Improving Cancer Pain Management Using AHCPR Cancer Pain Guidelines

NCT ID: NCT00012896

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2004-09-30

Brief Summary

Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge, effective cancer management is infrequently achieved. While this problem is multi-factorial, the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions.

Detailed Description

Background:

Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge, effective cancer management is infrequently achieved. While this problem is multi-factorial, the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions.

Objectives:

The primary objective of this study is to determine the effects of two nursing interventions on the improvement of pain management (PM), functional status (FS) and quality of life (QOL) in veterans receiving cancer care in VA ambulatory care clinics. The two interventions will utilize selected cancer pain management strategies developed as Clinical Practice Guidelines by the Agency for Health Care Policy and Research (AHCPR). This study will test the hypothesis that those veterans in the intervention arms will have lower pain intensity scores, greater pain relief and satisfaction with PM, and will have higher QOL and FS scores specifically in the areas of physical and social functioning. A secondary aim is to measure the extent that cancer PM is affected by the intervening variables of age, affect, attitudinal barriers, veteran culture, type/stage of disease, and type of cancer treatment.

Methods:

The design of this randomized trial has one between-subjects factor, GROUP, with three levels (usual care, structured education, individualized coaching), and one within-subjects factor, TIME, with two measures, pre-test and post-test. Patients with cancer pain (n=320) are randomly assigned to one of three groups after stratifications to control for the confounding variables of pain intensity and effects of cancer treatment. Those in the structured education arm view a video on cancer pain management and receive the AHCPR patient pamphlet on cancer pain management. Those subjects in the individualized coaching arm receive the same structured education as above, but also partake in four telephone coaching sessions focusing on the individual's specific pain management problems. The primary outcome variables measured after 12 weeks are: satisfaction with pain management, quality of life and functional status.

Status:

The project is in the final phase of data analysis and writing the final report. A total of 322 subjects were recruited: 289 eligible patients completed the Pre-test and 227 completed the Post-Test. Two papers are approximately 75% written. The main study paper is in the planning stage, to be completed after the final report is submitted.

Conditions

Cancers, Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Group Type: OTHER

Telephone Care + Educational (AV Materials)

Intervention Type: BEHAVIORAL

Interventions

Telephone Care + Educational (AV Materials)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patients must have a medical diagnosis of cancer, be experiencing pain as a result of their cancer or cancer treatment, be receiving treatment on an out-patient basis whereas they are taking their own medications, have a life expectancy of at least 6 months, have access to a telephone, are able to read and speak English, and do not have a drug abuse history.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marilyn K. Douglas, DNSc RN FAAN

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

Other Identifiers

NRI 97-026

Identifier Type: -

Identifier Source: org_study_id