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Recruiting NCT06133426

Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients

No phase Interventional Lymphoma, Non-Hodgkin Myeloma Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Connected scale "Body Comp Pro" from Withings.
Who it may be relevant to
Registry conditions: Lymphoma, Non-Hodgkin, Myeloma Multiple. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Connected scale "Body Comp Pro" from Withings
    Use once a day from inclusion to week 7.

Primary outcome measures

  • Percentage of patients who agreed to participate in research [Time frame: Inclusion]
Secondary outcome measures (8)
  • Frequency of use of the connected scale during the patient's participation in the research [Time frame: From inclusion to week 7]
  • Assessment of the patient's anxiety regarding the device [Time frame: week 7]
  • Evaluation of the ease of use of the device perceived by the patient [Time frame: week 7]
  • Evaluation of the implementation of the study by the patient [Time frame: week 7]
  • Evaluation of the consequences in care of alerts generated by the plateform [Time frame: From inclusion to week 7]
  • Evaluation of the consequences in care of alerts generated by the plateform [Time frame: From inclusion to week 7]
  • Evaluation of the consequences in care of alerts generated by the plateform [Time frame: From inclusion to week 7]
  • Evaluation of the consequences in care of alerts generated by the plateform [Time frame: From inclusion to week 7]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Cochin Hospital — Paris

Identifiers

NCT: NCT06133426 · APHP230916 · 2023-A01684-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