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

Le Mans Universite86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

* 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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sociability status

Change from baseline of a Comprehensive interview

Time frame: 18 months

Physical characteristics 1

Change from baseline of height (in meters)

Time frame: 18 months

Physical characteristics 2

Change from baseline of mass (in kilograms)

Time frame: 18 months

Physical characteristics 3

Change from baseline of fat mass (in percentage)

Time frame: 18 months

Physical characteristics 4

Change from baseline of leg volum

Time frame: 18 months

Postural stability

Change from baseline of maximum displacement speed of pressure centre at the postural stability test

Time frame: 18 months

Cognitive function 1

Change from baseline of Stroop test score (higher score means worse outcome)

Time frame: 18 months

Cognitive function 2

Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome)

Time frame: 18 months

Cognitive function 3

Change from baseline of Trail Making test score (higher score means worse outcome)

Time frame: 18 months

Fatigability

Change from baseline at critical force test measurement

Time frame: 18 months

Functional cardio-respiratory capability

Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test

Time frame: 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)

Time frame: 18 months

Fatigue

Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome)

Time frame: 18 months

Anxiety

Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome)

Time frame: 18 months

Emotional function

Change from baseline of the Brief Cope test score

Time frame: 18 months

Level of activity

Change from baseline of actimetry mesurement

Time frame: 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)

Time frame: 18 months

Inflammatory status (anti inflammatory cytokine)

Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra)

Time frame: 18 months

Sarcopenia 1

Change from baseline of body masse index

Time frame: 18 months

Sarcopenia 2

Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner

Time frame: 18 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes