Personalized Massive Online Open Course After Childhood Cancer

NCT ID: NCT05233189

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Long-Term Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

"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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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With the MOOC "Childhood cancer, living well, after"

Quantify the impact of the MOOC's membership on the CCS knowledge about LTFU adapted to the medical history of patients and measure how this MOOC can improve the LTFU care of each CCS.

Group Type EXPERIMENTAL

MOOC

Intervention Type OTHER

Registrants will be offered a personalized e-education consisting of 3 to 11 modules adapted to the treatment received in childhood by each in the form of a MOOC entitled "Cancer in childhood, living well after" over a total duration of about 3 to 7 weeks of training.

Without the MOOC "Childhood cancer, living well, after"

Quantify the impact of the MOOC's non-membership on the CCS knowledge about LTFU adapted to the medical history of patients and measure how this MOOC can improve the LTFU care of each CCS.

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

Patients will be followed up until 18 months only

Interventions

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MOOC

Registrants will be offered a personalized e-education consisting of 3 to 11 modules adapted to the treatment received in childhood by each in the form of a MOOC entitled "Cancer in childhood, living well after" over a total duration of about 3 to 7 weeks of training.

Intervention Type OTHER

No intervention

Patients will be followed up until 18 months only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire BERGER, PHD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

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CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2021-A02453-38

Identifier Type: OTHER

Identifier Source: secondary_id

21CH173

Identifier Type: -

Identifier Source: org_study_id

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