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Clinical Trials/NCT05582551
NCT05582551
Recruiting
Not Applicable

Highlighting Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors

Washington University School of Medicine1 site in 1 country146 target enrollmentAugust 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Cancer
Sponsor
Washington University School of Medicine
Enrollment
146
Locations
1
Primary Endpoint
Percentage of at risk patients who fail the assigned screening test
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2, 2023
End Date
May 31, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Percentage of at risk patients who fail the assigned screening test

Time Frame: Through completion of enrollment for all patients (estimated to be 9 months)

Percentage of patients with at risk for sensory deficits identified by HPARSS

Time Frame: Through completion of enrollment for all patients (estimated to be 9 months)

Percentage of patients in need of referral for screen test results who participate in formal diagnostic testing and/or treatment

Time Frame: Through 1 year after the completion of screening test for all participants (estimated to be 1 year and 9 months)

Secondary Outcomes

  • Number and types of barriers to participation in formal diagnostic testing and therapy in CCS failing to engage in sensory screening(At approximately 2 months following the patient's screening)
  • Acceptability of HPARSS as measured by the Acceptability of Intervention Measure (AIM)(To be completed at the time of enrollment completion (approximately 9 months))
  • Number and types of facilitators to participation in formal diagnostic testing and therapy in CCS failing to engage in sensory screening(At approximately 2 months following the patient's screening)
  • Feasibility of intervention as measured by Feasibility of Intervention Measure (FIM)(To be completed at the time of enrollment completion (approximately 9 months))

Study Sites (1)

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