Clinical trial NCT06262789: RAT-HEMATO : Return to Work After Malignant Hemopathy
Official title: RAT-HEMATO : Return to Work After Malignant Hemopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Leukemia
Lymphoma
Multiple Myeloma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-02-16
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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

Primary outcomes:
measure: Return-to-work rate at 1 year (percentage)
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative incidence of return-to-work at 1 year
timeFrame: 12 months
measure: Change or not of the professional situation in the 2 arms
timeFrame: 12 months
measure: Factors influencing return to work
timeFrame: 12 months
measure: Quality of life (SF-12 score) evolution
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Anxiety and depression (HAD scale) evolution
timeFrame: Baseline , 3 months, 6 months and 12 months
measure: Return-to-work self-efficacy (RTW-SE-11 scale) evolution
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Self-assessment of the benefit of the "return-to-work after cancer" consultation
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University hospital
city: Brest
country: France
facility: Brest University Hospital, Morvan Site
city: Caen
country: France
facility: Caen University hospital
city: Rennes
country: France
facility: Rennes University Hospital, Pontchaillou site
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: Rouen University Hospital
city: Tours
country: France
facility: Tours University Hospital, Bretonneau Site
Study officials:
affiliation: University Hospital, Angers
name: Jérome PAILLASSA, MD
role: PRINCIPAL_INVESTIGATOR
References: