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

NCT02876848 | Unknown

• 1 other identifier: MP-37-2017-2535
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Medication Adherence

Keywords

Administrative Claims, Healthcare; Aromatase Inhibitors; Breast Neoplasms; Health Services for the Aged; Medical Informatics Applications; Medication Adherence; Outcome and Process Assessment (Health Care); Selective Estrogen Receptor Modulators; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Primary Non-adherence

  1.5 years

• Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment

  1.5 years

• 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

Study Arms (2)

Intervention Site

EXPERIMENTAL

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

Other: OPTIMUM e-health tool

Control Site

NO INTERVENTION

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.

Interventions

OPTIMUM e-health tool 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.

Intervention Site

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• male gender

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Medication Adherence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ari N Meguerditchian, MD

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

  PRINCIPAL INVESTIGATOR

• Liane Feldman, MD

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

  STUDY DIRECTOR

Central Study Contacts

Ari N Meguerditchian, MD

CONTACT

(514) 934-1934; ari.meguerditchian@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncologist, McGill University Health Centre

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 24, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

CA (1)