Effects of Self-administered Acupressure Versus Aerobic Exercise for Treating Cancer-related Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Equivalence Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Fatigue levels
研究概览
简要总结
The primary aim of the study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), quality of life (QoL), cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention. This will be a prospective, assessor-blind, parallel group randomized controlled trial (RCT) that will strictly follow the CONSORT guidelines. A total of 138 patients aged 18 or above with a diagnosis of breast cancer scheduled to commence their first cycle of outpatient adjuvant chemotherapy will be recruited and randomized into self-administered acupressure and aerobic exercise groups. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. The acupressure arm comprises of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained Traditional Chinese Medicine (TCM) practitioner, and self-practice for 12 weeks. The exercise arm consists of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained exercise specialist, and self-practice for 12 weeks. Participants will be instructed to maintain self-practice after the intervention. Intention-to-treat analysis will be performed.
详细描述
Cancer-related fatigue (CRF) is recognized as the most frequently reported and distressing symptom among cancer patients. CRF is particularly prevalent in patients undergoing chemotherapy, reported to affect 82-100% of such patients, which in some cases may lead to treatment interruption or discontinuation. If CRF is left untreated during chemotherapy, patients are more likely to have clinically significant CRF that persists for months and years after the treatment. CRF has pervasive impact on a patient's mood, ability to perform daily activities, social relationships, and quality of life (QoL). It also imposes significant financial burden by limiting a patient's ability to work. CRF has been shown to be a risk factor of cancer recurrence and shortened survival. In view of its high prevalence and negative impact, combined with growing survival rates, CRF can be considered as a major public health concern.
Aerobic exercise is the most recommended non-pharmacological strategy for CRF, but it has practical limitations due to a number of barriers to exercise during cancer treatment. Self-administered acupressure is emerging as a promising new strategy for reducing CRF in post-treatment disease-free cancer survivors, but has not been tested rigorously among cancer patients receiving chemotherapy. Both exercise and acupressure are inexpensive and safe self-management strategies that can alleviate CRF and co-occurring cancer symptoms, but as acupressure demands less energy, it may thus be acceptable for a wider range of patients undergoing chemotherapy and experiencing CRF. While previous RCTs on acupressure have focused on post-treatment cancer patients, studies targeting patients undergoing cancer treatment are scarce. A rigorously designed RCT of self-administered acupressure among patients receiving chemotherapy is warranted. To date, no study has examined the equivalence of self-administered acupressure and exercise for reducing CRF. Knowledge of the equivalence of aerobic exercise and acupressure for relieving CRF has important clinical implications that could allow practitioners to target recommendations on the basis of patient preference for a particular type of self-care management.
The primary aim of this study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), QoL, cognitive impairment, return to work, chemotherapy completion, and adherence to 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)
盲法说明
Randomization will be performed using software that allows for replication by an independent randomizer. To aid allocation concealment, permuted blocks of varying sizes will be used. The randomizer will place the assignment results in sealed, sequentially numbered opaque envelopes and keep a secure copy of the randomization codes. Neither the research assistant (RA) conducting recruitment nor the participants will know the group assignments until the envelope is opened. All outcome assessments will be carried out by research staff blinded to allocation. Neither the specialist delivering exercise intervention nor the TCM practitioner delivering acupressure intervention will be told about the study design or involved in outcome assessment. The statistician performing data analysis will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 or above
- •with a diagnosis of breast cancer
- •scheduled to commence their first cycle of outpatient adjuvant chemotherapy
- •have an Eastern Cooperative Oncology Group performance status of 0 or 1
- •screened as no contraindications for exercise based on a pre-exercise safety assessment (including aspects of blood results, cardiorespiratory signs and symptoms, metastasis, and variations in cognitive functions)
- •written informed consent
排除标准
- •have received/self-administered acupressure or acupuncture in the previous 3 months
- •have engaged in >90 min of moderate intensity aerobic exercise per week in the previous 3 months
- •are pregnant or lactating
- •have any injury or ulcers around the acupoints
- •unable to communicate in Cantonese, Mandarin, or English
结局指标
主要结局
Fatigue levels
时间窗: one month after the end of all chemotherapy cycles
The Brief Fatigue Inventory (BFI, 9 items) will be used to assess fatigue levels. The first 3 items (fatigue severity subscale) ask patients to describe their current, usual, and worst fatigue in the past 24 hours. The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life. The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
次要结局
- Health-related quality of life (QoL)(post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles)
- Self-reported activity levels(post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles)
- Return to work(one month after the end of all chemotherapy cycles)
- Cognitive impairment(post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles)
- Objective measure of sleep quality and activity levels(post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles)
- Adherence(post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles)
- Self-reported sleep quality(post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles)
- Chemotherapy completion(one month after the end of all chemotherapy cycles)
研究者
Cheung Shuk-Ting
Assistant Professor
The University of Hong Kong