Pediatric CancerLOG-INCT06939322
LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact Study)
A study testing Use of the Log-AFTER software in people with Pediatric Cancer and Cancer Survivor, run by University Hospital, Angers at 1 site in France.
Trial summary
Childhood cancer survivors represent a high-risk population that requires risk-based follow-up. Follow-up recommendations have been harmonized. Education and information practices regarding follow-up recommendations should be personalized, to ensure understanding by all survivors, including those with neurocognitive… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pediatric Cancer, Cancer Survivor, Hemato-oncologic Patients
- What is being tested?
- Use of the Log-AFTER software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2025to 6 Jun 2030
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously treated for cancer or malignant hematological pathology before the age of 25
- Without residual disease or with a stable disease without treatment for 5 years or more
- Owning a computer, smartphone or equivalent I-Pad/tablet with internet access
- Having signed the consent (or their parents if the patient is a minor, or a third party if necessary)
- Having 3 or more recommended screenings in their survivorship care plan
- No access created to LOG-AFTER before the study or having never connected after opening their account if opening an account dating back 24 months or more at the time of inclusion
Who cannot join
- Patient who has relapsed or developed a second cancer with a post-treatment delay < 5 years
- Patient not covered by a health insurance
- Patient subject to a legal protection measure, patient deprived of liberty by judicial or administrative decision, patient subject to psychiatric care under duress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers, Maine Et Loire, 49933
Charlotte DEMOOR-GOLDSCHMIDT, Dr, (+33)2 41 35 38 63 ext. +33, Charlotte.DemoorGoldschmidt@chu-angers.fr
Pascal VEILLON, project manager, (+33)2 41 35 49 59 ext. +33, paveillon@chu-angers.fr
About this study
Official title: LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact Study) / Etude d'Impact du Logiciel LOG-AFTER Sur le Suivi à Long Terme Des Anciens Patients (LOG-I - LOG-Impact Study)
Childhood cancer survivors represent a high-risk population that requires risk-based follow-up. Follow-up recommendations have been harmonized. Education and information practices regarding follow-up recommendations should be personalized, to ensure understanding by all survivors, including those with neurocognitive disorders. Individualized follow-up is necessary to detect complications that may increase morbidity and decrease quality of life, or even increase the risk of early mortality.
In France, the LOG-AFTER software was developed in 2017 by university hospital of Angers and Epiconcept (approved health data host). The main differences with the European procedure concern radiotherapy information, the link with the General practitioner (GP), and the possible addition of information and/or access to therapeutic education in a video format. Indeed, there is the possibility of creating an GP account allowing to receive notifications concerning the follow-up of his patient to be scheduled, to have access to his file summary and his personalized follow-up plan, various information and blank prescription models. LOG-I is a study of the impact of the LOG-AFTER software for the "patient/GP" couple on adherence to follow-up recommendations. LOG-I is interested in all former patients with at least 3 recommendations in their personalized follow-up plan, taking into account the specific population of patients cured of a brain tumor.
Read the detailed description
Recruitment as long-term follow-up consultations progress. After checking the selection criteria, the investigator informs the patient of the study or the parents of the minor child orally and in writing with delivery of the information letter and answers any questions. If the patient, or their parents for minor patients, agrees to participate, the informed consent form is signed in 2 copies by the different parties. The date of the information and the date of signature of the consent are documented in the patient's source file. Following the inclusion of the patient, randomization is carried out (WITH and WITHOUT use of the LOG-AFTER software).
During this visit, for patients randomized in the LOG-AFTER software, an account is created within 5 days following the consultation.
For all patients (randomized with or without access to LOG-AFTER) the following data are collected in LOG-AFTER:
- Health data: type of first cancer, start and end dates of treatment
- Patient data required for research: gender, month and year of birth, after-effects, psychosocial data (level of education, life as a couple and children if concerned, profession if concerned).
The module to help create the Personalized After-Cancer Plan (PPAC) can be used for everyone and the PPAC is recorded in LOG-AFTER.
The PAM-13 questionnary is completed by the patient.
Contact with the GP : Following the patient's inclusion and randomization in the "WITH access to LOG-after" group, his GP is informed by mail and telephone call. He receives his codes by email via the software.
Patient follow-up : It is organized according to the habits of the specialist and/or his general practitioner.
