Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain (NCT00666211) | Clinical Trial Compass
CompletedPhase 3
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
United States98 participantsStarted 2005-05
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity
Timeframe: Baseline(Week 0) to week 8, Total time frame is 9 weeks.
2
Pain-related Distress
Timeframe: Baseline(Week 0) to week 8, Total time frame is 9 weeks.