ClinicalTrials.gg
RecruitingNCT05582551Updated Jun 15, 2026

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

An interventional study of Highlighting Patients at Risk for Sensory Screening (HPARSS) in Childhood Cancer, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Non-randomized
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Childhood Cancer

Keywords

  • childhood cancer survivors
  • electronic medical record
  • sensory deficit screening
  • hearing loss
  • peripheral neuropathy
  • vestibular
  • vision
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 146 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.

Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants (estimated)

Study arms

  • 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)

  • 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.

Interventions

  • OtherHighlighting 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.

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  1. 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

  2. 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

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

    -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.

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

  4. Feasibility of intervention as measured by Feasibility of Intervention Measure (FIM)

    -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.

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

07

Study locations

1 of 1 sites recruiting
  • St. Louis Children's Hospital - Washington University School of Medicine
    St Louis, Missouri 63110, United States
    Recruiting
    • Robert J Hayashi, M.D. · Contacthayashi_r@wustl.edu · 314-454-6018
    • Robert J Hayashi, M.D. · Principal investigator
    • Ashley Housten, OTD, MSCI · Sub investigator
    • Thomas Kannampallil, Ph.D. · 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
    • Feng Gao, M.D., Ph.D., MPH, MS · Sub investigator
08

References and documents

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for May 2027, 45 months after the start.

Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 45 months is above that.

Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2022
First posted
Oct 17, 2022
StartActual
Aug 2, 2023
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2027
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05582551
Responsible party
Sponsor
First posted
Oct 17, 2022
Start date
Aug 2, 2023
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

Robert J Hayashi, M.D.
Contact
hayashi_r@wustl.edu
314-454-6018
Robert J Hayashi, M.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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