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Completed

NCT Number: NCT01310387

Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)

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.

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Key information

Conditions

Lung Cancer Cancer Pain Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chonnam National University Hwasun Hospital

Jeonnam, South Korea

About this study

  • The recruited patients in both group will be provided the education about pain-killer, and received medicines including opioids according to their numeric rating scale (NRS)
  • Active management group will be provided additional telephone counseling and dosage modification by specialized nurse for cancer pain.
  • The percent of pain intensity difference (%PID)
  • PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Active pain management

Behavioral

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

Primary outcomes

  1. The percent of pain intensity difference

    Time frame: visit 3 (6 to 8 weeks)

    The percent of pain intensity difference (%PID)

    %PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1

Secondary outcomes

  1. Patients' satisfaction score about pain management

    Time frame: visit 3 (6 to 8 weeks)

    Qustionnaire of 5-point scale

  2. Eastern Cooperative Oncology Group (ECOG) Performance score

    Time frame: visit 3 (6 to 8 weeks)

    ECOG performance status: 0,1,2,3,4

  3. Assessment of Korean Brief Pain Inventory score

    Time frame: visit 3 (6 to 8 weeks)

    Qustionnaire; K-BPI(Korean Brief Pain Inventory)

  4. Investigator's global assessment score

    Time frame: visit 3 (6 to 8 weeks)

    Qustionnaire of 5-point scale

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • Janssen Korea, Ltd., Korea

Registry information

Official study title

A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)

Acronym: APM

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2011
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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