Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain

Phase 3

Completed

• Conditions: Pain; Brain and Central Nervous System Tumors; Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Precancerous Condition
• Interventions: Other: educational intervention; Other: questionnaire administration; Other: Titrated pain management

• Registration Number: NCT00666211
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2010-01
• Study Completion: 2010-05
• Results First Submitted: 2011-10-21
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-04
• Last Update Submitted: 2012-08-04
• Results First Posted: 2012-09-06
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	educational intervention	Standard pain control drugs.
Standard of Care	questionnaire administration	Standard pain control drugs.
Opioid Titration	educational intervention	Pain will be Monitored and Medication Titrated
Opioid Titration	Titrated pain management	Pain will be Monitored and Medication Titrated
Opioid Titration	questionnaire administration	Pain will be Monitored and Medication Titrated

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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	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	at 9 weeks	Pain duration in hours 0 to 24

Secondary Outcome Measures

Name	Time	Method
Ability to Engage in Activities of Daily Living (ADL)	Baseline(Week 0) to week 8, Total time frame is 9 weeks.	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.
Interference in Daily Life Due to Pain	9 weeks	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.
Mood Disturbance	9 weeks	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.
Quality of Life	9 weeks	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).

Trial Locations

Locations (11)

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States

Tennessee Plateau Oncology; 🇺🇸 Crossville, Tennessee, United States

Center for Biomedical Research; 🇺🇸 Knoxville, Tennessee, United States

Mitchell Memorial Cancer Center at Owensboro Medical Health System; 🇺🇸 Owensboro, Kentucky, United States

The Jones Clinic; 🇺🇸 Memphis, 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

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Jennie Stuart Medical Center; 🇺🇸 Hopkinsville, Kentucky, United States