Ignite Creation Date:
2024-05-06 @ 9:00 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02876848
Status:
UNKNOWN
Last Update Posted:
2016-08-24
First Post:
2016-08-16
Brief Title:
A Novel E-Health Approach in Optimizing Treatment for Seniors OPTIMUM Study
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer A Novel E-Health Approach in Optimizing Treatment for Seniors OPTIMUM Study
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Background In women with hormone receptor positive HR breast cancer adjuvant endocrine therapy AET is associated with a significant survival advantage Nonadherence is a particular challenge in older women even though they stand to benefit the most from AET Therefore a novel e-health tool OPTIMUM that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians
Detailed Description:
Objectives 1 To determine the effectiveness of a patient-specific real-time e-health alerts delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation 2 To assess integration of e-health alerts regarding deviations from best practices in administration of AET by cancer care teams
Methods A prospective two group controlled comparison pilot study will be conducted at two urban McGill University-affiliated hospitals the Royal Victoria Hospital and St Marys Hospital A minimum of 43 patients per study arm will be enrolled through site-level allocation Follow-up is 15 years Healthcare professionals at the intervention site will have access to the e-health tool which will report to them in real-time medical events with known associations to AET discontinuation AET adherence monitor and a discontinuation alert
Methods A prospective two group controlled comparison pilot study will be conducted at two urban McGill University-affiliated hospitals the Royal Victoria Hospital and St Marys Hospital A minimum of 43 patients per study arm will be enrolled through site-level allocation Follow-up is 15 years Healthcare professionals at the intervention site will have access to the e-health tool which will report to them in real-time medical events with known associations to AET discontinuation AET adherence monitor and a discontinuation alert
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None