Clinical trial NCT01801085: Nursing and Pharmacy Time for Delivering Xeloda® Versus 5-Fluoruracil Regimens
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Keywords: Time-and-Motion
Neoplasm
Colorectal Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Queen Elizabeth Hospital, Hong Kong
name: Princess Margaret Hospital, Hong Kong
First posted: 2013-02-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite preparation, dispensing and administration time
timeFrame: Up to 6 months after the initiation of chemotherapy
Secondary outcomes:
measure: Capital item utilization (hospital bed and infusion pump)
timeFrame: Up to 6 months after the initiation of chemotherapy
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: CUHK
name: Vivian WY Lee, PharmD
role: PRINCIPAL_INVESTIGATOR
References: