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NCT Number: NCT06650813

Adapting the FACETS Program to Sickle Cell Disease

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).

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Key information

Conditions

Fatigue Symptom Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fatigue Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Pathological Conditions, Signs and Symptoms Sickle Cell Disease Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble Alpes, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Drépa-FACETS Program

Other

Drépa-FACETS Program for Sickle Cell Disease

Primary outcomes

  1. Feasibility of the FACETS program for adult sickle-cell patients

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

    Main criterion is assessing feasibility. Composite criterion including three sub-criteria are :

    • 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.
    • 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.
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Damien OUDIN-DOGLIONI, PhD

CONTACT

[email protected]

0476748839 ext. +33

Michalina DANNOUNE

CONTACT

[email protected]

0139638856 ext. +33

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Collaborators

  • Paris Nanterre University
  • University Grenoble Alps
  • University Hospital, Grenoble

Registry information

Official study title

Adapting the FACETS Fatigue Management Program to Sickle Cell Disease

Acronym: Drépa-FACETS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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