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]

Background

Primary care providers (PCPs) have few tools for enhancing patient self-efficacy, a key mediator of myriad health-influencing behaviors.

Objective

To examine whether brief standardized patient instructor (SPI)-delivered training increases PCPs' use of self-efficacy-enhancing interviewing techniques (SEE IT).

Design

Randomized controlled trial.

Participants

Fifty-two family physicians and general internists from 12 primary care offices drawn from two health systems in Northern California.

Interventions

Experimental arm PCPs received training in the use of SEE IT training during three outpatient SPI visits scheduled over a 1-month period. Control arm PCPs received a single SPI visit, during which they viewed a diabetes treatment video. All intervention visits (experimental and control) were timed to last 20 min. SPIs portrayed patients struggling with self-care of depression and diabetes in the first 7 min, then delivered the appropriate intervention content during the remaining 13 min.

Main measures

The primary outcome was provider use of SEE IT (a count of ten behaviors), coded from three audio-recorded standardized patient visits at 1-3 months, again involving depression and diabetes self-care. Two five-point scales measured physician responses to training: Value (7 items: quality, helpfulness, understandability, relevance, feasibility, planned use, care impact), and Hassle (2 items: personal hassle, flow disruption).

Key results

Pre-intervention, study PCPs used a mean of 0.7 behaviors/visit, with no significant between-arm difference (P = 0.23). Post-intervention, experimental arm PCPs used more of the behaviors than controls (mean 2.7 vs. 1.0 per visit; adjusted difference 1.7, 95 % CI 1.1-2.2; P < 0.001). Experimental arm PCPs had higher training Value scores than controls (mean difference 1.05, 95 % CI 0.68-1.42; P < 0.001), and similarly low Hassle scores.

Conclusions

Primary care physicians receiving brief SPI-delivered training increased their use of SEE IT and found the training to be of value. Whether patients visiting SEE IT-trained physicians experience improved health behaviors and outcomes warrants study. CLINICALTRIALS.

Gov identifier

NCT01618552.