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Active, not recruitingNCT05350631OnKO T&T 2 0Updated Jan 2, 2026

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

An interventional study of OnKO-Tips&Tricks digital phone application in Cancer, sponsored by University Hospital, Strasbourg, France. Active, not recruiting at 10 sites in France. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
15 Years to 25 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cancer

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Keywords

  • Adolescents population
  • Young adults population
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    Control

    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

  • OtherOnKO-Tips&Tricks digital phone application

    Using daily OnKO-Tips\&Tricks digital phone application

06

What researchers measure

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.

    Time frame: 6 months of inclusion

Secondary outcomes

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

    Assessed using a psychosocial health score obtained from 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.

    Time frame: 3 months and 12 months of inclusion

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

    Assessed using total Quality of Life and physical health subscore scores obtained from 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.

    Time frame: 3 months, 6 months and 12 months of inclusion

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

    Rate of patients in the experimental and control groups who will participate in the proposed FTE program

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

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

    assessed by the number of consultations, medical and paramedical, the number of outpatient management, the number of unscheduled hospitalizations, the number of listed side effects, and the number of phone contacts (text, calls) and emails initiated by the patient towards the IDEC.

    Time frame: 3 months, 6 months and 12 months of inclusion

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

    Evaluated using the mHealth app usability questionnaire (MAUQ questionnaire).

    Time frame: 6 and 12 months

  6. Evaluate the adherence to the application in the experimental group

    Evaluated by collecting the number of uses of each feature

    Time frame: Per week and per month through study completion, an average of 1 year and 6 months

  7. Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on the quality of life of patients according to cancer pathology

    Comparative analysis of quality of life collection using the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales questionnaire taking into account the type of cancers: solid vs. blood cancer 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.

    Time frame: 6 months of inclusion

07

Study locations

10 sites
  • Institut d'Hématologie et d'Oncologie Pédiatrique
    Lyon, France 69 008, France
  • Hôpital enfant-adolescent
    Nantes, France 44093, France
  • CHU de Nice Hôpital Archet 2
    Nice, France 06202, France
  • CHU Reims - Hôpital Maison Blanche
    Reims, France 51092, France
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, France 67091, France
  • Assistance Publique - Hôpitaux de Marseille
    Marseille, 13005, France
  • CHU Rennes Hôpital Sud
    Rennes, 35200, France
  • Institut de Cancérologie de l'Ouest
    Saint-Herblain, 44805, France
  • Institut de Cancerologie Strasbourg Europe
    Strasbourg, 67200, France
  • Institut Gustave Roussy
    Villejuif, 94805, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05350631
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Apr 28, 2022
Start date
Apr 4, 2023
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jan 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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