For patients randomized with access to LOG-AFTER, patients are advised to report the completion of the examinations (date and overall conclusion of the examination), which allows the software to function properly. The GP is also advised to report any consultations his patient has had with him and to update the date of the examinations if his patient has not done so.
Visit at 36 months (+/- 3 months) • For patients randomized to the "LOG-AFTER" group: The patient is contacted 3 years after inclusion by the clinical research associate or reviewed in consultation by the doctor. The follow-up data according to the PPAC are updated if necessary in LOG-AFTER. If necessary, the PPAC can be updated and modified.
The satisfaction questionnaries (Software and Care Pathway) are given (paper format or via the software) to patients and GP. The PAM-13 questionnary is completed again by the patient. A telephone call (doctor or research associate) is made 2 weeks later if not completed with a proposal to do it by telephone.
- For patients randomized to the "usual care" group: The patient is contacted 3 years after inclusion by the clinical research associate or reviewed in consultation by the doctor. The follow-up data according to the PPAC are collected in LOG-AFTER. A satisfaction questionnary on the care pathway (paper format or via software) is sent to patients and GP. The PAM-13 questionnaire is completed again by the patient. A telephone call (doctor or research associate) is made 2 weeks later if not completed with a proposal to do it by telephone.
At the end, an account is created for the patient/GP couple if the patient wishes.
- Conditions
- Pediatric Cancer, Cancer Survivor, Hemato-oncologic Patients
- Being tested
- Use of the Log-AFTER software
- Keywords
- pediatry, oncology, hematology, radiotherapy, survivorship, preventive care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Log-AFTER softwareOther
The LOG-AFTER software is used for long-term follow-up care after cancer to empower patients
| Study group | Role | What they receive |
|---|---|---|
| Use of the software Log-AFTER | Experimental | Patients are monitored with the help of LOG-AFTER software. Patients are advised to report the completion of the examinations (date and overall conclusion), which allows the software to function properly. The GP is also advised to report any consultations his patient has had with him and to update the date of the examinations if his patient has not done so. Receives: Other: Use of the Log-AFTER software |
| WITHOUT Log-After | No intervention | Patients are monitored without the LOG-AFTER software. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPAC adherence
Evaluate the impact of LOG-AFTER on former patients' adherence to the Personalized After-Cancer Plan (PPAC) for those with at least 3 follow-up examinations.
(Adherence = For a number of screens between three and six (3-6), adherence is considered adequate if all screens or all but one screen have been completed. For seven or more screens (>7), it is considered adequate if all screens or all but two screens have been completed)
Measured: 3 years
Secondary outcomes (8)
PPAC adherence for survivors of brain tumor treated, at least, with radiotherapy
Evaluate the impact of LOG-AFTER on the adherence of former brain tumor patients who received radiotherapy to the Personalized After-Cancer Plan (PPAC) for those with at least 3 follow-up examinations. (Adherence = For a number of screens between three and six (3-6), adherence is considered adequate if all screens or all but one screen have been completed. For seven or more screens (>7), it is considered adequate if all screens or all but two screens have been completed)
Measured: 3 years
Health status
Establish a descriptive overview of the health status of former patients based on the treatment received =>Descriptive analysis of complications classified by Common Terminology Criteria for Adverse Events (CTCAE) score, including fatigue and cognitive impairment.
The CTCAE is divided into 5 grades (from grade 1 = Mild; asymptomatic or mild symptoms; diagnosed by clinical examination only; not requiring treatment; to grade 5 = Death related to the adverse event.
Measured: 3 years
PPAC adherence for new cancer survivors partients starting long term follow-up
Describe the impact of LOG-AFTER on the adherence of new cancer survivors starting long term follow-up (Adherence = For a number of screens between three and six (3-6), adherence is considered adequate if all screens or all but one screen have been completed. For seven or more screens (>7), it is considered adequate if all screens or all but two screens have been completed)
Measured: 3 years
PPAC adherence for cancer survivors already involved in long term follow-up before the study
Describe the impact of LOG-AFTER on the adherence of cancer survivors who are not new in long term follow-up (Adherence = For a number of screens between three and six (3-6), adherence is considered adequate if all screens or all but one screen have been completed. For seven or more screens (>7), it is considered adequate if all screens or all but two screens have been completed)
Measured: 3 years
Describe the patient satisfaction
- satisfaction score from the questionnaire derived from u-MARS for patients randomised with LOG-AFTER.
