Methodological challenges in conducting a multi-site randomized clinical trial of massage therapy in hospice

J Palliat Med. 2010 Jun;13(6):739-44. doi: 10.1089/jpm.2009.0408.

Abstract

Researchers conducting multi-site studies of interventions for end-of-life symptom management face significant challenges with respect to obtaining an adequate sample and training and retaining on-site study teams. The purpose of this paper is to describe the strategies and responses to these challenges in a multi-site randomized clinical trial (RCT) of the efficacy of massage therapy for decreasing pain among patients with advanced cancer in palliative care/hospice settings. Over a period of 36 months, we enrolled 380 participants across 15 sites; 27% of whom withdrew prior to study completion (less than the anticipated 30% rate). We saw an average of 68% turnover amongst study staff. Three key qualities characterized successful on-site study teams: (1) organizational commitment; (2) strong leadership from on-site study coordinators; and (3) effective lines of communication between the on-site study coordinators and both their teams and the university-based research team. Issues of recruitment, retention and training should be accounted for in hospice-based research study design and budgeting.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Colorado
  • Hospice Care*
  • Humans
  • Massage*
  • Neoplasms / complications
  • Neoplasms / nursing
  • Pain / etiology
  • Pain / nursing
  • Palliative Care / methods
  • Problem Solving
  • Research Design