Trials / Completed

CompletedNCT00666211

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

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

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 98 (actual)

Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
Sex: All
Age: 21 Years
Healthy volunteers: Not accepted

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 description

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 staff if he/she is made aware of any problems pertaining to the patient's pain control. The research nurse, in consultation with study physician, manages pain according to the OTOS and manages opioid side effects using standing orders. Referral to the treating physician is made as needed. Patients' pain is managed on study for 8 weeks in the absence of unacceptable toxicity, pain crisis, or new site of pain. Patients complete a demographic questionnaire at baseline and other questionnaires at 2, 4, and 6 weeks (over the telephone) and at 8 weeks (at site or by telephone), including the Functional Assessment Screening Questionnaire (FASQ), the Brief Pain Inventory-Interference (PPI-I), The Profile of Mood States-Short Form (POMS-SF), and the Quality of life (FACT-G) questionnaire. Patients also complete a pain diary recording daily measures of pain dimensions, analgesic use (i.e., fixed dose opioids, rescue doses, and non-opioids), adjuvant medications, and side effects that prevented the patient from taking medications. Data in the pain diary is transcribed over the telephone on a weekly basis. Clinical data, including the type of cancer, stage of disease, time since diagnosis, current treatment for cancer, type of pain, time since onset of pain, and time of first opioid prescription, as well as information regarding analgesics (opioid and non-opioid), adjuvant medications, and medications to manage side effects prescribed during the study is collected from patients' medical records. Anticancer and palliative treatment received during the study is monitored via treating physician records. The physician charts are reviewed after study completion to determine whether pain, treatment, and response are adequately documented and treated. The documentation in the physician charts is compared to the documentation obtained by the study staff during the study.

Conditions

Interventions

Type	Name	Description
OTHER	educational intervention	Participants will be educated on pain management.
OTHER	Titrated pain management	Pain will be Monitored and Medication Titrated
OTHER	questionnaire administration	Participants will be given questionnaires to complete.

Timeline

Start date: 2005-05-01
Primary completion: 2010-01-01
Completion: 2010-05-01
First posted: 2008-04-24
Last updated: 2012-09-06
Results posted: 2012-09-06

Locations

11 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00666211. Inclusion in this directory is not an endorsement.