An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC)

Study Overview
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Brief Summary
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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).

Official Title
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Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations for the Treatment of Patients With HER2-Positive Early Breast Cancer (EBC)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trastuzumab IV Infusion<br>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. | Drug: Trastuzumab<br>* Trastuzumab will be given on Day 1 of each 3-week cycle for a total of 18 cycles. Dosage will be according to the local labeling: 600 milligrams (mg) SC or 6 milligrams per kilogram (mg/kg) via IV infusion. For those assigned to the IV arm or if IV treatment is delayed >1 week, an initial loading/reloading dose of 8 mg/kg will be given instead. Due to the observational nature of this study, trastuzumab is not an investigational product but will be supplied in the MO22982 trial. Each route/device (SC single-use injection device, SC vial/syringe, IV infusion) will be observed in at least 12 episodes of care.<br>* Other names: Herceptin;|
| Trastuzumab SC Single-Use Injection Device<br>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. | Drug: Trastuzumab<br>* Trastuzumab will be given on Day 1 of each 3-week cycle for a total of 18 cycles. Dosage will be according to the local labeling: 600 milligrams (mg) SC or 6 milligrams per kilogram (mg/kg) via IV infusion. For those assigned to the IV arm or if IV treatment is delayed >1 week, an initial loading/reloading dose of 8 mg/kg will be given instead. Due to the observational nature of this study, trastuzumab is not an investigational product but will be supplied in the MO22982 trial. Each route/device (SC single-use injection device, SC vial/syringe, IV infusion) will be observed in at least 12 episodes of care.<br>* Other names: Herceptin;|
| Trastuzumab SC Vial/Syringe<br>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. | Drug: Trastuzumab<br>* Trastuzumab will be given on Day 1 of each 3-week cycle for a total of 18 cycles. Dosage will be according to the local labeling: 600 milligrams (mg) SC or 6 milligrams per kilogram (mg/kg) via IV infusion. For those assigned to the IV arm or if IV treatment is delayed >1 week, an initial loading/reloading dose of 8 mg/kg will be given instead. Due to the observational nature of this study, trastuzumab is not an investigational product but will be supplied in the MO22982 trial. Each route/device (SC single-use injection device, SC vial/syringe, IV infusion) will be observed in at least 12 episodes of care.<br>* Other names: Herceptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device | 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. | Data collection up to 1 year | 
| Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection | 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. | Data collection up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion | 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 preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds. | Data collection up to 1 year | 
| Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. | 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 | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. | Data collection up to 1 year | 
| Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. | Data collection up to 1 year | 
| Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. | Data collection up to 1 year | 
| Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. | Data collection up to 1 year | 
| Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes. | Data collection up to 1 year | 
| Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes. | Data collection up to 1 year |