Engaging and Activating Cancer Survivors in Genetic Services Study

Cancer Clinical Trial

— ENGAGE  

Official title:

Engaging and Activating Cancer Survivors in Genetic Services Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455698
• Other study ID #: CIRB21-0176
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: September 15, 2025

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: Tara Henderson, MD
• Phone: 7737026808
• Email: thenderson[@]peds.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 15, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Remote Telegenetic Counseling by Phone
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
• Remote Telegenetic Counseling by Videoconferencing
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois
United States	St Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Chicago	Fox Chase Cancer Center, National Institutes of Health (NIH), St. Jude Children's Research Hospital, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	Uptake of genetic counseling, testing, and identification of genetic carriers	Collected via remote services records (ARMS A/B)	6 month status survey (ARM C)
Secondary	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
Secondary	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
Secondary	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