Clinical trial NCT03154710: Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response
Official title: Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphoma, T-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Hodgkin
Keywords: Web-mediated follow up
Lymphoma
Personalized medicine
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Sivan Innovation Ltd.
name: Takeda
First posted: 2017-05-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, open, multicenter prospective trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. End-of-treatment imaging in the last 4 weeks
3. Age ≥ 18 years
4. PS ≤2 (WHO)
5. Patient with an initial symptoms score less than or equal to 5
6. Patient with internet access and mailbox
7. Patient affiliated to a social security scheme
8. Patient with written consent prior to any procedure specific to the study

Exclusion Criteria:

1. Patient whose lymphoma progressed at the end of the specific treatment (evaluation \<3 months after the end of the previous treatment)
2. Symptomatic brain or meninges localisation
3. 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
4. Persons deprived of their liberty or under trusteeship
5. 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
6. Patients who can not follow the protocol for psychological, social, family or geographical reasons,
7. Pregnancy or breast-feeding
8. Patient participating in another interventional study

Primary outcomes:
measure: Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Complication Detection Time
timeFrame: 24 months
measure: Number of Complication Observed
timeFrame: 24 months
measure: Rate of Hospitalization for Vital Emergency
timeFrame: 24 months
measure: Sensibility of the Web-application
timeFrame: 24 months
measure: Compliance
timeFrame: 24 months
measure: Performances Status (PS) at Relapse
timeFrame: 24 months
measure: Quality of Life
timeFrame: up to 12 months
measure: Depression
timeFrame: up to 12 months
measure: Satisfaction
timeFrame: 6 months
measure: Progression Free Survival
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Vannes
country: France
facility: CHBA Vannes
state: Bretagne
city: Bordeaux
country: France
facility: Institut Bergonié
state: Gironde
city: Caen
country: France
facility: Polyclinique du Parc
state: Normandie
city: Caen
country: France
facility: Institut d'Hématologie de Basse Normandie
state: Normandie
city: Nantes
country: France
facility: Hôpital Privé du Confluent
state: Pays De Loire
city: Besançon
country: France
facility: Centre Hospitalier Universitaire Jean Minjoz
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Dijon
country: France
facility: Centre Hospitalier Univeritaire
city: Grenoble
country: France
facility: CHU Grenoble
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Mont-de-Marsan
country: France
facility: Ch Mont de Marsan
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly
city: Paris
country: France
facility: Hopital Saint Louis
city: Strasbourg
country: France
facility: Clinique Saint Anne
city: Tours
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: Centre Jean Bernard - Le Mans
name: Katell LE DU, MD
role: PRINCIPAL_INVESTIGATOR
References: