Clinical trial NCT05582551: Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors
Official title: Highlighting Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Keywords: childhood cancer survivors
electronic medical record
sensory deficit screening
hearing loss
peripheral neuropathy
vestibular
vision
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
First posted: 2022-10-17
Enrollment: 146
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of this study is to attempt to overcome the organizational barriers that impede prompt screening for at-risk sensory deficits in childhood cancer survivors (CCS). Using a cross sectional design study, collaborators in the Informatics Research branch of the Institute of Informatics at the Washington University School of Medicine will identify CCS at risk for sensory deficits based upon their therapy exposure to generate the highlighting patients at risk for sensory screening (HPARSS) document. The investigators will utilize the HPARSS that will link therapy related risks for sensory deficits to specific screening procedures prompting the primary oncology provider to implement screening, diagnostic testing, and therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of pediatric cancer (diagnosis at \<18 years of age)
* Treatment including chemotherapy and/or radiation therapy
* Completion of all cancer therapy for at least 6 months and less than 2 years
* Followed in the Division of Pediatric Hematology/Oncology Program at the Washington University School of Medicine
* Current age between 7 and 17 years of age (age where all of the screening tests are both valid and have been successfully performed by our group)
* English speaking

Exclusion Criteria:

* Undergoing active cancer treatment
* Patient under the care of the Late Effects Program at St. Louis Children's Hospital
* Received previous diagnostic testing or rehabilitative therapy for a secondary deficit eligible for screening.
* Parents and/or patient illiteracy
* No contact with treatment team in the past two years
* In foster care or without a legal guardian

Primary outcomes:
measure: Percentage of patients with at risk for sensory deficits identified by HPARSS
timeFrame: Through completion of enrollment for all patients (estimated to be 9 months)
measure: Percentage of at risk patients who fail the assigned screening test
timeFrame: Through completion of enrollment for all patients (estimated to be 9 months)
measure: Percentage of patients in need of referral for screen test results who participate in formal diagnostic testing and/or treatment
timeFrame: Through 1 year after the completion of screening test for all participants (estimated to be 1 year and 9 months)
Secondary outcomes:
measure: Number and types of barriers to participation in formal diagnostic testing and therapy in CCS failing to engage in sensory screening
timeFrame: At approximately 2 months following the patient's screening
measure: Number and types of facilitators to participation in formal diagnostic testing and therapy in CCS failing to engage in sensory screening
timeFrame: At approximately 2 months following the patient's screening
measure: Acceptability of HPARSS as measured by the Acceptability of Intervention Measure (AIM)
timeFrame: To be completed at the time of enrollment completion (approximately 9 months)
measure: Feasibility of intervention as measured by Feasibility of Intervention Measure (FIM)
timeFrame: To be completed at the time of enrollment completion (approximately 9 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital - Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Robert J Hayashi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: