Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 30
- 主要终点
- Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up
研究概览
简要总结
Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance in elderly subjects.
With the continuous improvement of the diagnostic techniques and the treatments, the prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most often within 2 or 3 years after the end of treatment.
The current standard follow up includes a clinical examination and a biological check-up every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months. However, the interest of this systematic surveillance by imaging is controversial.
The use of new information and communication technologies, can improve the clinical follow-up of patients. To date, access to the Internet and portable technologies is sufficiently broad and democratized to envisage the use of this type of remote surveillance in the field of health. In particular to facilitate the dissemination of information between the patient and the physician. It is thus possible to imagine using this flow of information to generate alerts.
Strengthening the clinical follow-up in this indication, in which routine imaging has not demonstrated their interest, in particular by the implementation of remote monitoring completed by the patient, may present an advantage in terms of effectiveness and precocity of care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures for a relatively low benefit, is performed in symptomatic patients since several weeks.
The aim of this study is to evaluate the interest of a web-mediated follow up using a score based on the dynamics and the association of clinical and biological signs to alert the physician of a possible recurrence of the patients treated for a lymphoma in complete or partial response.
详细描述
Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance in elderly subjects.
With the continuous improvement of the diagnostic techniques and the treatments, the prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most often within 2 or 3 years after the end of treatment.
The current standard follow up includes a clinical examination and a biological check-up every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months. However, the interest of this systematic surveillance by imaging is controversial.
The use of new information and communication technologies, can improve the clinical follow-up of patients. To date, access to the Internet and portable technologies is sufficiently broad and democratized to envisage the use of this type of remote surveillance in the field of health. In particular to facilitate the dissemination of information between the patient and the physician. It is thus possible to imagine using this flow of information to generate alerts.
Strengthening the clinical follow-up in this indication, in which routine imaging has not demonstrated their interest, in particular by the implementation of remote monitoring completed by the patient, may present an advantage in terms of effectiveness and precocity of care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures for a relatively low benefit, is performed in symptomatic patients since several weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with either:
- •T-cell lymphoma in first complete or partial response
- •Hodgkin lymphoma in 2nd complete or partial response including after autograft
- •Large B-cell diffuse lymphoma in 2nd complete or partial response including after autograft
- •End-of-treatment imaging in the last 4 weeks
- •Age ≥ 18 years
- •PS ≤2 (WHO)
- •Patient with an initial symptoms score less than or equal to 5
- •Patient with internet access and mailbox
- •Patient affiliated to a social security scheme
- •Patient with written consent prior to any procedure specific to the study
排除标准
- •Patient whose lymphoma progressed at the end of the specific treatment (evaluation <3 months after the end of the previous treatment)
- •Symptomatic brain or meninges localisation
- •Presence or history of another cancer in the last 3 years, except skin cancers (other than melanoma), in situ cancers of the cervix or other cancers considered cured
- •Persons deprived of their liberty or under trusteeship
- •Dementia, mental impairment or psychiatric pathology that may compromise the informed consent of the patient and / or compliance with the protocol and follow-up of the study
- •Patients who can not follow the protocol for psychological, social, family or geographical reasons,
- •Pregnancy or breast-feeding
- •Patient participating in another interventional study
结局指标
主要结局
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up
时间窗: 6 months
In the experimental group, identification of the absence of alert in case of complications and in the standard arm, identification of the absence of medical consultation (referring physician) in case of complications.
次要结局
- Sensibility of the Web-application(24 months)
- Progression Free Survival(24 months)
- Depression(up to 12 months)
- Satisfaction(6 months)
- Overall Survival(24 months)
- Rate of Hospitalization for Vital Emergency(24 months)
- Compliance(24 months)
- Performances Status (PS) at Relapse(24 months)
- Quality of Life(up to 12 months)
- Complication Detection Time(24 months)
- Number of Complication Observed(24 months)