跳至主要内容
临床试验/NCT05233189
NCT05233189进行中(未招募)不适用

Personalized Massive Online Open Course After Childhood Cancer: Impact Study START-MOOC2

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 532 人开始时间: 2024年4月30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)
入组人数
532
试验地点
2
主要终点
Proportions of former patients with overall adherence to their recommended care pathway.

研究概览

简要总结

Many studies have shown Childhood Cancer Survivors (CCS) are ill-informed about long-term follow-up (LTFU). Massive open online courses (MOOCs) could easily allow a deployment at an international level and make reliable information available for all CCS, wherever they live. The MOOC team (specialists of LTFU care, communication professionals and CCS associations), bringing together nearly 130 people, designed a MOOC named "Childhood Cancer, Living Well, After" including three modules addressing transversal issues (lifestyle, psychological support, fertility problems) and eight modules covering organ-specific problems.

详细描述

Detailed data on childhood cancer treatments were used during a study of feasibility in spring 2020 to allocate specific modules to each participant. The aim of the present study is to quantify the impact of this MOOC on the CCS knowledge about LTFU adapted to their own medical history, but also to measure how this MOOC can improve the LTFU care of each CCS.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient affiliated or entitled to a social security plan,
  • Former patient included in the Childhood Cancer Observation Platform (CCOP) for pediatric cancer or leukemia (<15 years of age) between 2000 and 2010 with at least five years free of anticancer treatment
  • Availability of computerized and validated treatment data in the Childhood Cancer Observation Platform (CCOP),
  • A subject who has received informed information about the study and digitally signed the online express consent for subjects participating in the MOOC, and digitally signed the online express consent to continue for subjects not participating in the MOOC
  • A subject who completed an initial COHOPER survey from Childhood Cancer Observation Platform (CCOP) online self-questionnaire
  • Subject who has accepted that data collected as part of the COHOPER survey (including french national health data system (SNDS)) may be reused for scientific research purposes and shared with other research teams,

排除标准

  • A subject having already been drawn for the START-MOOC1 feasibility study,
  • A subject for whom a doubt, validated by the study coordinating physician, persists on the exact treatment received in childhood and does not allow the allocation of specific modules with certainty,
  • A subject who has had several cancers and whose anticancer therapies are not all known,
  • A subject who has not been treated in one of the participating referral centers,
  • Subject having expressed opposition to the french national health data system (SNDS) interrogation following the sending of the information letter or share the data with other research teams,

结局指标

主要结局

Proportions of former patients with overall adherence to their recommended care pathway.

时间窗: MONTH 18

The impact of the MOOC will be measured qualitatively by comparing the two groups "with MOOC" and "without MOOC" of the proportions of former patients with an overall adherence to the care pathway recommended to them.

次要结局

  • Level of knowledge of former patients on recommended care pathway.(Month 18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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