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NCT Number: NCT06133426

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Connected scale "Body Comp Pro" from Withings

Device

Use once a day from inclusion to week 7.

Primary outcomes

  1. Percentage of patients who agreed to participate in research

    Time frame: Inclusion

    Number of included patients / Number of indormed patients

Secondary outcomes

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

    Time frame: From inclusion to week 7

    Average of weighings/week

  2. Assessment of the patient's anxiety regarding the device

    Time frame: week 7

    Specific 5 points Likert Scale (1 - 5 ; Higher score mean a worse outcome)

  3. Evaluation of the ease of use of the device perceived by the patient

    Time frame: week 7

    Symptom Usability Scale (0 - 100 ; Higher score mean a better outcome)

  4. Evaluation of the implementation of the study by the patient

    Time frame: week 7

    FIM (Feasibility of Intervention Measure), AIM (Acceptability of Intervention Measure) and IAM (Intervention Appropriateness Measure) / (1 - 5 ; Higher score mean a better outcome)

  5. Evaluation of the consequences in care of alerts generated by the plateform

    Time frame: From inclusion to week 7

    Number of alerts generated/patient.

  6. Evaluation of the consequences in care of alerts generated by the plateform

    Time frame: From inclusion to week 7

    Number of calls made/patient.

  7. Evaluation of the consequences in care of alerts generated by the plateform

    Time frame: From inclusion to week 7

    Average time spent per call following the generation of an alert.

  8. Evaluation of the consequences in care of alerts generated by the plateform

    Time frame: From inclusion to week 7

    Number and type of consultations, hospitalizations, additional assessments resulting from the generation of an alert.

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie LEMADRE, Mrs

CONTACT

[email protected]

01.44.84.17.34 ext. +33

Rudy BIRSEN, Dr

CONTACT

[email protected]

01.58.41.42.90 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Withings

Registry information

Acronym: BTP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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