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Study protocol
Claire Munsie
University of Western Australia
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0268-9377
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
High quality evidence supports the integration of exercise to mitigate treatment- related side effects in a wide range of paediatric and adult cancer cohorts. However, the implementation of exercise in adolescent and young adult (AYA) cancer patients is yet to be explored in depth. FiGHTINGF!T is a randomised controlled cross over trial designed to determine if a supervised, structured and progressive exercise program can reduce the decline in physical fitness (V02peak) associated with cancer treatment in AYAs from diagnosis.
Methods/Design
A total of 40 AYAs recently diagnosed and due to commence systemic treatment (± 2 weeks) for a primary haematological malignancy or solid tumour will be recruited and randomised to either an immediate exercise intervention or usual care (delayed exercise) for 10 weeks. This randomised controlled crossover trial will see both groups engage in a supervised exercise intervention from either diagnosis (baseline assessment) for 10 weeks (0-10 weeks) or following an interim assessment to 20 weeks (10-20 weeks). The bi-weekly tailored exercise program will combine aerobic and resistance exercises and be supervised by an Accredited Exercise Physiologist. Participants will complete a range of assessments at 0, 10 and 20 weeks including cardiopulmonary exercise tests, 1 repetition maximum strength measures, physical functioning and self-reported quality of life measurements. Patient reported treatment-related toxicities will be recorded on a weekly basis.
Discussion
The FiGHTINGF!T trial will provide insight into the potential benefits of a supervised exercise program in AYAs undergoing cancer treatment. This trial will contribute to the evidence supporting the necessary integration of exercise during cancer treatment, specifically in the under-reported AYA cohort.
Trial registration
This trial was registered retrospectively with the Australia New Zealand Clinical Trial registry(ACTRN12620000663954;https://www.anzctr.org.au/ACTRN12620000663954.aspx). Trial registry date: 10th June 2020.
Keywords
Exercise, Treatment- Related Toxicity, Rehabilitation, Physical Activity.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
- Additionalfile1.FiGHTINGFTWeeklytoxicitymonitoring.pdf
Additional file 1. FiGHTINGF!T- Weekly toxicity monitoring example (pdf) Data collection tool for weekly patient-reported toxicity monitoring.
- Additionalfile2.SPIRITChecklist.doc
Additional file 2. SPIRIT checklist.
- FIGHTINGFTPICF13082019.docx
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Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 15 Mar, 2021
No community comments so far
Editorial decision: Major revision
On 13 Apr, 2021
Review #1 received
Received 03 Apr, 2021
Reviewer #1 agreed
On 20 Mar, 2021
Reviewers invited
Invitations sent on 18 Mar, 2021
Editor assigned
On 15 Mar, 2021
Submission checks complete
On 12 Mar, 2021
First submitted
On 09 Nov, 2020
Metrics
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PDF Downloads: ...
HTML Views: ...
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Claire Munsie
University of Western Australia
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0268-9377
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 15 Mar, 2021
No community comments so far
Editorial decision: Major revision
On 13 Apr, 2021
Review #1 received
Received 03 Apr, 2021
Reviewer #1 agreed
On 20 Mar, 2021
Reviewers invited
Invitations sent on 18 Mar, 2021
Editor assigned
On 15 Mar, 2021
Submission checks complete
On 12 Mar, 2021
First submitted
On 09 Nov, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
High quality evidence supports the integration of exercise to mitigate treatment- related side effects in a wide range of paediatric and adult cancer cohorts. However, the implementation of exercise in adolescent and young adult (AYA) cancer patients is yet to be explored in depth. FiGHTINGF!T is a randomised controlled cross over trial designed to determine if a supervised, structured and progressive exercise program can reduce the decline in physical fitness (V02peak) associated with cancer treatment in AYAs from diagnosis.
Methods/Design
A total of 40 AYAs recently diagnosed and due to commence systemic treatment (± 2 weeks) for a primary haematological malignancy or solid tumour will be recruited and randomised to either an immediate exercise intervention or usual care (delayed exercise) for 10 weeks. This randomised controlled crossover trial will see both groups engage in a supervised exercise intervention from either diagnosis (baseline assessment) for 10 weeks (0-10 weeks) or following an interim assessment to 20 weeks (10-20 weeks). The bi-weekly tailored exercise program will combine aerobic and resistance exercises and be supervised by an Accredited Exercise Physiologist. Participants will complete a range of assessments at 0, 10 and 20 weeks including cardiopulmonary exercise tests, 1 repetition maximum strength measures, physical functioning and self-reported quality of life measurements. Patient reported treatment-related toxicities will be recorded on a weekly basis.
Discussion
The FiGHTINGF!T trial will provide insight into the potential benefits of a supervised exercise program in AYAs undergoing cancer treatment. This trial will contribute to the evidence supporting the necessary integration of exercise during cancer treatment, specifically in the under-reported AYA cohort.
Trial registration
This trial was registered retrospectively with the Australia New Zealand Clinical Trial registry(ACTRN12620000663954;https://www.anzctr.org.au/ACTRN12620000663954.aspx). Trial registry date: 10th June 2020.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
- Additionalfile1.FiGHTINGFTWeeklytoxicitymonitoring.pdf
Additional file 1. FiGHTINGF!T- Weekly toxicity monitoring example (pdf) Data collection tool for weekly patient-reported toxicity monitoring.
- Additionalfile2.SPIRITChecklist.doc
Additional file 2. SPIRIT checklist.
- FIGHTINGFTPICF13082019.docx
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