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 (OnKO T&T 2 0)

University Hospital, Strasbourg, France

Status

Active, not recruiting

Conditions

Cancer

Treatments

Other: OnKO-Tips&Tricks digital phone application

Study type

Interventional

Funder types

Other

Identifiers

NCT05350631

8360

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

All

Ages

15 to 25 years old

Volunteers

No Healthy Volunteers

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