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NCT06184880 Clinical Trial

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

Head and Neck Cancer Clinical Trial

— APAORL2  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06184880
Other study ID # RIPH-CHV-14
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 1, 2025

Study information
Verified date February 2024
Source Centre Hospitalier de Valence
Contact Guillaume Buiret
Phone +33475752555
Email gbuiret@ch-valence.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 96
Est. completion date December 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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,

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier de Valence Claude Bernard University

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