Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06381024 |
Other study ID # |
2022 A02702-41 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 4, 2023 |
Est. completion date |
December 30, 2024 |
Study information
Verified date |
April 2024 |
Source |
Centre Hospitalier de Bligny |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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)
Description:
Rationale:
Telemonitoring of cancer patients provides patients with cancer-related information, as well
as allowing appointment management, early detection of side-effects/adverse events (AEs), and
the collection of safety and quality of life data from the patients' perspectives.1 Several
studies have assessed the benefit of telemonitoring from the patients' perspective.1-5
However, few studies have investigated the benefit of telemonitoring for healthcare
professionals.4,6,7 The Symptom Tracking and Reporting (STAR) randomized trial, performed at
the Memorial Sloan Kettering Institute, randomly allocated patients to either usual care or
the patient-reported outcome (PRO) group.8,9 Patients in the PRO group completed a web-based
questionnaire concerning 12 common AEs (based on the National Cancer Institute Common
Terminology Criteria for AEs [NCI-CTCAE version (v) 5.0]10) at or between visits. In the PRO
group, 63% of patients reported severe AEs during the study. Patients, in the PRO group,
reported improved quality of life, fewer admissions to emergency rooms or hospitalization,
extended duration of chemotherapy, and extended overall survival (OS). This increased OS is
potentially due to the early response by healthcare professionals to severe AEs identified by
the web-based questionnaire. For healthcare professionals, the study reported fewer
unscheduled visits for patients allocated to the PRO group.
Interestingly, in the STAR trial, 77% of the nurse interventions (either by email or
telephone) were in response to alerts (either counseling or symptom management), 12% were for
initiating or changing of supportive treatment, 8% were for referrals to the emergency room
or hospital, 2% were for chemotherapy dose modifications, and 2% were for ordering imagery or
biological test.11 In France, the Foch hospital initiated the Star program for patients
undergoing chemotherapy.12 The program collects patient data within at most 3 days prior to
each chemotherapy session and transfer these to healthcare professionals to prepare the
chemotherapy. The patient has the choice of completing a questionnaire via the internet or
providing the information by telephone with the aid of a nurse. The data includes health
status, presence of AEs, and blood test results. These data allow healthcare professionals to
adapt or delay the chemotherapy, change treatments, and provide the patient with personalized
advice according to the patient's health status. The program has improved the performance of
departments involved by increasing the number of patients treated per day, decreasing the
waiting times for patients, and by reducing the wastage of healthcare products.
Consequently, numerous French healthcare centers want to implement programs like the Star
program. However, a substantial portion of the data collection occurs via the telephone,
particularly outgoing calls (from the hospital staff to patients). This increase in telephone
communication means more work for healthcare professions. A digital telemonitoring platform,
like Cureety that can collect this data before chemotherapy, is expected to decrease outgoing
calls by between 30% to 50% and facilitate the implementing of these programs.
Furthermore, healthcare centers in France are continually facing budget restrictions. At the
same time, treating cancer patients is associated with an increase in incoming calls from
patients during cancer treatment, particularly for minor AEs. The treating of these incoming
calls is often repetitive and time consuming for hospital staff. The collection of data
concerning AEs, of varying severity, can be integrated in a digital platform. Patients with
minor AEs can be provided with the actions to be followed via the platform. This will allow
staff to concentrate on patients with severe AEs needing urgent attention.
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.
This study will assess the benefit of adding Cureety telemonitoring to standard of care,
compared to standard of care alone, for monitoring cancer patients undergoing oral or
intravenous cancer treatments.
Methodology:
The MINERVA study was designed as a prospective, randomized, unblinded, single-centre,
interventional study with minimal risks and constraints for patients.
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.
Data concerning the telephone calls between study patients and the staff at the CH Bligny
will be collected. The incoming and outgoing calls from the CH Bligny will be classified in
the following categories:
- Cancer treatments information (including the use of associated prophylactic treatments,
e.g., granulocyte colony-stimulating factor [G-CSF], antihistamines etc.)
- Appointments, in the following subcategories:
- Administration of cancer therapy (including oral and intravenous treatments, etc.).
- Consultations for a reason other than administering therapy.
- Blood tests and other examinations.
- Prescriptions.
- Biological examinations (in preparation for cancer treatment).
- Psychological support.
- Patient education and supportive care.
- Cancer treatment-related AEs.
- Non-cancer treatment-related AEs, excluding COVID-related.
- COVID-related.
- Related to Cureety.
- Other calls. The planned enrolment period is 5 months. The planned follow-up period for
each patient is 4 months.