Clinical trial NCT06939322: LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Cancer Survivor
Hemato-oncologic Patients
Keywords: pediatry
oncology
hematology
radiotherapy
survivorship
preventive care
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: National Cancer Institute, France
First posted: 2025-04-22
Enrollment: 320
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization WITH vs WITHOUT use of the software LOG-AFTER designed for survivorship
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PPAC adherence
timeFrame: 3 years
Secondary outcomes:
measure: PPAC adherence for survivors of brain tumor treated, at least, with radiotherapy
timeFrame: 3 years
measure: Health status
timeFrame: 3 years
measure: PPAC adherence for new cancer survivors partients starting long term follow-up
timeFrame: 3 years
measure: PPAC adherence for cancer survivors already involved in long term follow-up before the study
timeFrame: 3 years
measure: Describe the patient satisfaction
timeFrame: 3 years
measure: GP satisfaction
timeFrame: 3 years
measure: Describe the use
timeFrame: 3 years
measure: Empowerment
timeFrame: 3 years
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
state: Maine Et Loire
Study officials:
affiliation: University Hospital of Angers
name: Charlotte DEMOOR-GOLDSCHMIDT, Dr
role: PRINCIPAL_INVESTIGATOR
References: