NCT02876848

A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)

Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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. Mary's Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 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.

Conditions

• Breast Neoplasms
• Medication Adherence

Interventions

Type	Name	Description
OTHER	OPTIMUM e-health tool	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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2016-08-24
• Last updated: 2016-08-24

Locations

1 site across 1 country: Canada