Effects of Dance-based Multimodal Exercise Programme for Managing Chemotherapy-induced Peripheral Neuropathy in Patients With Solid Tumors: A Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
研究概览
简要总结
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a significant and distressing symptom experienced by cancer patients with different cancer types. Systematic reviews demonstrate that exercise is an effective non-pharmacological strategy for managing chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. Multimodal exercise was found to be superior to a single-modality exercise programme. However, the lack of using Information-Motivation-Behavioral Skill (IMB) model and addressing the social motivation component in current multimodal exercise programmes for cancer patients with solid tumors.
Objectives: This study aims to evaluate the effects of a 6-week dance-based multimodal exercise program on CIPN symptoms over a 3-month period, comparing outcomes with usual care in cancer patients with solid tumors.
Methods: An assessor-blinded pilot randomized controlled trial with process evaluation will be conducted at Community Cancer Centers/ Community Centers and Non-governmental organizations. A total of 76 participants will be recruited, with both intervention and control groups receiving educational booklets and logbooks. The intervention group will engage in a 6-week dance-based multimodal exercise program, supplemented by goal-setting evaluations and motivational messaging. The control group will receive weekly exercise videos and motivational messages. Outcomes, including CIPN severity, quality of life, pain, balance, exercise knowledge, motivation, self-efficacy, and adverse effects, will be measured using validated tools at baseline, immediately post-intervention, 4 weeks post-intervention, and 12 weeks post-intervention. Process evaluation will explore perceived benefits, program awareness, and facilitators and barriers to adherence.
Conclusion: This study aims to provide an evidence-based approach for managing CIPN in cancer patients through a dance-based multimodal exercise program. It underscores the importance of incorporating the IMB model to enhance exercise adherence and support self-management of CIPN in cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
An independent assessor will be blinded for the allocation of the participants and intervention. Cancer patients who are fulfilling the eligibility criteria and willing to participate in the programme will be randomized in 1:1 ratio after the baseline measurement. Block randomization of a block of 4 will be used in the randomization process. Allocation numbers are concealed in opaque sealed envelopes which only the principal investigator will open them and inform the participants about the program details.
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
- •Patients was diagnosed with malignant solid tumor (s) which is defined as abnormal, cancerous masses of tissue, for example, all carcinomas (such as breast cancer, stomach cancer, colorectal cancer and gynecological cancer, lung cancer and so on), sarcomas and lymphomas
- •Patients experience CIPN symptoms
- •Patients are able to use smart phone and WhatsApp
- •Patients are able to read or understand Chinese.
排除标准
- •Cancer patients suffer from severe organ failure or diseases that limit their level of activity
- •Patients are diagnosed with non-chemotherapy induced peripheral neuropathy, such as sciatica and diabetic neuropathy
- •Patients receive treatments that affect the severity of neuropathy, such as steroid, anticonvulsants and antidepressants
- •Patients age below 18 years old
- •Patients have cognitive impairments.
研究者
Lau Ka Yan
Student
Chinese University of Hong Kong