Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations for the Treatment of Patients With HER2-Positive Early Breast Cancer (EBC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 36
- Primary Endpoint
- Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection
Study Overview
Brief Summary
This prospective, non-interventional time and motion study will evaluate the costs of healthcare resource utilization associated with the administration of trastuzumab (Herceptin) SC and IV formulations in HER2-positive EBC. This is a sub-study of the clinical study MO22982 (NCT01401166/PrefHer).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants from the MO22982 (PrefHer) clinical trial who consent to the presence of an observer to record data for the study during administration of trastuzumab
- •Members of the care team responsible for management of participants from the MO22982 (PrefHer) clinical trial who also consent to the presence of an observer during administration of trastuzumab
Exclusion Criteria
- •None specified
Arms & Interventions
Trastuzumab IV Infusion
Participants with HER2-positive EBC will be evaluated for the costs and other factors associated with health care utilization with the administration of trastuzumab via IV infusion.
Intervention: Trastuzumab (Drug)
Trastuzumab SC Single-Use Injection Device
Participants with HER2-positive EBC will be evaluated for the costs and other factors associated with health care utilization with the administration of trastuzumab via SC single-use injection device.
Intervention: Trastuzumab (Drug)
Trastuzumab SC Vial/Syringe
Participants with HER2-positive EBC will be evaluated for the costs and other factors associated with health care utilization with the administration of trastuzumab via SC vial/syringe.
Intervention: Trastuzumab (Drug)
Outcomes
Primary Outcomes
Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection
Time Frame: Data collection up to 1 year
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device
Time Frame: Data collection up to 1 year
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Secondary Outcomes
- Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion(Data collection up to 1 year)
- Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion(Data collection up to 1 year)
- Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion(Data collection up to 1 year)
- Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion(Data collection up to 1 year)
- Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection(Data collection up to 1 year)
- Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion(Data collection up to 1 year)
- Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device(Data collection up to 1 year)
- Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection(Data collection up to 1 year)
- Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion(Data collection up to 1 year)
- Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion(Data collection up to 1 year)
- Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device(Data collection up to 1 year)
- Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection(Data collection up to 1 year)
- Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device(Data collection up to 1 year)
- Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab(Data collection up to 1 year)
- Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab(Data collection up to 1 year)