remote telegenetic platforms (phone or videoconference) with genetic counselors
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tara O Henderson, MD, MPH | University of Chicago | Principal Investigator |
| Angela Bradbury, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. Lancet Reg Health Am. 2026 Feb 13;55:101375. doi: 10.1016/j.lana.2026.101375. eCollection 2026 Mar. | |
| 41282828 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 5, 2026 | |
| Reset | Mar 26, 2026 | |
| Release | Apr 20, 2026 | |
| Reset | May 12, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 30, 2023 | Jul 3, 2025 | Prot_SAP_ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 5, 2026 | Mar 26, 2026 | |||
| Apr 20, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. |
|
Change in Anxiety (ARMS A/B only). Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better).
| Baseline - Within 7 Days After Result Disclosure |
| Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) | Change in Uncertainty (ARMS A/B only). Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better). | 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) | Change in performance of risk reductive and screening behaviors and communication of results - Yes/No responses (ARMS A/B only). | Baseline - 6 Months After Result Disclosure |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| St Jude Children's Research Hospital | Memphis | Tennessee | 38105-3678 | United States |
| 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. |
| 38414045 | 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. |
| May 12, 2026 |