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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2025-02-15

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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental Arm

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

Group Type EXPERIMENTAL

Experimental session

Intervention Type OTHER

* 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

Interventions

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Experimental session

* 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

Intervention Type OTHER

Other Intervention Names

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Experimental Arm

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No