Effect of Dance-based Multimodal Exercise for Managing CIPN in Cancer Patients
2. června 2026 aktualizováno: Lau Ka Yan, Chinese University of Hong Kong
Effects of Dance-based Multimodal Exercise Programme for Managing Chemotherapy-induced Peripheral Neuropathy in Patients With Solid Tumors: A Pilot Randomized Controlled Study
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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
76
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ka Yan Lau
- Telefonní číslo: +852 37024260
- E-mail: 1007615222@link.cuhk.edu.hk
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: dance-based multimodal exercise
Upon recruitment, participants will receive the exercise educational booklet and logbook.
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.
|
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.
|
|
Aktivní komparátor: Exercise 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Chemotherapy-induced peripheral neuropathy.
Časové okno: 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 .
|
from enrollment to 12 weeks after the intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Neuropathic pain
Časové okno: 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.
|
from enrollment to 12 weeks after the intervention
|
|
Quality of Life in cancer patients
Časové okno: 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 .
|
from enrollment to 12 weeks after the intervention
|
|
Anxiety
Časové okno: 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.
|
from enrollment to 12 weeks after intervention
|
|
Balance
Časové okno: 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.
|
from enrollment to 12 weeks after intervention
|
|
Knowledge of exercise, exercise motivation and exercise self-efficacy
Časové okno: 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
|
from enrollment to 12 weeks after intervention
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.
- Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
- Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.
- Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007 Mar-Apr;17(2):387-93. doi: 10.1111/j.1525-1438.2007.00794.x.
- Oakley A, Strange V, Bonell C, Allen E, Stephenson J; RIPPLE Study Team. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006 Feb 18;332(7538):413-6. doi: 10.1136/bmj.332.7538.413.
- Sum RKW, Cheng CF, Wallhead T, Kuo CC, Wang FJ, Choi SM. Perceived physical literacy instrument for adolescents: A further validation of PPLI. J Exerc Sci Fit. 2018 Apr;16(1):26-31. doi: 10.1016/j.jesf.2018.03.002. Epub 2018 Mar 14.
- Christopher A, Kraft E, Olenick H, Kiesling R, Doty A. The reliability and validity of the Timed Up and Go as a clinical tool in individuals with and without disabilities across a lifespan: a systematic review. Disabil Rehabil. 2021 Jun;43(13):1799-1813. doi: 10.1080/09638288.2019.1682066. Epub 2019 Oct 26.
- Bjordal K, de Graeff A, Fayers PM, Hammerlid E, van Pottelsberghe C, Curran D, Ahlner-Elmqvist M, Maher EJ, Meyza JW, Bredart A, Soderholm AL, Arraras JJ, Feine JS, Abendstein H, Morton RP, Pignon T, Huguenin P, Bottomly A, Kaasa S. A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group. Eur J Cancer. 2000 Sep;36(14):1796-807. doi: 10.1016/s0959-8049(00)00186-6.
- Cocks K, Wells JR, Johnson C, Schmidt H, Koller M, Oerlemans S, Velikova G, Pinto M, Tomaszewski KA, Aaronson NK, Exall E, Finbow C, Fitzsimmons D, Grant L, Groenvold M, Tolley C, Wheelwright S, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. Content validity of the EORTC quality of life questionnaire QLQ-C30 for use in cancer. Eur J Cancer. 2023 Jan;178:128-138. doi: 10.1016/j.ejca.2022.10.026. Epub 2022 Nov 1.
- Zhao H, Kanda K. Translation and validation of the standard Chinese version of the EORTC QLQ-C30. Qual Life Res. 2000 Mar;9(2):129-37. doi: 10.1023/a:1008981520920.
- Wang YF, Yang CC, Ro LS, Tsai YC, Lin KP, Sun WZ, Fang WT, Wang SJ. Development and validation of a Taiwan version of the DN4-T questionnaire. J Chin Med Assoc. 2019 Aug;82(8):623-627. doi: 10.1097/JCMA.0000000000000129.
- Busetto L, Wick W, Gumbinger C. How to use and assess qualitative research methods. Neurol Res Pract. 2020 May 27;2:14. doi: 10.1186/s42466-020-00059-z. eCollection 2020.
- Cheng HL, Lopez V, Lam SC, Leung AKT, Li YC, Wong KH, Au JSK, Sundar R, Chan A, De Ng TR, Suen LKP, Chan CW, Yorke J, Molassiotis A. Psychometric testing of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy. Health Qual Life Outcomes. 2020 Jul 23;18(1):246. doi: 10.1186/s12955-020-01493-y.
