Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317389
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-12
Brief Title:
PACOME PAtient Cancer Oral MEdication Cohort of Patients Treated with Oral Anticancer Drugs Benefiting from Oncoral Multidisciplinary Monitoring in Real Life Predictive Factors and Safety of Treatments
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
PACOME PAtient Cancer Oral MEdication Cohort of Patients Treated with Oral Anticancer Drugs Benefiting from Oncoral Multidisciplinary Monitoring in Real Life Predictive Factors and Safety of Treatments
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
PACOME
Brief Summary:
With the shift to ambulatory care and the rise of ATCO oral anticancer drugs a growing number of cancer patients are benefiting from oral treatment in an outpatient setting which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital However outside the safe hospital context the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction in life actual dose-intensity and expected response Furthermore insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination DRPs lead to an increase in the consumption of care
Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs Set up in 2014 by the Hospices Civils de Lyon this educational monitoring is based on a tripartite hospital intervention oncologist pharmacist nurse and a structured city-hospital link with private health professionals attending doctor community pharmacist and freelance nurse Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities
The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population on the real-life use of ATCO and on new methods of organizing ambulatory cancer care
The PACOME database collects sociodemographic clinical and therapeutic data and experiences in this population Patients quality of life and other PROs symptoms and adverse effects experienced by patients social determinants health care consumption the caregiver-patient relationship the use of digital technology in health the organization of care the city-hospital link interventions of actors and their temporality
This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials which are expected by health professionals and decision-makers With patient data from the secure Oncoral pathway PACOME brings together the three major and inseparable assets of real-life databases quality completeness and meaning of the data It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies which will contribute to the animation of the new ecosystem of real-life health data in oncology
Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs Set up in 2014 by the Hospices Civils de Lyon this educational monitoring is based on a tripartite hospital intervention oncologist pharmacist nurse and a structured city-hospital link with private health professionals attending doctor community pharmacist and freelance nurse Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities
The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population on the real-life use of ATCO and on new methods of organizing ambulatory cancer care
The PACOME database collects sociodemographic clinical and therapeutic data and experiences in this population Patients quality of life and other PROs symptoms and adverse effects experienced by patients social determinants health care consumption the caregiver-patient relationship the use of digital technology in health the organization of care the city-hospital link interventions of actors and their temporality
This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials which are expected by health professionals and decision-makers With patient data from the secure Oncoral pathway PACOME brings together the three major and inseparable assets of real-life databases quality completeness and meaning of the data It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies which will contribute to the animation of the new ecosystem of real-life health data in oncology
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