Cancer Patients, Chemotherapy-Induced Peripheral Neuropathy, Exercise Intervention
Conditions
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
Interventions
BEHAVIORALExercise and Mindfulness
Participants in the intervention group will receive a structured exercise- and mindfulness-based cognitive therapy program. This combined behavioral intervention includes two integrated components: (1) exercise training, consisting of aerobic exercise and resistance training, performed 3-5 times per week for 20-30 minutes per session; and (2) mindfulness practice, consisting of mindfulness breathing, body scan, and mindful walking, performed daily for 10-15 minutes per session. Unlike routine care or single-component interventions, this program combines physical exercise with mindfulness practice to target both physical and psychological symptoms associated with chemotherapy-induced peripheral neuropathy. Weekly symptom assessments and symptom change records will be completed during the intervention period.
Sponsors
Nanjing Medical University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy. | 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.) |
Outcome results
None listed