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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Childhood Cancer
• Intervention / Treatment: Diagnostic test: Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatment

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80804
    • Kinderklinik München Schwabing, TUM School of Medicine, Department of Paediatrics and Children's Cancer Research Center, Technical University of Munich, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study polulation will be recruited at the Oncology and Hematology Day Hospital at the Dr. von Hauner Children's Hospital of the University of Munich.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Comparison cohort; Children and adolescents at the end of acute treatment for leukemia and non-Hodgkin lymphoma without any exercise 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Sabine Kesting, Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Activities of daily living; Physical activity; Leukemia; Non-Hodgkin Lymphoma; Motor performance
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: ADL Comparison Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No