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

Not Applicable

Recruiting

• Conditions: Childhood Cancer

• Registration Number: NCT05582551
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Study Start: 2023-08-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of at risk patients who fail the assigned screening test	Through completion of enrollment for all patients (estimated to be 9 months)
Percentage of patients with at risk for sensory deficits identified by HPARSS	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	Through 1 year after the completion of screening test for all participants (estimated to be 1 year and 9 months)

Secondary Outcome Measures

Name	Time	Method
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)	-4 questions inquiring about the acceptability of HPARSS with answers ranging from completely disagree=1 to completely agree=5. The higher the score indicates higher acceptability of the HPARSS.
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)	-4 questions inquiring about the feasibility of HPARSS with answers ranging from completely disagree=1 to completely agree=5. The higher the score indicates higher feasibility of the HPARSS.

Trial Locations

Locations (1)

St. Louis Children's Hospital - Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States