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Not yet recruiting NCT06262789

RAT-HEMATO : Return to Work After Malignant Hemopathy

No phase Interventional Leukemia Lymphoma Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: "Return-to-work after cancer" consultation.
Who it may be relevant to
Registry conditions: Leukemia, Lymphoma, Multiple Myeloma. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other "Return-to-work after cancer" consultation
    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 ap

Primary outcome measures

  • Return-to-work rate at 1 year (percentage) [Time frame: 12 months]
Secondary outcome measures (7)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 7 centers
  • Angers University hospital — Angers
  • Brest University Hospital, Morvan Site — Brest
  • Caen University hospital — Caen
  • Rennes University Hospital, Pontchaillou site — Rennes
  • Centre Henri Becquerel — Rouen
  • Rouen University Hospital — Rouen
  • Tours University Hospital, Bretonneau Site — Tours

Identifiers

NCT: NCT06262789 · 49RC23_0011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