Cell Phone Application to Help Adolescents and Young Adults in Their Therapeutic and Educational Journey (OnKO-TnT-1-0)

Feasibility Study of the Implementation of a Cell Phone Application to Help Adolescents and Young Adults in Their Therapeutic and Educational Journey

About 2000 cancers/year in France are diagnosed in Adolescents and Young Adults (15-25 years old, AYA). The cancer plans and the INCA recommend support during and after cancer, taking into account both medical and psychosocial specificities related to age (supportive care, school learning/training and professional integration, fertility preservation, therapeutic education, addictology, sexology...). The care offered is often heterogeneous for these AYAs in transition between the pediatric and adult worlds. They may be cared for either in pediatric oncology units or in adult structures. In this context, an AYA team has been developed in the Strasbourg center, led by a Nurse Coordinator (IDEC), social workers, psychologists and doctors. Thus, the young patients and their relatives are accompanied by professionals during their therapeutic care. In spite of this global care and closer to the patient, it is still necessary to find connected health tools for these AYA.

Study Overview

• Status: Recruiting
• Conditions: Cancer

Detailed Description

In this context, the Strasbourg team has initiated the development of a digital application compatible for any cell phone OnKO-Tips &Tricks meeting these criteria of necessity. The application is currently in its final phase and requires validation by patients through a feasibility study that will last 6 months. Thus, all patients currently followed or newly diagnosed with liquid or solid cancer and aged between 15 and 25 years old will be included and will have the opportunity to test the application, its practicality as well as its current use and in particular its expected benefits for an optimization of our ETP program.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Natacha ENTZ-WERLE, MD, PhD; Phone Number: 33 3 88 12 83 89; Email: natacha.entz-werle@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France
    • Principal Investigator: Natacha ENTZ-WERLE, MD, PhD
    • Sub-Investigator: Catherine PAILLARD, MD, PhD
    • Contact: Natacha ENTZ-WERLE, MD, PhD; Phone Number: 33 3 88 12 83 89; Email: natacha.entz-werle@chru-strasbourg.fr
    • Sub-Investigator: Jean-Emmanuel KURTZ, MD, PhD
    • Sub-Investigator: Cécile SONNTAG, MD
    • Sub-Investigator: Alexandra SPIEGEL, MD
    • Sub-Investigator: Alexandra SALMON, MD
    • Sub-Investigator: Claire Charlotte GAULIER, IDEC
    • Sub-Investigator: Justine GANTZER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subject, whose age is ≥ 15 years and ≤ 25 years, diagnosed at the Strasbourg center (HUS and ICANS) with solid or liquid cancer

Description

Inclusion criteria:

• Subject whose age is ≥ 15 years and ≤ 25 years
• Subject diagnosed at the Strasbourg center (HUS and ICANS) with solid or liquid cancer
• Subject followed in the Strasbourg center (HUS and ICANS)
• Subject (or his/her legal representatives) having given his/her (their) agreement to participate in the evaluation survey of the OnKO-TnT digital application
• Subject agreeing to complete all satisfaction questionnaires
• The subject understands, speaks and writes French fluently
• Subject having a cell phone capable of downloading the application (developed for any type of cell phone)

Criteria for non-inclusion :

• Opposition of the subject (or the holders of parental authority) to participate in the satisfaction survey
• Subject under legal protection
• Subject under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of the global score of the MAUQ questionnaire (item 1 to 21), filled in by the patients after 6 months of use of the OnKO-TnT application	MAUQ questionnaire of 21 items with a score ranging from 1 to 7. Score 7 means a better result	after 6 months of use of the OnKO-TnT application

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Solid cancer; Liquid cancer; Connected health tools; OnKO-TnT digital application
• Other Study ID Numbers: 7599

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No