LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Use of the Log-AFTER software
Other interventionThe LOG-AFTER software is used for long-term follow-up care after cancer to empower patients
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: Use of the software Log-AFTERExperimental treatment 1 intervention
Group B: WITHOUT Log-AfterNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
3 yearsSecondary outcomes
1
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)
Time frame
3 years2
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.
Time frame
3 years3
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)
Time frame
3 years4
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)
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Angers
Lead sponsor
National Cancer Institute, France
Collaborator
Source ClinicalTrials.gov