Acute Myeloid LeukemiaCOHABILITNCT03595787
COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
A study testing Coaching and Habilitation in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Coaching and Habilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2022to 4 May 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute myeloid leukemia or high-risk myelodysplastic syndrome
- Age between 18 and 70 years
- Eligible for an intensive chemotherapy
- Eligible for allograft
- Able to answer a questionnaire
Who cannot join
- Diagnosis of acute promyelocytic Leukemia
- Palliative treatment
- Contraindication to moderate physical activity
- Performans status 4, unless it is related to the disease
- Patient who does not understand French
- Patient unable to use a smartphone
- Patient deprived of liberty or placed under the authority of a tutor,
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Tripartite Prehabilitation of Patients With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndromes During Intensive Chemotherapy Before Allogenic Haematopoietic Stem Cell Transplantation: the COHABILIT Protocol
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Coaching and Habilitation
- Keywords
- prehabilitation, coaching, nutritional support, physical activity, allogeneic stem cells transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching and HabilitationProcedure or surgery
nutritional support, adapted physical activity and coaching
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation program | Experimental | Program based on nutritional support, physical activity program and coaching. Home-based monitoring will be done thanks to connected watches (step counter pedometer) and a connected body fat weight scale Receives: Procedure: Coaching and Habilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility to the adapted multidisciplinary program
proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed
Measured: 6 months
Secondary outcomes (39)
Evaluate change in functional capacity
Test SPPB
Measured: 6 months
Evaluate changes in upper limb strengt
Prehension strength with handgrip
Measured: 6 months
Evaluate changes in lower limb strength
Quadriceps strength with dynamometer
Measured: 6 months
Evaluate physical activity sessions modalities
Data from connected watch
Measured: 6 months
Evaluate physical activity sessions feasability
Number of sessions not undertaken and reason for refusal
Measured: 6 months
Evaluate positive and negative affect
Outcomes of questionaries : PANAS,
Measured: 6 months
Evaluate life satisfaction
Outcomes of questionaries LSS
Measured: 6 months
Evaluate the level of depression
Outcomes of questionaries HADS
Measured: 6 months
Evaluate the quality of the trainer-trainee relationship
Outcomes of questionaries CART-Q
Measured: 6 months
Evaluate self-efficacy
Outcomes of questionaries Self-efficacy
Measured: 6 months
Evaluate relationship dynamics
Semi-directive interviews
Measured: 6 months
Evaluate QoL
Outcomes of questionaries FACT-Leu
Measured: 6 months
Evaluate the cancer related fatigue
Outcomes of questionaries FACT-Fa
Measured: 6 months
Evaluate correlation between APA coaching sessions undertaken and NRM
Correlation between number of APA sessions and NRM
Measured: 6 months
Evaluate correlation between APA coaching sessions undertaken and survival
Correlation between number of APA sessions and survival rates
Measured: 6 months
Evaluate correlation between APA coaching sessions undertaken and QoL
Correlation between number of APA sessions and Fact-Leu
Measured: 6 months
Evaluate correlation between APA coaching sessions undertaken and fatigue
Correlation between number of APA sessions and Fact-Fa
Measured: 6 months
Evaluate changes in weight
Change in weight (impedancemetry data via connected weighing machine)
Measured: 6 months
Evaluate body mass index
Change in body mass index (BMI= Weight/Height²)
Measured: 6 months
changes in impedancemetry data
Impedaneimetry mesures (connected weighing machine): body mass index variations,
Measured: 6 months
Evaluate muscle mass
Change in muscle mass (impedancemetry data via connected weighing machine)
Measured: 6 months
Evaluate fat mass
Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height)
Measured: 6 months
Evaluate skeletal muscle mass index (SMI) change in the course of the treatment
Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height)
Measured: 6 months
Evaluate adherence to nutrition programme
Number of days enteral and parenteral nutrition
Measured: 6 months
Study correlation between variation in weight, BMI, muscle mass, fat mass and SMI on physical capacities, QoL, number of infections, number of days of hospitalisation, patients' outcomes (NRM, survival) and GvHD in allotransplant patients.
Correlation between variation in weight, BMI, muscle mass, fat mass and SMI with NRM, overall survival, number of days of hospitalisation, number of infections documented, QoL, physical capacities and GvHD
Measured: 6 months
Complete remision
Complete remision rate
Measured: 6 months
- Evaluate number of infections documented
number of infections documented
Measured: 6 months
evaluate number of days of hospitalisation
number of days of hospitalisation mesured in nights
Measured: 6 months
evaluate rate of early mortality
rate of premature mortality
Measured: 30 days
evaluate rate of overall mortality
rate of overall mortality
Measured: 30 days
evaluate cause of overall mortality
cause of premature mortality
Measured: 6 months
Evaluate rate of non relapse Mortality (RNM)
Rate of NRM
Measured: 6 months
evaluate overall survival
overal survival rate
Measured: 6 months
evaluate survival without relapse
survival without relapse rate
Measured: 6 monts
evaluate survival without events
survival without events rate
Measured: 6 monts
evaluate number of allotransplant patients
number of allotransplant patients
Measured: 6 monts
evalaute number of patients disqualified for allotransplant
number of patients with transplant indication disqualified for allotransplant
Measured: 6 monts
degree of digestive GVH disease
GVH disease grade
Measured: 6 monts
Evaluation of the severity of digestive GVH disease
severity of GVH desease
Measured: 6 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start4 Apr 2022
- Primary completion4 May 2025 (estimated)
- Study completion4 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Bannier Braticevic, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595787
- Sponsor's protocol ID
- COHABILIT-IPC 2017-046
- Acronym
- COHABILIT
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2018
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saillard C, Cuvelier S, Villaron-Goetgheluck C, Boher JM, Almeida-Lopez L, Le Corroller AG, Denis P, Rivieccio C, Calvin S, Vey N, Bannier-Braticevic C. Tripartite prehabilitation of patients with acute myeloid leukaemia and high-risk myelodysplastic syndromes during intensive chemotherapy before allogeneic haematopoietic stem cell transplantation (COHABILIT): protocol for an innovating prospective multicentre study. BMJ Open. 2024 Mar 29;14(3):e076321. doi: 10.1136/bmjopen-2023-076321.
