RAT-HEMATO : Return to Work After Malignant Hemopathy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06262789
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Angers
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jérome PAILLASSA, MD
Principal Investigator Affiliation University Hospital, Angers
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Leukemia, Lymphoma, Multiple Myeloma
Arms & Interventions

Arms

Experimental: Experimental arm with "return-to-work after cancer" consultation

No Intervention: Standard arm without with "return-to-work after cancer" consultation

Patient are treated according to usual care, according to local practice.

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 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Angers University hospital, Angers, France

Status

Address

Angers University hospital

Angers, ,

Site Contact

PAILLASSA Jérome, MD

jerome.paillassa@chu-angers.fr

02.41.35.45.24 #+33

Brest University Hospital, Morvan Site, Brest, France

Status

Address

Brest University Hospital, Morvan Site

Brest, ,

Site Contact

Marie-Anne Couturier, MD

marie-anne.couturier@chu-brest.fr

02.98.22.30.37

Caen University hospital, Caen, France

Status

Address

Caen University hospital

Caen, ,

Site Contact

Ghandi Laurent DAMAJ, MD

damaj-gl@chu-caen.fr

02.31.27.21.40 #+33

Rennes, France

Status

Address

Rennes University Hospital, Pontchaillou site

Rennes, ,

Site Contact

Roch HOUOT, MD

roch.houot@chu-rennes.fr

02.99.28.42.91 #+33

Centre Henri Becquerel, Rouen, France

Status

Address

Centre Henri Becquerel

Rouen, ,

Site Contact

Stéphane LEPRETRE, MD

stephane.lepretre@chb.unicancer.fr

02.32.08.22.23 #+33

Rouen University Hospital, Rouen, France

Status

Address

Rouen University Hospital

Rouen, ,

Site Contact

Laetitia ROLLIN, MD

laetitia.rollin@chu-rouen.fr

02.32.88.82.69

Tours, France

Status

Address

Tours University Hospital, Bretonneau Site

Tours, ,

Site Contact

Emmanuel GYAN

e.gyan@chu-tours.fr

02.47.47.38.11