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.
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: Group A: control group: standard care with recommendations on physical activity. Group B: experimental group: Physical activity program
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
96
International Physical Activity (IPAQ) Questionnaire, Quality of Life Questionnaire QLQ-C30, HN 43 questionnaire, Multidimensional Fatigue Inventory (MFI) Questionnaire, Big Five Inventory Questionnaire, illness Identity Questionnaire,
Actimetry (cumulative time without movement over 24h, prolonged sedentary periods \>30 min without movement. Continuous recording 7 days prior to visit T0, T1, T2, T3, T4, T5
sedentary level
cumulative time without movement over a day, as well as prolonged sedentary periods (\>30min without movement): continuous recording 7 days prior to hospital visits
Time frame: Change between baseline and 3, 6, 12 months and 18 months
International Physical Activity Questionnaire
Physical Activity level
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Quality of Life Questionnaire QLQ-C30
Quality of Life
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Head Neck (HN) 43 questionnaire
Quality of Life
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Multidimensional Fatigue Inventory: MFI questionnaire
fatigue level
Time frame: Change between baseline and 3 months
Big Five Inventory questionnaire
measure personality traits.
Time frame: Change between baseline and 3 months
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