Personalized Massive Online Open Course After Childhood Cancer

NCT05233189 | Active Not Recruiting

• 2 other identifiers: 21CH1732021-A02453-38
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

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.

Conditions

Long-Term Survivors

Keywords

Long-term follow-up; childhood cancer; massive online open course

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Level of knowledge of former patients on recommended care pathway.

  Month 18

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

MOOC 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.

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

No intervention OTHER

Patients will be followed up until 18 months only

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Claire BERGER, PHD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: "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

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: April 30, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)