BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)

Study Overview
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Brief Summary
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One of the most common and stressful side effects of the disease and associated treatments is cancer-related fatigue. It deeply disrupts quality of life and can have a negative impact on patient survival. However, cancer-related fatigue is largely underestimated by patients and poorly taken into account by clinicians. One of the reasons for its poor management is a lack of knowledge of the underlying mechanisms and risk factors. Although a multiplicity of factors are associated with the appearance of cancer-related fatigue, we do not know their respective share, nor the nature of their interactions. The phenomenon studied reveals complex and systemic interactions between the biological, psychological and social dimensions. Recent systematic reviews clearly identify 2 locks currently preventing a better understanding of the mechanisms of cancer-related fatigue: i) lack of longitudinal studies, ii) lack of interdisciplinary studies. It is precisely these two challenges that the BIOCARE FActory project wishes to respond to.

Official Title
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BIOpsychosocial Approach of the CAncer-RElated FAtigue

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Experimental session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient followed at the Victor Hugo Clinic, Le Mans. Patients aged >or= 18 and < 80 years old at the time of inclusion Patients with a histologically proven primary breast cancer from stage I to IIIc Naive patient of anti-cancer treatment for this cancer Agreement to participate in the study by written, informed and signed consent of the patient Affiliated patients or beneficiaries of a social security scheme ECOG Performance Status score ≤ 2 Exclusion Criteria: Comorbidity which can explain the symptoms of fatigue (Long-term illness other than cancer, chronic fatigue syndrome) Breathing difficulties requiring the use of respiratory assistance Signs of polyneuropathy, amyotrophy or myasthenic syndrome Contraindications to physical exercise linked to heart failure. Treatment based on psychostimulants, psychotropics, antidepressants, antiepileptics or benzodiazepines for more than 3 months at the time of the study Presence or history of psychosis, bipolarity or severe depression History of stroke History of chronic fatigue History of musculoskeletal disorders of the lower limbs Pregnancy, breastfeeding Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>4 experimental session (baseline, after treatment, 6 month post treatment and 12 months post treatment) with : comprehensive interview cognitive tests anthropometric measures postural balance test critical force test Astrand-Ryhming test self-questionnaire (QLQ-C30, FA12, Brief Cope et Hospital Anxiety and Depression Scale) actimetry clinical and biological characteristics determination of inflammatory markers skeletal muscle index | Other: Experimental session<br>* comprehensive interview cognitive tests anthropometric measures postural balance test critical force test Astrand-Ryhming test self-questionnaire (QLQ-C30, FA12, Brief Cope et Hospital Anxiety and Depression Scale) actimetry clinical and biological characteristics determination of inflammatory markers skeletal muscle index<br>* Other names: Experimental Arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociability status | Change from baseline of a Comprehensive interview | 18 months | 
| Physical characteristics 1 | Change from baseline of height (in meters) | 18 months | 
| Physical characteristics 2 | Change from baseline of mass (in kilograms) | 18 months | 
| Physical characteristics 3 | Change from baseline of fat mass (in percentage) | 18 months | 
| Physical characteristics 4 | Change from baseline of leg volum | 18 months | 
| Postural stability | Change from baseline of maximum displacement speed of pressure centre at the postural stability test | 18 months | 
| Cognitive function 1 | Change from baseline of Stroop test score (higher score means worse outcome) | 18 months | 
| Cognitive function 2 | Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome) | 18 months | 
| Cognitive function 3 | Change from baseline of Trail Making test score (higher score means worse outcome) | 18 months | 
| Fatigability | Change from baseline at critical force test measurement | 18 months | 
| Functional cardio-respiratory capability | Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test | 18 months | 
| Quality of life status | Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome) | 18 months | 
| Fatigue | Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome) | 18 months | 
| Anxiety | Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome) | 18 months | 
| Emotional function | Change from baseline of the Brief Cope test score | 18 months | 
| Level of activity | Change from baseline of actimetry mesurement | 18 months | 
| Inflammatory status (pro-inflammatory cytokines) | Change from baseline of blood inflammatory markers determined by ELISA test (pro-inflammatory cytokines : IL-6, TNFα, IL-8, IL-1β) | 18 months | 
| Inflammatory status (anti inflammatory cytokine) | Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra) | 18 months | 
| Sarcopenia 1 | Change from baseline of body masse index | 18 months | 
| Sarcopenia 2 | Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner | 18 months |