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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
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