Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: behavioral, Sedentary.
- Who it may be relevant to
- Registry conditions: Upper Aerodigestive Tract Cancer, Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer
Overview
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
Interventions
- Behavioral behavioral
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, - Other Sedentary
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
Primary outcome measures
- sedentary level [Time frame: Change between baseline and 3, 6, 12 months and 18 months]
Secondary outcome measures (5)
- International Physical Activity Questionnaire [Time frame: Change between baseline and 3, 6, 12 months and 18 months]
- Quality of Life Questionnaire QLQ-C30 [Time frame: Change between baseline and 3, 6, 12 months and 18 months]
- Head Neck (HN) 43 questionnaire [Time frame: Change between baseline and 3, 6, 12 months and 18 months]
- Multidimensional Fatigue Inventory: MFI questionnaire [Time frame: Change between baseline and 3 months]
- Big Five Inventory questionnaire [Time frame: Change between baseline and 3 months]
Eligibility criteria
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,
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Ch Valence — Valence
Identifiers
NCT: NCT06184880 · RIPH-CHV-14