ENGAGE: Engaging and Activating Cancer Survivors in Genetic Services Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Number of participants who received testing or genetic counseling [6 Months status survey (ARM C)]
Primary composite outcome collected via remote services records-Yes/No (ARMS A/B)
- Genetic Knowledge Scale [Baseline - Within 7 Days After Result Disclosure]
Change in knowledge (ARMS A/B only). Increased change score indicates increase in knowledge (better).
- Impact of Events Scale (IES) [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).
- Patient-Reported Outcomes Measurement Information System (PROMIS) [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).
Secondary Outcome Measures
- Uptake of genetic counseling, testing, and identification of genetic carriers [6 month status survey (ARM C)]
Collected via remote services records (ARMS A/B)
- Patient Reported Outcomes Measurement Information Systems (PROMIS) [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).
- Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) [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).
- Change in Health Behaviors (Selected from the Behavioral Risk Factor Surveillance System Questionnaire and the Health and Diet survey Dietary Guidelines Supplement) [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to understand and communicate in English or Spanish
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Currently residing in the US
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Childhood Cancer Survivor Study Participant survivors of the following primary cancers:
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CNS tumor
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Sarcoma (except Ewing sarcoma)
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Hepatoblastoma
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Leukemia
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Childhood Cancer Survivor Study Participant with a family history of a child with cancer:
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2 or more malignancies in childhood (age 18 or younger)
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A first degree relative (parent or sibling) with cancer aged 45 or younger
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2 or more second degree relatives with cancer aged 45 or younger (same side of family)
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Parents of the child with cancer are related (consanguinity)
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Other family history that meets NCCN criteria
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Able to communicate remotely through remote telegenetic platforms (phone or videoconference) with genetic counselors
Exclusion Criteria:
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Uncorrected or uncompensated speech defects that would lead to the participant being unable to communicate effectively with genetic counselor
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Currently residing in a US state or territory where genetic counselors are not licensed to provide care
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Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and task
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Participants who have already completed and received a clinically appropriate multi-gene panel genetic testing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637 |
| 2 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 3 | St Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105-3678 |
Sponsors and Collaborators
- University of Chicago
- University of Pennsylvania
- St. Jude Children's Research Hospital
- Fox Chase Cancer Center
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Tara O Henderson, MD, MPH, FASCO, University of Chicago
- Principal Investigator: Angela Bradbury, MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIRB21-0176