Physical Activity and Quality of Life in Childhood Cancersurvivors- a Long-term Follow-up
NCT ID: NCT07046481
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-02-01
2031-12-31
Brief Summary
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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.
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Detailed Description
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Methodology Participants must have been treated for brain tumor or acute lymphoblastic leukemia and be eligible for follow-up at the Pediatric Department at Skåne University Hospital before the age of 18.
Physical functioning, level of physical activity/sedentary behavior, health-related quality of life and fatigue are studied in a descriptive cross-sectional study. All children and adolescents aged 5-17 years treated for leukemia or brain tumor and scheduled for their usual follow-up 5-10 years after diagnosis identified using registers from (Swedish national registry of long-term follow-up in childhood cancer) SALUB are invited to participate, the sample is consecutive over a three-year period. Assessments of physical functioning and physical activity are performed by a physiotherapist in conjunction with a visit to the pediatric clinic. Prior to the visit, participants will complete the questionnaires on health related quality of life and fatigue.
Participants identified as physically inactive according to the WHO guidelines will be recruited to the intervention study where the PAP will be offered.
The intervention study explores the feasibility of benefits and effects on physical functioning, physical activity/ sedentary behavior, fatigue and health related quality of life after a PAP intervention in physically inactive childhood cancer survivors in a feasibility study. Participants identified as physically inactive in the initial study are invited to participate.
Data collection from the cross sectional study will be used as baseline and supplemented with objective measurements of physical activity using an accelerometer before the start of the three-month intervention. Participants will be allowed to choose one or two physical activities. The activity can either be an organized sport activity or an everyday task such as walking the dog or cycling to school. To facilitate the selection of an activity that the participants are motivated to perform, a standardized survey is conducted. During the intervention, participants complete an exercise diary regarding intensity and frequency but also other experiences related to the activity. Motivational interviewing is used to support participants to make changes in their physical activity level. At the end of the intervention, levels of physical activity, sedentary behavior, physical functioning, health-related quality of life and fatigue and accelerometer measurements are compared to baseline measurements.
The total number of participants treated for brain tumor or leukemia and available for screening of inactivity over a three-year period corresponds to about 50-55 and 70 persons respectively. This means that in total there will be approximately 120 participants to invite to the screening study. Participants will be included until the total number of participants reaches 50. Those who are inactive will be recruited to the intervention study, where physical activity on prescription will be used in order to increase the participant's activity level. We estimate that twenty participants may be eligible for participating.
The study is descriptive in nature, so a power calculation cannot be performed.
Importance of the project The project will increase knowledge about young cancer survivors' functional capacity, physical activity level, health-related quality of life and prevalence of fatigue. In addition, the need for rehabilitative interventions will be identified, knowledge will be deepened on how physical activity can be promoted for young cancer survivors and how this can affect the individual's future functional capacity and quality of life.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Physical activity on prescription
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.
Physical activity
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.
Interventions
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Physical activity
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
17 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Christina Brogårdh, Prof
Role: STUDY_DIRECTOR
Department of health Sciences, Medical faculty, Lund University. Sweden
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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World Health Organization's guidelines on physical activity and sedentary behaviour.
Other Identifiers
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2023-06785-01
Identifier Type: OTHER
Identifier Source: secondary_id
2024-1162 SUS S&D
Identifier Type: -
Identifier Source: org_study_id
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