CancerENGAGENCT04455698
Engaging and Activating Cancer Survivors in Genetic Services Study
A study testing Remote Telegenetic Counseling by Phone and Remote Telegenetic Counseling by Videoconferencing in people with Cancer, run by University of Chicago at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Remote Telegenetic Counseling by Phone and Remote Telegenetic Counseling by Videoconferencing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Aug 2021to 31 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
St Jude Children's Research Hospital
Memphis, Tennessee, 38105-3678
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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
- Being tested
- Remote Telegenetic Counseling by Phone, Remote Telegenetic Counseling by Videoconferencing, Usual Care Arm
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Telegenetic Counseling by PhoneBehavioural
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
Remote Telegenetic Counseling by VideoconferencingBehavioural
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.
Usual Care ArmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Usual Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received Genetic Services
Primary composite outcome collected via remote services records-Yes/No
Measured: Assessed at 6 Months for ARMS A/B/C
Genetic Knowledge Scale
Change in knowledge. Score range=0-16, and increased change score indicates increase in knowledge (better).
Measured: Average time from baseline to disclosure was 152.3 days (standard deviation=150.0). (ARMS A/B only)
Impact of Events Scale (IES)
Change in Cancer Specific Distress. Raw Score Range = 0-40. Decreased score change indicates a decrease in distress (better).
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only)
Patient-Reported Outcomes Measurement Information System (PROMIS)
Change in Depression. Score Range = 4-20. Decreased score change indicates a decrease in depression (better).
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only)
Secondary outcomes (8)
Uptake of Genetic Counseling and Testing
The uptake of genetic services was obtained through available GC records for the telehealth genetic services arms. The 6-month post-enrollment survey was used for the usual care arm and for the telehealth genetic services arms when GC records did not indicate completion.
Measured: 6 month status survey (ARMS A/B/C)
Patient Reported Outcomes Measurement Information Systems (PROMIS) Anxiety
Change in Anxiety. Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better).
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) Uncertainty
Change in Uncertainty. Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better).
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: Change in Number of Wine/Beer/Mixed Drinks Per Day Among Those With Genetic Testing
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: Change in Minutes of Vigorous Exercise Per Week Among Those With Genetic Testing
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: Change in Minutes of Moderate Exercise Per Week Among Those With Genetic Testing
Change in performance of ris k reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: New Sigmoidoscopy or Colonoscopy Among Those Who Did Not Have One Within a Year of the Baseline Visit
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: New Mammogram Within One Year at 6 Months Among Those Who Did Not Have One Within a Year at Baseline
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Measured: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start16 Aug 2021
- Primary completion5 Mar 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, St. Jude Children's Research Hospital, Fox Chase Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tara O Henderson, MD, MPH, Principal investigator, University of ChicagoAngela Bradbury, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455698
- Sponsor's protocol ID
- CIRB21-0176
- Other IDs
- R01CA237369
- Acronym
- ENGAGE
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2020
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41867409Henderson 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.
PubMed 41282828Henderson 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.
PubMed 38414045