Impact of a Multidisciplinary End-of-treatment Day Hospital on the Quality of Life of Adolescents and Young Adults With Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorCentre Leon Berard

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary day hospitalization

    Other intervention

    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.

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: Group A : former patients with multidisciplinary day hospitalizationExperimental treatment 1 intervention
Group B: Group B : former patients without multidisciplinary day hospitalizationNo intervention 0 interventions

Trial outcomes

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.

Time frame
12 to 15 months after cancer treatment completion

Secondary outcomes

1

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

The evolution of the QOL at 12 months will be studied via all the dimensions of QOL of the PedsQL questionnaire which will be completed by the patients of the two groups at inclusion ( from 0 to 3 months after the end of the treatments), and at 12 months

Time frame
from 0 to 3 months after the end of the treatments, and at 12 months after cancer treatment completion
2

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

The evolution of QoL will be measured via all the QoL dimensions of the PedsQL questionnaire which will be completed by patients in both groups at inclusion (0 to 3 months after the end of treatment), and at 3, 6, 9 and 12 months

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

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

Anxiety and depression levels will be measured via the HADS questionnaire (Hospital Anxiety and Depression Scale) in the two groups (multidisciplinary DH in addition to standard oncology follow-up vs. standard oncology follow-up without multidisciplinary DH) at inclusion (0 to 3 months after the end of treatment) and at 12 months

Time frame
at inclusion (0 to 3 months after the end of treatment) and at 12 months after cancer treatment completion
4

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

Emotional regulation strategies will be measured using the DERS scale (Difficulties in Emotion Regulation Scale), in both groups (multidisciplinary DH in addition to standard oncological follow-up vs. standard oncological follow-up without multidisciplinary DH) at inclusion (0 to 3 months after the end of treatment) and at 12 months

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

Other outcomes

Sponsors and contacts

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