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

NCT04391543 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-04-09

No results posted yet for this study

Summary

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

Interventions

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

Sponsors & Collaborators

  • Le Mans Universite

    lead OTHER

Principal Investigators

  • Hugues Bourgeois, MD · Clinique Victor Hugo - LE MANS

  • Caroline Fonsegrive, MD · Centre Hospitalier du Mans

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-08-15
Completion
2025-02-15

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391543 on ClinicalTrials.gov