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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| ClinicalTrials.gov Identifier: NCT03154710 |
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Recruitment Status :
Terminated
(Negative interim analysis)
First Posted : May 16, 2017
Results First Posted : April 28, 2021
Last Update Posted : April 28, 2021
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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: MOOVCARE | Not Applicable |
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 (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 |
| Actual Study Start Date : | July 12, 2017 |
| Actual Primary Completion Date : | October 14, 2020 |
| Actual Study Completion Date : | March 12, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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
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Device: MOOVCARE
web-mediated follow up |
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No Intervention: Standard
Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
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- 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.
- 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
- Number of Complication Observed [ Time Frame: 24 months ]Collection of all complication presented by patients
- Rate of Hospitalization for Vital Emergency [ Time Frame: 24 months ]Collection of serious adverse events
- 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
- Compliance [ Time Frame: 24 months ]Number of assessement completed (usually 1 per 2 weeks) by patients
- Performances Status (PS) at Relapse [ Time Frame: 24 months ]PS according to WHO
- 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
- Depression [ Time Frame: up to 12 months ]Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
- Satisfaction [ Time Frame: 6 months ]Completion of a questionnaire after 6 months
- Progression Free Survival [ Time Frame: 24 months ]Time between the diagnostic of partial or complete response and the diagnostic of relapse
- Overall Survival [ Time Frame: 24 months ]Time between the diagnostic of partial or complete response and the patient's death
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154710
| 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 | |
| Principal Investigator: | Katell LE DU, MD | Centre Jean Bernard - Le Mans |
| 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 Key Record Dates |
| Results First Posted: | April 28, 2021 |
| Last Update Posted: | April 28, 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 |
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Web-mediated follow up Lymphoma Personalized medicine |
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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 |