Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance Symptom Cluster in Breast Cancer Survivors Receiving Aromatase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Feasibility measure
研究概览
简要总结
This study aims to evaluate the feasibility, acceptability and preliminary effects of self-applied acupressure on arthralgia-fatigue-sleep disturbance symptom cluster in breast cancer survivors receiving aromatase inhibitors. This is a preliminary randomized controlled trial, with a three-arm trial design including verum self-acupressure, sham self-acupressure, and usual care. Subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of the two symptoms including fatigue and sleep disturbance. Subjects who are randomized to either the verum self-acupressure group (group A) or the sham self-acupressure group (group B) will receive up to 8 weeks of the intervention consisting of two components: (1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. The method and duration of self-acupressure in the sham group will be the same to those in the verum intervention group. The control group will receive usual care. The outcome measures of this study will be related to feasibility, acceptability and preliminary effects of self-acupressure. Individual in-depth interviews will be conducted with selected participants in group A and B to understand their perceptions and perceived effectiveness of the intervention.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult aged 18 and older;
- •Clinical diagnosis of early-stage (Stage I, II, or IIIa), hormone-receptor-positive breast cancer;
- •Completion of surgery, and/or chemotherapy and/or radiotherapy;
- •Currently taking the third generation of AIs (anastrozole, letrozole, or exemestane) for at least 1 month;
- •Based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance;
- •Willing to comply with the intervention protocol, and
- •Being able to communicate in Chinese .
排除标准
- •Previous receipt of acupuncture and acupressure within the past six months;
- •Currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance;
- •Prior joint surgery or fracture during the past six months;
- •Mentally incapable of participating in the study (Hong Kong version of Montreal Cognitive Assessment score<22);and
- •Inability to perform self-care (Karnofsky Performance Scale score<70).
研究组 & 干预措施
True self-acupressure
1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks.
干预措施: Ture self-acupressure (Other)
Sham self-acupressure
Same protocol to the true self-acupressure group but on the sham acupoints
干预措施: Sham self-acupressure (Other)
Usual care
General advise on managing symptoms provided by healthcare providers
干预措施: Usual care (Other)
结局指标
主要结局
Feasibility measure
时间窗: Immediately after completion of the intervention (T1)
Eligibility rate
Acceptability measure
时间窗: Immediately after completion of the intervention (T1)
Appropriateness of the intervention components using a self-developed questionnaire (15 close-ended questions mostly on a scale of 1 to 5, higher score indicating higher acceptability and 3 open-ended questions)
次要结局
- Fatigue(Baseline(T0) and Immediately after completion of the intervention (T1))
- Sleep disturbance(Baseline(T0) and Immediately after completion of the intervention (T1))
- Arthralgia(Baseline(T0) and Immediately after completion of the intervention (T1))
- Health-related quality of life(Baseline(T0) and Immediately after completion of the intervention (T1))
研究者
Dr CHENG Huilin
Assistant Professor
The Hong Kong Polytechnic University