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

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: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Remote Telegenetic Counseling by Phone; Behavioral: Remote Telegenetic Counseling by Videoconferencing; Behavioral: Usual Care Arm

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: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tara Henderson, MD; Phone Number: 7737026808; Email: thenderson@peds.bsd.uchicago.edu
• Study Contact Backup: Name: Mary A Allen; Phone Number: 7738347165; Email: mallen12@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
      • Contact: Tara Henderson, MD; Phone Number: 773-702-6808; Email: thenderson@peds.bsd.uchicago.edu
      • Contact: Melissa Marx, MPH; Phone Number: (773)702-2927; Email: mailto:mmarx@peds.bsd.uchicago.edu
      • Principal Investigator: Tara Henderson, MD, MPH
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Angela Bradbury, MD; Phone Number: 800-789-7366; Email: angela.bradbury@pennmedicine.upenn.edu
      • Contact: Beth Wood; Phone Number: 215-662-4303; Email: elisabeth.wood@pennmedicine.upenn.edu
      • Principal Investigator: Angela Bradbury, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38105-3678
      • Recruiting
      • St Jude Children's Research Hospital
      • Contact: Aaron McDonald, PhD; Phone Number: 901-595-6177; Email: aaron.mcdonald@stjude.org
      • Contact: Shani Alston; Email: Shani.Alston@STJUDE.ORG

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Fox Chase Cancer Center; University of Pennsylvania; National Institutes of Health (NIH); St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Tara O Henderson, MD, MPH, FASCO, University of Chicago; Principal Investigator: Angela Bradbury, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CIRB21-0176

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