A Study of Telemonitoring in Cancer Patients

NCT06381024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-01-05

No results posted yet for this study

Summary

The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.

Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:

* In-person care alone (Standard of care group).
* In-person care with Cureety telemonitoring (Standard of care with Cureety group).

Participants will:

* be monitored with digital application Cureety (Standard of care with Cureety group)
* fill out quality of life questionnaire (baseline, 2 months, 4 months)
* fill out satisfaction questionnaire (2 months, 4 months)
* have the ongoing and incoming phone calls logged (duration and type)

Conditions

Interventions

DEVICE

remote patient monitoring

Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool is adaptable to specific treatments and disease settings. The platform collects various data including treatment delays, dose reductions, quality of life and safety data. In terms of safety, once configured for the treatment and disease setting, the patient responds to an electronic PRO (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0.10 Depending on the responses, an algorithm classifies patients as either "correct", "compromised", "state to be monitored", or "critical state". Depending on the classification, patients are notified of the actions to be taken.

Sponsors & Collaborators

  • Exystat

    collaborator OTHER
  • Cureety

    collaborator INDUSTRY
  • Pharmaspecific

    collaborator UNKNOWN
  • ProPens

    collaborator UNKNOWN
  • Centre Hospitalier de Bligny

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2024-09-04
Completion
2024-09-04

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381024 on ClinicalTrials.gov