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Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients (BTP)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Myeloma Multiple
Lymphoma, Non-Hodgkin

Treatments

Device: Connected scale "Body Comp Pro" from Withings

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06133426
2023-A01684-41 (Other Identifier)
APHP230916

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Cohort group
Other group
Description:
Patients will be used a connected scale during the duration of their participation in the study. Patients will be invited to use the scale once a day. Patient's data will be accesible by medical team via a specific remote plateform. Alert will be generated according to the evolution of clinical data, permetting a early patient management by the medical team.
Treatment:
Device: Connected scale "Body Comp Pro" from Withings

Trial contacts and locations

1

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Central trial contact

Rudy BIRSEN, Dr; Elodie LEMADRE, Mrs

Data sourced from clinicaltrials.gov

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