A Study of Telemonitoring in Cancer Patients

NCT06381024 | Completed DMC

• 1 other identifier: 2022 A02702-41
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment

  Number of calls, defined as the number of incoming and outgoing calls that occurs during the 4 months from randomization

  4 months after randomization

Secondary Outcomes (6)

• Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment

  During 4 months after randomization

• Numbers of telephone calls during the first 4 months of cancer treatment in subgroups

  During 4 months after randomization

• Hospital-free survival rate

  During 4 months after randomization

• Quality of life at 2 and 4 months after initiation of cancer treatment.

  During 4 months after randomization

• Patient satisfaction with the healthcare provided

  During 4 months after randomization

Study Arms (2)

Standard of care group

NO INTERVENTION

Standard of care

Standard of care with Cureety group

EXPERIMENTAL

In-person care with remote patient monitoring with the Cureety application

Device: remote patient monitoring

Interventions

remote patient monitoring DEVICE

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.

Also known as: Cureety

Standard of care with Cureety group

Eligibility Criteria

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

You may qualify if:

• Patients that have provide written informed consent for study participation.
• Patients aged 18 years or older.
• Patients initiating oral or intravenous treatment (chemotherapy, immunotherapy, targeted therapies etc.) for localized or metastatic or recurrent cancer treated at the CH Bligny.
• Patients with the capacity, personally (e.g., language and capacity to use the application), and in terms of infrastructure (internet access, possessing a smart phone etc.) to perform telemonitoring with Cureety.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

You may not qualify if:

• Patients treated for cancer at the CH Bligny in the last 5 years

Sponsors & Collaborators

• Cureety: collaborator
• Pharmaspecific: collaborator
• ProPens: collaborator
• Centre Hospitalier de Bligny: lead
• Exystat: collaborator

Study Sites (1)

Centre Hospitalier de Bligny

Briis-sous-Forges, 91640, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 telemonitoring (Standard of care with Cureety group). The randomization will be stratified by: • Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 24, 2024
• Study Start: April 4, 2023
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)