An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reasons for dropping out
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female breast cancer survivors ≥18 years age;
- •has a confirmed diagnosis of breast cancer at stage I, II or IIIa;
- •has been experiencing pain since cancer diagnosis constantly or intermittently for ≥3 months, with the average pain intensity in the last seven days on a numerical scale ≥4/10 ("0" indicates no pain and "10" indicates the worst pain);
- •has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;
- •agrees to participate in the research and is willing to give informed consent;
- •can read and understand Mandarin Chinese.
排除标准
- •extremely weak and unable to perform the breathing exercises;
- •mentally incapable (i.e., unable to follow the study instructions);
- •has scheduled pain management interventions, such as having a procedure or operation;
- •receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;
- •has any pre-existing chronic pain conditions before cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, Complex Regional Pain Syndrome, endometriosis, etc.
研究组 & 干预措施
Intervention group
Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care.
干预措施: Breathing exercise (Other)
Control group
Participants in the control group will receive pain information booklet and usual care.
结局指标
主要结局
Reasons for dropping out
时间窗: Immediately once a dropout occurs
Feedback from the dropout subjects to identify their reasons for dropping out
Feasibility: Adherence rates
时间窗: Immediately after completion of the 4-week intervention (T2)
the percentage of BE sessions performed by participants divided by the total number of BE sessions required
Adverse events associated with the intervention
时间窗: Immediately once an adverse event occurs
Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact
Feasibility: Time taken to recruit planned sample
时间窗: Immediately after the allocation of the last subject
The time that was taken to recruit the planned sample size of participants
Feasibility: Referral rate
时间窗: Immediately after the referral of the last subject
The number of referrals made by clinicians in different departments divided by all referrals
Feasibility: Recruitment rate
时间窗: Immediately after the recruitment of the last subject
Proportion of subjects who participated in the study from all subjects eligible for participation
Feasibility: Dropout rate
时间窗: At the follow-up assessment 4 weeks after the intervention completion (T3)
The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study
Feasibility: Retention rate
时间窗: At the follow-up assessment 4 weeks after the intervention completion (T3)
Proportion of participants who completed the whole study divided by all subjects who enrolled in the study
Participants' feedback
时间窗: Immediately after completion of the 4-week intervention (T2)
Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form
Feasibility of the questionnaires
时间窗: 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)
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)
次要结局
- Chronic pain(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)(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(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)(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))