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      Physical ACTivity in Survivorship (PACTS): study protocol for a randomized controlled trial evaluating a goal-directed therapeutic exercise program in pediatric posterior fossa brain tumor survivors

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          Abstract

          Background

          Posterior fossa brain tumors (PFBT) are the most common solid tumor in children. Recent increases in survival rates are encouraging; however, survivors may experience a plethora of disease- and treatment-related complications that can persist into adulthood. Therapeutic exercise interventions have been shown to improve quality of survivorship in other pediatric cancer diagnoses. There is also evidence that goal-directed interventions are effective at improving motor activities, function, and self-care in children with complex health conditions. Yet, there is currently no evidence on the efficacy of goal-directed therapeutic exercise in pediatric PFBT survivors. The Physical ACTivity in Survivorship (PACTS) study aims to investigate the effects of a novel goal-directed therapeutic exercise program on cardiorespiratory fitness and physical activity-related goal attainment in pediatric survivors of PFBT.

          Method

          PFBT survivors, aged five to 17 years, who underwent surgery at least 12 months earlier and completed radiation therapy and/or chemotherapy at least 6 months prior will be recruited from the Queensland Children’s Hospital (Brisbane, Australia) (target n = 48). Following baseline assessment, participants are randomized into either the intervention or usual care group. The intervention group will receive weekly individualized, goal-directed exercise therapy delivered face-to-face for 12 weeks, along with an accompanying home-based program (three sessions per week). Outcomes will be assessed at baseline, immediately post-intervention, and at 6- and 12-months post-intervention. The primary outcomes are cardiorespiratory fitness (Peak VO 2) and physical activity-related goal attainment. Secondary outcomes are cardiorespiratory endurance, high-level mobility skills, functional muscle strength, habitual physical activity, gait, balance, quality of life, fatigue, participation, perceived movement skill competence and parameters of body composition.

          Discussion

          PACTS is the first study to investigate the efficacy of goal-directed therapeutic exercise in children with PFBT and provide evidence needed to inform clinical practice recommendations for managing quality of survivorship in PFBT survivors.

          Trial registration

          ACTRN12619000841178.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12887-021-02566-7.

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          Most cited references73

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          PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations.

          James Varni, Michael Seid, Paul Kurtin (2001)
          The PedsQL (Pediatric Quality of Life Inventory) (Children's Hospital and Health Center, San Diego, California) is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions. The 4 PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School) were administered to 963 children and 1,629 parents (1,677 subjects accrued overall) recruited from pediatric health care settings. Item-level and scale-level measurement properties were computed. Internal consistency reliability for the Total Scale Score (alpha = 0.88 child, 0.90 parent report), Physical Health Summary Score (alpha = 0.80 child, 0.88 parent), and Psychosocial Health Summary Score (alpha = 0.83 child, 0.86 parent) were acceptable for group comparisons. Validity was demonstrated using the known-groups method, correlations with indicators of morbidity and illness burden, and factor analysis. The PedsQL distinguished between healthy children and pediatric patients with acute or chronic health conditions, was related to indicators of morbidity and illness burden, and displayed a factor-derived solution largely consistent with the a priori conceptually-derived scales. The results demonstrate the reliability and validity of the PedsQL 4.0 Generic Core Scales. The PedsQL 4.0 Generic Core Scales may be applicable in clinical trials, research, clinical practice, school health settings, and community populations.
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            A systematic review of interventions for children with cerebral palsy: state of the evidence.

            Iona Novak, Sarah McIntyre, Catherine Morgan … (2013)
            The aim of this study was to describe systematically the best available intervention evidence for children with cerebral palsy (CP). This study was a systematic review of systematic reviews. The following databases were searched: CINAHL, Cochrane Library, DARE, EMBASE, Google Scholar MEDLINE, OTSeeker, PEDro, PsycBITE, PsycINFO, and speechBITE. Two independent reviewers determined whether studies met the inclusion criteria. These were that (1) the study was a systematic review or the next best available; (2) it was a medical/allied health intervention; and (3) that more than 25% of participants were children with CP. Interventions were coded using the Oxford Levels of Evidence; GRADE; Evidence Alert Traffic Light; and the International Classification of Function, Disability and Health. Overall, 166 articles met the inclusion criteria (74% systematic reviews) across 64 discrete interventions seeking 131 outcomes. Of the outcomes assessed, 16% (21 out of 131) were graded 'do it' (green go); 58% (76 out of 131) 'probably do it' (yellow measure); 20% (26 out of 131) 'probably do not do it' (yellow measure); and 6% (8 out of 131) 'do not do it' (red stop). Green interventions included anticonvulsants, bimanual training, botulinum toxin, bisphosphonates, casting, constraint-induced movement therapy, context-focused therapy, diazepam, fitness training, goal-directed training, hip surveillance, home programmes, occupational therapy after botulinum toxin, pressure care, and selective dorsal rhizotomy. Most (70%) evidence for intervention was lower level (yellow) while 6% was ineffective (red). Evidence supports 15 green light interventions. All yellow light interventions should be accompanied by a sensitive outcome measure to monitor progress and red light interventions should be discontinued since alternatives exist. © 2013 Mac Keith Press.
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              The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module.

