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)

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT02658461
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Results First Submitted: 2016-02-18
• Results First Submitted QC: 2016-02-18
• Status Verified: 2016-03
• Results First Posted: 2016-03-25
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trastuzumab IV Infusion	Trastuzumab	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.
Trastuzumab SC Vial/Syringe	Trastuzumab	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.
Trastuzumab SC Single-Use Injection Device	Trastuzumab	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.

Primary Outcome Measures

Name	Time	Method
Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection	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	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 Outcome Measures

Name	Time	Method
Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion	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 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.
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion	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. 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.
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion	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 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.
Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion	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 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.
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection	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 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.
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion	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 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.
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	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.
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection	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. 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.
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion	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. 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.
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	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.
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device	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 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.
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection	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 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.
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device	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 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.
Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab	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. 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.
Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab	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. 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.