RAT-HEMATO : Return to Work After Malignant Hemopathy (RAT-HEMATO)

September 1, 2026 updated by: University Hospital, Angers
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
      • Brest, France
      • Caen, France
        • Not yet recruiting
        • Caen University hospital
        • Contact:
      • Cholet, France
        • Not yet recruiting
        • Service Hématologie, Cholet Hospital
        • Contact:
      • Montivilliers, France
        • Not yet recruiting
        • Le Havre Hospital Group
        • Contact:
      • Morlaix, France
        • Not yet recruiting
        • Pays de Morlaix Hospital
        • Contact:
      • Rennes, France
        • Not yet recruiting
        • Rennes University Hospital, Pontchaillou site
        • Contact:
      • Rouen, France
      • Rouen, France
        • Not yet recruiting
        • Rouen University Hospital
        • Contact:
      • Tours, France
        • Recruiting
        • Tours University Hospital, Bretonneau Site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm with "return-to-work after cancer" consultation
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 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.
No Intervention: Standard arm without with "return-to-work after cancer" consultation
Patient are treated according to usual care, according to local practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of return-to-work at 1 year
Time Frame: 12 months
It is measured by the cumulative incidence rate of return-to-work at 1 year
12 months
Change or not of the professional situation in the 2 arms
Time Frame: 12 months
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.
12 months
Factors influencing return to work
Time Frame: 12 months
The factors investigated are type of hematological malignancy, sex, type of profession, presence of anxio-depressive disorders
12 months
Quality of life (SF-12 score) evolution
Time Frame: Baseline, 3 months, 6 months and 12 months

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.
Baseline, 3 months, 6 months and 12 months
Anxiety and depression (HAD scale) evolution
Time Frame: Baseline , 3 months, 6 months and 12 months

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.
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

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.
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

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).
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Jérome PAILLASSA, MD, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC23_0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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