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

NCT03154710 | Terminated Results

• 2 other identifiers: ILC-1-20162016-A01024-47
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 15

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.

Conditions

Lymphoma, T-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Hodgkin

Keywords

Web-mediated follow up; Lymphoma; Personalized medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (11)

• Complication Detection Time

  24 months

• Number of Complication Observed

  24 months

• Rate of Hospitalization for Vital Emergency

  24 months

• Sensibility of the Web-application

  24 months

• Compliance

  24 months

Study Arms (2)

Web-application follow up

EXPERIMENTAL

Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the MOOVCARE 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: MOOVCARE

Standard

NO INTERVENTION

Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)

Interventions

MOOVCARE DEVICE

web-mediated follow up

Web-application follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weprom: lead
• Sivan Innovation Ltd.: collaborator
• Takeda: collaborator

Study Sites (15)

CHBA Vannes

Vannes, Brittany Region, 56017, France

Location

Institut Bergonié

Bordeaux, Gironde, 33076, France

Location

Polyclinique du Parc

Caen, Normandy, 14000, France

Location

Institut d'Hématologie de Basse Normandie

Caen, Normandy, 14033, France

Location

Hôpital Privé du Confluent

Nantes, Pays de Loire, 44277, France

Location

Centre Hospitalier Universitaire Jean Minjoz

Besançon, 25030, France

Location

Polyclinique Bordeaux Nord

Bordeaux, 33077, France

Location

Centre Hospitalier Univeritaire

Dijon, 21000, France

Location

CHU Grenoble

Grenoble, 38700, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Ch Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre d'Oncologie de Gentilly

Nancy, 54000, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

Clinique Saint Anne

Strasbourg, 67000, France

Location

Centre Hospitalier Universitaire

Tours, 37044, France

Location

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, Large B-Cell, Diffuse; Hodgkin Disease; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Results Point of Contact

• Title: Dr Katell LE DU
• Organization: Weprom

k.ledu@cjb72.org

241682940

Study Officials

• Katell LE DU, MD

  Centre Jean Bernard - Le Mans

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, open, multicenter prospective trial

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: July 12, 2017
• Primary Completion: October 14, 2020
• Study Completion: March 12, 2021
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)