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Clinical Trials in France / NCT05350631
Active, not recruiting Not applicable

Efficacy Study on Quality of Life Criteria of a Digital Application on Any Cellphone (OnKO-Tips&Tricks) for Adolescents and Young Adults Diagnosed With Cancer

NCT05350631 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-04-04
Last updated
2026-01-02

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

OnKO-Tips&Tricks digital phone application

OnKO-Tips&Tricks digital phone application: Using daily OnKO-Tips\&Tricks digital phone application

Study summary

Approximately 2,200 cancers per year in France are diagnosed within the adolescents and young adults population (15-25 years old, AYA). The cancer plans and the INCA recommend support during and after cancer treatment, taking into account both medical and psycho-social specificities related to age (support care, school learning/training and professional integration, fertility preservation, therapeutic education, addictology, sexology...). In this context, AJA teams have been developed in which the Nurse Coordinators (IDEC) play a fundamental role. These Nurse Coordinators are available to young patients, their families and the professionals who accompany follow them in their therapeutic journey. Their main missions are to assess the specific needs of these young people and their loved ones, to inform, orient and participate in the coordination of their care by providing psychosocial and paramedical solutions to these young patients. The circular of 30/05/2016 on the coordinated regional organization of care for AJAs supports the development of connected health tools for AJAs. This population is adept to new technologies, social networks allowing them to continue to be informed and remain integrated to the outside world while helping them prepare for life after cancer.

In this context, our team initiated the development of a digital application compatible for any cellphone OnKO-Tips\&Tricks meeting these criteria of necessity with the company CAPCOD. We would want to move on to a validation stage by carrying out a national multicenter efficacy study in AJA mobile units by comparing two groups of patients: users/non-users of this digital tool on a main criterion of quality of life after using it for 6 months. As it should promote autonomy and integration into the care pathway as well as active participation in therapeutic education programs (TPE), these different items will be evaluated as secondary endpoints of our study

Eligibility

Sex
ALL
Min age
15 Years
Max age
25 Years
Healthy volunteers
No
Inclusion Criteria: * Patient age ≥ 15 years and ≤ 25 years * Diagnosed with solid or blood cancers less than 1 month old or patient with relapsed cancer more than 5 years after completion of initial treatment * Follow-up at one of the participating study centers * Informed and signed consent from the patient and, if the subject is a minor, from the holders of parental authority * Inclusion in the study at the latest at the time of initiation of chemotherapy or radiotherapy * Patient agrees to 12-month post-inclusion follow-up * Patient agreeing to complete all study questionnaires * Patient with a cellphone capable of downloading the app (developed for all types of cellphones) * Affiliated to a social health insurance plan Exclusion Criteria: * Patient deprived of liberty by a judicial or administrative decision * Patient with protected person status * Patient who does not understand, speak or write French * Patient unable to understand the follow-up protocol according to the investigating physician or the IDEC of the AJA unit * Patient with a scheduled hospitalization of at least 5 weeks during study participation

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Institut d'Hématologie et d'Oncologie Pédiatrique Lyon France
Hôpital enfant-adolescent Nantes France
CHU de Nice Hôpital Archet 2 Nice France
CHU Reims - Hôpital Maison Blanche Reims France
Hôpitaux Universitaires de Strasbourg Strasbourg France
Assistance Publique - Hôpitaux de Marseille Marseille France
CHU Rennes Hôpital Sud Rennes France
Institut de Cancérologie de l'Ouest Saint-Herblain France
Institut de Cancerologie Strasbourg Europe Strasbourg France
Institut Gustave Roussy Villejuif France

More University Hospital, Strasbourg, France trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05350631 on ClinicalTrials.gov ↗ ← All trials in France