Status:
COMPLETED
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
21+ years
Phase:
PHASE3
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 k...
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 qualit...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00666211
Start Date
May 1 2005
End Date
May 1 2010
Last Update
September 6 2012
Active Locations (11)
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1
Jennie Stuart Medical Center
Hopkinsville, Kentucky, United States, 44240
2
Mitchell Memorial Cancer Center at Owensboro Medical Health System
Owensboro, Kentucky, United States, 42303
3
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
4
Tennessee Plateau Oncology
Crossville, Tennessee, United States, 38555