title: Overcoming recruitment challenges in palliative care clinical trials.
abstract: OBJECTIVE
  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.
  
  
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: LeBlanc
authors.forename: Jordan E
authors.initials: JE
authors.lastname: Lodato
authors.forename: David C
authors.initials: DC
authors.lastname: Currow
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
mesh_terms: D001294:Attitude to Health; D002986:Clinical Trials as Topic; D006801:Humans; D009369:Neoplasms / Q000150:complications / Q000628:therapy*; D010146:Pain / Q000209:etiology; D059408:Pain Management; D010166:Palliative Care; D018579:Patient Selection / Q000941:ethics; D016032:Randomized Controlled Trials as Topic; D040241:Social Marketing