Clinical trial NCT05233189: Personalized Massive Online Open Course After Childhood Cancer
Official title: Personalized Massive Online Open Course After Childhood Cancer: Impact Study START-MOOC2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Long-Term Survivors
Keywords: Long-term follow-up
childhood cancer
massive online open course
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "Cohort multiple randomised controlled trial" design. Patients randomized "no MOOC" group will not be aware of the MOOC. Patients randomized group "with MOOC" will be composed of all former patients who will be offered the MOOC, whether they accept it or not
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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,
* Pregnant

Primary outcomes:
measure: Proportions of former patients with overall adherence to their recommended care pathway.
timeFrame: MONTH 18
Secondary outcomes:
measure: Level of knowledge of former patients on recommended care pathway.
timeFrame: Month 18
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Claire BERGER, PHD
role: PRINCIPAL_INVESTIGATOR
References: