Overcoming Recruitment Challenges in Palliative Care Clinical Trials

Copyright © 2013 by American Society of Clinical Oncology

Overcoming Recruitment Challenges in Palliative Care Clinical Trials

1. Thomas W. LeBlanc, MD, MA,
2. Jordan E. Lodato,
3. David C. Currow, MPH, FRACP and
4. Amy P. Abernethy, MD⇑

+ Author Affiliations

1. Duke University Medical Center; Duke Cancer Institute; Center for Learning Health Care, Duke Clinical Research Institute, Duke University, Durham, NC; and Flinders University, Adelaide, Australia

1. Corresponding author: Amy Abernethy, MD, Box 3436, Duke University Medical Center, Durham, NC 27710; e-mail: amy.abernethy@duke.edu.

Abstract

Purpose: Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research—especially participant recruitment—is difficult. Major barriers include (1) patient factors, (2) “gatekeeping,” and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study.

Patients and Methods: The PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of “social marketing,” an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications.

Results: From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%).

Conclusion: Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing–based protocol shows the benefits of such an approach.