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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666211
• Other study ID #: VICC SUPP 0424
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2008
• Last updated: August 4, 2012
• Start date: May 2005
• Est. completion date: May 2010

Study information

• Verified date: August 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Chronic Myeloproliferative Disorders
• Disease
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nervous System Neoplasms
• Pain
• Plasmacytoma
• Precancerous Condition
• Precancerous Conditions
• Preleukemia
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• educational intervention
Participants will be educated on pain management.
• Titrated pain management
Pain will be Monitored and Medication Titrated
• questionnaire administration
Participants will be given questionnaires to complete.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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