Fatigue SymptomDrépa-FACETSNCT06650813
Adapting the FACETS Program to Sickle Cell Disease
A study testing Drépa-FACETS Program in people with Fatigue Symptom and Sickle Cell Disease, run by Versailles Hospital at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue Symptom, Sickle Cell Disease
- What is being tested?
- Drépa-FACETS Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Jan 2025to 2 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38000
Caroline MAKOWSKI, PhD, CMakowski@chu-grenoble.fr
- Completed
Hospital Versailles
Le Chesnay, 78150
About this study
Official title: Adapting the FACETS Fatigue Management 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).
- Conditions
- Fatigue Symptom, Sickle Cell Disease
- Being tested
- Drépa-FACETS Program
- Medical subject headings
- Fatigue, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drépa-FACETS ProgramOther
Drépa-FACETS Program for Sickle Cell Disease
| Study group | Role | What they receive |
|---|---|---|
| Patients with sickle cell disease | Experimental | Not described Receives: Other: Drépa-FACETS Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the FACETS program for adult sickle-cell patients
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.
Measured: From the enrollment to the end of the protocol visits (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start10 Jan 2025
- Primary completion2 May 2026 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble, University Grenoble Alps, Paris Nanterre University
- Responsible party
- Principal investigator, Michalina DANNOUNE, Versailles Hospital
- Investigators
- Marie-Claire GAY, Pr, Study director, Paris Nanterre University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650813
- Sponsor's protocol ID
- P23/09 - Drépa-FACETS
- Acronym
- Drépa-FACETS
- Status last verified
- Aug 2025
- First submitted
- 15 Oct 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the FACETS Fatigue Management Program to Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06650813
- Acronym / sponsor ID
- Drépa-FACETS / P23/09 - Drépa-FACETS
- Conditions
- Fatigue Symptom, Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble, University Grenoble Alps, Paris Nanterre University
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with sickle cell disease | Experimental | Other: Drépa-FACETS Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drépa-FACETS ProgramDrépa-FACETS Program for Sickle Cell Disease | Other | Patients with sickle cell disease |
Primary outcome
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 : 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Claire GAY, Pr study director
Paris Nanterre University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drépa-FACETS Program in people with Fatigue Symptom and Sickle Cell Disease, run by Versailles Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michalina DANNOUNE (0139638856 ext. +33, mdannoune@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the FACETS program for adult sickle-cell patients (time frame: From the enrollment to the end of the protocol visits (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.