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Implementing a behavioral physical activity program in children and adolescent survivors of childhood cancer: a pilot randomized controlled trial

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Purpose We aimed to document the acceptability (enrollment rate) and feasibility (phone call delivery rate) of implementing a behavioral PA intervention over 12 weeks, in addition to documenting its effects on patient-reported outcomes and physical functioning. This study also describes the costs of carrying out a behavioral PA intervention. A total of 40 participants were randomized in a 1:1 ratio. The tailored behavioral PA intervention was developed based on the most recent PA guidelines in pediatric oncology and on the COM-B framework to enact PA behavior changes. The prescription (frequency, intensity, time and type (FITT)) was adjusted each week during the weekly support calls. The control group did not receive the intervention. 26 males and 14 females (13.6 years old on average and 2.9 years post-cancer treatment on average) participated in our study. The acceptability rate was 90.9% and the feasibility rate was > 85%. We found that 85% improved PA frequency, 80% improved PA intensity, 100% improved PA time, and 50.0% achieved the recommended PA guidelines. No adverse events were reported over the duration of the intervention. Physical function improved with longer 6-minute walk distances in the intervention group (465.8 ± 74.5 m) than in the control group (398.7 ± 92.9 m) (p = 0.016). PROs scores for all participants were within the limits of the normal range. The estimated cost per participant of carrying out this intervention was USD $126.57. Our 12-week behavioral PA intervention, based on the COM-B framework, was found to be acceptable, feasible and safe in childhood cancer survivors. This study is an important step in the right direction to make exercise standard practice in pediatric oncology.

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NCT04947709.

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Data availability

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

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Acknowledgements

The authors would like to thank the participants for their participation in this trial. The authors would also like to thank the clinical team at Penn State Children’s Hospital as well as Katie Sneeringer, BS, Database Manager, Christina Toepke, CRNP, MSN, J. Renee Rencher, CRNP, RN, BSN, Teresa Terry Shapiro, CRNP, MSN, Holly Galeschewski, RN, Jamie Boyer, RN, Heather Gill, RN, and Moye West Stauffer, RN for their support.

Funding

This work was funded by a grant from the Four Diamonds Research Funds. MC is supported by the Four Diamonds Research Funds, Department of Pediatrics, Division of Hematology and Oncology, Pennsylvania State Health Children’s Hospital, Hershey, PA, USA. BG is funded by a postdoctoral fellowship from the National Institute on Aging F32AG078229.

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Authors

Contributions

MC Conceptualization, Methodology, Validation, Formal analysis, Investigation, Resources, Data curation, Project administration, Visualization, Writing - Original draft; SD Resources, Methodology, Project administration, Resources, Writing - Review & Editing; BG Conceptualization, Methodology, Project administration, Writing - Review & Editing; DE.C Methodology, Validation, Formal analysis, Visualization, Writing - Review & Editing; ED.B Investigation, Writing - Review & Editing; SE.D Project administration, Writing - Review & Editing; GM.S Resources, Writing - Review & Editing; DJ.McK Resources, Writing - Review & Editing; NB.S Resources, Writing - Review & Editing; RJ.G Resources, Writing - Review & Editing; JW.S Resources, Writing - Review & Editing; PR Resources, Writing - Review & Editing; LMcG Resources, Supervision, Writing - Review & Editing; KH.S Conceptualization, Methodology, Validation, Formal analysis, Resources, Project administration, Visualization, Supervision, Funding acquisition, Writing - Review & Editing.

Corresponding author

Correspondence to Maxime Caru.

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Ethical approval

This study was conducted in accordance with the Declaration of Helsinki. The study protocol and informed consent documents were approved by the Penn State University Institutional Review Board (#00018148). Written informed consent was obtained from parents or legal guardians and assent was obtained from the participants prior to the initiation of any study-related activities.

Consent to participate

Written informed consent was obtained from parents or legal guardians and assent was obtained from the participants prior to the initiation of any study-related activities.

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The authors declare that they have no conflicts of interest and no competing interests.

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Caru, M., Dandekar, S., Gordon, B. et al. Implementing a behavioral physical activity program in children and adolescent survivors of childhood cancer: a pilot randomized controlled trial. J Behav Med (2024). https://doi.org/10.1007/s10865-024-00497-z

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