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NCT05350631Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
14 Apr 2022
Start date
4 Apr 2023
Primary completion date
Jul 2026
Lead sponsor
University Hospital, Strasbourg, France
NCT number
NCT05350631

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 4 Apr 2023 to the primary completion date, Jul 2026
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 15 years to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut d'Hématologie et d'Oncologie Pédiatrique
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LyonFranceUnknown status
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceUnknown status
Hôpital enfant-adolescent
Coordinator of this site? Confirm its status
NantesFranceUnknown status
CHU de Nice - Hôpital Archet 2
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NiceFranceUnknown status
CHU Reims Hôpital Maison Blanche
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ReimsFranceUnknown status
CHU Rennes - Hôpital Sud
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RennesFranceUnknown status
Institut de Cancérologie de l'Ouest
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Saint-HerblainFranceUnknown status
Institut de Cancérologie Strasbourg Europe
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StrasbourgFranceUnknown status
Hopitaux Universitaires de Strasbourg
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StrasbourgFranceUnknown status
Institut Gustave Roussy
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VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.