Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response
Primary Purpose
Lymphoma, T-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Hodgkin
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MOOVCARE
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma, T-Cell focused on measuring Web-mediated follow up, Lymphoma, Personalized medicine
Eligibility Criteria
Inclusion Criteria:
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
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
Sites / Locations
- CHBA Vannes
- Institut Bergonié
- Polyclinique du Parc
- Institut d'Hématologie de Basse Normandie
- Hôpital Privé du Confluent
- Centre Hospitalier Universitaire Jean Minjoz
- Polyclinique Bordeaux Nord
- Centre Hospitalier Univeritaire
- CHU Grenoble
- Centre Jean Bernard
- Ch Mont de Marsan
- Centre d'Oncologie de Gentilly
- Hopital Saint Louis
- Clinique Saint Anne
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Web-application follow up
Standard
Arm Description
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
Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Complication Detection Time
Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed
Number of Complication Observed
Collection of all complication presented by patients
Rate of Hospitalization for Vital Emergency
Collection of serious adverse events
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
Compliance
Number of assessement completed (usually 1 per 2 weeks) by patients
Performances Status (PS) at Relapse
PS according to WHO
Quality of Life
Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months
Depression
Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
Satisfaction
Completion of a questionnaire after 6 months
Progression Free Survival
Time between the diagnostic of partial or complete response and the diagnostic of relapse
Overall Survival
Time between the diagnostic of partial or complete response and the patient's death
Full Information
NCT ID
NCT03154710
First Posted
May 11, 2017
Last Updated
April 2, 2021
Sponsor
Weprom
Collaborators
SIVAN Innovation, Takeda
1. Study Identification
Unique Protocol Identification Number
NCT03154710
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Negative interim analysis
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weprom
Collaborators
SIVAN Innovation, Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Hodgkin
Keywords
Web-mediated follow up, Lymphoma, Personalized medicine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised, open, multicenter prospective trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-application follow up
Arm Type
Experimental
Arm Description
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
Arm Title
Standard
Arm Type
No Intervention
Arm Description
Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
Intervention Type
Device
Intervention Name(s)
MOOVCARE
Intervention Description
web-mediated follow up
Primary Outcome Measure Information:
Title
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complication Detection Time
Description
Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed
Time Frame
24 months
Title
Number of Complication Observed
Description
Collection of all complication presented by patients
Time Frame
24 months
Title
Rate of Hospitalization for Vital Emergency
Description
Collection of serious adverse events
Time Frame
24 months
Title
Sensibility of the Web-application
Description
Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert
Time Frame
24 months
Title
Compliance
Description
Number of assessement completed (usually 1 per 2 weeks) by patients
Time Frame
24 months
Title
Performances Status (PS) at Relapse
Description
PS according to WHO
Time Frame
24 months
Title
Quality of Life
Description
Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months
Time Frame
up to 12 months
Title
Depression
Description
Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
Time Frame
up to 12 months
Title
Satisfaction
Description
Completion of a questionnaire after 6 months
Time Frame
6 months
Title
Progression Free Survival
Description
Time between the diagnostic of partial or complete response and the diagnostic of relapse
Time Frame
24 months
Title
Overall Survival
Description
Time between the diagnostic of partial or complete response and the patient's death
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katell LE DU, MD
Organizational Affiliation
Centre Jean Bernard - Le Mans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHBA Vannes
City
Vannes
State/Province
Bretagne
ZIP/Postal Code
56017
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique du Parc
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Facility Name
Institut d'Hématologie de Basse Normandie
City
Caen
State/Province
Normandie
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Privé du Confluent
City
Nantes
State/Province
Pays De Loire
ZIP/Postal Code
44277
Country
France
Facility Name
Centre Hospitalier Universitaire Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Polyclinique Bordeaux Nord
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Centre Hospitalier Univeritaire
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Ch Mont de Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Centre d'Oncologie de Gentilly
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Clinique Saint Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response
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