Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE)
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99424897. Available under License Creative Commons Attribution 4.0. |
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Description
Background: Intense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. Methods: A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. Trial registration number: ACTRN12621001084875. Retrospectively Registered 16 August 2021.
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| ID Code: | 213724 | ||||||||
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| Item Type: | Contribution to Journal (Journal Article) | ||||||||
| Refereed: | Yes | ||||||||
| ORCID iD: |
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| Additional Information: | Funding Information: This trial is supported by National Health and Medical Research Council (NHMRC) funding: APP1173243. The NHMRC independently peer reviewed the study protocol and was not involved in the design, data collection, analysis, interpretation or writing of the manuscript in relation to this study. The pilot study was supported by funding from the Children’s Hospital Foundation Queensland. | ||||||||
| Measurements or Duration: | 10 pages | ||||||||
| Additional URLs: | |||||||||
| Keywords: | Adolescent, Cancer, Child, Digital health, Health services research, Implementation, Mobile health, Patient Reported Outcome, Symptoms and side effect, Trial | ||||||||
| DOI: | 10.1186/s12913-021-06943-x | ||||||||
| ISSN: | 1472-6963 | ||||||||
| Pure ID: | 99424897 | ||||||||
| Divisions: | Current > Research Centres > Centre for Healthcare Transformation Current > Research Centres > Cancer and Palliative Care Outcomes Centre Current > Research Centres > Australian Centre for Health Services Innovation Current > QUT Faculties and Divisions > Faculty of Health Current > Schools > School of Nursing Current > Schools > School of Public Health & Social Work |
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| Funding Information: | This trial is supported by National Health and Medical Research Council (NHMRC) funding: APP1173243. The NHMRC independently peer reviewed the study protocol and was not involved in the design, data collection, analysis, interpretation or writing of the manuscript in relation to this study. The pilot study was supported by funding from the Children’s Hospital Foundation Queensland. The authors acknowledge the support of the Oncology Services Group, Children’s Hospital Queensland in supporting this project. We acknowledge the children and families, and clinicians who have contributed to the development of the RESPONSE intervention. We also acknowledge Distinguished Professor Patsy Yates, and Professors Raymond Chan, Lillian Sung and Lee Dupuis for their contributions to the development of this study. The authors acknowledge the support of the Oncology Services Group, Children?s Hospital Queensland in supporting this project. We acknowledge the children and families, and clinicians who have contributed to the development of the RESPONSE intervention. We also acknowledge Distinguished Professor Patsy Yates, and Professors Raymond Chan, Lillian Sung and Lee Dupuis for their contributions to the development of this study. | ||||||||
| Copyright Owner: | © 2021, The Author(s). | ||||||||
| Copyright Statement: | This work is covered by copyright. Unless the document is being made available under a Creative Commons Licence, you must assume that re-use is limited to personal use and that permission from the copyright owner must be obtained for all other uses. If the document is available under a Creative Commons License (or other specified license) then refer to the Licence for details of permitted re-use. It is a condition of access that users recognise and abide by the legal requirements associated with these rights. If you believe that this work infringes copyright please provide details by email to qut.copyright@qut.edu.au | ||||||||
| Deposited On: | 07 Oct 2021 01:23 | ||||||||
| Last Modified: | 07 Aug 2024 01:58 |
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