Childhood CancerNCT05582551
Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors
A study testing Highlighting Patients at Risk for Sensory Screening (HPARSS) in people with Childhood Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Highlighting Patients at Risk for Sensory Screening (HPARSS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Louis Children's Hospital - Washington University School of Medicine
St Louis, Missouri, 63110
Robert J Hayashi, M.D., 314-454-6018, hayashi_r@wustl.edu
Robert J Hayashi, M.D.
About this study
Official title: 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.
- Conditions
- Childhood Cancer
- Being tested
- Highlighting Patients at Risk for Sensory Screening (HPARSS)
- Keywords
- childhood cancer survivors, electronic medical record, sensory deficit screening, hearing loss, peripheral neuropathy, vestibular, vision
- Medical subject headings
- Neoplasms, Hearing Loss, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at risk for sensory deficits identified by HPARSS
Measured: Through completion of enrollment for all patients (estimated to be 9 months)
Percentage of at risk patients who fail the assigned screening test
Measured: 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
Measured: 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
Measured: 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
Measured: At approximately 2 months following the patient's screening
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.
Measured: To be completed at the time of enrollment completion (approximately 9 months)
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.
Measured: To be completed at the time of enrollment completion (approximately 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start2 Aug 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- St. Jude Children's Research Hospital
- Responsible party
- Sponsor
- Investigators
- Robert J Hayashi, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582551
- Sponsor's protocol ID
- 202208066
- Status last verified
- Jun 2026
- First submitted
- 13 Oct 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highlighting Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT05582551
- Acronym / sponsor ID
- 202208066
- Conditions
- Childhood Cancer
- Keywords
- childhood cancer survivors, electronic medical record, sensory deficit screening, hearing loss, peripheral neuropathy, vestibular, vision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- St. Jude Children's Research Hospital
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients: Highlighting Patients at Risk for Sensory Screening (HPARSS) | Experimental | Other: 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. |
| 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients: Highlighting Patients at Risk for Sensory Screening (HPARSS) |
Primary outcome
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)
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)
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)
4 secondary outcomes
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
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
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert J Hayashi, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highlighting Patients at Risk for Sensory Screening (HPARSS) in people with Childhood Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert J Hayashi, M.D. (314-454-6018, hayashi_r@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.