ADLs at the End of Acute Treatment for Childhood Leukemia and Non-Hodgkin Lymphoma

Childhood Cancer Clinical Trial

Official title:

Activities of Daily Living at the End of Acute Treatment for Acute Leukemia or Non-Hodgkin Lymphona During Childhood and Adolescence

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05235633
• Other study ID #: ADL Comparison Cohort
• Status: Enrolling by invitation
• Start date: April 19, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. This associated investigation to the study with the ClinicalTrials.gov Identifier NCT03934060 aims at collecting data in a comparison cohort with respect to ADLs in children and adolescents who did not receive a standardized strenght training intervention during the whole course of treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children and adolescents aged 4-18 years

• At the end of acute treament for leukemia or non-Hodgkin lymphoma

• Diagnosed and/or treated at the Dr. von Hauner Children's Hospital, University of Munich

• Informed consent as documented by signature

Exclusion Criteria:

• Medical contraindication to perform this unique test battery (e.g., acute bleeding risk, pain, nausea, acute orthopedic impairments)

• Inability to follow study procedures (e.g., language problems, mental retardation)

Related Conditions & MeSH terms

• Childhood Cancer
• Leukemia

Intervention

Diagnostic Test:
• Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatment
Participants perform a test battery to assess the capability to accomplish Activities of Daily Living that includes a standardized and validated questionnaire, a parcour with tasks based on Activities of Daily Living and a motor performance test.

Locations

Country	Name	City	State
Germany	Kinderklinik München Schwabing, TUM School of Medicine, Department of Paediatrics and Children's Cancer Research Center, Technical University of Munich, Germany	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Munich	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the Activities Scale for Kids - performance version	The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions and the current status of accomplishment of activities of daily living. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer).	During the procedure
Secondary	Motor Performance	Motor performance is assessed by the MOON-test (Motor performance test in Pediatiric Oncology), a tool to examine motor performance abilities in children and adolescents during and after cancer treatment. There's no summary score; reference values of healthy children enable comparison of the tested children.	During the procedure
Secondary	Performance in a Parkour in Activities of Daily Living	A standardized parkour with tasks imitating activities of daily living is used to objectively verify the ASK score. Points from 0-4 are counted for each task depending on quality of movement (0 = task can not be completed, 1 = task can be completed with help, 2 = task can be completed with several attempts, 3 = task can be completed with only little effort, 4 = task can be completed without any problems or effort). There are no reference values for the parkour, but intra-individual changes are analyzed.	During the procedure