CLINICAL TRIAL / NCT04455698
Engaging and Activating Cancer Survivors in Genetic Services Study
- Interventional
- Recruiting
- NCT04455698
Contact Information
Engaging and Activating Cancer Survivors in Genetic Services 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.
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
Accepts Healthy Volunteers
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