NCT05858424

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Nov 2022

Longer than P75 for not_applicable

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 Progress92%
Nov 2022Sep 2026

First Submitted

Initial submission to the registry

October 20, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

October 20, 2022

Last Update Submit

April 17, 2026

Conditions

Solid TumorLymphoma

Keywords

SurvivorshipSupportive care needsAdolescents and Young AdultsPost-treatmentOncologyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Health-related Quality of life - emotional functioning

    The PedsQL is a standardised, generic assessment of health-related perceptions of quality of life in paediatric patients. The PedsQL consists of 4 subscale scores (physical, emotional, social and school) and 3 summary scores (physical health, psychosocial health and total scale). All PedsQL scores range from 0 to 100, with higher scores indicating better quality of life.

    12 to 15 months after cancer treatment completion

Secondary Outcomes (7)

  • To evaluate and compare the evolution of health-related quality of life at 12 months in the 2 groups

    from 0 to 3 months after the end of the treatments, and at 12 months after cancer treatment completion

  • To evaluate and compare the evolution of QOL over time in the two groups: longitudinal analysis

    at inclusion (0 to 3 months after the end of treatment), and at 3, 6, 9 and 12 months after cancer treatment completion

  • To evaluate and compare the level of anxiety and depression in the 2 groups at inclusion (0 to 3 months after the end of treatment) and at 12 months

    at inclusion (0 to 3 months after the end of treatment) and at 12 months after cancer treatment completion

  • To evaluate and compare the emotional regulation difficulties of the AYAs in the 2 groups at inclusion (0 to 3 months after the end of treatment) and at 12 months

    at inclusion (0 to 3 months after the end of treatment) and at 12 months after cancer treatment completion

  • To describe the compliance of the AJAs to the multidisciplinary DH vs. to the standard oncological follow-up without multidisciplinary DH, and to the proposed medical and paramedical orientations

    12 months after cancer treatment completion

  • +2 more secondary outcomes

Study Arms (2)

Group A : former patients with multidisciplinary day hospitalization

EXPERIMENTAL

In this group, a multidisciplinary day hospitalization will be programmed after the end-of-treatment evaluation and 2 months after the end of treatment at the latest. This day hospitalization will consist at least of a psychological interview, an interview with a social worker and a medical interview.

Other: Multidisciplinary day hospitalization

Group B : former patients without multidisciplinary day hospitalization

NO INTERVENTION

In this group, the former patients will experiment the standard of care, with an oncological follow-up.

Interventions

Multidisciplinary day hospitalizationOTHER

This multidisciplinary day hospitalization will consist at least of a psychological interview, an interview with a social worker and a medical interview. The objectives of this medical interview, conducted by a clinician researcher, are to summarize the pathology, the treatment(s) received, and to develop a personalized after-cancer plan. The psychological interview will assess the needs for further care, and will refer the former patient if necessary. The social interview will take stock of the former patient's return to school and/or professional life, and direct him/her to possible applications for social assistance if needed. If needs of supportive care emerge from the history of treatment period, some consultations can be added during the day hospitalization, like an interview with a dietician or an adapted physical activity assessment.

Group A : former patients with multidisciplinary day hospitalization

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • Be previously treated at the Paediatric Hematology and Oncology Institute (IHOPe) and/or at CLB in AYA Department
  • For a solid tumor or a lymphoma
  • Be in complete oncological response at the end of treatment; have received their end-of-treatment evaluation
  • Have finished their therapy since less than 2 months (therapy is defined by any treatment received, including maintenance)
  • Be capable of understanding, reading and writing French
  • Be affiliated to a health insurance plan
  • Have been informed of the study and have consented to it
  • For minor patients, consent of parents and/or legal tutors must be collected.

You may not qualify if:

  • cannot be followed-up throughout the duration of the study (12 months),
  • be deprived of liberty by a court or administrative decision,
  • have not consent to participate or are incapable of objecting in an informed manner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

LymphomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Amandine BERTRAND, MD

    Institut d'Hématologie et d'Oncologie Pédiatrique

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine BERTRAND, MD

CONTACT

04787872606Amandine.BERTRAND@ihope.fr

Véronique CHRISTOPHE, PU

CONTACT

veronique.christophe@lyon.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomization will be performed according to a minimization algorithm of the Ennov Clinical software. The ratio will be 1:1 by stratifying on the criterion: management service (CLB vs IHOPe).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a monocentric open-label clinical research with 2 parallel groups. Patients will be 1:1 randomly assigned in both groups. * Group A : former patients with multidisciplinary day hospitalization * Group B : former patients without multidisciplinary day hospitalization
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

May 15, 2023

Study Start

November 29, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

FR(1)