Effects of a Traditional Chinese Exercise Program- Tai Chi on Symptom Cluster of Fatigue-sleep Disturbance-depression in Female Breast Cancer Patients: 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
- 2
- 主要终点
- Feasibility of the questionnaires
研究概览
简要总结
The Medical Research Council Framework for Developing and Evaluating Complex Interventions (MRC Framework) will be utilized to develop and evaluate an evidence-based tai chi intervention for managing the symptom cluster of fatigue-sleep disturbance-depression in breast cancer patients.
详细描述
The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is regarded as one of the most common symptom clusters among breast cancer (BC) patients. Considering the fact that no specific medications can be recommended to relieve symptom clusters, numerous non-pharmacological interventions have therefore been performed with medication as a combination intervention for the treatment of symptom clusters in cancer patients. Among these interventions, tai chi could be an optimal option for relieving the FSDSC. The overall aims are to develop an evidence-based traditional Chinese exercise (TCE) tai chi protocol, test the feasibility of the protocol, and preliminarily examine the effectiveness of tai chi on the FSDSC and quality of life (QoL) through a pilot randomized controlled trial (RCT). The MRC Framework will be used to develop and evaluate an evidence-based intervention for BC patients. In phase one, an evidence-based TCE tai chi intervention protocol will be developed. An expert panel will then be invited to assess the content validity of the intervention protocol. Testing the feasibility of the tai chi intervention protocol, and preliminarily examining the effects of tai chi on the FSDSC will be conducted in phase two. After completion of the pilot RCT, semi-structured interviews will be conducted to assess the participants' experience of participating in the pilot trial and performing the tai chi exercise. The evidence-based tai chi intervention protocol for managing the FSDSC in breast cancer patients will be developed. The feasibility and effects of utilizing the tai chi intervention for BC patients will be explored. A future multicentre large-scale RCT to further evaluate the effects of tai chi on the FSDSC in the BC population will benefit from the study results of this doctoral research project.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 18 years old or above;
- •a confirmed diagnosis of non-metastatic stage I, II, or IIIa BC;
- •have experienced at least a moderate level of tiredness, sleep disturbance, and depressive mood, with a score of greater than 3 on a 10-point numeric rating scale, from "0 (no symptom)" to "10 (worst symptom)" for each symptom in the previous one month;
- •have recently commenced adjuvant chemotherapy; and
- •able to follow instructions in Mandarin, interested in participating in the study, and willing to sign an informed consent.
排除标准
- •Currently using psychostimulants, antidepressant medications, or hypnotics medications;
- •extremely weak or have mental illness and/or intellectual disability;
- •have been involved in other exercise programs > 30 minutes, three times weekly, for past 3 months;
- •have practised tai chi for the past six months; and
- •have scheduled elective surgery during the study period.
结局指标
主要结局
Feasibility of the questionnaires
时间窗: Baseline (T1), immediately after completion of the 8-week intervention (T2), and four weeks after completion of the intervention (T3)
The percentage of missing values for each item of the scales used, including the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Participant feedback
时间窗: Immediately after completion of the 8-week intervention (T2)
Participants' feedback on and satisfaction with the intervention using a self-designed feedback form
Time taken to recruit planned sample
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
the time that was taken to recruit the planned sample size of participants
Adherence rates
时间窗: Immediately after completion of the 8-week intervention (T2)
The adherence rates will be measured by the number of tai chi sessions performed divided by the total possible tai chi sessions
Referral rate
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of referrals made by clinicians in different departments and hospitals divided by all referrals
Reasons for dropping out
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
Feedback from the dropout subjects to identify their reasons for dropping out
Recruitment rate
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of subjects who enrolled in the study divided by all subjects eligible for enrolment
Dropout rate
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study
Adverse events associated with the intervention
时间窗: Immediately after completion of the 8-week intervention (T2)
In each tai chi session, the subjects in the intervention group will record whether they had any uncomfortable feelings
Retention rate
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of subjects who completed the study divided by all subjects who enrolled in the study
Number of patients completed the exercise log
时间窗: Immediately after completion of the 8-week intervention (T2)
The participants in the tai chi group will be required to keep a diary to monitor their tai chi exercise after each tai chi session
次要结局
- Symptom cluster assessment: depression(Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3))
- Quality of life (QoL) assessment(Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3))
- Symptom cluster assessment: sleep disturbance(Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3))
- Symptom cluster assessment: fatigue(Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3))
研究者
Jing-Yu Tan, BNSc, MMed, PhD
Professor in Nursing
Charles Darwin University