Clinical trial NCT05350631: 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
Official title: Efficacy Study on Quality of Life Criteria of a Digital Application on Any Cellphone (OnKO-Tips&Tricks) Allowing Daily Follow-ups, Implementation of an ETP Program and a Direct Link With the Nurse Coordinator of Units Specifically Dealing With Adolescents and Young Adults Diagnosed With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Adolescents population
Young adults population
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 criteria: 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 outcomes:
measure: Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on the psychosocial dimension of patients' quality of life
timeFrame: 6 months of inclusion
Secondary outcomes:
measure: Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on the psycho-social dimension of patients' quality of life
timeFrame: 3 months and 12 months of inclusion
measure: Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on patients' overall and physical quality of life
timeFrame: 3 months, 6 months and 12 months of inclusion
measure: Evaluate the impact on each patient's participation in a therapeutic education program (TPE)
timeFrame: through study completion, an average of 1 year and 6 months
measure: Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application throughout the patient's care pathway
timeFrame: 3 months, 6 months and 12 months of inclusion
measure: Assess patient satisfaction with the use of the OnKO-Tips&Tricks digital phone application using the MAUQ questionnaire
timeFrame: 6 and 12 months
measure: Evaluate the adherence to the application in the experimental group
timeFrame: Per week and per month through study completion, an average of 1 year and 6 months
measure: Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on the quality of life of patients according to cancer pathology
timeFrame: 6 months of inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Institut d'Hématologie et d'Oncologie Pédiatrique
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
city: Nantes
country: France
facility: Hôpital enfant-adolescent
city: Nice
country: France
facility: CHU de Nice Hôpital Archet 2
city: Reims
country: France
facility: CHU Reims - Hôpital Maison Blanche
city: Rennes
country: France
facility: CHU Rennes Hôpital Sud
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: