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 | Active Not Recruiting

• 1 other identifier: 8360
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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

Conditions

Cancer

Keywords

Adolescents population; Young adults population

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on the psychosocial dimension of patients' quality of life

  Assessed using a psychosocial health score obtained by the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales questionnaire. The PedsQL 4.0 Generic Core Scale contains 23 items that measures physical (eight items), emotional (five items), social (five items), and school (five items) functions. The Scale comprises parallel patient self-report and parent proxy-report formats. The items are reverse-scored and trans- formed to a 0-100 scale according to the instructions, and higher scores indicate a better HRQOL.

  6 months of inclusion

Secondary Outcomes (7)

• Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on the psycho-social dimension of patients' quality of life

  3 months and 12 months of inclusion

• Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on patients' overall and physical quality of life

  3 months, 6 months and 12 months of inclusion

• Evaluate the impact on each patient's participation in a therapeutic education program (TPE)

  through study completion, an average of 1 year and 6 months

• Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application throughout the patient's care pathway

  3 months, 6 months and 12 months of inclusion

• Assess patient satisfaction with the use of the OnKO-Tips&Tricks digital phone application using the MAUQ questionnaire

  6 and 12 months

Study Arms (2)

Control

NO INTERVENTION

only follow-ups consultations, phone contact and TVE workshop with the AJA mobile team centralized by the IDEC

Experimental

EXPERIMENTAL

using a digital tool in addition to follow-ups by consultations, phone contact and PTE workshop with the AJA mobile team centralized by the IDEC

Other: OnKO-Tips&Tricks digital phone application

Interventions

OnKO-Tips&Tricks digital phone application OTHER

Using daily OnKO-Tips\&Tricks digital phone application

Experimental

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (10)

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, France, 69 008, France

Location

Hôpital enfant-adolescent

Nantes, France, 44093, France

Location

CHU de Nice Hôpital Archet 2

Nice, France, 06202, France

Location

CHU Reims - Hôpital Maison Blanche

Reims, France, 51092, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67091, France

Location

Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

Location

CHU Rennes Hôpital Sud

Rennes, 35200, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67200, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 28, 2022
• Study Start: April 4, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (10)