The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study

Cancers, Pain Clinical Trial

Official title:

A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043068
• Other study ID #: CAPAM-1
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2010
• Last updated: April 25, 2012
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patient with the somatic and/or visceral pain having an untreated intensity greater than 3 on a 10 cm visual analog scale (VAS; 0 = no pain, 10 = unbearable pain)over the week prior to enrollment

• A minimum age of 18 years

Exclusion Criteria:

• Opioid intolerance

• No longer treatment for their underlying disease.

• Intracerebral primary or metastatic lesion

• Impaired sensory or cognitive function

• Pregnant or lactating woman

• Women of child bearing potential not using a contraceptive method

• Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential

• Any patients judged by the investigator to be unfit to participate in the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancers, Pain

Intervention

Drug:
• Cancer pain management
Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain scores		Jan 2010 - October 2010	Yes