The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: Baseline findings, methodological challenges, and solutions Journal Article


Authors: Bakitas, M.; Lyons, K. D.; Hegel, M. T.; Balan, S.; Barnett, K. N.; BrokawF.C, Frances C.; Byock, I. R.; Hull, J. G.; Li, Z.; McKinstry, E.; Seville, J. I.; Ahles, T. A.
Article Title: The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: Baseline findings, methodological challenges, and solutions
Abstract: Objective: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. Methods: Half of the participants recruited from our rural U.S.comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. Results: Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. Significance of results: It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT. © 2009 Cambridge University Press.
Keywords: controlled study; clinical trial; advanced cancer; prospective study; prospective studies; neoplasm; nursing; neoplasms; palliative care; controlled clinical trial; randomized controlled trial; palliative therapy; terminally ill patient; health service; intervention study; methodological issues; rural; adaptive behavior; patient care; patient participation; psychological aspect; rural population; sickness impact profile; social support; utilization review; adaptation, psychological; health services; patient care team; terminally ill
Journal Title: Palliative and Supportive Care
Volume: 7
Issue: 1
ISSN: 1478-9515
Publisher: Cambridge University Press  
Date Published: 2009-03-01
Start Page: 75
End Page: 86
Language: English
DOI: 10.1017/s1478951509000108
PUBMED: 19619377
PROVIDER: scopus
PMCID: PMC3685415
DOI/URL:
Notes: --- - "Cited By (since 1996): 3" - "Export Date: 30 November 2010" - "Source: Scopus"
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  1. Tim A Ahles
    112 Ahles