Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer
- Conditions
- Upper Aerodigestive Tract CancerHead and Neck Cancer
- Interventions
- Behavioral: behavioralOther: Sedentary
- Registration Number
- NCT06184880
- Lead Sponsor
- Centre Hospitalier de Valence
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A control group Sedentary 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 B experimental Group Sedentary 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 A control group behavioral 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 B experimental Group behavioral 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
- Primary Outcome Measures
Name Time Method sedentary level 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
- Secondary Outcome Measures
Name Time Method International Physical Activity Questionnaire Change between baseline and 3, 6, 12 months and 18 months Physical Activity level
Multidimensional Fatigue Inventory: MFI questionnaire Change between baseline and 3 months fatigue level
Quality of Life Questionnaire QLQ-C30 Change between baseline and 3, 6, 12 months and 18 months Quality of Life
Head Neck (HN) 43 questionnaire Change between baseline and 3, 6, 12 months and 18 months Quality of Life
Big Five Inventory questionnaire Change between baseline and 3 months measure personality traits.