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CancerOnKO T&T 2 0NCT05350631

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

A study testing OnKO-Tips&Tricks digital phone application in people with Cancer, run by University Hospital, Strasbourg, France at 10 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 25 years
Conditions the study is for
Cancer
What is being tested?
OnKO-Tips&Tricks digital phone application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
10 sitesFrance
Study dates
4 Apr 2023to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Institut d'Hématologie et d'Oncologie Pédiatrique

    Lyon, France, 69 008

  • Assistance Publique - Hôpitaux de Marseille

    Marseille, 13005

  • Hôpital enfant-adolescent

    Nantes, France, 44093

  • CHU de Nice Hôpital Archet 2

    Nice, France, 06202

  • CHU Reims - Hôpital Maison Blanche

    Reims, France, 51092

  • CHU Rennes Hôpital Sud

    Rennes, 35200

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, France, 67091

  • Institut de Cancerologie Strasbourg Europe

    Strasbourg, 67200

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: 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

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
Being tested
OnKO-Tips&Tricks digital phone application
Keywords
Adolescents population, Young adults population
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OnKO-Tips&Tricks digital phone applicationOther

    Using daily OnKO-Tips\&Tricks digital phone application

Study groups in NCT05350631
Study groupRoleWhat they receive
ControlNo interventiononly follow-ups consultations, phone contact and TVE workshop with the AJA mobile team centralized by the IDEC
ExperimentalExperimentalusing a digital tool in addition to follow-ups by consultations, phone contact and PTE workshop with the AJA mobile team centralized by the IDEC
Receives: Other: OnKO-Tips&Tricks digital phone application

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months of inclusion

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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).

    Measured: 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

    Measured: 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.

    Measured: 6 months of inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start4 Apr 2023
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05350631
Sponsor's protocol ID
8360
Acronym
OnKO T&T 2 0
Status last verified
Dec 2025
First submitted
14 Apr 2022
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing OnKO-Tips&Tricks digital phone application in people with Cancer, run by University Hospital, Strasbourg, France at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of the OnKO-Tips&Tricks digital phone application on the psychosocial dimension of patients' quality of life (time frame: 6 months of inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05350631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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