Lymphoma, Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
Conditions
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
web-mediated follow up
Sponsors
Study design
Intervention model description
Randomised, open, multicenter prospective trial
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complication Observed | 24 months | Collection of all complication presented by patients |
| Rate of Hospitalization for Vital Emergency | 24 months | Collection of serious adverse events |
| Sensibility of the Web-application | 24 months | Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert |
| Compliance | 24 months | Number of assessement completed (usually 1 per 2 weeks) by patients |
| Performances Status (PS) at Relapse | 24 months | PS according to WHO |
| Complication Detection Time | 24 months | Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed |
| Depression | up to 12 months | Completion of the HUMEUR PhQ9 questionnaire at baseline and after 3, 6, 9 and 12 months |
| Satisfaction | 6 months | Completion of a questionnaire after 6 months |
| Progression Free Survival | 24 months | Time between the diagnostic of partial or complete response and the diagnostic of relapse |
| Overall Survival | 24 months | Time between the diagnostic of partial or complete response and the patient's death |
| Quality of Life | up to 12 months | Completion 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
| Arm | Count |
|---|---|
| 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 |
| Total | 40 |
Baseline characteristics
| Characteristic | Standard | Total | Web-application Follow up |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 12.9 | 65 years STANDARD_DEVIATION 13.5 | 66 years STANDARD_DEVIATION 14.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 27 | 1 / 25 |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 4 / 27 | 5 / 25 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-application Follow up | Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up | 9 Participants |
| Standard | Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up | 2 Participants |
Compliance
Number of assessement completed (usually 1 per 2 weeks) by patients
Time frame: 24 months
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
Depression
Completion of the HUMEUR PhQ9 questionnaire at baseline and after 3, 6, 9 and 12 months
Time frame: up to 12 months
Number of Complication Observed
Collection of all complication presented by patients
Time frame: 24 months
Overall Survival
Time between the diagnostic of partial or complete response and the patient's death
Time frame: 24 months
Performances Status (PS) at Relapse
PS according to WHO
Time frame: 24 months
Progression Free Survival
Time between the diagnostic of partial or complete response and the diagnostic of relapse
Time frame: 24 months
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
Rate of Hospitalization for Vital Emergency
Collection of serious adverse events
Time frame: 24 months
Satisfaction
Completion of a questionnaire after 6 months
Time frame: 6 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
Time frame: 24 months