NCT05858424 Impact of a Multidisciplinary End-of-treatment Day Hospital on the Quality of Life of Adolescents and Young Adults With Cancer
| NCT ID | NCT05858424 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Leon Berard |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2022-11-29 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2022-11-29 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rational: 800 cases of cancer per year are diagnosed in France among Adolescents and Young Adults (AYA). This population has been specifically targeted since 2008 by the INCa, leading to the development of structures entirely dedicated to its management. Indeed, the occurrence of cancer in this period of transition leads to specific problems, which require a special attention. The various measures taken since then (Cancer Plan 2014-2019, DGOS instruction in 2016, 10-year strategy to fight cancer 2021-2030) have enabled the implementation of multidisciplinary structures, resulting in better access to care, and consideration of the social, family and relational dimensions of this population. However, the transition from the end of oncology treatment to the follow-up period remains a sensitive period, generating both positive (relief, joy) and negative feelings (uncertainty, feelings of abandonment, anxiety). The investigators therefore hypothesize that the creation of a multidisciplinary end-of-treatment day hospital (DH) involving at least one medical interview, one psychological consultation and one social interview, would improve the quality of life of these former patients during the first year of oncology follow-up. Method: This is a clinical research study conducted in a single centre. At their last visit for treatment, the study will be offered to patients. If the participants agree to participate, they will be randomized to benefit from DH in addition to their planned follow-up with their oncologist. The main objective is to compare the quality of life of former patients according to participation in DH or not. 210 patients will be included for a 20-month recruitment period. Expected results: Throughout the development of DH, the investigators plan to improve the quality of life of former patients during this transitional phase.
Eligibility Criteria
Inclusion Criteria: 1. Be aged between 15 and 25 years at diagnosis. This age range corresponds to the one chosen at the Leon Berard comprehensive cancer care center (CLB) for support in the AYA Department. 2. Be previously treated at the Paediatric Hematology and Oncology Institute (IHOPe) and/or at CLB in AYA Department 3. For a solid tumor or a lymphoma 4. Be in complete oncological response at the end of treatment; have received their end-of-treatment evaluation 5. Have finished their therapy since less than 2 months (therapy is defined by any treatment received, including maintenance) 6. Be capable of understanding, reading and writing French 7. Be affiliated to a health insurance plan 8. Have been informed of the study and have consented to it 9. For minor patients, consent of parents and/or legal tutors must be collected. Exclusion Criteria: 1. cannot be followed-up throughout the duration of the study (12 months), 2. be deprived of liberty by a court or administrative decision, 3. have not consent to participate or are incapable of objecting in an informed manner.
Contact & Investigator
Amandine BERTRAND, MD
PRINCIPAL INVESTIGATOR
Institut d'Hématologie et d'Oncologie Pédiatrique
Frequently Asked Questions
Who can join the NCT05858424 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 25 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05858424 currently recruiting?
Yes, NCT05858424 is actively recruiting participants. Contact the research team at Amandine.BERTRAND@ihope.fr for enrollment information.
Where is the NCT05858424 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT05858424 clinical trial?
NCT05858424 is sponsored by Centre Leon Berard. The principal investigator is Amandine BERTRAND, MD at Institut d'Hématologie et d'Oncologie Pédiatrique. The trial plans to enroll 214 participants.