Head and Neck Cancer, Upper Aerodigestive Tract Cancer
Conditions
Keywords
Physical Activity, head and neck cancer
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
Interventions
BEHAVIORALbehavioral
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,
OTHERSedentary
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
Sponsors
Centre Hospitalier de Valence
Claude Bernard University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
a randomized, open label, controlled, monocentric, study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Big Five Inventory questionnaire | Change between baseline and 3 months | measure personality traits. |
| International Physical Activity Questionnaire | Change between baseline and 3, 6, 12 months and 18 months | Physical Activity 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 |
| Multidimensional Fatigue Inventory: MFI questionnaire | Change between baseline and 3 months | fatigue level |
Countries
France
Contacts
CONTACTGuillaume Buiret
PRINCIPAL_INVESTIGATORGuillaume Guillaume
CH VALENCE
Outcome results
None listed