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Improving Cancer Pain Management Using AHCPR Cancer Pain Guidelines


N/A
N/A
N/A
Not Enrolling
Both
Cancers, Pain

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Trial Information

Improving Cancer Pain Management Using AHCPR Cancer Pain Guidelines


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.


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.

Exclusion Criteria:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind

Principal Investigator

Marilyn K. Douglas, DNSc RN FAAN

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Palo Alto Health Care System

Authority:

United States: Federal Government

Study ID:

NRI 97-026

NCT ID:

NCT00012896

Start Date:

Completion Date:

September 2004

Related Keywords:

  • Cancers, Pain

Name

Location

VA Palo Alto Health Care System Palo Alto, California  94304-1207