NCT01043068

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

January 5, 2010

Last Update Submit

April 25, 2012

Conditions

Cancers, Pain

Keywords

cancer painopioidguideline

Outcome Measures

Primary Outcomes (1)

  • Reduction in pain scores

    Jan 2010 - October 2010

Study Arms (1)

Pain control

EXPERIMENTAL

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.

Drug: Cancer pain management

Interventions

Cancer pain managementDRUG

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.

Pain control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

NeoplasmsPainCancer Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dae Hyun Kim, Prof

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

KR(1)