Health TrialsbyHealthPanel

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

ConditionsUpper Aerodigestive Tract CancerHead and Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Valence

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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,

  • Sedentary

    Other intervention

    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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: A control groupActive comparator 2 interventions
Group B: B experimental GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Change between baseline and 3, 6, 12 months and 18 months

Secondary outcomes

1

International Physical Activity Questionnaire

Physical Activity level

Time frame
Change between baseline and 3, 6, 12 months and 18 months
2

Quality of Life Questionnaire QLQ-C30

Quality of Life

Time frame
Change between baseline and 3, 6, 12 months and 18 months
3

Head Neck (HN) 43 questionnaire

Quality of Life

Time frame
Change between baseline and 3, 6, 12 months and 18 months
4

Multidimensional Fatigue Inventory: MFI questionnaire

fatigue level

Time frame
Change between baseline and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier de Valence

Lead sponsor

Claude Bernard University

Collaborator

Source ClinicalTrials.gov
Apply now