Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 98
- Locations
- 11
- Primary Endpoint
- Pain Intensity
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed carcinoma
- •Cancer-related pain requiring fixed-dose opioid therapy
- •Has received ≥ 1 week of fixed-dose opioid therapy AND meets any of the following criteria:
- •Inadequate pain control as defined by the patient
- •Requires 2 or more rescue doses per day
- •Requires adjustments in pain regimen (either fixed or breakthrough dosing)
- •No pain crisis that requires hospitalization or immediate anesthetic or neurosurgical intervention
- •No predominantly neuropathic pain (e.g., peripheral neuropathy) as assessed by the treating physician
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •ANC > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Serum bilirubin < 1.5 mg/dL
- •Serum creatinine < 2.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Nutritional, pulmonary, and cardiac status must be considered adequate to tolerate the proposed study therapy
- •Must be available for active follow-up
- •No documented active psychiatric disorder (i.e., psychosis or major depression) that would preclude informed consent or the patient's ability to comply with study procedures
- •No significant infection
- •No concerns about compliance with medication regimens or medical follow-up
- •No excessive alcohol use
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Concurrent chemotherapy or radiotherapy allowed
Exclusion Criteria
- Not provided
Arms & Interventions
Standard of Care
Standard pain control drugs.
Intervention: educational intervention (Other)
Standard of Care
Standard pain control drugs.
Intervention: questionnaire administration (Other)
Opioid Titration
Pain will be Monitored and Medication Titrated
Intervention: educational intervention (Other)
Opioid Titration
Pain will be Monitored and Medication Titrated
Intervention: Titrated pain management (Other)
Opioid Titration
Pain will be Monitored and Medication Titrated
Intervention: questionnaire administration (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Ability to Engage in Activities of Daily Living (ADL)(Baseline(Week 0) to week 8, Total time frame is 9 weeks.)
- Interference in Daily Life Due to Pain(9 weeks)
- Mood Disturbance(9 weeks)
- Quality of Life(9 weeks)
Investigators
Nancy Wells
Research Professor of Nursing; Director, VUMC Nursing; Researcher
Vanderbilt-Ingram Cancer Center