Trial Title:
RAT-HEMATO : Return to Work After Malignant Hemopathy
NCT ID:
NCT06262789
Condition:
Leukemia
Lymphoma
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
"Return-to-work after cancer" consultation
Description:
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.
Arm group label:
Experimental arm with "return-to-work after cancer" consultation
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria :
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Angers University hospital
Address:
City:
Angers
Country:
France
Contact:
Last name:
PAILLASSA Jérome, MD
Phone:
02.41.35.45.24
Phone ext:
+33
Email:
jerome.paillassa@chu-angers.fr
Facility:
Name:
Brest University Hospital, Morvan Site
Address:
City:
Brest
Country:
France
Contact:
Last name:
Marie-Anne Couturier, MD
Phone:
02.98.22.30.37
Email:
marie-anne.couturier@chu-brest.fr
Facility:
Name:
Caen University hospital
Address:
City:
Caen
Country:
France
Contact:
Last name:
Ghandi Laurent DAMAJ, MD
Phone:
02.31.27.21.40
Phone ext:
+33
Email:
damaj-gl@chu-caen.fr
Facility:
Name:
Rennes University Hospital, Pontchaillou site
Address:
City:
Rennes
Country:
France
Contact:
Last name:
Roch HOUOT, MD
Phone:
02.99.28.42.91
Phone ext:
+33
Email:
roch.houot@chu-rennes.fr
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Country:
France
Contact:
Last name:
Stéphane LEPRETRE, MD
Phone:
02.32.08.22.23
Phone ext:
+33
Email:
stephane.lepretre@chb.unicancer.fr
Facility:
Name:
Rouen University Hospital
Address:
City:
Rouen
Country:
France
Contact:
Last name:
Laetitia ROLLIN, MD
Phone:
02.32.88.82.69
Email:
laetitia.rollin@chu-rouen.fr
Facility:
Name:
Tours University Hospital, Bretonneau Site
Address:
City:
Tours
Country:
France
Contact:
Last name:
Emmanuel GYAN
Phone:
02.47.47.38.11
Email:
e.gyan@chu-tours.fr
Start date:
March 15, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
University Hospital, Angers
Agency class:
Other
Source:
University Hospital, Angers
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06262789
