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)

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
  • Cardiff, United Kingdom, CF14 2TL
  • Maidstone, United Kingdom, ME16 9QQ
  • Nottingham, United Kingdom, NG5 1PB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Adult females with HER2-positive EBC who participated in the parent study MO22982 will be observed in this non-interventional study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Trastuzumab; 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.; Other Names: Herceptin
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.	Drug: Trastuzumab; 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.; Other Names: Herceptin
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.	Drug: Trastuzumab; 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.; Other Names: Herceptin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (ESTIMATE): January 18, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: ML29123; 2010-024099-25 (EudraCT Number)