Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
Sponsor study identifier
interventional
120
1 country
1
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 16, 2016
Actual (reported)August 24, 2016
Actual (reported)September 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of patients discontinuing adjuvant endocrine therapy treatment
In each trial arm, the proportion of patients discontinuing AET treatment will be calculated as the number of patients discontinuing AET treatment divided by the total number of patients in that trial arm.
1.5 years
Primary Non-adherence
1.5 years
Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment
1.5 years
The hospital that will be the intervention site will have access to the OPTIMUM e-health tool. The intervention site cancer care team will receive the following OPTIMUM e-health alerts: 1. An electronic alert of increased Adjuvant Endocrine Therapy discontinuation risk. 2. An adherence to Adjuvant Endocrine Therapy monitor. 3. An electronic discontinuation occurrence alert
The hospital that will be the control site will not have access to the OPTIMUM e-health tool. The cancer care team will continue to deliver care according to standard processes.
If you are treated in a hospital that is using the OPTIMUM e-health tool ("intervention" group), once your care team receives any alerts, they may choose to: * Contact you over the phone or in person to provide medical advice on how to better take your pills, * Contact your pharmacist(s) and other doctors about your anti-cancer treatment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Ari N Meguerditchian, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Liane Feldman, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
First Submitted
August 16, 2016
First Posted
August 24, 2016
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Myocardial Infarction Prescription Duration Adherence Study
Mean time to adjuvant endocrine therapy treatment re-initiation.
1.5 years
Medical Possession Ratio ≥80%
1.5 years
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with patient
1.5 years
Contact the study team to confirm eligibility.
June 2018
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 24, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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