Personalized Massive Online Open Course After Childhood Cancer

Long-Term Survivors Clinical Trial

— START_MOOC2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05233189
• Other study ID #: 21CH173
• Secondary ID: 2021-A02453-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Claire BERGER, MD-PHD
• Phone: (0)4 77 82 86 55
• Email: claire.berger[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 532
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Long-Term Survivors

Intervention

Other:
• 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.
• No intervention
Patients will be followed up until 18 months only

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions of former patients with overall adherence to their recommended care pathway.	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.	MONTH 18
Secondary	Level of knowledge of former patients on recommended care pathway.	The quiz concerns 3 modules : "Taking care of yourself after childhood cancer," "Feeling good about yourself, feeling good about yourself," and "Fertility: talking about it!". Global score = 300.; For each of the 8 specific modules assigned in a personalized way according to the former patients, the average score of the corresponding quiz, also presented in the form of a percentage of correct answers.	Month 18