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

Centre Hospitalier de Valence

Status: Not yet enrolling

Conditions: Head and Neck Cancer; Upper Aerodigestive Tract Cancer

Treatments: Behavioral: behavioral; Other: Sedentary

Study type: Interventional

Funder types: Other

Identifiers

NCT06184880

RIPH-CHV-14

Details and patient eligibility

About

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.

Full 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

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

A control group

Active Comparator group

Description:

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

Treatment:

Other: Sedentary

Behavioral: behavioral

B experimental Group

Experimental group

Description:

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

Treatment:

Other: Sedentary

Behavioral: behavioral