Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- sedentary level
研究概览
简要总结
APAORL2 study aims to evaluate the efficacy of a physical activity program on the sedentary and physical activity level during the 18-month program.
APAORL2 study is a randomized, open label, controlled, monocentric, intervention study that will be conducted among 96 patients treated for localized upper aerodigestive tract cancer.
详细描述
Rationale:
A sedentary lifestyle has been clearly shown to reduce survival in cancer patients, mainly through metabolic changes. While the notions of sedentary lifestyle and physical inactivity overlap, they are not entirely synonymous.
The aim of this study is to examine the contribution of a physical activity program, during the treatment and post-treatment phases, in addition to the current care program, on behavior change (i.e. sedentary behaviors and Physical activity levels), quality of life and fatigue in patients with upper aerodigestive tract cancer
The primary objective is to show that the experimental group (combining the current care pathway + physical Activity program) has lower levels of sedentary behaviour and higher levels of physical activity than the control group (following the classic care pathway with Physical Activity awareness) after the treatment phase.
Patients will be randomly assigned to one of the 2 arms of the study according to a 1:1 ratio:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years
- •newly diagnosed, histologically proven Upper Aerodigestive Tract Cancer, non-metastatic,
- •life expectancy ≥18 months
- •having a smartphone, tablet or computer with an internet connection enabling remote physical Activity sessions for the experimental group
排除标准
- •Presenting a contraindication to moderate physical activity
- •Deprived of their liberty by court or administrative decision
- •Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,
结局指标
主要结局
sedentary level
时间窗: Change between baseline and 3, 6, 12 months and 18 months
cumulative time without movement over a day, as well as prolonged sedentary periods (\>30min without movement): continuous recording 7 days prior to hospital visits
次要结局
- International Physical Activity Questionnaire(Change between baseline and 3, 6, 12 months and 18 months)
- Multidimensional Fatigue Inventory: MFI questionnaire(Change between baseline and 3 months)
- Quality of Life Questionnaire QLQ-C30(Change between baseline and 3, 6, 12 months and 18 months)
- Head Neck (HN) 43 questionnaire(Change between baseline and 3, 6, 12 months and 18 months)
- Big Five Inventory questionnaire(Change between baseline and 3 months)