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Trial Title:
Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients
NCT ID:
NCT06133426
Condition:
Lymphoma, Non-Hodgkin
Myeloma Multiple
Conditions: Official terms:
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Hematology
Connected scale
Remote monitoring
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Pilot study of feasibility and acceptability, non-comparative, non-controlled,
non-randomized
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Connected scale "Body Comp Pro" from Withings
Description:
Use once a day from inclusion to week 7.
Arm group label:
Cohort group
Summary:
In this research, we will evaluate the feasibility of following by remote monitoring,
using a connected scale, in hematology patients suffering from myeloma or lymphoma and
requiring treatment with chemotherapy. 30 patients will be included in the research and
will all use a connected scale for the duration of their participation (7 weeks +/- 1
week). During their participation, patients will be asked to weigh themselves once a day,
ideally at a set time. Patient data will be accessible by the medical team via a remote
monitoring platform.
Alerts will be generated in the event of abnormal development of certain clinical
parameters (weight, heart rate, etc.) allowing early treatment to be implemented by the
medical team.
At the end of their participation, we will evaluate patients' support and perception of
this tool, as well as the healthcare consequences of the alerts generated by the remote
monitoring platform.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient aged 18 and over (male or female)
- Patient suffering from aggressive non-Hodgkin's lymphoma or multiple myeloma with a
plan for systemic chemotherapy or having started two cycles or less or patient with
the need for therapeutic intensification under the cover of autograft in the context
of myeloma or lymphoma
- Patient who can be contacted by telephone during their participation in the research
- Patient able to return home at the end of their initial hospitalization
- Patient affiliated to social security
- Patient able to read and speak French
- Patient having signed free, informed and written consent
Exclusion Criteria:
- Patient with an estimated life expectancy < 3 months
- Patient with moderate to severe cognitive impairment (assessed by MMSE < 20)
- Patient with a psychiatric or physical disability that does not allow the use of the
device
- Patient with a pacemaker
- Patient participating in another intervention research project
- Pregnant patient
- Patient deprived of liberty
- Patient under legal protection (guardianship or curatorship)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
Withings
Agency class:
Industry
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06133426