- overall subjective score between 1 and 5 for patients randomised with LOG-AFTER.
- qualitative aspect - open field questions, comments
- qualitative aspect concerning the care pathway
Measured: 3 years
GP satisfaction
Satisfaction via questionnary derived from of the MARS (Mobile Application Rating Scale) (professionals) for those with access to LOG-AFTER.
Overall subjective score between 1 (not satified) and 5 (completely satisfied) for those with access to LOG-AFTER.
Qualitative aspect (free field)
Measured: 3 years
Describe the use
- number of connections per user
- number of connections per of account closures
- number of inactive accounts (no use during 6 months or more)
Measured: 3 years
Empowerment
Patient Activation Measure® (PAM®)-13. The score can be 0 (patient not activated) to 100 (patient activated)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start6 Jun 2025
- Primary completion6 Nov 2026 (estimated)
- Study completion6 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- 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
- Randomization WITH vs WITHOUT use of the software LOG-AFTER designed for survivorship
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Charlotte DEMOOR-GOLDSCHMIDT, Dr, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939322
- Sponsor's protocol ID
- 49RC25_0035
- Other IDs
- 2025-A00237-42
- Acronym
- LOG-I
- Status last verified
- Jun 2025
- First submitted
- 6 Mar 2025
- Last updated
- 2 Jul 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact Study) / Etude d'Impact du Logiciel LOG-AFTER Sur le Suivi à Long Terme Des Anciens Patients (LOG-I - LOG-Impact Study)
- ClinicalTrials.gov ID
- NCT06939322
- Acronym / sponsor ID
- LOG-I / 49RC25_0035
- Conditions
- Pediatric Cancer, Cancer Survivor, Hemato-oncologic Patients
- Keywords
- pediatry, oncology, hematology, radiotherapy, survivorship, preventive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- National Cancer Institute, France
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 6 Jun 2030 (estimated)
- First posted
- 22 Apr 2025 (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.
Childhood cancer survivors represent a high-risk population that requires risk-based follow-up. Follow-up recommendations have been harmonized. Education and information practices regarding follow-up recommendations should be personalized, to ensure understanding by all survivors, including those with neurocognitive disorders. Individualized follow-up is necessary to detect complications that may increase morbidity and decrease quality of life, or even increase the risk of early mortality.
In France, the LOG-AFTER software was developed in 2017 by university hospital of Angers and Epiconcept (approved health data host). The main differences with the European procedure concern radiotherapy information, the link with the General practitioner (GP), and the possible addition of information and/or access to therapeutic education in a video format. Indeed, there is the possibility of creating an GP account allowing to receive notifications concerning the follow-up of his patient to be scheduled, to have access to his file summary and his personalized follow-up plan, various information and blank prescription models. LOG-I is a study of the impact of the LOG-AFTER software for the "patient/GP" couple on adherence to follow-up recommendations. LOG-I is interested in all former patients with at least 3 recommendations in their personalized follow-up plan, taking into account the specific population of patients cured of a brain tumor.
Detailed description
Recruitment as long-term follow-up consultations progress. After checking the selection criteria, the investigator informs the patient of the study or the parents of the minor child orally and in writing with delivery of the information letter and answers any questions. If the patient, or their parents for minor patients, agrees to participate, the informed consent form is signed in 2 copies by the different parties. The date of the information and the date of signature of the consent are documented in the patient's source file. Following the inclusion of the patient, randomization is carried out (WITH and WITHOUT use of the LOG-AFTER software).
During this visit, for patients randomized in the LOG-AFTER software, an account is created within 5 days following the consultation.
For all patients (randomized with or without access to LOG-AFTER) the following data are collected in LOG-AFTER:
- Health data: type of first cancer, start and end dates of treatment
- Patient data required for research: gender, month and year of birth, after-effects, psychosocial data (level of education, life as a couple and children if concerned, profession if concerned).
The module to help create the Personalized After-Cancer Plan (PPAC) can be used for everyone and the PPAC is recorded in LOG-AFTER.
The PAM-13 questionnary is completed by the patient.
Contact with the GP : Following the patient's inclusion and randomization in the "WITH access to LOG-after" group, his GP is informed by mail and telephone call. He receives his codes by email via the software.
