Clinical trial NCT02876848: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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

Primary outcomes:
measure: Proportion of patients discontinuing adjuvant endocrine therapy treatment
timeFrame: 1.5 years
Secondary outcomes:
measure: Primary Non-adherence
timeFrame: 1.5 years
measure: Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment
timeFrame: 1.5 years
measure: Mean time to adjuvant endocrine therapy treatment re-initiation.
timeFrame: 1.5 years
measure: Medical Possession Ratio ≥80%
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - perform telephone follow-up with patient
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - perform telephone follow-up with community pharmacist
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - arrange for return to clinic with doctor
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - arrange for return to clinic with nurse
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - referral to doctor for closer follow-up
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - referral to cancer nurse for closer follow-up
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - ignore the alert
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - no changes in usual treatment despite new information provided
timeFrame: 1.5 years
measure: Cancer Care Team Actions in the intervention arm - Other
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Ari N Meguerditchian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Liane Feldman, MD
role: STUDY_DIRECTOR
References: