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NCT Number: NCT05582551

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.

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Key information

Conditions

Childhood Cancer Ear Diseases Hearing Disorders Hearing Loss Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sensation Disorders Signs and Symptoms

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Anna Perlmutter, OTR/L

SUB_INVESTIGATOR

Ashley Housten, OTD, MSCI

SUB_INVESTIGATOR

Belinda Sinks, AUD

SUB_INVESTIGATOR

Feng Gao, M.D., Ph.D., MPH, MS

SUB_INVESTIGATOR

Patrick Lyons, M.D., MSc

SUB_INVESTIGATOR

Robert J Hayashi, M.D.

CONTACT

[email protected]

314-454-6018

Robert J Hayashi, M.D.

PRINCIPAL_INVESTIGATOR

Susan Hayashi, MA

SUB_INVESTIGATOR

Thomas Kannampallil, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

    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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert J Hayashi, M.D.

CONTACT

[email protected]

314-454-6018

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • St. Jude Children's Research Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 17, 2022
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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