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 no...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e064358.full |
| _version_ | 1797778338236858368 |
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| author | Xian-Liang Liu Daniel Bressington Jing-Yu (Benjamin) Tan Si-Lin Zheng Hou-Qiang Huang Haiying Wang |
| author_facet | Xian-Liang Liu Daniel Bressington Jing-Yu (Benjamin) Tan Si-Lin Zheng Hou-Qiang Huang Haiying Wang |
| author_sort | Xian-Liang Liu |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-12T23:15:48Z |
| format | Article |
| id | doaj.art-c65018ec0bd6452eb91fc95b91aab30e |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T23:15:48Z |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-c65018ec0bd6452eb91fc95b91aab30e2023-07-17T09:00:07ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-064358Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trialXian-Liang Liu0Daniel Bressington1Jing-Yu (Benjamin) Tan2Si-Lin Zheng3Hou-Qiang Huang4Haiying Wang52 School of Nursing, Midwifery & Paramedicine, Australian Catholic University (McAuley Campus), Brisbane, Queensland, AustraliaFaculty of Health, Charles Darwin University, Darwin, Northern Territory, AustraliaCollege of Nursing and Midwifery, CDU Brisbane Centre, Charles Darwin University, Brisbane, Queensland, AustraliaDepartment of Nursing, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, ChinaDepartment of Nursing, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, ChinaFaculty of Health, Charles Darwin University, Brisbane, Queensland, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/12/12/e064358.full |
| spellingShingle | Xian-Liang Liu Daniel Bressington Jing-Yu (Benjamin) Tan Si-Lin Zheng Hou-Qiang Huang Haiying Wang Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial BMJ Open |
| 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 |
| url | https://bmjopen.bmj.com/content/12/12/e064358.full |
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