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Clinical Trials in France / NCT06650813
Recruiting Not applicable

Adapting the FACETS Program to Sickle Cell Disease

NCT06650813 · tracked via the Priya Life Science France tracker
Sponsor
Versailles Hospital
Phase
Not applicable
Started
2025-01-10
Last updated
2025-08-19

Condition(s) studied

Fatigue SymptomSickle Cell Disease

Investigational drug(s) / intervention(s)

Drépa-FACETS Program

Drépa-FACETS Program: Drépa-FACETS Program for Sickle Cell Disease

Study summary

Adaptation of a fatigue management program combining the principles of cognitive-behavioral therapy and energy conservation strategies (FACETS program) for a population of adult patients with sickle cell disease (Drépa-FACETS program).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant having freely given his oral agreement. * Participant with a major sickle cell syndrome, regardless of genotype (e.g. SS, SC, Sbeta). * Participant with a sufficient command of spoken and written French to take the assessments, complete the questionnaires, follow the program sessions and carry out the home exercises. Exclusion Criteria: * Participant with one or more severe psychiatric pathologies (e.g. severe depression, psychosis) that could interfere with the conduct of the study, in particular the primary and secondary endpoints. * Participants with another chronic pathology causing fatigue. * Participants in vaso-occlusive crisis (VOC) or hospitalization. * Participant under legal protection (guardianship, curatorship, safeguard of justice, deprived of liberty).

Primary outcome measure(s)

  • Feasibility of the FACETS program for adult sickle-cell patients — From the enrollment to the end of the protocol visits (10 weeks)
    Main criterion is assessing feasibility. Composite criterion including three sub-criteria are : 1. Participation rate in the main sessions of the program. This criterion will be met if the participant attends at least 4 of the 6 sessions of the program. 2. Success rate in completing home exercises. This criterion will be met if the participant completes at least 50% of the home exercises assigned at the end of each session. 3. Acquisition of fatigue management skills. This criterion will be met if the participant has been able to implement one of the fatigue management techniques proposed by the Drépa-FACETS program in their daily life. The main criterion for evaluating the feasibility/acceptability of the DrépaFACETS program will be met if 2 of the 3 sub-criteria are met.

Trial sites (2)

FacilityCityRegionStatus
CHU Grenoble Alpes Grenoble France Recruiting
Hospital Versailles Le Chesnay France Completed

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Long-term Follow-up of Subjects with Sickle Cell Disease Treated with Ex Vivo Gene Therapy Enrolling by invitation
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06650813 on ClinicalTrials.gov ↗ ← All trials in France