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Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial
INTRODUCTION: Chronic pain is a common symptom significantly affecting the quality of life of breast cancer survivors. Despite the achievement of pharmacological interventions, the barriers associated with this approach such as inaccessibility, misuse and side effects drive research into effective n...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9756203/ https://www.ncbi.nlm.nih.gov/pubmed/36517097 http://dx.doi.org/10.1136/bmjopen-2022-064358 |
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author | Wang, Haiying Tan, Jing-Yu (Benjamin) Wang, Tao Liu, Xian-Liang Bressington, Daniel Zheng, Si-Lin Huang, Hou-Qiang |
author_facet | Wang, Haiying Tan, Jing-Yu (Benjamin) Wang, Tao Liu, Xian-Liang Bressington, Daniel Zheng, Si-Lin Huang, Hou-Qiang |
author_sort | Wang, Haiying |
collection | PubMed |
description | INTRODUCTION: Chronic pain is a common symptom significantly affecting the quality of life of breast cancer survivors. Despite the achievement of pharmacological interventions, the barriers associated with this approach such as inaccessibility, misuse and side effects drive research into effective non-pharmacological interventions to improve chronic pain management, quality of life, anxiety and depression. Breathing exercise (BE) can be a promising option, but research evidence is sparse. This pilot study aims to examine the feasibility and preliminary effect of using an evidence-based BE intervention for chronic pain management in breast cancer survivors. METHOD AND ANALYSIS: This study will be a two-parallel-arm, open-labelled, phase II randomised controlled trial with 1:1 allocation. Seventy-two participants will be recruited from a tertiary hospital in China and randomly allocated to either a BE intervention group (n=36) or a control group (n=36). The participants in the intervention group will receive the usual care, a pain information booklet and a 4-week self-administered BE intervention; the participants in the control group will receive the usual care and the pain information booklet only. The assessment will be conducted at three time points: baseline (week 0), immediately after the intervention completion (week 5) and 4 weeks after the intervention completion (week 9). The primary outcomes will be the acceptability and feasibility assessment of the study protocol and methodological procedures. The secondary outcomes will be the effects of BE on pain, quality of life, anxiety and depression in breast cancer survivors. Descriptive statistics will be applied to present the primary outcomes and the Generalised Estimating Equation Model will be utilised to analyse the clinical outcomes. ETHICS AND DISSEMINATION: This study has received ethical approvals from the Human Research Ethics Committee at Charles Darwin University (H21089) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Southwest Medical University (KY2022107). Findings from this study will be presented at academic conferences and submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05257876. |
format | Online Article Text |
id | pubmed-9756203 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-97562032022-12-17 Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial Wang, Haiying Tan, Jing-Yu (Benjamin) Wang, Tao Liu, Xian-Liang Bressington, Daniel Zheng, Si-Lin Huang, Hou-Qiang BMJ Open Oncology INTRODUCTION: Chronic pain is a common symptom significantly affecting the quality of life of breast cancer survivors. Despite the achievement of pharmacological interventions, the barriers associated with this approach such as inaccessibility, misuse and side effects drive research into effective non-pharmacological interventions to improve chronic pain management, quality of life, anxiety and depression. Breathing exercise (BE) can be a promising option, but research evidence is sparse. This pilot study aims to examine the feasibility and preliminary effect of using an evidence-based BE intervention for chronic pain management in breast cancer survivors. METHOD AND ANALYSIS: This study will be a two-parallel-arm, open-labelled, phase II randomised controlled trial with 1:1 allocation. Seventy-two participants will be recruited from a tertiary hospital in China and randomly allocated to either a BE intervention group (n=36) or a control group (n=36). The participants in the intervention group will receive the usual care, a pain information booklet and a 4-week self-administered BE intervention; the participants in the control group will receive the usual care and the pain information booklet only. The assessment will be conducted at three time points: baseline (week 0), immediately after the intervention completion (week 5) and 4 weeks after the intervention completion (week 9). The primary outcomes will be the acceptability and feasibility assessment of the study protocol and methodological procedures. The secondary outcomes will be the effects of BE on pain, quality of life, anxiety and depression in breast cancer survivors. Descriptive statistics will be applied to present the primary outcomes and the Generalised Estimating Equation Model will be utilised to analyse the clinical outcomes. ETHICS AND DISSEMINATION: This study has received ethical approvals from the Human Research Ethics Committee at Charles Darwin University (H21089) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Southwest Medical University (KY2022107). Findings from this study will be presented at academic conferences and submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05257876. BMJ Publishing Group 2022-12-14 /pmc/articles/PMC9756203/ /pubmed/36517097 http://dx.doi.org/10.1136/bmjopen-2022-064358 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Oncology Wang, Haiying Tan, Jing-Yu (Benjamin) Wang, Tao Liu, Xian-Liang Bressington, Daniel Zheng, Si-Lin Huang, Hou-Qiang Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial |
title | Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial |
title_full | Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial |
title_fullStr | Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial |
title_full_unstemmed | Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial |
title_short | Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial |
title_sort | feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase ii randomised controlled trial |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9756203/ https://www.ncbi.nlm.nih.gov/pubmed/36517097 http://dx.doi.org/10.1136/bmjopen-2022-064358 |
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