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

McGill University

Status: Unknown

Conditions: Medication Adherence; Breast Neoplasms

Treatments: Other: OPTIMUM e-health tool

Study type: Interventional

Funder types: Other

Identifiers

NCT02876848

MP-37-2017-2535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must be ≥ 65 years old,
2. Have been diagnosed with incident (non-metastatic) breast cancer,
3. Have a histologically-confirmed breast adenocarcinoma,
4. Have undergone breast surgery for stages I-III disease,
5. Have medical insurance with the Régie de l'Assurance Maladie du Québec (RAMQ) for at least 1 year prior to surgery,
6. Have HR positive disease,
7. Have no history of AET use prior to the diagnosis of breast cancer,
8. Expected to initiate AET or have only recently initiated AET (<6 months) but are free of previous discontinuation events,
9. Have the ability to consent for herself.

Exclusion criteria

male gender

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Intervention Site

Experimental group

Description:

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

Treatment:

Other: OPTIMUM e-health tool

Control Site

No Intervention group

Description:

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.