Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Active 21 and over NCI VU-VICC-SUPP-0424 VICCSUPP0424, VU-VICC-040410, NCT00666211

Objectives

1. To examine the effect of an opioid titration order sheet on pain outcomes.
2. To examine the effect of an opioid titration order sheet on secondary outcomes of function, mood, and quality of life.

Entry Criteria

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

Prior/Concurrent Therapy:

• See Disease Characteristics
• Concurrent chemotherapy or radiotherapy allowed

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

Expected Enrollment

Outcomes

Pain, including intensity, duration, and pain-related distress

Function
Mood
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.

Trial Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

Nancy Wells, DNSc, RN, Principal investigator		Ph: 800-811-8480
Mary Dietrich, Study coordinator		Ph: 800-811-8480
Tony Hudson, Study coordinator		Ph: 800-811-8480
Patty Hendricks, Study coordinator		Ph: 800-811-8480
Hannah Spahr, Study coordinator		Ph: 800-811-8480

U.S.A.
Kentucky
	Owensboro
	Mitchell Memorial Cancer Center at Owensboro Medical Health System
		Contact Person	Ph:  270-688-3600 800-947-7102
Tennessee
	Chattanooga
	Erlanger Cancer Center at Erlanger Hospital - Baroness
		Clinical Trials Office - Erlanger Cancer Center	Ph:  423-778-6947
	Nashville
	MBCCOP - Meharry Medical College - Nashville
		Contact Person	Ph:  615-327-6000
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
	Vanderbilt-Ingram Cancer Center - Cool Springs
		Nancy Wells	Ph:  615-322-6184
	Vanderbilt-Ingram Cancer Center at Franklin
		Nancy Wells	Ph:  615-322-6184

Registry Information
Official Title		Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients with Cancer Related Pain.
Trial Start Date		2005-05-19
Trial Completion Date		2011-05-19 (estimated)
Registered in ClinicalTrials.gov		NCT00666211
Date Submitted to PDQ		2008-04-18
Information Last Verified		2008-12-18
NCI Grant/Contract Number		CA68485

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