Personalized Massive Online Open Course After Childhood Cancer (START_MOOC2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Long-Term Survivors
• Intervention / Treatment: Other: MOOC; Other: No intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 532
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Other: No intervention; Patients will be followed up until 18 months only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Claire BERGER, PHD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: childhood cancer; Long-term follow-up; massive online open course
• Other Study ID Numbers: 21CH173; 2021-A02453-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No