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.
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. In addition, strengthened clinical follow-up may improve the early detection of relapses and also improve surveillance of all significant clinical complications commonly seen in patients with severe disease (sepsis, thromboembolism, late iatrogenics, etc.). If a benefit in survival is to be expected, it will most likely be due to the early detection of relapses and better control of recidivism through early treatment and management and the early implementation of appropriate supportive care, if only by the management of depressive symptoms, or the management of iatrogenic or other complications. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
52
web-mediated follow up
CHBA Vannes
Vannes, Brittany Region, France
Institut Bergonié
Bordeaux, Gironde, France
Polyclinique du Parc
Caen, Normandy, France
Institut d'Hématologie de Basse Normandie
Caen, Normandy, France
Hôpital Privé du Confluent
Nantes, Pays de Loire, France
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France
Polyclinique Bordeaux Nord
Bordeaux, France
Centre Hospitalier Univeritaire
Dijon, France
CHU Grenoble
Grenoble, France
Centre Jean Bernard
Le Mans, France
...and 5 more locations
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up
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.
Time frame: 6 months
Complication Detection Time
Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed
Time frame: 24 months
Number of Complication Observed
Collection of all complication presented by patients
Time frame: 24 months
Rate of Hospitalization for Vital Emergency
Collection of serious adverse events
Time frame: 24 months
Sensibility of the Web-application
Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert
Time frame: 24 months
Compliance
Number of assessement completed (usually 1 per 2 weeks) by patients
Time frame: 24 months
Performances Status (PS) at Relapse
PS according to WHO
Time frame: 24 months
Quality of Life
Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months
Time frame: up to 12 months
Depression
Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
Time frame: up to 12 months
Satisfaction
Completion of a questionnaire after 6 months
Time frame: 6 months
Progression Free Survival
Time between the diagnostic of partial or complete response and the diagnostic of relapse
Time frame: 24 months
Overall Survival
Time between the diagnostic of partial or complete response and the patient's death
Time frame: 24 months
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