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Annals of Oncology Advance Access originally published online on April 8, 2005
Annals of Oncology 2005 16(6):972-980; doi:10.1093/annonc/mdi191
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© 2005 European Society for Medical Oncology

Does an oral analgesic protocol improve pain control for patients with cancer? An intergroup study coordinated by the Eastern Cooperative Oncology Group

C. S. Cleeland1,*, R. K. Portenoy2, M. Rue3, T. R. Mendoza1, E. Weller2, R. Payne1,4, J. Kirshner5, J. N. Atkins6, P. A. Johnson7 and A. Marcus8

1 The University of Texas M. D. Anderson Cancer Center, Houston, Texas; 2 Beth Israel Medical Center, New York, New York; 3 Dana-Farber Cancer Institute, Boston, Massachusetts; 4 Duke Institute on Care at the End of Life, Duke University Divinity School, Durham, North Carolina; 5 Syracuse Hematology-Oncology CCOP, Syracuse, New York; 6 Southeast Cancer Control Consortium Inc. CCOP, Goldsboro, North Carolina; 7 Carle Clinic, Urbana, Illinois; 8 AMC Research Center, Denver, Colorado, USA

* Correspondence to: Dr C. S. Cleeland, Department of Symptom Research, The University of Texas M. D. Anderson Cancer Center, 1100 Holcombe Boulevard, Box 221, Houston, TX 77030, USA. Tel: +1-713-745-3470; Fax: +1-713-745-3475; Email: ccleeland{at}mdanderson.org

Background:: Cancer pain is highly prevalent and commonly undertreated. This study was designed to determine whether dissemination of a clinical protocol for pain management would improve outcomes in community oncology practices.

Patients and methods:: A pain management protocol was developed based on accepted guidelines. After baseline assessment, oncology practices were randomly assigned to ‘analgesic protocol’ (AP) sites, where oncologists implemented the guidelines in a group of lung or prostate cancer patients, or to ‘physician discretion’ (PD) sites, where customary treatment was continued. Patients treated on protocol and a comparison group of patients with pain due to breast cancer or myeloma were monitored for change in pain using the Brief Pain Inventory, and for change in other symptoms or mood.

Results:: The protocol terminated early because of poor accrual. We compared groups using proportions of patients who had no or mild pain at follow-up. Although measures of protocol adherence did not suggest the occurrence of major practice change, the proportion of lung or prostate cancer patients with no or mild pain increased significantly from baseline for those treated at AP sites compared with those treated at PD sites. There was no significant difference between the breast and myeloma patients treated at AP sites versus those treated at PD sites.

Conclusion:: A protocol for cancer pain management can improve pain control. Diffusion of these benefits to other patients was not confirmed. Given the small sample size, these findings require confirmation in a larger trial.

Key words: Brief Pain Inventory, cancer pain, management guidelines, randomized clinical trial


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