• Pain, including intensity, duration, and pain-related distress [ Designated as safety issue: No ]
  

• Function [ Designated as safety issue: No ]
  
• Mood [ Designated as safety issue: No ]
  
• Quality of life [ Designated as safety issue: No ]
  

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.