Clinical trial NCT06184880: Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer
Official title: Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Upper Aerodigestive Tract Cancer
Head and Neck Cancer
Keywords: Physical Activity
head and neck cancer
Lead sponsor: Centre Hospitalier de Valence
Sponsor class: OTHER
Collaborators: name: Claude Bernard University
First posted: 2023-12-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, open label, controlled, monocentric, study
Primary purpose: SUPPORTIVE_CARE

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

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,

Primary outcomes:
measure: sedentary level
timeFrame: Change between baseline and 3, 6, 12 months and 18 months
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Change between baseline and 3, 6, 12 months and 18 months
measure: Quality of Life Questionnaire QLQ-C30
timeFrame: Change between baseline and 3, 6, 12 months and 18 months
measure: Head Neck (HN) 43 questionnaire
timeFrame: Change between baseline and 3, 6, 12 months and 18 months
measure: Multidimensional Fatigue Inventory: MFI questionnaire
timeFrame: Change between baseline and 3 months
measure: Big Five Inventory questionnaire
timeFrame: Change between baseline and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: CH VALENCE
name: Guillaume Guillaume
role: PRINCIPAL_INVESTIGATOR
References: