Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse 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.

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 Overview

• Status: Terminated
• Conditions: Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell; Lymphoma, Hodgkin
• Intervention / Treatment: Device: MOOVCARE

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Centre Hospitalier Universitaire Jean MINJOZ
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord
  • Dijon, France, 21000
    • Centre Hospitalier Univeritaire
  • Grenoble, France, 38700
    • CHU Grenoble
  • Le Mans, France, 72000
    • Centre Jean Bernard
  • Mont-de-Marsan, France, 40000
    • CH Mont de Marsan
  • Nancy, France, 54000
    • Centre d'oncologie de Gentilly
  • Paris, France, 75475
    • Hopital Saint Louis
  • Strasbourg, France, 67000
    • Clinique Saint Anne
  • Tours, France, 37044
    • Centre Hospitalier Universitaire
  • Bretagne
    • Vannes, Bretagne, France, 56017
      • CHBA Vannes
  • Gironde
    • Bordeaux, Gironde, France, 33076
      • Institut Bergonie
  • Normandie
    • Caen, Normandie, France, 14000
      • Polyclinique du Parc
    • Caen, Normandie, France, 14033
      • Institut d'Hématologie de Basse Normandie
  • Pays De Loire
    • Nantes, Pays De Loire, France, 44277
      • Hôpital Privé du Confluent

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-application follow up; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Weprom
• Collaborators: Takeda; SIVAN Innovation
• Investigators: Principal Investigator: Katell LE DU, MD, Centre Jean Bernard - LE MANS

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Lymphoma; Personalized medicine; Web-mediated follow up
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Hodgkin Disease; Lymphoma, T-Cell
• Other Study ID Numbers: ILC-1-2016; 2016-A01024-47 (Other Identifier: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No