Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381024
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-28
Brief Title:
A Study of Telemonitoring in Cancer Patients
Sponsor:
Centre Hospitalier de Bligny
Organization:
Centre Hospitalier de Bligny
Study Overview
Official Title:
A Study of the Benefit of Telemonitoring for Hospital Staff Treating Patients With Oral or Intravenous Cancer Treatments a French Prospective Randomized Unblinded Single-centre Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINERVA
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 11 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
Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 11 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
Detailed Description:
Rationale
Telemonitoring of cancer patients provides patients with cancer-related information as well as allowing appointment management early detection of side-effectsadverse events AEs and the collection of safety and quality of life data from the patients perspectives1 Several studies have assessed the benefit of telemonitoring from the patients perspective1-5 However few studies have investigated the benefit of telemonitoring for healthcare professionals467 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 group89 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 5010 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 test11 In France the Foch hospital initiated the Star program for patients undergoing chemotherapy12 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 patients 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 v5010 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 11 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 eg 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
Telemonitoring of cancer patients provides patients with cancer-related information as well as allowing appointment management early detection of side-effectsadverse events AEs and the collection of safety and quality of life data from the patients perspectives1 Several studies have assessed the benefit of telemonitoring from the patients perspective1-5 However few studies have investigated the benefit of telemonitoring for healthcare professionals467 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 group89 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 5010 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 test11 In France the Foch hospital initiated the Star program for patients undergoing chemotherapy12 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 patients 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 v5010 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 11 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None