Palliative and Supportive Care

Original Articles

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

Marie Bakitasa1a2a3 c1, Kathleen Doyle Lyonsa4, Mark T. Hegela4, Stefan Balana5, Kathleen N. Barnetta4, Frances C. Brokawa2a6, Ira R. Byocka1a2, Jay G. Hulla7, Zhongze Lia8, Elizabeth Mckinstrya4, Janette L. Sevillea4 and Tim A. Ahlesa9

a1 Department of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire

a2 Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

a3 School of Nursing, Yale University, New Haven, Connecticut

a4 Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire

a5 White River Junction, Veterans Administration Medical Center, White River Junction, Vermont

a6 Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire, USA

a7 Dartmouth College, Hanover, New Hampshire

a8 Biostatistics Shared Resource, Norris Cotton Cancer Center, Dartmouth College, Hanover, New Hampshire

a9 Department of Psychiatry, Memorial Sloan-Kettering Cancer Center, New York, New York

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.

(Received July 25 2008)

(Accepted October 10 2008)

Correspondence:

c1 Address correspondence and reprint requests to: Marie Bakitas, Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756. E-mail: marie.bakitas@dartmouth.edu