• J Palliat Med · Jun 2010

    Randomized Controlled Trial Multicenter Study

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

    • Jean Kutner, Marlaine Smith, Karen Mellis, Sue Felton, Traci Yamashita, and Lisa Corbin.
    • Department of Internal Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado 80045, USA. jean.kutner@ucdenver.edu
    • J Palliat Med. 2010 Jun 1; 13 (6): 739-44.

    AbstractResearchers 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.

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