Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Официальное название

A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).

Обзор

The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. This will be done by determining whether it is better to receive the EX-CIPN program or better to receive no additional intervention. To do this, some of the participants in this study will get EX-CIPN and others will receive usual care. Those who receive usual care will be offered EX-CIPN upon study completion. The main question it aims to answer is: • Is EX-CIPN effective in improving CIPN symptoms for cancer survivors experiencing persistent CIPN? Participants in both study groups will be asked to: • Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention Participants in the EX-CIPN group will be asked to: * Complete an additional aassessment at 6-months post-intervention * Complete a 10-week remote, individualized exercise program * Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention * Wear a FitBit throughout the study to track physical activity and promote behaviour change

Вмешательства

• Поведенческое EX-CIPN
  The 10-week intervention includes: Individualized Exercise Program: Each participant will receive an individualized progressive exercise program that includes cardiovascular and strength training as well as balance and desensitization exercises specific to CIPN symptoms. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change. Remote Person-to-Person Clinical Support: Participants will

Первичные конечные точки

• CIPN Symptoms [Срок оценки: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]

Вторичные конечные точки (6)

• CIPN-related disability [Срок оценки: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
• Strength (Upper Body) [Срок оценки: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
• Strength (Lower Body) [Срок оценки: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
• Balance [Срок оценки: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
• Gait Speed [Срок оценки: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
• Aerobic Functional Capacity [Срок оценки: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]

Критерии участия

Критерии включения

• diagnosed with any type of cancer
• received chemotherapy treatment as part of curative-intent therapy (no minimum dose)
• >6 months following chemotherapy completion with no current plans for further chemotherapy
• report Grade 1 or higher on the numbness and tingling severity item of the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
• neuropathic pain 3 or higher on the Neuropathic Pain 4 (DN4) (interview)
• capable of ambulation and transfers (with or without gait/transfer aid) (ECOG score 0-2)
• are able to communicate sufficiently in English to complete intervention, questionnaires, and consent
• have access to and able to operate videoconferencing

Критерии исключения

• currently meeting all recommendations from the physical activity guidelines for cancer survivors
• have any neurological conditions influencing cognition (i.e. dementia, Alzheimer's) and preventing safe or appropriate engagement with exercise recommendation
• have neuropathy that pre-existed chemotherapy receipt (i.e. diabetic neuropathy)
• currently enrolled in other rehabilitation or exercise-based interventions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• ELLICSR: Health Wellness and Cancer Survivorship Centre — Toronto

Идентификаторы

NCT: NCT07481149 · 25-5957

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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