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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01801085
• Other study ID #: Roche-TR116581
• Secondary ID: TR116581VLKZ002
• Status: Terminated
• Phase: N/A
• First received: September 5, 2012
• Last updated: February 1, 2017
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Hong Kong	Princess Margaret Hospital	Kowloon
Hong Kong	Queen Elizabeth Hospital	Kowloon

Sponsors (4)

Lead Sponsor	Collaborator
Vivian Wing Yan Lee	Hoffmann-La Roche, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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