Adapting the FACETS Program to Sickle Cell Disease

Not Applicable

Not yet recruiting

• Conditions: Fatigue Symptom; Sickle Cell Disease

• Registration Number: NCT06650813
• Lead Sponsor: Versailles Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Study Start: 2024-11-04
• Primary Completion: 2025-11-04
• Study Completion: 2025-11-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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. Attendance at main program sessions. The criterion will be met if the participant attends at least 4 of the 6 program sessions.; 2. Ability to perform exercises at home. This criterion will be met if the participant performs at least 50% of the home exercises proposed 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 his or her daily life.; The primary assessment criterion of the feasibility/acceptability of the DrépaFACETS program will be met if 2 out of 3 sub-criteria are met.