CancerOnKO-TnT-1-0NCT05617131
Cell Phone Application to Help Adolescents and Young Adults in Their Therapeutic and Educational Journey
An observational study of Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Cancer
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Child, Adult
Study population: Subject, whose age is ≥ 15 years and ≤ 25 years, diagnosed at the Strasbourg center (HUS and ICANS) with solid or liquid cancer
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France
Strasbourg, 67091
Natacha ENTZ-WERLE, MD, PhD, 33 3 88 12 83 89, natacha.entz-werle@chru-strasbourg.fr
Natacha ENTZ-WERLE, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Keywords
- Solid cancer, Liquid cancer, Connected health tools, OnKO-TnT digital application
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 6 months of use of the OnKO-TnT application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jan 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617131
- Sponsor's protocol ID
- 7599
- Acronym
- OnKO-TnT-1-0
- Status last verified
- Dec 2023
- First submitted
- 7 Nov 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Implementation of a Cell Phone Application to Help Adolescents and Young Adults in Their Therapeutic and Educational Journey
- ClinicalTrials.gov ID
- NCT05617131
- Acronym / sponsor ID
- OnKO-TnT-1-0 / 7599
- Conditions
- Cancer
- Keywords
- Solid cancer, Liquid cancer, Connected health tools, OnKO-TnT digital application
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Subject, whose age is ≥ 15 years and ≤ 25 years, diagnosed at the Strasbourg center (HUS and ICANS) with solid or liquid cancer
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital, Strasbourg, France at 1 site 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 11 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha ENTZ-WERLE, MD, PhD (33 3 88 12 83 89, natacha.entz-werle@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: after 6 months of use of the OnKO-TnT application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2023.