Effect of an Exercise- and Mindfulness-Based Cognitive Therapy Intervention on Physical and Psychological Symptoms in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy.
研究概览
简要总结
The goal of this clinical trial is to learn whether an exercise- and mindfulness-based cognitive therapy intervention can improve physical and psychological symptoms in cancer patients with chemotherapy-induced peripheral neuropathy. It will also examine whether this intervention can improve quality of life. The main questions it aims to answer are:
Can this intervention reduce physical symptoms related to chemotherapy-induced peripheral neuropathy? Can this intervention reduce psychological symptoms in affected patients? Can this intervention improve patients' quality of life?
Participants will:
Follow a structured program of regular exercise and mindfulness practice Undergo weekly assessments of symptom changes Keep records of their symptom changes during the intervention period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a pathologically confirmed malignant tumor;
- •Currently receiving neurotoxic chemotherapy and experiencing chemotherapy-induced peripheral neuropathy (CIPN);
- •Cancer stage Tis or stage I-III;
- •Aged 18 years or older, with normal consciousness, mental status, and verbal communication ability; able to understand and judge their own sensations and general condition; and able to complete the questionnaires;
- •Willing to participate in the study and able to provide written informed consent;
- •Patients with NCI-CTCAE grade <2 who are considered suitable for exercise intervention.
排除标准
- •Presence of other neurological diseases or severe psychiatric disorders;
- •Presence of other serious illnesses, such as severe heart disease or respiratory failure;
- •Inability to understand or complete the questionnaires;
- •Participation in psychological counseling, psychotherapy, or other clinical trials within the past 6 months;
- •Inability or expected inability to complete the full 6-week intervention.
研究组 & 干预措施
Routine nursing.
The intervention group will receive an exercise- and mindfulness-based cognitive therapy program. Exercise training will include aerobic exercise and resistance training, conducted 3-5 times per week for 20-30 minutes per session. Mindfulness practice will include mindfulness breathing, body scan, and mindful walking, conducted daily for 10-15 minutes per session.
干预措施: Exercise and Mindfulness (Behavioral)
结局指标
主要结局
Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy.
时间窗: Baseline, 6 weeks and 3 months.
The degree of change from baseline after the intervention (using the Treatment-Induced Neuropathy Assessment Scale (TNAS) to assess patients' CIPN-related physical symptom burden. The scale consists of 9 items, each scored from 0 to 10, with higher scores indicating a greater symptom burden. The Kessler Psychological Distress Scale (K10) was used to assess the level of psychological distress. The scale consists of 10 items, rated on a 5-point scale, with higher total scores indicating more severe psychological distress.)
次要结局
未报告次要终点
研究者
Qingchun Geng
Student
Nanjing Medical University