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Spots Global Cancer Trial Database for A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)

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Trial Identification

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

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

Study ID: NCT02876848

Study Description

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. 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.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

McGill University Health Centre, Montreal, Quebec, Canada

Contact Details

Name: Ari N Meguerditchian, MD

Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

Role: PRINCIPAL_INVESTIGATOR

Name: Liane Feldman, MD

Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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