Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer (APAORL2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer; Upper Aerodigestive Tract Cancer
• Intervention / Treatment: Behavioral: behavioral; Other: Sedentary

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

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Buiret; Phone Number: +33475752555; Email: gbuiret@ch-valence.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A control group; 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	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; Other Names: Physical Activity level
Experimental: B experimental Group; 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	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; Other Names: Physical Activity level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Valence
• Collaborators: Claude Bernard University
• Investigators: Principal Investigator: Guillaume Guillaume, Ch Valence

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; head and neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: RIPH-CHV-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No