RAT-HEMATO : Return to Work After Malignant Hemopathy

Обзор

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.

Вмешательства

• Другое "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 ap

Первичные конечные точки

• Return-to-work rate at 1 year (percentage) [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Cumulative incidence of return-to-work at 1 year [Срок оценки: 12 months]
• Change or not of the professional situation in the 2 arms [Срок оценки: 12 months]
• Factors influencing return to work [Срок оценки: 12 months]
• Quality of life (SF-12 score) evolution [Срок оценки: Baseline, 3 months, 6 months and 12 months]
• Anxiety and depression (HAD scale) evolution [Срок оценки: Baseline , 3 months, 6 months and 12 months]
• Return-to-work self-efficacy (RTW-SE-11 scale) evolution [Срок оценки: Baseline, 3 months, 6 months and 12 months]
• Self-assessment of the benefit of the "return-to-work after cancer" consultation [Срок оценки: 3 months and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 7 центров

• Angers University hospital — Angers
• Brest University Hospital, Morvan Site — Brest
• Caen University hospital — Caen
• Rennes University Hospital, Pontchaillou site — Rennes
• Centre Henri Becquerel — Rouen
• Rouen University Hospital — Rouen
• Tours University Hospital, Bretonneau Site — Tours

Идентификаторы

NCT: NCT06262789 · 49RC23_0011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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