Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response

Not Applicable

Terminated

Conditions: Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, Hodgkin

Registration Number: NCT03154710

Lead Sponsor: Weprom

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 52

Inclusion Criteria

Patient with either:
1. T-cell lymphoma in first complete or partial response
2. Hodgkin lymphoma in 2nd complete or partial response including after autograft
3. 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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Sensibility of the Web-application	24 months	Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert
Progression Free Survival	24 months	Time between the diagnostic of partial or complete response and the diagnostic of relapse
Depression	up to 12 months	Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
Satisfaction	6 months	Completion of a questionnaire after 6 months
Overall Survival	24 months	Time between the diagnostic of partial or complete response and the patient's death
Rate of Hospitalization for Vital Emergency	24 months	Collection of serious adverse events
Compliance	24 months	Number of assessement completed (usually 1 per 2 weeks) by patients
Performances Status (PS) at Relapse	24 months	PS according to WHO
Quality of Life	up to 12 months	Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months
Complication Detection Time	24 months	Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed
Number of Complication Observed	24 months	Collection of all complication presented by patients

Trial Locations

Locations (15): CHBA Vannes
🇫🇷
Vannes, Bretagne, France
Institut Bergonié
🇫🇷
Bordeaux, Gironde, France
Polyclinique du Parc
🇫🇷
Caen, Normandie, France
Institut d'Hématologie de Basse Normandie
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Caen, Normandie, 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
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CHBA Vannes
🇫🇷Vannes, Bretagne, France