Pain Clinical Trial
Official title:
Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | May 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Erlanger Health System | Chattanooga | Tennessee |
United States | Tennessee Plateau Oncology | Crossville | Tennessee |
United States | Jennie Stuart Medical Center | Hopkinsville | Kentucky |
United States | Center for Biomedical Research | Knoxville | Tennessee |
United States | The Jones Clinic | Memphis | Tennessee |
United States | Meharry Medical College | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee |
United States | Veterans Affairs Medical Center - Nashville | Nashville | Tennessee |
United States | Mitchell Memorial Cancer Center at Owensboro Medical Health System | Owensboro | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity | Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8: Average daily pain intensity 0 (no pain) to 10 (worst) scale Worst daily pain intensity 0 (no pain) to 10 (worst) scale |
Baseline(Week 0) to week 8, Total time frame is 9 weeks. | No |
Primary | Pain-related Distress | 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). | Baseline(Week 0) to week 8, Total time frame is 9 weeks. | No |
Primary | Pain Duration | Pain duration in hours 0 to 24 | at 9 weeks | No |
Secondary | Ability to Engage in Activities of Daily Living (ADL) | 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. | Baseline(Week 0) to week 8, Total time frame is 9 weeks. | No |
Secondary | Interference in Daily Life Due to Pain | 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. | 9 weeks | No |
Secondary | Mood Disturbance | 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. | 9 weeks | No |
Secondary | Quality of Life | 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). | 9 weeks | No |
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