Adapting the FACETS Program to Sickle Cell Disease

NCT06650813 | Recruiting

• 1 other identifier: P23/09 - Drépa-FACETS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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).

Conditions

Fatigue Symptom; Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Feasibility of the FACETS program for adult sickle-cell patients

  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.

  From the enrollment to the end of the protocol visits (10 weeks)

Study Arms (1)

Patients with sickle cell disease

EXPERIMENTAL

Other: Drépa-FACETS Program

Interventions

Drépa-FACETS Program OTHER

Drépa-FACETS Program for Sickle Cell Disease

Patients with sickle cell disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Versailles Hospital: lead
• University Hospital, Grenoble: collaborator
• University Grenoble Alps: collaborator
• Paris Nanterre University: collaborator

Study Sites (2)

CHU Grenoble Alpes

Grenoble, 38000, France

RECRUITING

Hospital Versailles

Le Chesnay, 78150, France

COMPLETED

MeSH Terms

Conditions

Fatigue; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marie-Claire GAY, Pr

  Paris Nanterre University

  STUDY DIRECTOR

Central Study Contacts

Michalina DANNOUNE

CONTACT

0139638856; mdannoune@ght78sud.fr

Damien OUDIN-DOGLIONI, PhD

CONTACT

0476748839; damien.oudin-doglioni@univ-grenoble-alpes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Coordonnator

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: January 10, 2025
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

FR (2)