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

• Sponsor: Weprom (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03154710
• Collaborator: SIVAN Innovation (Other), Takeda (Industry)
• Enrollment: 52
• Locations: 15
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Hodgkin	Device: MOOVCARE	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised, open, multicenter prospective trialRandomised, 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: Jul 12, 2017
• Actual Primary Completion Date: Oct 14, 2020
• Actual Study Completion Date: Mar 12, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Complication Detection Time [24 months]

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

2. Number of Complication Observed [24 months]

   Collection of all complication presented by patients

3. Rate of Hospitalization for Vital Emergency [24 months]

   Collection of serious adverse events

4. 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

5. Compliance [24 months]

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

6. Performances Status (PS) at Relapse [24 months]

   PS according to WHO

7. 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

8. Depression [up to 12 months]

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

9. Satisfaction [6 months]

   Completion of a questionnaire after 6 months

10. Progression Free Survival [24 months]

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

11. Overall Survival [24 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient with either:

2. T-cell lymphoma in first complete or partial response

3. Hodgkin lymphoma in 2nd complete or partial response including after autograft

4. Large B-cell diffuse lymphoma in 2nd complete or partial response including after autograft

5. End-of-treatment imaging in the last 4 weeks

6. Age ≥ 18 years

7. PS ≤2 (WHO)

8. Patient with an initial symptoms score less than or equal to 5

9. Patient with internet access and mailbox

10. Patient affiliated to a social security scheme

11. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHBA Vannes	Vannes	Bretagne	France	56017
2	Institut Bergonié	Bordeaux	Gironde	France	33076
3	Polyclinique du Parc	Caen	Normandie	France	14000
4	Institut d'Hématologie de Basse Normandie	Caen	Normandie	France	14033
5	Hôpital Privé du Confluent	Nantes	Pays De Loire	France	44277
6	Centre Hospitalier Universitaire Jean Minjoz	Besançon		France	25030
7	Polyclinique Bordeaux Nord	Bordeaux		France	33077
8	Centre Hospitalier Univeritaire	Dijon		France	21000
9	CHU Grenoble	Grenoble		France	38700
10	Centre Jean Bernard	Le Mans		France	72000
11	Ch Mont de Marsan	Mont-de-Marsan		France	40000
12	Centre d'Oncologie de Gentilly	Nancy		France	54000
13	Hopital Saint Louis	Paris		France	75475
14	Clinique Saint Anne	Strasbourg		France	67000
15	Centre Hospitalier Universitaire	Tours		France	37044

Sponsors and Collaborators

• Weprom
• SIVAN Innovation
• Takeda

Investigators

• Principal Investigator: Katell LE DU, MD, Centre Jean Bernard - Le Mans

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 17, 2019

More Information

Publications

None provided.

• Responsible Party: Weprom
• ClinicalTrials.gov Identifier: NCT03154710
• Other Study ID Numbers: ILC-1-2016; 2016-A01024-47
• First Posted: May 16, 2017
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Weprom: Web-mediated follow up; Lymphoma; Personalized medicine
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell; Hodgkin Disease

Study Results

Participant Flow

Arm/Group Title	Web-application Follow up	Standard
Arm/Group 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 MOOVCARE: web-mediated follow up	Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
Period Title: Overall Study
STARTED	27	25
COMPLETED	20	20
NOT COMPLETED	7	5

Baseline Characteristics

Arm/Group Title	Web-application Follow up	Standard	Total
Arm/Group 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 MOOVCARE: web-mediated follow up	Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (14.4)	64 (12.9)	65 (13.5)
Sex: Female, Male (Count of Participants)
Female	9 45%	10 50%	19 47.5%
Male	11 55%	10 50%	21 52.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
France	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Web-application Follow up	Standard
Arm/Group 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 MOOVECARE application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem MOOVECARE: web-mediated follow up	Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
Measure Participants	20	20
Count of Participants [Participants]	9 45%	2 10%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Number of Complication Observed
Description	Collection of all complication presented by patients
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Rate of Hospitalization for Vital Emergency
Description	Collection of serious adverse events
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Compliance
Description	Number of assessement completed (usually 1 per 2 weeks) by patients
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Performances Status (PS) at Relapse
Description	PS according to WHO
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Satisfaction
Description	Completion of a questionnaire after 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Progression Free Survival
Description	Time between the diagnostic of partial or complete response and the diagnostic of relapse
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Overall Survival
Description	Time between the diagnostic of partial or complete response and the patient's death
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	2 years
Arm/Group Title	Web-application Follow-up		Standard
Arm/Group 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 MOOVECARE application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem MOOVECARE: web-mediated follow up		Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
All Cause Mortality
	Web-application Follow-up		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/27 (7.4%)		1/25 (4%)
Serious Adverse Events
	Web-application Follow-up		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/27 (14.8%)		5/25 (20%)
Cardiac disorders
myocardial infarction	1/27 (3.7%)	1	0/25 (0%)	0
General disorders
fever	1/27 (3.7%)	1	0/25 (0%)	0
falls	0/27 (0%)	0	1/25 (4%)	1
Infections and infestations
sepsis	0/27 (0%)	0	1/25 (4%)	1
influenza A	1/27 (3.7%)	1	0/25 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
endometriel carcinoma	0/27 (0%)	0	1/25 (4%)	1
Renal and urinary disorders
pyelonephritis	1/27 (3.7%)	1	0/25 (0%)	0
Respiratory, thoracic and mediastinal disorders
pneumonitis	0/27 (0%)	0	2/25 (8%)	2
respiratory distress	1/27 (3.7%)	1	0/25 (0%)	0
Other (Not Including Serious) Adverse Events
	Web-application Follow-up		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.