NCT06748820

Brief Summary

About 2000 adolescents and young adults (AYA) are diagnosed with cancer each year in France. This period of life is marked by a maturation and transition phase in various areas (psychological, physical, sexual, socio-professional...). Cancer occurrence has a very particular impact. AYAs diagnosed and treated for cancer have specific medical and psychosocial needs.In response to these specific needs, Therapeutic Education (TPE), initially developed for patients with chronic disease to help them acquire and maintain skills needed to better manage their daily lives with the constraints of their disease and its treatments, has now its place in cancerology. It has been shown to promote patient independence, improve therapeutic adherence (which is particularly poor in adolescents with cancer), and strengthen the therapeutic alliance between patients and their healthcare team. The strengthening of adolescents's self-care and adaptation skills is also recognized as essential during the experience of an oncological disease. In addition, over the past few years, in the context of the increasing use of the internet and digital technologies, particularly in the daily lives of young people, the implementation of remote TPE sessions (e-TPEs) has developed significantly. In cancerology, digital health interventions have the potential to expand access to the support available to youth with cancer. E-health offers flexibility to the delivery of psychosocial care and could help strengthen youth engagement and enable them to interact with professionals and other young people in a reassuring digital context.This project aims to demonstrate the feasibility of conducting remote health education workshops (e-TPE) for AYAs with cancer, regardless of their place of care in French territory. Following an educational assessment conducted by a professional trained in TPE, three digitalized workshops from the DYNAMO program, will be offered. The adherence to this type of educational interventions, the satisfaction of the patients and the professionals involved, but also the obstacles and difficulties encountered will be analyzed. Demonstrating the feasibility of these e-workshops would allow the spread and the enrichment of this type of interventions. This could facilitate their accessibility for all AYAs in French territory. At the end of this experiment, a randomized study could provide scientific evidence that the development of such a program is a relevant strategy to help young people with cancer manage the challenges associated with their diagnosis and treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 19, 2024

Last Update Submit

January 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assess the patient's adherence to the implementation of remote health educational actions (e-TPE), in AYA patients with cancer undergoing treatment

    Online self-administered satisfaction questionnaires filled out by the patients 70 questions, scores between 1 and 4, yes or no, multiple choice questions, open-ended questions.

    Between 2 and 4 times over 18 months

Secondary Outcomes (1)

  • Assess the suitability of the pedagogical methods

    3 times over 12 months

Study Arms (1)

Remote Therapeutic Patient Education (e-TPE)

TPE is a set of practices aiming at allowing a patient to acquire and preserve abilities and skills to manage actively their disease, cares, and surveillance, in collaboration with the caregivers

Behavioral: Remote Therapeutic Patient Education (e-TPE)

Interventions

TPE is a set of practices aiming at allowing a patient to acquire and preserve abilities and skills to manage actively their disease, cares, and surveillance, in collaboration with the caregivers

Remote Therapeutic Patient Education (e-TPE)

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents and young adults between 15 and 25 years old with cancer followed in a French AYA center.

You may qualify if:

  • Patient with cancer diagnosed for at least one month.
  • Patient followed by an AYA Coordinating Nurse in one of the 27 French AYA centres.
  • Patient with Life expectancy ≥ 6 months.
  • Patient ealth status consistent with program requirements.
  • Karnosky index \> 60%.
  • Patient who agrees to participate in the program and benefits from social security.
  • Patient able to understand, speak and read French.
  • Patient with no major cognitive impairment (assessed by the patient's referees).
  • Patient with no sensory disability.
  • Patient with access to a computer tool (smartphone, tablet, computer) and a WiFi or 4G network.
  • Non opposition from patient or their legal representative collected.
  • Patient who has signed the Privacy Policy.
  • Patient who consented to participate in PTE program.

You may not qualify if:

  • Patient unable to use informatic tools.
  • Known superior cognitive function disorders.
  • Progressive psychiatric pathology
  • Drug user or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Maryline Poirée

CONTACT

Audrey Jullian

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations