Clinical trial NCT04455698: Engaging and Activating Cancer Survivors in Genetic Services Study
Official title: Engaging and Activating Cancer Survivors in Genetic Services Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: St. Jude Children's Research Hospital
name: Fox Chase Cancer Center
name: National Institutes of Health (NIH)
First posted: 2020-07-02
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who received testing or genetic counseling
timeFrame: 6 Months status survey (ARM C)
measure: Genetic Knowledge Scale
timeFrame: Baseline - Within 7 Days After Result Disclosure
measure: Impact of Events Scale (IES)
timeFrame: Baseline - Within 7 Days After Result Disclosure
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline - Within 7 Days After Result Disclosure
Secondary outcomes:
measure: Uptake of genetic counseling, testing, and identification of genetic carriers
timeFrame: 6 month status survey (ARM C)
measure: Patient Reported Outcomes Measurement Information Systems (PROMIS)
timeFrame: Baseline - Within 7 Days After Result Disclosure
measure: Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
timeFrame: Baseline - Within 7 Days After Result Disclosure
measure: Change in Health Behaviors (Selected from the Behavioral Risk Factor Surveillance System Questionnaire and the Health and Diet survey Dietary Guidelines Supplement)
timeFrame: Baseline - 6 Months After Result Disclosure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: University of Chicago
name: Tara O Henderson, MD, MPH, FASCO
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Angela Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References: