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

Published online by Cambridge University Press:  13 February 2009

Marie Bakitas ,
Kathleen Doyle Lyons ,
Mark T. Hegel ,
Stefan Balan ,
Kathleen N. Barnett ,
Frances C. Brokaw ,
Ira R. Byock ,
Jay G. Hull ,
Zhongze Li  and
Elizabeth Mckinstry
...Show all authors
Marie Bakitas*
Affiliation:
Department of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire School of Nursing, Yale University, New Haven, Connecticut
Kathleen Doyle Lyons
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Mark T. Hegel
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Stefan Balan
Affiliation:
White River Junction, Veterans Administration Medical Center, White River Junction, Vermont
Kathleen N. Barnett
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Frances C. Brokaw
Affiliation:
Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire, USA
Ira R. Byock
Affiliation:
Department of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
Jay G. Hull
Affiliation:
Dartmouth College, Hanover, New Hampshire
Zhongze Li
Affiliation:
Biostatistics Shared Resource, Norris Cotton Cancer Center, Dartmouth College, Hanover, New Hampshire
Elizabeth Mckinstry
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Janette L. Seville
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Tim A. Ahles
Affiliation:
Department of Psychiatry, Memorial Sloan-Kettering Cancer Center, New York, New York
*
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
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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.

Keywords

Palliative CareRandomized Controlled TrialAdvanced CancerMethodological IssuesIntervention StudyRural
Type
Original Articles
Information
Palliative & Supportive Care , Volume 7 , Issue 1 , March 2009 , pp. 75 - 86
Copyright
Copyright © Cambridge University Press 2009

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