跳至主要内容
临床试验/NCT05355987
NCT05355987已完成不适用

Impact of Point in Time of Introducing Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma

Centre Henri Becquerel1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Comparison of quality of life evolution in outpatients with multiple myeloma between the two groups

研究概览

简要总结

Multiple myeloma is the second most frequent hematologic malignancy, which incidence augmented between 1995 and 2018, with an annual mean variation of +0.6% to 1.1%. Although treatment improved in the last years, the patients' prognostic is associated with cytogenetic abnormalities.

Oncological supportive care provides patients with a global perspective, in addition to specific medical treatment adapted to pathology and patient profile. It contributes to the improvement of quality of life of patients, throughout their care pathway regarding physical, psychological and social aspects, according to their specific needs as well as their caregivers'.

The aim of this study is to evaluate the quality of life at 6 months after multiple myeloma diagnosis in outpatients receiving paramedical consultations in oncological supportive care from the diagnosis versus outpatients receiving paramedical consultations in oncological supportive care after 6 months after diagnosis.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age superior to 18 years old
  • Patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital
  • Patient coming regularly to Centre Henri Becquerel for treatment and follow up for multiple myeloma
  • Informed consent form signed

排除标准

  • Inclusion Criteria:
  • Age superior to 18 years old
  • Patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital
  • Patient coming regularly to Centre Henri Becquerel for treatment and follow up for multiple myeloma
  • Informed consent form signed
  • Exclusion Criteria:
  • Patient with urgent need of treatment after multiple myeloma diagnosis with urgent and absolute need of oncological supportive care immediately after diagnosis
  • Patient deprived of liberty, under judicial supervision, under guardianship or trusteeship
  • History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation

结局指标

主要结局

Comparison of quality of life evolution in outpatients with multiple myeloma between the two groups

时间窗: 6 months

Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary

次要结局

  • Qualitative evaluation of quality of life(6 months)
  • Comparison of quality of life in outpatients with multiple myeloma between the two groups(9 months)
  • Comparison of autonomy evolution in outpatients with multiple myeloma between the two groups(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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