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临床试验/NCT05731661
NCT05731661进行中(未招募)不适用

Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase

Centre Francois Baclesse1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
99
试验地点
1
主要终点
Proportion of patients who used at least one of the oncology support services recommended in the Personalized After-Cancer Care Plan within 4 months of receiving the Personalized After-Cancer Care Plan

研究概览

简要总结

While the sequelae and toxicities after ovarian and endometrial cancer treatments are well described in the literature, the actual needs of patients for supportive oncology care remain poorly documented. Moreover, there is no data available to estimate the complexity of the oncological support care actions to be implemented.

It is expected that an evaluation of the needs for supportive oncology care and its organization in day hospitalization for supportive oncology care will lead to an improvement in personalized post-cancer follow-up for these patients and to an improvement in their long-term quality of life.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient > 18 years old
  • Patient in complete remission after first-line treatment for endometrial or ovarian/fallopian tube/peritoneal cancer
  • Patient having completed her initial treatment; patients with maintenance treatments are eligible
  • Mastery of the French language
  • Patient with a telephone line
  • Patient affiliated to a social security scheme
  • Signature of informed consent before any specific procedure related to the study

排除标准

  • Any associated medical or psychiatric conditions that could compromise the patient's ability to participate in the study
  • Patient with locoregional or metastatic recurrence
  • Patient deprived of liberty, under guardianship or curatorship
  • Simultaneous participation in a therapeutic clinical trial

结局指标

主要结局

Proportion of patients who used at least one of the oncology support services recommended in the Personalized After-Cancer Care Plan within 4 months of receiving the Personalized After-Cancer Care Plan

时间窗: Up to 4 months

次要结局

  • Proportion of patients with sequelae after the initial treatment of their cancer, as well as the type and grade of the sequelae, based on the National Cancer Institute's screening grids (levels 1 and 2) during the consultation with a nurse referent(Up to 4 months)
  • Description of the types of oncological support care needs identified(Up to 4 months)
  • Proportion of patients with identified cancer care needs (at least one cancer care need to be implemented) 4 months after the submission of the Personalized Cancer Care Plan(Up to 4 months)

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (1)

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