Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371911
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment
Sponsor:
Centre Francois Baclesse
Organization:
Centre Francois Baclesse
Study Overview
Official Title:
Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment a Multicentric French Prospective Randomized Study The OPTIMACURE Protocol
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
OPTIMACURE
Brief Summary:
Currently during usual care it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration To assess this blood tests are usually performed in the days leading up to the planned administration A hospital staff member then telephones the patients and evaluates using the tests results and other patient data including the presence of adverse events AEs and Eastern Cooperative Oncology Group ECOG performance status whether the patient is apt for treatment or whether the treatment needs to be deferred
In France the Centre François Baclesse in Caen France launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital
A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse
Following the positive impact of both the OPTIMA and Star programs several French healthcare centers have implemented similar programs However a large proportion of the data during the program are collected by telephone particularly outgoing calls from the hospital staff to patients Thus implementing these programs is expected to increase the number andor duration of outgoing calls and consequently the workload of hospital staff
Since the deployment of the OPTIMA program between 2014 and 2016 and other equivalent programs more and more patients have asked for the telephone calls to be replaced by a web-based application Indeed patients do not always respond to the telephone calls made by hospital staff thus forcing staff to repeat calls several times Also some patients with language or hearing difficulties are unable to answer the questionnaires by telephone a web-based alternative would be more appropriate for these patients
Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment Telemonitoring can then identify the few patients that need to be contacted by hospital staff thus reducing the number of outgoing telephone calls
There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment The benefits include the early detection of AEs improved quality of life QoL fewer admissions to emergency rooms or hospitalization the longer remaining on chemotherapy for patients and extended overall survival
Cureety is a digital telemonitoring platform specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients The digital tool includes questionnaires for each class of medication to monitor patients adverse events remotely The data collected include blood results treatment-related data including delays dose reductions as well as QoL and safety data In terms of safety patients respond to an electronic patient-reported outcome ePRO questionnaire based on the NCI-CTCAE version v50 Depending on the responses the Cureety TechCare algorithm classifies the patient state as correct compromised to be monitored or critical The patients are then notified of the actions to be taken according to their classification In preparation for injectable cancer treatment Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration The collection and evaluation of this data is expected to decrease outgoing calls by between 30 to 50
This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment OPTIMA program or equivalent
In France the Centre François Baclesse in Caen France launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital
A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse
Following the positive impact of both the OPTIMA and Star programs several French healthcare centers have implemented similar programs However a large proportion of the data during the program are collected by telephone particularly outgoing calls from the hospital staff to patients Thus implementing these programs is expected to increase the number andor duration of outgoing calls and consequently the workload of hospital staff
Since the deployment of the OPTIMA program between 2014 and 2016 and other equivalent programs more and more patients have asked for the telephone calls to be replaced by a web-based application Indeed patients do not always respond to the telephone calls made by hospital staff thus forcing staff to repeat calls several times Also some patients with language or hearing difficulties are unable to answer the questionnaires by telephone a web-based alternative would be more appropriate for these patients
Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment Telemonitoring can then identify the few patients that need to be contacted by hospital staff thus reducing the number of outgoing telephone calls
There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment The benefits include the early detection of AEs improved quality of life QoL fewer admissions to emergency rooms or hospitalization the longer remaining on chemotherapy for patients and extended overall survival
Cureety is a digital telemonitoring platform specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients The digital tool includes questionnaires for each class of medication to monitor patients adverse events remotely The data collected include blood results treatment-related data including delays dose reductions as well as QoL and safety data In terms of safety patients respond to an electronic patient-reported outcome ePRO questionnaire based on the NCI-CTCAE version v50 Depending on the responses the Cureety TechCare algorithm classifies the patient state as correct compromised to be monitored or critical The patients are then notified of the actions to be taken according to their classification In preparation for injectable cancer treatment Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration The collection and evaluation of this data is expected to decrease outgoing calls by between 30 to 50
This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment OPTIMA program or equivalent
Detailed Description:
None
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