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

NCT06133426 | Recruiting

• 2 other identifiers: APHP2309162023-A01684-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, Non-Hodgkin; Myeloma Multiple

Keywords

Hematology; Connected scale; Remote monitoring

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who agreed to participate in research

  Number of included patients / Number of indormed patients

  Inclusion

Secondary Outcomes (8)

• Frequency of use of the connected scale during the patient's participation in the research

  From inclusion to week 7

• Assessment of the patient's anxiety regarding the device

  week 7

• Evaluation of the ease of use of the device perceived by the patient

  week 7

• Evaluation of the implementation of the study by the patient

  week 7

• Evaluation of the consequences in care of alerts generated by the plateform

  From inclusion to week 7

Study Arms (1)

Cohort group

OTHER

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.

Device: Connected scale "Body Comp Pro" from Withings

Interventions

Connected scale "Body Comp Pro" from Withings DEVICE

Use once a day from inclusion to week 7.

Cohort group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Withings: collaborator

Study Sites (1)

Cochin Hospital

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Central Study Contacts

Rudy BIRSEN, Dr

CONTACT

01.58.41.42.90; rudy.birsen@aphp.fr

Elodie LEMADRE, Mrs

CONTACT

01.44.84.17.34; elodie.lemadre@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study of feasibility and acceptability, non-comparative, non-controlled, non-randomized

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 15, 2023
• Study Start: September 4, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)