RAT-HEMATO : Return to Work After Malignant Hemopathy

NCT06262789 | Not Yet Recruiting

• 1 other identifier: 49RC23_0011
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 7

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.

Conditions

Leukemia; Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Return-to-work rate at 1 year (percentage)

  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 Outcomes (7)

• Cumulative incidence of return-to-work at 1 year

  12 months

• Change or not of the professional situation in the 2 arms

  12 months

• Factors influencing return to work

  12 months

• Quality of life (SF-12 score) evolution

  Baseline, 3 months, 6 months and 12 months

• Anxiety and depression (HAD scale) evolution

  Baseline , 3 months, 6 months and 12 months

Study Arms (2)

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

EXPERIMENTAL

Other: "Return-to-work after cancer" consultation

Standard arm without with "return-to-work after cancer" consultation

NO INTERVENTION

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

Interventions

"Return-to-work after cancer" consultation OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (7)

Angers University hospital

Angers, France

Location

Brest University Hospital, Morvan Site

Brest, France

Location

Caen University hospital

Caen, France

Location

Rennes University Hospital, Pontchaillou site

Rennes, France

Location

Centre Henri Becquerel

Rouen, France

Location

Rouen University Hospital

Rouen, France

Location

Tours University Hospital, Bretonneau Site

Tours, France

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Jérome PAILLASSA, MD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérome PAILLASSA, MD

CONTACT

02 41 35 44 72; Jerome.Paillassa@chu-angers.fr

Aline SCHMIDT, MD

CONTACT

02 41 35 44 82; AlSchmidt@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 16, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)