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

NCT ID: NCT02876848

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

Breast Neoplasms; Medication Adherence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Site

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

Group Type: EXPERIMENTAL

OPTIMUM e-health tool

Intervention Type: OTHER

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.

Control Site

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Ari Meguerditchian

Surgical Oncologist, McGill University Health Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ari N Meguerditchian, MD

Role: PRINCIPAL_INVESTIGATOR

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

Liane Feldman, MD

Role: STUDY_DIRECTOR

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

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Ari N Meguerditchian, MD

Role: CONTACT

ari.meguerditchian@mcgill.ca

(514) 934-1934 ext. 32999

Facility Contacts

Ari N Meguerditchian, MD

Role: primary

ari.meguerditchian@mcgill.ca

(514) 934-1934 ext. 32999

Other Identifiers

MP-37-2017-2535

Identifier Type: -

Identifier Source: org_study_id