              James Varni, Tasha Burwinkle, Ernest R Katz … (2002)
              The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents ages 2-18 years. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL disease specific modules. The PedsQL Multidimensional Fatigue Scale was designed to measure fatigue in pediatric patients. The PedsQL 3.0 Cancer Module was designed to measure pediatric cancer specific HRQOL. The PedsQL Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module were administered to 339 families (220 child self-reports; 337 parent proxy-reports). Internal consistency reliability for the PedsQL Generic Core Total Scale Score (alpha = 0.88 child, 0.93 parent report), Multidimensional Fatigue Total Scale Score (alpha = 0.89 child, 0.92 parent report) and most Cancer Module Scales (average alpha = 0.72 child, 0.87 parent report) demonstrated reliability acceptable for group comparisons. Validity was demonstrated using the known-groups method. The PedsQL distinguished between healthy children and children with cancer as a group, and among children on-treatment versus off-treatment. The validity of the PedsQL Multidimensional Fatigue Scale was further demonstrated through hypothesized intercorrelations with dimensions of generic and cancer specific HRQOL. The results demonstrate the reliability and validity of the PedsQL Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module in pediatric cancer. The PedsQL may be utilized as an outcome measure in clinical trials, research, and clinical practice. Copyright 2002 American Cancer Society.
              Article 0 comments Cited 229 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Stewart G. Trost:
                ORCID: http://orcid.org/0000-0001-9587-3944
                s.trost@qut.edu.au
                Journal
                Journal ID (nlm-ta): BMC Pediatr
                Journal ID (iso-abbrev): BMC Pediatr
                Title: BMC Pediatrics
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2431
                Publication date (Electronic): 1 March 2021
                Publication date PMC-release: 1 March 2021
                Publication date Collection: 2021
                Volume: 21
                Electronic Location Identifier: 105
                Affiliations
                [1 ]GRID grid.1024.7, ISNI 0000000089150953, Institute of Health and Biomedical Innovation at the Queensland Centre for Children’s Health Research, , Queensland University of Technology (QUT), ; Brisbane, Queensland Australia
                [2 ]GRID grid.1024.7, ISNI 0000000089150953, School of Exercise and Nutrition Science, , Queensland University of Technology (QUT), ; Brisbane, Queensland Australia
                [3 ]GRID grid.1022.1, ISNI 0000 0004 0437 5432, School of Allied Health Sciences, , Griffith University, ; Gold Coast, Queensland Australia
                [4 ]GRID grid.1005.4, ISNI 0000 0004 4902 0432, UNSW Fatigue Research Program, Kirby Institute, , University of New South Wales, ; Sydney, NSW Australia
                [5 ]GRID grid.1024.7, ISNI 0000000089150953, School of Clinical Sciences, , Queensland University of Technology (QUT), ; Brisbane, Queensland Australia
                [6 ]GRID grid.240562.7, Queensland Children’s Hospital, ; Brisbane, Queensland Australia
                Author information
                http://orcid.org/0000-0001-9587-3944
                Article
                Publisher ID: 2566
                DOI: 10.1186/s12887-021-02566-7
                PMC ID: 7919081
                PubMed ID: 33648474
                SO-VID: e814b74b-52ac-48eb-9b2c-6220cad33600
                Copyright © © The Author(s) 2021
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 18 January 2021
                Date accepted : 22 February 2021
                Funding
                Funded by: Queensland Children's Hospital Foundation
                Award ID: CCABCR010
                Award Recipient :
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2021

                ScienceOpen disciplines: Pediatrics
                Keywords: oncology,children,physical activity,cardiorespiratory fitness,goal attainment,quality of life
                Data availability:
                ScienceOpen disciplines: Pediatrics
                Keywords: oncology, children, physical activity, cardiorespiratory fitness, goal attainment, quality of life

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