Clinical trial · Interventional
BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)
BIOpsychosocial Approach of the CAncer-RElated FAtigue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental session | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 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
- interventionNames
- Other: Experimental session
Primary outcomes (20)
- measure
- Sociability status
- timeFrame
- 18 months
- description
- Change from baseline of a Comprehensive interview
- measure
- Physical characteristics 1
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDLeclercq A, Chatrenet A, Bourgeois H, Cojocarasu O, Mathie C, Martin T, Rahmani A, Morel B. Multidisciplinary analysis of cancer-related fatigue at the time of diagnosis: preliminary results of the BIOCARE FActory cohort. Support Care Cancer. 2024 Apr 30;32(5):319. doi: 10.1007/s00520-024-08520-4. PMID 38689167
- DERIVEDChartogne M, Rahmani A, Landry S, Morel B. Comparison of neuromuscular fatigability amplitude and etiologies between fatigued and non-fatigued cancer patients. Eur J Appl Physiol. 2024 Apr;124(4):1175-1184. doi: 10.1007/s00421-023-05347-5. Epub 2023 Nov 12. PMID 37952231
- DERIVEDChartogne M, Leclercq A, Beaune B, Boyas S, Forestier C, Martin T, Thomas-Ollivier V, Landry S, Bourgeois H, Cojocarasu O, Pialoux V, Zanna O, Messonnier LA, Rahmani A, Morel B. Building a biopsychosocial model of cancer-related fatigue: the BIOCARE FActory cohort study protocol. BMC Cancer. 2021 Oct 23;21(1):1140. doi: 10.1186/s12885-021-08831-3. PMID 34688272