Clinical trial NCT02658461: 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)
Official title: Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations for the Treatment of Patients With HER2-Positive Early Breast Cancer (EBC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device
timeFrame: Data collection up to 1 year
measure: Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection
timeFrame: Data collection up to 1 year
Secondary outcomes:
measure: Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion
timeFrame: Data collection up to 1 year
measure: Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
timeFrame: Data collection up to 1 year
measure: Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
timeFrame: Data collection up to 1 year
measure: Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
timeFrame: Data collection up to 1 year
measure: Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
timeFrame: Data collection up to 1 year
measure: Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
timeFrame: Data collection up to 1 year
measure: Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
timeFrame: Data collection up to 1 year
measure: Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
timeFrame: Data collection up to 1 year
measure: Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
timeFrame: Data collection up to 1 year
measure: Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
timeFrame: Data collection up to 1 year
measure: Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
timeFrame: Data collection up to 1 year
measure: Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
timeFrame: Data collection up to 1 year
measure: Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
timeFrame: Data collection up to 1 year
measure: Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab
timeFrame: Data collection up to 1 year
measure: Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab
timeFrame: Data collection up to 1 year
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Maidstone
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: