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| Name | Class |
|---|---|
| Claude Bernard University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A control group | Active Comparator | 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 |
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| B experimental Group | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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, |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Buiret | Contact | +33475752555 | gbuiret@ch-valence.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume Guillaume | CH VALENCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Valence | Recruiting | Valence | 26000 | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001519 | Behavior |
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a randomized, open label, controlled, monocentric, study
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| Sedentary | Other | 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 |
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| 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 |