Trial Outcomes & Findings for Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response (NCT NCT03154710)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

6 months

Results posted on

2021-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	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	Standard Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
Overall Study STARTED	27	25
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Web-application Follow up n=20 Participants 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	Standard n=20 Participants Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)	Total n=40 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 14.4 • n=20 Participants	64 years STANDARD_DEVIATION 12.9 • n=20 Participants	65 years STANDARD_DEVIATION 13.5 • n=40 Participants
Sex: Female, Male Female	9 Participants n=20 Participants	10 Participants n=20 Participants	19 Participants n=40 Participants
Sex: Female, Male Male	11 Participants n=20 Participants	10 Participants n=20 Participants	21 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Web-application Follow up n=20 Participants 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	Standard n=20 Participants Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up	9 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Collection of all complication presented by patients

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Collection of serious adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

PS according to WHO

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Completion of a questionnaire after 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome data not reported

Adverse Events

Web-application Follow-up

Serious events: 4 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Web-application Follow-up n=27 participants at risk 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	Standard n=25 participants at risk Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
Respiratory, thoracic and mediastinal disorders pneumonitis	0.00% 0/27 • 2 years	8.0% 2/25 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders respiratory distress	3.7% 1/27 • Number of events 1 • 2 years	0.00% 0/25 • 2 years
General disorders fever	3.7% 1/27 • Number of events 1 • 2 years	0.00% 0/25 • 2 years
General disorders falls	0.00% 0/27 • 2 years	4.0% 1/25 • Number of events 1 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) endometriel carcinoma	0.00% 0/27 • 2 years	4.0% 1/25 • Number of events 1 • 2 years
Cardiac disorders myocardial infarction	3.7% 1/27 • Number of events 1 • 2 years	0.00% 0/25 • 2 years
Renal and urinary disorders pyelonephritis	3.7% 1/27 • Number of events 1 • 2 years	0.00% 0/25 • 2 years
Infections and infestations sepsis	0.00% 0/27 • 2 years	4.0% 1/25 • Number of events 1 • 2 years
Infections and infestations influenza A	3.7% 1/27 • Number of events 1 • 2 years	0.00% 0/25 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr Katell LE DU

Weprom

Phone: 241682940

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place