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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03154710
Enrollment
52
Registered
2017-05-16
Start date
2017-07-12
Completion date
2021-03-12
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Web-mediated follow up, Lymphoma, Personalized medicine

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.

Interventions

DEVICEMOOVCARE

web-mediated follow up

Sponsors

Sivan Innovation Ltd.
CollaboratorINDUSTRY
Takeda
CollaboratorINDUSTRY
Weprom
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Randomised, open, multicenter prospective trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up6 monthsIn 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

MeasureTime frameDescription
Number of Complication Observed24 monthsCollection of all complication presented by patients
Rate of Hospitalization for Vital Emergency24 monthsCollection of serious adverse events
Sensibility of the Web-application24 monthsNumber of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert
Compliance24 monthsNumber of assessement completed (usually 1 per 2 weeks) by patients
Performances Status (PS) at Relapse24 monthsPS according to WHO
Complication Detection Time24 monthsTime between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed
Depressionup to 12 monthsCompletion of the HUMEUR PhQ9 questionnaire at baseline and after 3, 6, 9 and 12 months
Satisfaction6 monthsCompletion of a questionnaire after 6 months
Progression Free Survival24 monthsTime between the diagnostic of partial or complete response and the diagnostic of relapse
Overall Survival24 monthsTime between the diagnostic of partial or complete response and the patient's death
Quality of Lifeup to 12 monthsCompletion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months

Countries

France

Participant flow

Participants by arm

ArmCount
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 MOOVCARE: web-mediated follow up
20
Standard
Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
20
Total40

Baseline characteristics

CharacteristicStandardTotalWeb-application Follow up
Age, Continuous64 years
STANDARD_DEVIATION 12.9
65 years
STANDARD_DEVIATION 13.5
66 years
STANDARD_DEVIATION 14.4
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
France
20 participants40 participants20 participants
Sex: Female, Male
Female
10 Participants19 Participants9 Participants
Sex: Female, Male
Male
10 Participants21 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 271 / 25
other
Total, other adverse events
0 / 270 / 25
serious
Total, serious adverse events
4 / 275 / 25

Outcome results

Primary

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.

Time frame: 6 months

Population: The results presented are those of the interim analysis planned for the first 40 patients included.~A complete analysis will be done on all the patients (52) after incrementing all the data of the patients included in a second step.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Web-application Follow upNumber of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up9 Participants
StandardNumber of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up2 Participants
Secondary

Compliance

Number of assessement completed (usually 1 per 2 weeks) by patients

Time frame: 24 months

Secondary

Complication Detection Time

Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed

Time frame: 24 months

Secondary

Depression

Completion of the HUMEUR PhQ9 questionnaire at baseline and after 3, 6, 9 and 12 months

Time frame: up to 12 months

Secondary

Number of Complication Observed

Collection of all complication presented by patients

Time frame: 24 months

Secondary

Overall Survival

Time between the diagnostic of partial or complete response and the patient's death

Time frame: 24 months

Secondary

Performances Status (PS) at Relapse

PS according to WHO

Time frame: 24 months

Secondary

Progression Free Survival

Time between the diagnostic of partial or complete response and the diagnostic of relapse

Time frame: 24 months

Secondary

Quality of Life

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

Secondary

Rate of Hospitalization for Vital Emergency

Collection of serious adverse events

Time frame: 24 months

Secondary

Satisfaction

Completion of a questionnaire after 6 months

Time frame: 6 months

Secondary

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

Time frame: 24 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026