Effect of an Exercise- and Mindfulness-Based Cognitive Therapy Intervention on Physical and Psychological Symptoms in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Nanjing Medical University
- Enrollment
- 40
- Primary Endpoint
- Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy.
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Exercise and Mindfulness (Behavioral)
Outcomes
Primary Outcomes
Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy.
Time Frame: 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.)
Secondary Outcomes
No secondary outcomes reported
Investigators
Qingchun Geng
Student
Nanjing Medical University