Patient follow-up : It is organized according to the habits of the specialist and/or his general practitioner.
For patients randomized with access to LOG-AFTER, patients are advised to report the completion of the examinations (date and overall conclusion of the examination), which allows the software to function properly. The GP is also advised to report any consultations his patient has had with him and to update the date of the examinations if his patient has not done so.
Visit at 36 months (+/- 3 months) • For patients randomized to the "LOG-AFTER" group: The patient is contacted 3 years after inclusion by the clinical research associate or reviewed in consultation by the doctor. The follow-up data according to the PPAC are updated if necessary in LOG-AFTER. If necessary, the PPAC can be updated and modified.
The satisfaction questionnaries (Software and Care Pathway) are given (paper format or via the software) to patients and GP. The PAM-13 questionnary is completed again by the patient. A telephone call (doctor or research associate) is made 2 weeks later if not completed with a proposal to do it by telephone.
- For patients randomized to the "usual care" group: The patient is contacted 3 years after inclusion by the clinical research associate or reviewed in consultation by the doctor. The follow-up data according to the PPAC are collected in LOG-AFTER. A satisfaction questionnary on the care pathway (paper format or via software) is sent to patients and GP. The PAM-13 questionnaire is completed again by the patient. A telephone call (doctor or research associate) is made 2 weeks later if not completed with a proposal to do it by telephone.
At the end, an account is created for the patient/GP couple if the patient wishes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization WITH vs WITHOUT use of the software LOG-AFTER designed for survivorship
| Arm | Type | Receives |
|---|---|---|
| Use of the software Log-AFTER | Experimental | Other: Use of the Log-AFTER softwarePatients are monitored with the help of LOG-AFTER software. Patients are advised to report the completion of the examinations (date and overall conclusion), which allows the software to function properly. The GP is also advised to report any consultations his patient has had with him and to update the date of the examinations if his patient has not done so. |
| WITHOUT Log-After | No intervention | –Patients are monitored without the LOG-AFTER software. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Previously treated for cancer or malignant hematological pathology before the age of 25
- Without residual disease or with a stable disease without treatment for 5 years or more
- Owning a computer, smartphone or equivalent I-Pad/tablet with internet access
- Having signed the consent (or their parents if the patient is a minor, or a third party if necessary)
- Having 3 or more recommended screenings in their survivorship care plan
Key exclusion criteria (3 listed)
- Patient who has relapsed or developed a second cancer with a post-treatment delay < 5 years
- Patient not covered by a health insurance
- Patient subject to a legal protection measure, patient deprived of liberty by judicial or administrative decision, patient subject to psychiatric care under duress
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 |
|---|---|---|
| Use of the Log-AFTER softwareThe LOG-AFTER software is used for long-term follow-up care after cancer to empower patients | Other | Use of the software Log-AFTER |
Primary outcome
PPAC adherence
Time frame: 3 years
Evaluate the impact of LOG-AFTER on former patients' adherence to the Personalized After-Cancer Plan (PPAC) for those with at least 3 follow-up examinations. (Adherence = For a number of screens between three and six (3-6), adherence is considered adequate if all screens or all but one screen have been completed. For seven or more screens (>7), it is considered adequate if all screens or all but two screens have been completed)
8 secondary outcomes
PPAC adherence for survivors of brain tumor treated, at least, with radiotherapy
Time frame: 3 years
Health status
Time frame: 3 years
PPAC adherence for new cancer survivors partients starting long term follow-up
Time frame: 3 years
PPAC adherence for cancer survivors already involved in long term follow-up before the study
Time frame: 3 years
Describe the patient satisfaction
Time frame: 3 years
GP satisfaction
Time frame: 3 years
Describe the use
Time frame: 3 years
Empowerment
Time frame: 3 years
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 2 Jul 2025.
- Related InfoLink provided by the sponsor.
- 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.
Charlotte DEMOOR-GOLDSCHMIDT, Dr principal investigator
University Hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Log-AFTER software in people with Pediatric Cancer and Cancer Survivor, run by University Hospital, Angers 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 3 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: looking for participants now, as of the sponsor's last update on 2 Jul 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?
Contact Sandra MERZEAU ((+33)2 41 35 59 70 ext. +33, samerzeau@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPAC adherence (time frame: 3 years). 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 2 Jul 2025.