Engaging and Activating Cancer Survivors in Genetic Services Study (ENGAGE)

February 6, 2026 updated by: University of Chicago
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
391

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Memphis, Tennessee, United States, 38105-3678
        • St Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Remote Telegenetics: TELEPHONE (ARM A)

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
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
Experimental: Remote Telegenetics: VIDEOCONFERENCING (ARM B)

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants who received testing or genetic counseling
Time Frame: 6 Months status survey (ARM C)
Primary composite outcome collected via remote services records-Yes/No (ARMS A/B)
6 Months status survey (ARM C)
Genetic Knowledge Scale
Time Frame: Baseline - Within 7 Days After Result Disclosure
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)
Time Frame: Baseline - Within 7 Days After Result Disclosure
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)
Time Frame: Baseline - Within 7 Days After Result Disclosure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Uptake of genetic counseling, testing, and identification of genetic carriers
Time Frame: 6 month status survey (ARM C)
Collected via remote services records (ARMS A/B)
6 month status survey (ARM C)
Patient Reported Outcomes Measurement Information Systems (PROMIS)
Time Frame: Baseline - Within 7 Days After Result Disclosure
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)
Time Frame: Baseline - Within 7 Days After Result Disclosure
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)
Time Frame: Baseline - 6 Months After Result Disclosure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Fox Chase Cancer Center
University of Pennsylvania
St. Jude Children's Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angela Bradbury, MD, University of Pennsylvania
  • Principal Investigator: Tara O Henderson, MD, MPH, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIRB21-0176
  • R01CA237369 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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