RAT-HEMATO : Return to Work After Malignant Hemopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity Hospital, Angers
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
"Return-to-work after cancer" consultation
Other interventionThe "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.
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: Experimental arm with "return-to-work after cancer" consultationExperimental treatment 1 intervention
Group B: Standard arm without with "return-to-work after cancer" consultationNo intervention 0 interventions
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
Cumulative incidence of return-to-work at 1 year
It is measured by the cumulative incidence rate of return-to-work at 1 year
Time frame
12 months2
Change or not of the professional situation in the 2 arms
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.
Time frame
12 months3
Factors influencing return to work
The factors investigated are type of hematological malignancy, sex, type of profession, presence of anxio-depressive disorders
Time frame
12 months4
Quality of life (SF-12 score) evolution
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.
Time frame
Baseline, 3 months, 6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov