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临床试验/NCT05048771
NCT05048771Unknown不适用

Fertility and Temporality in Pediatric Oncology

Central Hospital, Nancy, France5 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
5
主要终点
Evaluate the impact of infertility on psychological health

研究概览

简要总结

Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Immediately after the diagnosis, a fertility preservation consultation is proposed to discuss fertility preservation options. In practice, it is often difficult to organize.

Several years after the end of treatments, a second information consultation is proposed to inform about fertility, evaluate the fertility status and propose a second line of Fertility Preservation when possible. The literature reflects a lack of knowledge regarding the degree of fertility-related distress among pediatric cancer patients as well as insufficient tools at the disposal of medical doctors and nurses to discuss about reproduction with children and young adolescents.

Project objective: Understand how young cancer patients and their parents felt about sterility risk at the diagnostic time and now as cured adolescents.

Patients & Methods:

300 patients (15-25 years) from 5 different centers (20 patients per year and per center for 3 years) will be included in this study at the information consultation. They will be surveyed through self-administered questionnaires and semidirected interviews that will 1) retrieve perceptions and emotional being of children during the fertility preservation consultation; 2) assess the decision-making process of parents and family since the fertility preservation consultation through the patient's speech; 3) interview the patients about personal history and experience of cancer and consequences of potential fertility impairment and 4) survey the current experience and projections in the future and evaluate their reaction to the proposition of a second line of Fertility Preservation.

Expected results: what points should the doctor / psychologist discuss with pediatric cancer survivors in response to their fertility stress? and how to do it? for better initial and follow-up care to improve their quality of life after cancer.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age between 15 -25
  • having been diagnosed with cancer during childhood or adolescence,
  • having finished the treatments and being in remission for at least 2 years

排除标准

  • Recurrence of cancer at the time of the study
  • Lack of cognitive autonomy to be able to agree to participate in the study

结局指标

主要结局

Evaluate the impact of infertility on psychological health

时间窗: december 2023

Patients will report the outcomes of the infertility risks on the questionnaire provided in this study. Positive and negative impacts will be questioned.

次要结局

  • Develop a decision aid tool for clinicians designed to increase referral for fertility preservation(december 2023)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabelle KOSCINSKI

Principal Investigator

Central Hospital, Nancy, France

研究点 (5)

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