Impact Evaluation of a Multidisciplinary End-of-treatment Day Hospital on the Quality of Life of Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Health-related Quality of life - emotional functioning
研究概览
简要总结
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.
详细描述
HOPAYA is a monocentric open-label clinical research with 2 parallel groups. Patients will be 1:1 randomly assigned in both groups.
The main objective of the study is to compare the evolution of the health-related quality of life of former patients who have benefited of a multidisciplinary day hospitalization to those who only had standard oncological follow-up during the first year after cancer treatment completion.
The secondary objectives are:
- to evaluate and compare the anxiety and depression level in both groups (with or without day hospitalization);
- to evaluate emotional competence in both groups (with or without day hospitalization);
- to evaluate the satisfaction about the multidisciplinary day hospitalization.
This study will be presented to patients (and their parents/legal tutors in case of minor patients) during the last visit for any treatment, by coordinating nurses of AYA Department and/or by the adult or pediatric oncologist. At the same time, the information sheet with the consent form will be provided in order to give them a reasonable time for reflection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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).
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A : former patients with multidisciplinary day hospitalization
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.
干预措施: Multidisciplinary day hospitalization (Other)
Group B : former patients without multidisciplinary day hospitalization
In this group, the former patients will experiment the standard of care, with an oncological follow-up.
结局指标
主要结局
Health-related Quality of life - emotional functioning
时间窗: 12 to 15 months after cancer treatment completion
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.
次要结局
- 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)
- To describe the sequelae of the AJA 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 the satisfaction of the AJAs who participate in the multidisciplinary DH following it(Immediately after the multidisciplinary DH)