RAT-HEMATO : Return to Work After Malignant Hemopathy
- Conditions
- LymphomaMultiple MyelomaLeukemia
- Interventions
- Other: "Return-to-work after cancer" consultation
- Registration Number
- NCT06262789
- Lead Sponsor
- University Hospital, Angers
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 264
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental arm with "return-to-work after cancer" consultation "Return-to-work after cancer" consultation -
- Primary Outcome Measures
Name Time Method Return-to-work rate at 1 year (percentage) 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.
- Secondary Outcome Measures
Name Time Method Quality of life (SF-12 score) evolution 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.Change or not of the professional situation in the 2 arms 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.
Return-to-work self-efficacy (RTW-SE-11 scale) evolution 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.Self-assessment of the benefit of the "return-to-work after cancer" consultation 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).Cumulative incidence of return-to-work at 1 year 12 months It is measured by the cumulative incidence rate of return-to-work at 1 year
Factors influencing return to work 12 months The factors investigated are type of hematological malignancy, sex, type of profession, presence of anxio-depressive disorders
Anxiety and depression (HAD scale) evolution 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.
Trial Locations
- Locations (7)
Centre Henri Becquerel
🇫🇷Rouen, France
Rouen University Hospital
🇫🇷Rouen, France
Angers University hospital
🇫🇷Angers, France
Brest University Hospital, Morvan Site
🇫🇷Brest, France
Rennes University Hospital, Pontchaillou site
🇫🇷Rennes, France
Caen University hospital
🇫🇷Caen, France
Tours University Hospital, Bretonneau Site
🇫🇷Tours, France