Physical Activity and Quality of Life in Childhood Cancersurvivors- a Long-term Follow-up

NCT07046481 | Withdrawn

• 2 other identifiers: 2024-1162 SUS S&D2023-06785-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The project intends to study physical functional capacity and degree of physical activity health related quality of life and fatigue. Also, we aim to study if the Physical Activity on Prescription (PAP) intervention is a useful method among physically inactive childhood cancer survivors to increase level of activity. The questions the study aim to answer:

• What is the physical functional capacity, degree of physical activity, health related quality of life and fatigue among childhood cancer survivors 5- 10 yars after dignosis?
• Is the Physical Activity on Prescription intervention feasible for physically inactive childhood cancer survivors and what effect do they experience in terms of physical functioning, physical activity, sedentary behavior, fatigue and health-related quality of life? Participants aged 5-17 years who have been treated for leukemia or brain tumor will be invited to participate. Physical functional capacity and degree of physical activity are assessed with standardized assessment instruments by a physiotherapist. Prior to the visit, participants are also asked to complete questionnaires on HRQoL and fatigue. Participants identified as physically inactive are offered to participate in a PAP intervention. Functional ability scores from previous studies are used as a baseline and are supplemented with objective measurements of physical activity and followed up after the intervention.

Conditions

Leukemia, Acute; Brain Neoplasms; Physical Fitness; Quality of Life; Fatigue

Keywords

physical activity; physical function; rehabilitation; inactivity; pediatric

Outcome Measures

Primary Outcomes (1)

• Bruiniks Oseretsky test of motor proficiency

  BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate. The BOT-2 provides several types of derived scores that assists in interpreting performance. Scale scores (mean = 15, standard deviation = 5), confidence intervals, age equivalents, and descriptive categories are used to describe subtest performance. Standard scores (mean = 50, standard deviation = 10), confidence intervals, percentile ranks, and descriptive categories are used to describe composite and Short Form performance.

  Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

Secondary Outcomes (7)

• 6 minut- walk test

  Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

• Grippit

  Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

• Canadian Occupational Performance Measure

  Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

• Pediatric Quality of Life

  Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

• Pediatric Quality of Life Multifatigue scale

  Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

Study Arms (1)

Physical activity on prescription

EXPERIMENTAL

World Health Organization recommends that children should engage in moderate to vigorous physical activity for at least 60 minutes a day. Participants who in the cross-sectional study are found not to fulfill the WHO recommendation on physical activity, will be recruited to the study where physical activity will be prescribed and performed according to the preferences of the participant. Pre and post intervention physical activity, physical function, health related quality of life and fatigue will be assessed using standardized measures.

Other: Physical activity

Interventions

Physical activity OTHER

One or two physical activities according to the participant´s preferences will be selected and prescribed and specified for frequence and intensity. The selected activity/-ies could be of any type, as long as they increase the heart rate. The activity/-ies should be performed regularly during 12 weeks, A training diary will be used to monitor and register the activities.

Physical activity on prescription

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants diagnosed with Acute Lymphatic Leukemia or brain tumor 5- 10 years ago and available for follow-up at Lund University hospital.

You may not qualify if:

• Unable to walk with assistive devices, unable to communicate in the Swedish language

Sponsors & Collaborators

• Region Skane: lead

Related Publications (10)

• Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.

  PMID: 16925881 RESULT

• Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.

  PMID: 11932914 RESULT

• Lauruschkus K, Hallstrom I, Westbom L, Tornberg A, Nordmark E. Participation in physical activities for children with cerebral palsy: feasibility and effectiveness of physical activity on prescription. Arch Physiother. 2017 Nov 28;7:13. doi: 10.1186/s40945-017-0041-9. eCollection 2017.

  PMID: 29340207 RESULT

• Dinas PC, Koutedakis Y, Flouris AD. Effects of exercise and physical activity on depression. Ir J Med Sci. 2011 Jun;180(2):319-25. doi: 10.1007/s11845-010-0633-9. Epub 2010 Nov 14.

  PMID: 21076975 RESULT

• Slater ME, Steinberger J, Ross JA, Kelly AS, Chow EJ, Koves IH, Hoffmeister P, Sinaiko AR, Petryk A, Moran A, Lee J, Chow LS, Baker KS. Physical Activity, Fitness, and Cardiometabolic Risk Factors in Adult Survivors of Childhood Cancer with a History of Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2015 Jul;21(7):1278-83. doi: 10.1016/j.bbmt.2015.04.007. Epub 2015 Apr 10.

  PMID: 25865649 RESULT

• Han JW, Kim HS, Hahn SM, Jin SL, Shin YJ, Kim SH, Lee YS, Lee J, Lyu CJ. Poor bone health at the end of puberty in childhood cancer survivors. Pediatr Blood Cancer. 2015 Oct;62(10):1838-43. doi: 10.1002/pbc.25581. Epub 2015 May 13.

  PMID: 25970742 RESULT

• Landier W, Armenian S, Bhatia S. Late effects of childhood cancer and its treatment. Pediatr Clin North Am. 2015 Feb;62(1):275-300. doi: 10.1016/j.pcl.2014.09.017. Epub 2014 Oct 18.

  PMID: 25435123 RESULT

• Moody K, Meyer M, Mancuso CA, Charlson M, Robbins L. Exploring concerns of children with cancer. Support Care Cancer. 2006 Sep;14(9):960-6. doi: 10.1007/s00520-006-0024-y. Epub 2006 Apr 26.

  PMID: 16639553 RESULT

• Cox CL, Montgomery M, Oeffinger KC, Leisenring W, Zeltzer L, Whitton JA, Mertens AC, Hudson MM, Robison LL. Promoting physical activity in childhood cancer survivors: results from the Childhood Cancer Survivor Study. Cancer. 2009 Feb 1;115(3):642-54. doi: 10.1002/cncr.24043.

  PMID: 19117349 RESULT

• Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209.

  PMID: 19224548 RESULT

Related Links

• World Health Organization's guidelines on physical activity and sedentary behaviour.

MeSH Terms

Conditions

Leukemia; Brain Neoplasms; Fatigue; Motor Activity; Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christina Brogårdh, Prof

  Department of health Sciences, Medical faculty, Lund University. Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasiblity study of the intervention Physical Activity on Prescription. Participants who are inactive according to the WHO recommendations, will be recruited to the study. Pre and post intervention assessment will be compared and participant's notes in a personal activity diary will be analyzed.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: July 1, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR