LeukemiaRAT-HEMATONCT06262789
RAT-HEMATO : Return to Work After Malignant Hemopathy
A study testing "Return-to-work after cancer" consultation in people with Leukemia and Lymphoma, run by University Hospital, Angers at 10 sites in France.
Trial summary
Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Leukemia, Lymphoma, Multiple Myeloma
- What is being tested?
- "Return-to-work after cancer" consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 10 sitesFrance
- Study dates
- 27 Sep 2024to Mar 2028
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with hematological malignancy controlled after treatment
- Induction/consolidation chemotherapy completed (excluding maintenance therapy)
- Patient aged 18 to 55
- Patient having worked at least 6 months in the 2 years before diagnosis of hematological malignancy
- Patient who has not yet returned to work since diagnosis of hematological malignancy
- Signed informed consent form
Who cannot join
- Patient choosing not to return to work
- Patient not affiliated to a social security system
- Patient with legal guardian or legal trustee
- Patient not understanding French
- Patient with severe cognitive impairment at diagnosis, incompatible with the study
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Angers University hospital
Angers
PAILLASSA Jérome, MD, 02.41.35.45.24 ext. +33, jerome.paillassa@chu-angers.fr
- Recruiting
Brest University Hospital, Morvan Site
Brest
Marie-Anne Couturier, MD, 02.98.22.30.37, marie-anne.couturier@chu-brest.fr
- Not yet recruiting
Caen University hospital
Caen
Ghandi Laurent DAMAJ, MD, 02.31.27.21.40 ext. +33, damaj-gl@chu-caen.fr
- Not yet recruiting
Service Hématologie, Cholet Hospital
Cholet
Christopher NUNES GOMEZ, Doctor of Medecine, +33(0)2.41.49.68.60, christopher.numes-gomes@ch-cholet.fr
- Not yet recruiting
Le Havre Hospital Group
Montivilliers
Pierre LEBRETON, MD, + 33 6 04 51 41 31 ext. + 33, pierre.lebreton@ch-havre.fr
- Not yet recruiting
Pays de Morlaix Hospital
Morlaix
Christophe NICOL, MD, +33 2 98 62 60 38 ext. +33, cnicol@ch-morlaix.fr
- Not yet recruiting
Rennes University Hospital, Pontchaillou site
Rennes
Roch HOUOT, MD, 02.99.28.42.91 ext. +33, roch.houot@chu-rennes.fr
- Recruiting
Centre Henri Becquerel
Rouen
Stéphane LEPRETRE, MD, 02.32.08.22.23 ext. +33, stephane.lepretre@chb.unicancer.fr
- Not yet recruiting
Rouen University Hospital
Rouen
Laetitia ROLLIN, MD, 02.32.88.82.69, laetitia.rollin@chu-rouen.fr
- Recruiting
Tours University Hospital, Bretonneau Site
Tours
Emmanuel GYAN, 02.47.47.38.11, e.gyan@chu-tours.fr
About this study
Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality.
- Conditions
- Leukemia, Lymphoma, Multiple Myeloma
- Being tested
- "Return-to-work after cancer" consultation
- Medical subject headings
- Leukemia, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Return-to-work after cancer" consultationOther
The "return-to-work after cancer" consultation is carried out by a specialist in occupational pathology, who may be assisted by a psychologist and/or a nurse and/or a social worker, depending on the patient's personal situation. During this consultation, the team assesses the patient's medical situation, social situation and psychological situation. This consultation lasts approximatively 1 hour and aims to guide the patient in the different stages of return to work, to identify obstacles and apprehensions about return to work, to assess the patient's functional capacities and motivations, to provide information on the legislation, actors and tools for employment maintenance and to discuss possible adjustments of the work situation. The consultation provides a response to potential or encountered problems, directs the patient towards the actors and tools adapted to his/her situation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm with "return-to-work after cancer" consultation | Experimental | Not described Receives: Other: "Return-to-work after cancer" consultation |
| Standard arm without with "return-to-work after cancer" consultation | No intervention | Patient are treated according to usual care, according to local practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return-to-work rate at 1 year (percentage)
The return-to-work rate at 1 year is used to assess the impact of an early "Return-to-work" after cancer consultation for patients with hematological malignancies. It is defined as the percentage of patients having returned to work, including part-time work, 1 year after the inclusion visit.
Measured: 12 months
Secondary outcomes (7)
Cumulative incidence of return-to-work at 1 year
It is measured by the cumulative incidence rate of return-to-work at 1 year
Measured: 12 months
Change or not of the professional situation in the 2 arms
It is defined as the rate of patients with a change of their professional situation since the diagnosis. The changes of professional situation include: employment yes/no, full-time/part-time work, adaptation of work station yes/non, change of profession compared to before diagnosis.
Measured: 12 months
Factors influencing return to work
The factors investigated are type of hematological malignancy, sex, type of profession, presence of anxio-depressive disorders
Measured: 12 months
Quality of life (SF-12 score) evolution
The 12-Item Short Form Survey (SF-12) is one of the most widely used tools in oncology to assess health-related quality of life. It is a general health questionnaire that measures physical and mental health. It consists of 12 questions split into 8 different dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.
We will evaluate SF-12 evolution between Baseline visit and each other visits.
Measured: Baseline, 3 months, 6 months and 12 months
Anxiety and depression (HAD scale) evolution
Hospital Anxiety and Depression Scale (HAD scale) is one the most widely tools used in oncology to assess patient anxiety and depression. It consists of 14 questions rated form 0 to 3: 7 questions relate to anxiety (total A) and 7 to depression (total D), giving two scores (maximum score for each = 21). Scores between 0 et 7 correspond to an absence of anxiety or depression, scores between 8 and 10 are considered as doubtful, and scores 11 and above correspond to depression or anxiety.
We will evaluate HAD scale evolution between Baseline visit and each other visits.
Measured: Baseline , 3 months, 6 months and 12 months
Return-to-work self-efficacy (RTW-SE-11 scale) evolution
The Return-to-Work Self-Efficacy Scale - 11 items (RTW-SE-11) is an 11-item questionnaire measuring an individual's confidence in his or her ability to return to work. It integrates beliefs in the patient's abilities to support the physical, cognitive, emotional, relational and professional aspects of the work environment that have been identified as strong predictors of RTW following a cancer diagnosis. The final score ranges between 1 and 6, with a higher score indicating higher self-efficacy.
We will evaluate RTW-SE-11 scale evolution between Baseline visit and each other visits.
Measured: Baseline, 3 months, 6 months and 12 months
Self-assessment of the benefit of the "return-to-work after cancer" consultation
Patients assess the benefit of the "return-to-work after cancer" consultation using a questionnaire specially designed for the study, composed of Likert-scale questions. For each question, score ranges from 1 to 5. Higher scores indicate higher satisfaction.
We will evaluate RTW-SE-11 scale evolution between 3 months visit and 6 months visit (only for patients randomized in intervention arm).
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start27 Sep 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jérome PAILLASSA, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262789
- Sponsor's protocol ID
- 49RC23_0011
- Acronym
- RAT-HEMATO
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAT-HEMATO : Return to Work After Malignant Hemopathy
- ClinicalTrials.gov ID
- NCT06262789
- Acronym / sponsor ID
- RAT-HEMATO / 49RC23_0011
- Conditions
- Leukemia, Lymphoma, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Feb 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.
Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm with "return-to-work after cancer" consultation | Experimental | Other: "Return-to-work after cancer" consultation |
| Standard arm without with "return-to-work after cancer" consultation | No intervention | –Patient are treated according to usual care, according to local practice. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient with hematological malignancy controlled after treatment
- Induction/consolidation chemotherapy completed (excluding maintenance therapy)
- Patient aged 18 to 55
- Patient having worked at least 6 months in the 2 years before diagnosis of hematological malignancy
- Patient who has not yet returned to work since diagnosis of hematological malignancy
Key exclusion criteria (5 listed)
- Patient choosing not to return to work
- Patient not affiliated to a social security system
- Patient with legal guardian or legal trustee
- Patient not understanding French
- Patient with severe cognitive impairment at diagnosis, incompatible with the study
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 |
|---|---|---|
| "Return-to-work after cancer" consultationThe "return-to-work after cancer" consultation is carried out by a specialist in occupational pathology, who may be assisted by a psychologist and/or a nurse and/or a social worker, depending on the patient's personal situation. During this consultation, the team assesses the patient's medical situation, social situation and psychological situation. This consultation lasts approximatively 1 hour and aims to guide the patient in the different stages of return to work, to identify obstacles and apprehensions about return to work, to assess the patient's functional capacities and motivations, to provide information on the legislation, actors and tools for employment maintenance and to discuss possible adjustments of the work situation. The consultation provides a response to potential or encountered problems, directs the patient towards the actors and tools adapted to his/her situation. | Other | Experimental arm with "return-to-work after cancer" consultation |
Primary outcome
Return-to-work rate at 1 year (percentage)
Time frame: 12 months
The return-to-work rate at 1 year is used to assess the impact of an early "Return-to-work" after cancer consultation for patients with hematological malignancies. It is defined as the percentage of patients having returned to work, including part-time work, 1 year after the inclusion visit.
7 secondary outcomes
Cumulative incidence of return-to-work at 1 year
Time frame: 12 months
Change or not of the professional situation in the 2 arms
Time frame: 12 months
Factors influencing return to work
Time frame: 12 months
Quality of life (SF-12 score) evolution
Time frame: Baseline, 3 months, 6 months and 12 months
Anxiety and depression (HAD scale) evolution
Time frame: Baseline , 3 months, 6 months and 12 months
Return-to-work self-efficacy (RTW-SE-11 scale) evolution
Time frame: Baseline, 3 months, 6 months and 12 months
Self-assessment of the benefit of the "return-to-work after cancer" consultation
Time frame: 3 months and 6 months
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Jérome PAILLASSA, MD principal investigator
University Hospital, Angers
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Return-to-work after cancer" consultation in people with Leukemia and Lymphoma, run by University Hospital, Angers at 10 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 6 inclusion and 5 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Jérome PAILLASSA, MD (02 41 35 44 72 ext. +33, Jerome.Paillassa@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return-to-work rate at 1 year (percentage) (time frame: 12 months). 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 4 Sep 2026.