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| Name | Class |
|---|---|
| The Affiliated Hospital Of Southwest Medical University | OTHER |
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The study will follow the MRC Framework to develop an evidence-based BE intervention protocol to help breast cancer survivors with better management of cancer-related chronic pain.
Cancer-related chronic pain remains as a big challenge for cancer survivors, which significantly affects the quality of life of cancer survivors. Evidence suggests that pain is well managed through combination of pharmacological and non-pharmacological interventions. Among all non-pharmacological interventions, breathing exercise (BE) might have potential effect for chronic pain management in cancer survivors, but the evidence is sparse in current literature. Therefore, this study will follow the Medical Research Council Framework for Developing and Evaluating Complex intervention (the MRC Framework) to develop an evidence-based BE protocol to help with cancer-related chronic pain management in breast cancer survivors. The first two phases of the MRC Framework will be included in this study. In the first phase, an evidence-based method will be utilized to develop the BE intervention protocol. In the second phase, a pilot randomised controlled trial (RCT) will be conducted to examine the feasibility of study and the acceptability of the BE intervention by the participants as well as to preliminarily assess the effect of the BE on chronic pain management in breast cancer survivors. Semi-structured interviews will be conducted after the RCT to explore participants' experiences of participating in the study and practicing the BE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care. |
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| Control group | No Intervention | Participants in the control group will receive pain information booklet and usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing exercise | Other | Participants will receive breathing exercise training, and a 4-week self exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Time taken to recruit planned sample | The time that was taken to recruit the planned sample size of participants | Immediately after the allocation of the last subject |
| Feasibility: Referral rate | The number of referrals made by clinicians in different departments divided by all referrals | Immediately after the referral of the last subject |
| Feasibility: Recruitment rate | Proportion of subjects who participated in the study from all subjects eligible for participation | Immediately after the recruitment of the last subject |
| Feasibility: Retention rate | Proportion of participants who completed the whole study divided by all subjects who enrolled in the study | At the follow-up assessment 4 weeks after the intervention completion (T3) |
| Feasibility: Dropout rate | The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study | At the follow-up assessment 4 weeks after the intervention completion (T3) |
| Reasons for dropping out | Feedback from the dropout subjects to identify their reasons for dropping out | Immediately once a dropout occurs |
| Feasibility of the questionnaires | The percentage of missing values for each item of the scales used, including the Brief Pain Inventory (BPI), Quality of life Cancer Survivors Version (QOL-CSV), Functional Assessment Cancer Therapy-Breast (FACT-B), and Hospital Anxiety and Depression Scale (HADS) |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic pain | Chronic pain will be measured by using the Brief Pain Inventory which measures pain intensity and pain interference with the life. For pain severity, four items are used to measure the "worst", "least", "average" and "now" with a rating scale from 0 to 10, higher number indicating the higher score in each item. For pain interference, pain is measured from 7 aspects of general activity, mood, walking, work, relations with others, sleep and enjoyment of life with a scale of 0-10, and higher score indicates severe impact of pain. |
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Inclusion Criteria:
Exclusion Criteria:
Gender eligibility is based on the physical appearance.
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| Name | Affiliation | Role |
|---|---|---|
| Professor Jing-Yu (Benjamin) Tan, PhD | Charles Darwin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital Of Southwest Medical University | Luzhou | Sichuan | 646000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36517097 | Derived | Wang H, Tan JB, Wang T, Liu XL, Bressington D, Zheng SL, Huang HQ. 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. 2022 Dec 14;12(12):e064358. doi: 10.1136/bmjopen-2022-064358. |
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It needs to get the participants' consent if the data is shared with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2023 | Sep 6, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001943 | Breast Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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Open-labelled parallel pilot RCT
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| At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3) |
| Feasibility: Adherence rates | the percentage of BE sessions performed by participants divided by the total number of BE sessions required | Immediately after completion of the 4-week intervention (T2) |
| Participants' feedback | Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form | Immediately after completion of the 4-week intervention (T2) |
| Adverse events associated with the intervention | Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact | Immediately once an adverse event occurs |
| At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3) |
| Quality of life of breast cancer survivors ( using tool 1) | Quality of life will be measured by using the Quality of Life Cancer Survivors Version. This questionnaire contains 41 items measuring quality of life of cancer survivors from four aspects including physical well-being, psychological well-being, social well-being and spiritual well-being. The score of each item is based on a scale of 0 ( worse outcome) to 10 ( best outcome). Higher score indicates better quality of life. | At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3) |
| Quality of Life of breast cancer survivors ( using tool 2) | Quality of life will also be measured by using the Functional Assessment of Cancer Therapy-Breast. This questionnaire has 37 items with a 5-point Likert scale ranging from 0 to 4, a higher score indicating better QoL. | At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3) |
| Anxiety and Depression | Anxiety and depression will be measured by using the Hospital Anxiety and Depression Scale (HADS). This scale contains 14 items consisting of two subscales: the anxiety subscale and depression subscale with 7 items in each. The scale uses a 4-point Likert scale ranging from 0 to 3, and higher score indicates severe anxiety and depression. | At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3) |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D026741 |
| Physical Therapy Modalities |