N/A
Completed N=36
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)
Source: ClinicalTrials.gov NCT02658461 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device — 33.03 pounds
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device |
33.03 | — |
| PRIMARY Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection |
33.15 | — |
| SECONDARY Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion |
22.07; 122.89 | — |
| SECONDARY Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device |
4.0; 4.2; 6.1; 1.4; 2.2; 2.2 | — |
| SECONDARY Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection |
2.9; 12.5; 3.5; 5.3; 0.3; 1.9 | — |
| SECONDARY Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion |
8.6; 4.6; 32.5; 2.5; 9.4; 1.6 | — |
| SECONDARY Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion |
4.6; 7.2; 2.3; 20.7; 2.6 | — |
| SECONDARY Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device |
16.0 | — |
| SECONDARY Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection |
24.6 | — |
| SECONDARY Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion |
58.1 | — |
| SECONDARY Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion |
34.5 | — |
| SECONDARY Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device |
1.2; 1.0; 1.0; 1.2; 1.6; 1.0 | — |
| SECONDARY Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection |
1.3; 1.0; 1.0; 1.0; 1.6; 1.0 | — |
| SECONDARY Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion |
1.5; 2.8; 1.1; 1.5; 2.3; 1.0 | — |
| SECONDARY Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion |
1.0; 3.0; 4.0; 2.7; 2.6; 3.5 | — |
| SECONDARY Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab |
56.7; 30.3; 94.5 | — |
| SECONDARY Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab |
30.0; 19.8; 75 | — |
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
Data sourced from ClinicalTrials.gov (NCT02658461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.