Clinical Trial: Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.

Brief Summary:

RATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the dose and schedule of pain medication may help improve pain treatment for patients with cancer. It is not yet known whether the use of an Opioid Titration Order Sheet is more effective than standard care in treating pain caused by cancer.

PURPOSE: This randomized phase III trial is studying an Opioid Titration Order Sheet to see how well it works compared with standard care in treating patients with cancer pain.


Detailed Summary:

OBJECTIVES:

  • To examine the effect of an opioid titration order sheet on pain outcomes.
  • To examine the effect of an opioid titration order sheet on secondary outcomes of function, mood, and quality of life.

OUTLINE: This is a multicenter study. Participating centers are randomized to 1 of 2 treatment arms.

  • Arm I (usual care): After completion of baseline assessments, patients undergo a standardized pain education program over approximately 15 minutes. The program consists of standard written materials about communicating pain to providers, opioids and side effect management, as well as a tailored discussion about patient concerns and specific information about prescribed opioid medications. Patients are also instructed in the use of the daily pain diary. Patients are then discharged from the clinic with instructions to contact the treating physician (through standard procedures) for problems with pain or side effects. The study staff conducts weekly telephone interviews to prevent changes in patient pain management practice. The treating physician continues to manage pain in their usual manner.
  • Arm II (opioid titration order sheet): After completion of baseline assessments, patients undergo the standardized pain education program and are instructed in the use of the daily pain diary as described in arm I. The treating physician signs an Opioid Titration Order Sheet (OTOS) providing a baseline dose and schedule. The OTOS is faxed to study staff and verified. Patients are then discharged from the clinic with instructions to contact the research nurse for problems with pain or side effects. The treating physician also contacts the study st
    Sponsor: Vanderbilt-Ingram Cancer Center

    Current Primary Outcome:

    • Pain Intensity [ Time Frame: Baseline(Week 0) to week 8, Total time frame is 9 weeks. ]

      Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8:

      1. Average daily pain intensity 0 (no pain) to 10 (worst) scale
      2. Worst daily pain intensity 0 (no pain) to 10 (worst) scale
    • Pain-related Distress [ Time Frame: Baseline(Week 0) to week 8, Total time frame is 9 weeks. ]
      Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8. Pain-related distress scale is from 0 (no pain) to 10 (worst pain).
    • Pain Duration [ Time Frame: at 9 weeks ]
      Pain duration in hours 0 to 24


    Original Primary Outcome: Pain including intensity, duration, and pain-related distress

    Current Secondary Outcome:

    • Ability to Engage in Activities of Daily Living (ADL) [ Time Frame: Baseline(Week 0) to week 8, Total time frame is 9 weeks. ]
      The Functional Assessment Screening Questionnaire (FASQ) scale is used, scored at baseline and at weeks 2, 4, 6, 8. The FASQ consists of 15 questions about ability to perform ADL with minimum score of 1 (easy to perform) to a maximum score of 5 (N/A, meaning someone else performs this activity for the patient or else the patient chooses not to do it). A summary mean score is generated with a minimum score of 1 and a maximum score of 5.
    • Interference in Daily Life Due to Pain [ Time Frame: 9 weeks ]
      Patients in each arm will each have 5 measures on the Brief Pain Inventory (BPI) scale: baseline + weeks 2, 4, 6, 8. The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average from the 7 questions, with higher score indicating greater interference due to pain.
    • Mood Disturbance [ Time Frame: 9 weeks ]
      Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.
    • Quality of Life [ Time Frame: 9 weeks ]
      Each patient in each arm is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) at baseline + week 8 with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded & items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).


    Original Secondary Outcome:

    • Function
    • Mood
    • Quality of Life


    Information By: Vanderbilt-Ingram Cancer Center

    Dates:
    Date Received: April 23, 2008
    Date Started: May 2005
    Date Completion:
    Last Updated: August 4, 2012
    Last Verified: August 2012