PubMed 38553062
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Tripartite Prehabilitation of Patients With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndromes During Intensive Chemotherapy Before Allogenic Haematopoietic Stem Cell Transplantation: the COHABILIT Protocol
- ClinicalTrials.gov ID
- NCT03595787
- Acronym / sponsor ID
- COHABILIT / COHABILIT-IPC 2017-046
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- prehabilitation, coaching, nutritional support, physical activity, allogeneic stem cells transplantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 4 May 2025 (estimated)
- Study completion
- 4 May 2025 (estimated)
- First posted
- 23 Jul 2018 (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.
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation program | Experimental | Procedure: Coaching and HabilitationProgram based on nutritional support, physical activity program and coaching. Home-based monitoring will be done thanks to connected watches (step counter pedometer) and a connected body fat weight scale |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of acute myeloid leukemia or high-risk myelodysplastic syndrome
- Age between 18 and 70 years
- Eligible for an intensive chemotherapy
- Eligible for allograft
- Able to answer a questionnaire
Key exclusion criteria (8 listed)
- Diagnosis of acute promyelocytic Leukemia
- Palliative treatment
- Contraindication to moderate physical activity
- Performans status 4, unless it is related to the disease
- Patient who does not understand French
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 |
|---|---|---|
| Coaching and Habilitationnutritional support, adapted physical activity and coaching | Procedure or surgery | Prehabilitation program |
Primary outcome
feasibility to the adapted multidisciplinary program
Time frame: 6 months
proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed
39 secondary outcomes
Evaluate change in functional capacity
Time frame: 6 months
Evaluate changes in upper limb strengt
Time frame: 6 months
Evaluate changes in lower limb strength
Time frame: 6 months
Evaluate physical activity sessions modalities
Time frame: 6 months
Evaluate physical activity sessions feasability
Time frame: 6 months
Evaluate positive and negative affect
Time frame: 6 months
Evaluate life satisfaction
Time frame: 6 months
Evaluate the level of depression
Time frame: 6 months
Evaluate the quality of the trainer-trainee relationship
Time frame: 6 months
Evaluate self-efficacy
Time frame: 6 months
Evaluate relationship dynamics
Time frame: 6 months
Evaluate QoL
Time frame: 6 months
Evaluate the cancer related fatigue
Time frame: 6 months
Evaluate correlation between APA coaching sessions undertaken and NRM
Time frame: 6 months
Evaluate correlation between APA coaching sessions undertaken and survival
Time frame: 6 months
Evaluate correlation between APA coaching sessions undertaken and QoL
Time frame: 6 months
Evaluate correlation between APA coaching sessions undertaken and fatigue
Time frame: 6 months
Evaluate changes in weight
Time frame: 6 months
Evaluate body mass index
Time frame: 6 months
changes in impedancemetry data
Time frame: 6 months
Evaluate muscle mass
Time frame: 6 months
Evaluate fat mass
Time frame: 6 months
Evaluate skeletal muscle mass index (SMI) change in the course of the treatment
Time frame: 6 months
Evaluate adherence to nutrition programme
Time frame: 6 months
Study correlation between variation in weight, BMI, muscle mass, fat mass and SMI on physical capacities, QoL, number of infections, number of days of hospitalisation, patients' outcomes (NRM, survival) and GvHD in allotransplant patients.
Time frame: 6 months
Complete remision
Time frame: 6 months
- Evaluate number of infections documented
Time frame: 6 months
evaluate number of days of hospitalisation
Time frame: 6 months
evaluate rate of early mortality
Time frame: 30 days
evaluate rate of overall mortality
Time frame: 30 days
evaluate cause of overall mortality
Time frame: 6 months
Evaluate rate of non relapse Mortality (RNM)
Time frame: 6 months
evaluate overall survival
Time frame: 6 months
evaluate survival without relapse
Time frame: 6 monts
evaluate survival without events
Time frame: 6 monts
evaluate number of allotransplant patients
Time frame: 6 monts
evalaute number of patients disqualified for allotransplant
Time frame: 6 monts
degree of digestive GVH disease
Time frame: 6 monts
Evaluation of the severity of digestive GVH disease
Time frame: 6 monts
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 18 Dec 2024.
- Derived from this study: PubMed 38553062Saillard C, Cuvelier S, Villaron-Goetgheluck C, Boher JM, Almeida-Lopez L, Le Corroller AG, Denis P, Rivieccio C, Calvin S, Vey N, Bannier-Braticevic C. Tripartite prehabilitation of patients with acute myeloid leukaemia and high-risk myelodysplastic syndromes during intensive chemotherapy before allogeneic haematopoietic stem cell transplantation (COHABILIT): protocol for an innovating prospective multicentre study. BMJ Open. 2024 Mar 29;14(3):e076321. doi: 10.1136/bmjopen-2023-076321.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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. This study is not recruiting at the moment.
Cécile Bannier Braticevic, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and Habilitation in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Institut Paoli-Calmettes at 1 site 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility to the adapted multidisciplinary program (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595787, which also lists 1 linked publication.
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 18 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.