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Open Access Highly Accessed Study protocol

Cancer Health Empowerment for Living without Pain (Ca-HELP): study design and rationale for a tailored education and coaching intervention to enhance care of cancer-related pain

Richard L Kravitz13*, Daniel J Tancredi23, Richard L Street8, Donna Kalauokalani45, Tim Grennan5, Ted Wun6, Christina Slee3, Dionne Evans Dean3, Linda Lewis3, Naomi Saito3 and Peter Franks37

Author Affiliations

1 Department of Internal Medicine, University of California, Davis, School of Medicine, Sacramento, California, USA

2 Department of Pediatrics, University of California, Davis, School of Medicine, Sacramento, California, USA

3 Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California, USA

4 Department of Anesthesiology and Pain Medicine, University of California, Davis, Sacramento, California, USA

5 Kaiser Permanente, Northern California, California, USA

6 UCD Cancer Center, Sacramento, California, USA

7 Department of Family and Community Medicine, University of California, Davis, School of Medicine, Sacramento, CA, USA

8 Department of Communications, Texas A & M University, College Station, TX, USA

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BMC Cancer 2009, 9:319  doi:10.1186/1471-2407-9-319

Published: 9 September 2009

Abstract

Background

Cancer-related pain is common and under-treated. This article describes a study designed to test the effectiveness of a theory-driven, patient-centered coaching intervention to improve cancer pain processes and outcomes.

Methods/Design

The Cancer Health Empowerment for Living without Pain (Ca-HELP) Study is an American Cancer Society sponsored randomized trial conducted in Sacramento, California. A total of 265 cancer patients with at least moderate pain severity (Worst Pain Numerical Analog Score >=4 out of 10) or pain-related impairment (Likert score >= 3 out of 5) were randomly assigned to receive tailored education and coaching (TEC) or educationally-enhanced usual care (EUC); 258 received at least one follow-up assessment. The TEC intervention is based on social-cognitive theory and consists of 6 components (assess, correct, teach, prepare, rehearse, portray). Both interventions were delivered over approximately 30 minutes just prior to a scheduled oncology visit. The majority of visits (56%) were audio-recorded for later communication coding. Follow-up data including outcomes related to pain severity and impairment, self-efficacy for pain control and for patient-physician communication, functional status and well-being, and anxiety were collected at 2, 6, and 12 weeks.

Discussion

Building on social cognitive theory and pilot work, this study aims to test the hypothesis that a brief, tailored patient activation intervention will promote better cancer pain care and outcomes. Analyses will focus on the effects of the experimental intervention on pain severity and impairment (primary outcomes); self-efficacy and quality of life (secondary outcomes); and relationships among processes and outcomes of cancer pain care. If this model of coaching by lay health educators proves successful, it could potentially be implemented widely at modest cost.

Trial Registration

[Clinical Trials Identifier: NCT00283166]