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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02525-52 | Other Identifier | French Health Products Safety Agency |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | 4 experimental session (baseline, after treatment, 6 month post treatment and 12 months post treatment) with :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental session | Other |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugues Bourgeois, MD | Clinique Victor Hugo - LE MANS | Principal Investigator |
| Caroline Fonsegrive, MD | Centre Hospitalier du Mans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le Mans University | Le Mans | 72085 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38689167 | Derived | Leclercq 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. | |
| 37952231 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
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| 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 |
| Chartogne 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. |
| 34688272 | Derived | Chartogne 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. |
| D017437 |
| Skin and Connective Tissue Diseases |