Cancer
Conditions
Keywords
cancers, malignant solid tumors, chemotehrapy-induced peripheral neuropathy, CIPN
Brief summary
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.
Interventions
BEHAVIORALdance-based multimodal exercise
This study applies the Information-Motivation-Behavioral Skills (IMB) model in a six-week Zumba Gold dance program for cancer survivors. Each weekly 75-minute session includes vital sign checks, 50 minutes of multimodal exercise (warm-up, workout, cool-down), and group sharing. Dance styles taught are Merengue, Salsa, Cumbia, Belly dance, Flamenco, Tango, and cool-down, with revision in later sessions. Videos with safety guidance are shared via WhatsApp for home practice. Chair-based options are available for those with balance issues. Motivational support and tele-consultation by an oncology nurse provide ongoing guidance and symptom management to enhance self-efficacy in CIPN care.
BEHAVIORALExercise education
Control group participants will receive an educational booklet and logbook, plus weekly WhatsApp exercise videos recommended by the Department of Health, HKSAR (Elderly Health Service, 2025) during the first six weeks. They are encouraged to follow NCCN and ACSM guidelines for cancer survivors: at least 150 minutes of moderate activity weekly, or 75 minutes vigorous, with warm-up and stretching before sessions. Stretching should occur on two non-resistance days, and resistance training 2-3 times weekly (2-3 sets of 10-15 reps, 2-3 minutes rest). For CIPN survivors, balance training is emphasized, with alternatives like cycling or water exercise. Encouragement messages follow in weeks 10 and 14.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy-induced peripheral neuropathy. | from enrollment to 12 weeks after the intervention | In the main randomized control trial, the primary outcome is chemotherapy-induced peripheral neuropathy (CIPN). The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx) subscale contains 11 items measuring the CIPN symptoms on a 5-point Likert scale (from 0= not at all to 4= very much) . A higher score indicates the worse CIPN symptoms . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain | from enrollment to 12 weeks after the intervention | Douleur Neuropathique en 4 Questions (DN-4) contains ten items in four questions with dichotomous answers (Yes=1; No= 0) assessing the symptoms, associated symptoms and the aggregating factors of neuropathic pain in cancer patients. |
| Quality of Life in cancer patients | from enrollment to 12 weeks after the intervention | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30) contains of 30 items assessing five functioning (physical, role, emotional, cognitive and social), nine symptom burdens (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) and one global health status using 4-likert scale (from 1= not at all to 4= very much), except two items in global health status using the 7-point scale (from 1= very poor to 7= excellent) . Higher scores in functioning subscales indicate better functioning; while higher scores in symptom subscales indicate higher level of impairment . |
| Anxiety | from enrollment to 12 weeks after intervention | Hospital Anxiety and Depression Scale (HADS) is a self-reported measure consisting of 14 items, in which seven of them assess the anxiety level. Higher scores in anxiety subscale indicate the higher level of anxiety. Individuals have borderline anxiety when the overall anxiety subscale is 8-10. It would be considered as anxiety if overall anxiety subscale above 11. |
| Balance | from enrollment to 12 weeks after intervention | Time up-to-go is used to assess cancer patients' gait and balance when changing positions from sitting to standing, turning, walking and from standing to sitting. The time taken that participants start from sitting on the chair, then standing and walking for 3m, followed by turning around and walking back, lastly sitting on the chair is recorded. Participants are asked to perform two trials. The quicker measurement is counted. |
| Knowledge of exercise, exercise motivation and exercise self-efficacy | from enrollment to 12 weeks after intervention | Perceived Physical Literacy Instrument (PPLI) contains nine items measuring knowledge and understanding, self-expression and communication with others, and sense of self and self-confidence (Sum et al., 2018). Participants rate each item using 5-point Likert scale (from 1= strongly disagree to 5=strongly agree). Higher scores indicate better knowledge, motivation and self-efficacy in exercise skills |
Contacts
CONTACTKa Yan Lau
Outcome results
None listed