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临床试验/NCT06262789
NCT06262789招募中不适用

RAT-HEMATO : Return to Work After Malignant Hemopathy

University Hospital, Angers15 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2024年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
264
试验地点
15
主要终点
Return-to-work rate at 1 year (percentage)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

Experimental

干预措施: "Return-to-work after cancer" consultation (Other)

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

No Intervention

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

结局指标

主要结局

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

时间窗: 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.

次要结局

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

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (15)

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