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

June 12, 2026 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital - Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Robert J Hayashi, M.D.
        • Sub-Investigator:
          • Ashley Housten, OTD, MSCI
        • Sub-Investigator:
          • Patrick Lyons, M.D., MSc
        • Sub-Investigator:
          • Susan Hayashi, MA
        • Sub-Investigator:
          • Belinda Sinks, AUD
        • Sub-Investigator:
          • Anna Perlmutter, OTR/L
        • Sub-Investigator:
          • Thomas Kannampallil, Ph.D.
        • Sub-Investigator:
          • Feng Gao, M.D., Ph.D., MPH, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients: Highlighting Patients at Risk for Sensory Screening (HPARSS)
  • 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)
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.
No Intervention: Providers: Highlighting Patients at Risk for Sensory Screening (HPARSS)
-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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Robert J Hayashi, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202208066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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