Long-Term SurvivorsSTART_MOOC2NCT05233189
Personalized Massive Online Open Course After Childhood Cancer
A study testing MOOC in people with Long-Term Survivors, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Long-Term Survivors
- What is being tested?
- MOOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Long-Term Survivors
- Being tested
- MOOC, No intervention
- Keywords
- Long-term follow-up, childhood cancer, massive online open course
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOOCOther
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 interventionOther
Patients will be followed up until 18 months only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MONTH 18
Secondary outcomes (1)
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.
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start30 Apr 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-Term SurvivorsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire BERGER, PHD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233189
- Sponsor's protocol ID
- 21CH173
- Other IDs
- 2021-A02453-38
- Acronym
- START_MOOC2
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Massive Online Open Course After Childhood Cancer: Impact Study START-MOOC2
- ClinicalTrials.gov ID
- NCT05233189
- Acronym / sponsor ID
- START_MOOC2 / 21CH173
- Conditions
- Long-Term Survivors
- Keywords
- Long-term follow-up, childhood cancer, massive online open course
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| With the MOOC "Childhood cancer, living well, after" | Experimental | Other: MOOCQuantify 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. |
| Without the MOOC "Childhood cancer, living well, after" | Active comparator | Other: No interventionQuantify 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOOCRegistrants 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. | Other | With the MOOC "Childhood cancer, living well, after" |
| No interventionPatients will be followed up until 18 months only | Other | Without the MOOC "Childhood cancer, living well, after" |
Primary outcome
Proportions of former patients with overall adherence to their recommended care pathway.
Time frame: MONTH 18
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.
1 secondary outcome
Level of knowledge of former patients on recommended care pathway.
Time frame: Month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire BERGER, PHD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOOC in people with Long-Term Survivors, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of former patients with overall adherence to their recommended care pathway. (time frame: MONTH 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.