Nursing and Pharmacy Time for Delivering Xeloda® Versus 5-Fluoruracil Regimens

The Impact of Nursing and Pharmacy Care Between Xeloda® and 5-Fluoruracil Regimens in the Management of Colorectal Cancer (CRC) in Hong Kong

This is a prospective time-and-motion study to document and compare the time used in preparation, dispensing and administration for capecitabine/oxaliplatin (XELOX) versus IV 5-FU/leucovorin/oxaliplatin (FOLFOX4) regimens in colorectal cancer (CRC) patients.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer

Detailed Description

Colorectal cancer (CRC) is the second most common cause of cancer-related death in Hong Kong. The traditional chemotherapy for CRC remains on intravenous (IV) fluorouracil (5-FU) based regimens with the response rates of 10-20% and a median survival of approximately one year. Recent years, oral chemotherapy has a more practical and economic advantages over IV regimen. It is understandable that patients prefer oral regimens as long as the clinical efficacy is maintained. Oral treatment strategy preserves quality of life for CRC patients. In a previous cost-minimization study conducted in Hong Kong, it was demonstrated that capecitabine was more cost-effective than 5-FU plus oxaliplatin assuming they had equal clinical efficacy. Not only is capecitabine more cost-effective, it may also have additional cost saving in the nursing and pharmacy time . It is because a significant amount of time can be saved in both nursing and pharmacy for the preparation and administration of IV chemotherapy. In the UK, it was demonstrated that capecitabine required less pharmacy and administration time per cycle than 5-FU based IV chemotherapy. However, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine comparing to traditional IV chemotherapy in CRC patients of Hong Kong.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Princess Margaret Hospital
  • Kowloon, Hong Kong
    • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Colorectal patients who were newly prescribed to receive either the XELOX or the FOLOFX4 chemotherapy regimen will be identified from the colorectal clinic.

Description

Inclusion Criteria:

• Age 18 or above
• Diagnosed with CRC and prescribed with either XELOX for FOLFOX4 chemotherapy treatment

Exclusion Criteria:

• Patients less than 18 years of age
• Persons related unequally to investigators
• Patients who are mentally/cognitively disabled
• Patients who refuse to give consent to participate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
FOLFOX4; Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and 2 5-FU 400 mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d 1 and d2 Oxaliplatin (Eloxatin) 85 mg/m2 iv d1 Q2w x 12 cycles
XELOX; Capecitabine (Xeloda) 1000 mg/m2 po bid x 14 days Oxaliplatin (Eloxatin) 130 mg/m2 iv over 2 hrs d1 Q3w x 8 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite preparation, dispensing and administration time	Composite time is measured via real-time recording. Total length of the said time points are to be recorded using a stop-watch and the sum is tabulated in the end.	Up to 6 months after the initiation of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capital item utilization (hospital bed and infusion pump)	Capital item utilization is measured as the amount of time each healthcare resource is used and the associated cost for usage.	Up to 6 months after the initiation of chemotherapy

Collaborators and Investigators

• Sponsor: Vivian Wing Yan Lee
• Collaborators: Hoffmann-La Roche; Queen Elizabeth Hospital, Hong Kong; Princess Margaret Hospital, Hong Kong
• Investigators: Principal Investigator: Vivian WY Lee, PharmD, CUHK

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Neoplasm; Time-and-Motion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Roche-TR116581; TR116581VLKZ002 (Other Identifier: CUHK)