LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact Study) (LOG-I)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Survivor; Pediatric Cancer; Hemato-oncologic Patients
• Intervention / Treatment: Other: Use of the Log-AFTER software

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 Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra MERZEAU; Phone Number: +33 (+33)2 41 35 59 70; Email: samerzeau@chu-angers.fr
• Study Contact Backup: Name: Pascal VEILLON; Phone Number: +33 (+33)2 41 35 49 59; Email: paveillon@chu-angers.fr

Study Locations

• France
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49933
      • Recruiting
      • University hospital of Angers
      • Contact: Charlotte DEMOOR-GOLDSCHMIDT, Dr; Phone Number: +33 (+33)2 41 35 38 63; Email: Charlotte.DemoorGoldschmidt@chu-angers.fr
      • Contact: Pascal VEILLON, project manager; Phone Number: +33 (+33)2 41 35 49 59; Email: paveillon@chu-angers.fr
      • Principal Investigator: Charlotte DEMOOR-GOLDSCHMIDT, Dr
      • Principal Investigator: Natacha ENTZ-WERLE, Pr
      • Principal Investigator: Amandine BERTRAND, Dr
      • Principal Investigator: Eric THEBAULT, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of the software Log-AFTER; 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.	Other: Use of the Log-AFTER software; The LOG-AFTER software is used for long-term follow-up care after cancer to empower patients
No Intervention: WITHOUT Log-After; Patients are monitored without the LOG-AFTER software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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)	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)	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	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)	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)	3 years
Empowerment	Patient Activation Measure® (PAM®)-13. The score can be 0 (patient not activated) to 100 (patient activated)	3 years

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: National Cancer Institute, France
• Investigators: Principal Investigator: Charlotte DEMOOR-GOLDSCHMIDT, Dr, University hospital of Angers

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): June 6, 2030

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: oncology; radiotherapy; survivorship; preventive care; hematology; pediatry
• Other Study ID Numbers: 49RC25_0035; 2025-A00237-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No