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

• ClinicalTrials.gov Identifier: NCT03154710
• Recruitment Status: Suspended
• First Posted: May 16, 2017
• Last Update Posted: February 18, 2021
• Sponsor: Weprom
• Collaborators: SIVAN Innovation; Takeda
• Information provided by (Responsible Party): Weprom

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lymphoma, T-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Hodgkin	Device: SENTINEL	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised, open, multicenter prospective trial
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 (SENTINEL Lymphome)
• Actual Study Start Date: July 12, 2017
• Actual Primary Completion Date: October 14, 2020
• Estimated Study Completion Date: April 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: SENTINEL; Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the SENTINEL application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem	Device: SENTINEL; web-mediated follow up
No Intervention: Standard; Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)

Outcome Measures

Primary Outcome Measures :

1. Number of significant complications detected and confirmed by a medical consultation performed outside the standard follow-up [ Time Frame: 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 :

1. Complication detection time [ Time Frame: 24 months ]
   Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed
2. Number of complication observed [ Time Frame: 24 months ]
   Collection of all complication presented by patients
3. Rate of hospitalization for vital emergency [ Time Frame: 24 months ]
   Collection of serious adverse events
4. Sensibility of the web-application [ Time Frame: 24 months ]
   Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert
5. Compliance [ Time Frame: 24 months ]
   Number of assessement completed (usually 1 per 2 weeks) by patients
6. Performances status (PS) at relapse [ Time Frame: 24 months ]
   PS according to WHO
7. Quality of life [ Time Frame: up to 12 months ]
   Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months
8. Depression [ Time Frame: up to 12 months ]
   Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
9. Satisfaction [ Time Frame: 6 months ]
   Completion of a questionnaire after 6 months
10. Progression free survival [ Time Frame: 24 months ]
    Time between the diagnostic of partial or complete response and the diagnostic of relapse
11. Overall survival [ Time Frame: 24 months ]
    Time between the diagnostic of partial or complete response and the patient's death

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

CHBA Vannes

Vannes, Bretagne, France, 56017

Institut Bergonié

Bordeaux, Gironde, France, 33076

Polyclinique du Parc

Caen, Normandie, France, 14000

Institut d'Hématologie de Basse Normandie

Caen, Normandie, France, 14033

Hôpital Privé du Confluent

Nantes, Pays De Loire, France, 44277

Centre Hospitalier Universitaire Jean Minjoz

Besançon, France, 25030

Polyclinique Bordeaux Nord

Bordeaux, France, 33077

Centre Hospitalier Univeritaire

Dijon, France, 21000

CHU Grenoble

Grenoble, France, 38700

Centre Jean Bernard

Le Mans, France, 72000

Ch Mont de Marsan

Mont-de-Marsan, France, 40000

Centre d'Oncologie de Gentilly

Nancy, France, 54000

Hopital Saint Louis

Paris, France, 75475

Clinique Saint Anne

Strasbourg, France, 67000

Centre Hospitalier Universitaire

Tours, France, 37044

Sponsors and Collaborators

Weprom

SIVAN Innovation

Takeda

Investigators

• Principal Investigator: Katell LE DU, MD; Centre Jean Bernard - Le Mans

More Information

• Responsible Party: Weprom
• ClinicalTrials.gov Identifier: NCT03154710
• Other Study ID Numbers: ILC-1-2016; 2016-A01024-47 ( Other Identifier: French Health Products Safety Agency )
• First Posted: May 16, 2017
• Last Update Posted: February 18, 2021
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weprom:

Web-mediated follow up; Lymphoma; Personalized medicine

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell; Hodgkin Disease; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin