Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer

Conditions
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Upper Aerodigestive Tract Cancer, Head and Neck Cancer

Intervention / Treatment
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* Behavioral: behavioral
* Other: Sedentary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized, open label, controlled, monocentric, study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A control group<br>Patients will receive standard care, recommendations on physical activity. patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5 | Behavioral: behavioral<br>* 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,<br>Other: Sedentary<br>* 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<br>* Other names: Physical Activity level;|
| Experimental: B experimental Group<br>1 or 2 physical activity sessions per week, either face-to-face or by videoconference at patient convenience: low-to-moderate intensity aerobic and anaerobic muscle-strengthening session and a 40-minute stretching/yoga session. patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5 | Behavioral: behavioral<br>* 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,<br>Other: Sedentary<br>* 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<br>* Other names: Physical Activity level;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change between baseline and 3, 6, 12 months and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaire | Physical Activity level | Change between baseline and 3, 6, 12 months and 18 months | 
| Quality of Life Questionnaire QLQ-C30 | Quality of Life | Change between baseline and 3, 6, 12 months and 18 months | 
| Head Neck (HN) 43 questionnaire | Quality of Life | Change between baseline and 3, 6, 12 months and 18 months | 
| Multidimensional Fatigue Inventory: MFI questionnaire | fatigue level | Change between baseline and 3 months | 
| Big Five Inventory questionnaire | measure personality traits. | Change between baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, head and neck cancer