- Wondie Y, Mehnert A, Hinz A. The Hospital Anxiety and Depression Scale (HADS) applied to Ethiopian cancer patients. PLoS One. 2020 Dec 3;15(12):e0243357. doi: 10.1371/journal.pone.0243357. eCollection 2020.
- Singer S, Kuhnt S, Gotze H, Hauss J, Hinz A, Liebmann A, Krauss O, Lehmann A, Schwarz R. Hospital anxiety and depression scale cutoff scores for cancer patients in acute care. Br J Cancer. 2009 Mar 24;100(6):908-12. doi: 10.1038/sj.bjc.6604952. Epub 2009 Feb 24.
- Pergolizzi J Jr, LeQuang JAK, Coluzzi F, Magnusson P, Lara-Solares A, Varrassi G. Considerations for Pain Assessments in Cancer Patients: A Narrative Review of the Latin American Perspective. Cureus. 2023 Jun 22;15(6):e40804. doi: 10.7759/cureus.40804. eCollection 2023 Jun.
- Muller K, Karrer S, Szeimies RM, Steinbauer J, Kohl E, Steinbauer D, Zeman F, Berneburg M, Koller M. Quality of life assessment in patients with nonmelanoma skin cancer - psychometric validation of the EORTC QLQ-C30 questionnaire. J Dtsch Dermatol Ges. 2017 Nov;15(11):1090-1100. doi: 10.1111/ddg.13357.
- Morse JM. Approaches to qualitative-quantitative methodological triangulation. Nurs Res. 1991 Mar-Apr;40(2):120-3. No abstract available.
- Li Q, Lin Y, Hu C, Xu Y, Zhou H, Yang L, Xu Y. The Chinese version of hospital anxiety and depression scale: Psychometric properties in Chinese cancer patients and their family caregivers. Eur J Oncol Nurs. 2016 Dec;25:16-23. doi: 10.1016/j.ejon.2016.09.004. Epub 2016 Sep 21.
- Leung FH, Savithiri R. Spotlight on focus groups. Can Fam Physician. 2009 Feb;55(2):218-9. No abstract available.
- Lantis K, Schnell P, Bland CR, Wilder J, Hock K, Vargo C, Glover NA, Hackney ME, Lustberg MB, Worthen-Chaudhari L. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data. Trials. 2023 Sep 1;24(1):564. doi: 10.1186/s13063-023-07554-z.
- Hendriks S, Huisman MG, Ghignone F, Vigano A, de Liguori Carino N, Farinella E, Girocchi R, Audisio RA, van Munster B, de Bock GH, van Leeuwen BL. Timed up and go test and long-term survival in older adults after oncologic surgery. BMC Geriatr. 2022 Dec 5;22(1):934. doi: 10.1186/s12877-022-03585-4.
- Gill P, Stewart K, Treasure E, Chadwick B. Methods of data collection in qualitative research: interviews and focus groups. Br Dent J. 2008 Mar 22;204(6):291-5. doi: 10.1038/bdj.2008.192.
- Curran, P. J., West, S. G., & Finch, J. F. (1996). The robustness of test statistics to nonnormality and specification error in confirmatory factor analysis. Psychological Methods, 1(1), 16-29.
- Blackwood J, Rybicki K. Assessment of Gait Speed and Timed Up and Go Measures as Predictors of Falls in Older Breast Cancer Survivors. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211006462. doi: 10.1177/15347354211006462.
- Bingham, A. J. (2023). From data management to actionable findings: A five-phase process of qualitative data analysis. International Journal of Qualitative Methods, 22. https://doi.org/10.1177/16094069231183620
- Ahmed, S. K. (2024). The pillars of trustworthiness in qualitative research. Journal of Medicine, Surgery, and Public Health, 2, 100051. https://doi.org/https://doi.org/10.1016/j.glmedi.2024.100051
- Abolkhair AB, El-Kabbani AO, Al-Mulhem A, AlFattani AA, Al-Hammadi A, Alghamdi H, Haddarra M, Alraffa A, Kamal AS, Alsaigh RN, Mubarak MM, Terkawi AS. Psychometric and accuracy comparison of three commonly used questionnaires for the diagnosis of neuropathic pain. Saudi J Anaesth. 2021 Oct-Dec;15(4):409-418. doi: 10.4103/sja.sja_352_21. Epub 2021 Sep 2.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
31. prosince 2026
Dokončení studie (Odhadovaný)
31. prosince 2026
Termíny zápisu do studia
První předloženo
27. května 2026
První předloženo, které splnilo kritéria kontroly kvality
2. června 2026
První zveřejněno (Aktuální)
8. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026.192
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .