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

NCT05582551 | Recruiting

• 1 other identifier: 202208066
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer

Keywords

childhood cancer survivors; electronic medical record; sensory deficit screening; hearing loss; peripheral neuropathy; vestibular; vision

Outcome Measures

Primary Outcomes (3)

• 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 at risk patients who fail the assigned screening test

  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 Outcomes (4)

• 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

• 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

• Acceptability of HPARSS as measured by the Acceptability of Intervention Measure (AIM)

  To be completed at the time of enrollment completion (approximately 9 months)

• Feasibility of intervention as measured by Feasibility of Intervention Measure (FIM)

  To be completed at the time of enrollment completion (approximately 9 months)

Study Arms (2)

Patients: Highlighting Patients at Risk for Sensory Screening (HPARSS)

EXPERIMENTAL

* The primary oncology team will utilize the HPARSS to identify patients who are at risk for sensory deficits based on prior treatment. The HPARSS will constitute a file of that will contain eligible patients based upon their past treatment and their corresponding risk for a particular sensory deficit based upon that treatment. The patient and parent/guardian will be approached to participate in the study. * Sensory deficit screening will be completed in the clinic and any screening results that indicate the need for referral for diagnostic testing or therapy will be scheduled by the primary treatment team staff.

Other: Highlighting Patients at Risk for Sensory Screening (HPARSS)

Providers: Highlighting Patients at Risk for Sensory Screening (HPARSS)

NO INTERVENTION

-Providers will complete a survey regarding their views of the HPARSS. The Acceptability of Intervention Measure has 4 questions and the Feasibility of Intervention Measure has 4 questions.

Interventions

Highlighting Patients at Risk for Sensory Screening (HPARSS) OTHER

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 HPARSS document.

Patients: Highlighting Patients at Risk for Sensory Screening (HPARSS)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• St. Jude Children's Research Hospital: collaborator

Study Sites (1)

St. Louis Children's Hospital - Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Neoplasms; Hearing Loss; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases

Study Officials

• Robert J Hayashi, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert J Hayashi, M.D.

CONTACT

314-454-6018; hayashi_r@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: August 2, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)