Digital Home-Based Prehabilitation Before Surgery

Обзор

This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.

Подробное описание

Patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. The eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in Norwegian able to consent and to understand questionnaires. The main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. In addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. Participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. The control group will receive no organized prehabilitation in the period of time between diagnose and surgery.

Вмешательства

• Другое Prehabilitation
  * Nutritional optimization: A nutritionist will perform a structured interview, comprehensive nutrition assessment, and provide personalized dietary advice. The main goal is to ensure optimal protein intake to support exercise-induced anabolism. A daily protein intake of 1.2-2.0 g/kg will meet needs as outlined in surgical nutrition guidelines. * Exercise: Based on current guidelines and instructed by a dedicated physiotherapist, for 1 hour per day preoperatively to increase muscle strength, aer

Первичные конечные точки

• 6MWT [Срок оценки: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery]

Вторичные конечные точки (8)

• EuroQol Group Questionnaire 5D (EQ-5D) [Срок оценки: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery]
• European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire [Срок оценки: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery]
• Generic Short Patient Experiences Questionnaire (GS-PEQ) [Срок оценки: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery]
• Mortality [Срок оценки: 3 months after surgery]
• Complications [Срок оценки: 3 months after surgery]
• Need of additional health care support [Срок оценки: 4-6 weeks after surgery]
• Aggregated length-of-stay (aLoS) [Срок оценки: 4-6 weeks after surgery]
• Cost-effectiveness [Срок оценки: 3 months after surgery]

Критерии участия

Критерии включения

• Planned for major gastrointestinal cancer surgery
• Fluent in Norwegian and able to consent and to understand questionnaires

Критерии исключения

• Inability to walk for six minutes or to rise independently from a chair
• Inability to comprehend exercise program or to comply with written and oral instructions
• Presence of a cardio-pulmonary condition that precludes exercise
• Living in very remote areas making a hospital-based intervention group impossible to implement
• Being without a permanent address
• Admittance to a hospital facility for > 50% of the time from diagnosis to surgery

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kleve G, Santa CD, Kristiansen F, Tegnander M, Buch V, Hagemann CS, Helgheim M, Engene P, Pesonen H, Kleveland MK, Hverven GL, Nilsen TS, Vervaart MAM, Aanesen H, Uglane KT, Bjelland M, Zory R, Chorin F, Cardot-Ruffino V, Beltran EEM, Neuzillet C, Soerensen M, Jylhava J, Anzar I, Normand VA, Myrstad M, Klungland A, Nilsen HL, Ougland R. Digital home-based multimodal prehabilitation of colorectal c PMID 41132395

Идентификаторы

NCT: NCT06231576 · 23/08551

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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