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

Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582551
• Other study ID #: 202208066
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: August 2023
• Source: Washington University School of Medicine
• Contact: Robert J Hayashi, M.D.
• Phone: 314-454-6018
• Email: hayashi_r[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital - Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with at risk for sensory deficits identified by HPARSS		Through completion of enrollment for all patients (estimated to be 9 months)
Primary	Percentage of at risk patients who fail the assigned screening test		Through completion of enrollment for all patients (estimated to be 9 months)
Primary	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	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
Secondary	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
Secondary	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.	To be completed at the time of enrollment completion (approximately 9 months)
Secondary	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.	To be completed at the time of enrollment completion (approximately 9 months)

External Links

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