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

BIOpsychosocial Approach of the CAncer-RElated FAtigue

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 Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Experimental session

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72085
    • Le Mans University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Other: 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; Other Names: Experimental Arm

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Le Mans Universite
• Investigators: Principal Investigator: Hugues Bourgeois, MD, Clinique Victor Hugo - Le Mans; Principal Investigator: Caroline Fonsegrive, MD, Centre Hospitalier du Mans

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): August 15, 2023
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: MIP-2019-001; 2019-A02525-52 (Other Identifier: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No