NCT01310387

Brief Summary

This study is:

  • A single-center, randomized, prospective controlled trial.
  • To prove superiority of active pain management group compared to control group by the percent of pain intensity difference of outpatients with lung cancer pain.
  • 204 patients will be recruited.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3 lung-cancer

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, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 1, 2011

Last Update Submit

February 4, 2016

Conditions

Lung Cancer

Keywords

Lung cancerCancer painOpioid

Outcome Measures

Primary Outcomes (1)

  • The percent of pain intensity difference

    The percent of pain intensity difference (%PID) %PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1

    visit 3 (6 to 8 weeks)

Secondary Outcomes (4)

  • Patients' satisfaction score about pain management

    visit 3 (6 to 8 weeks)

  • Eastern Cooperative Oncology Group (ECOG) Performance score

    visit 3 (6 to 8 weeks)

  • Assessment of Korean Brief Pain Inventory score

    visit 3 (6 to 8 weeks)

  • Investigator's global assessment score

    visit 3 (6 to 8 weeks)

Study Arms (1)

active pain management

EXPERIMENTAL

active pain management (APM) by specialized nurses for cancer pain

Behavioral: Active pain management

Interventions

Active pain managementBEHAVIORAL

Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.

active pain management

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with lung cancer.
  • The patients with uncontrolled lung cancer pain - more than and equal NRS 4 pain during previous 24 hours for background pain, or more than and equal 3 times/day for breakthrough painkiller medication.
  • Over 20 year-old male or female.
  • The patients can be able to received telephone counseling by investigator's decision.

You may not qualify if:

  • Drug or alcohol abusers.
  • Child-bearing women or pregnant women.
  • The patients with moderate to severe psychiatric problems.
  • The patients who have hypersensitivity to opioids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Jeonnam, South Korea

Location

MeSH Terms

Conditions

Lung NeoplasmsCancer Pain

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Young-Chul Kim, MD,PhD

    Chonnam National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2011

First Posted

March 8, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

KR(1)