title: Methodological challenges in conducting a multi-site randomized clinical trial of massage therapy in hospice.
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.
authors.affiliation: Department of Internal Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado 80045, USA. jean.kutner@ucdenver.edu
authors.forename: Jean
authors.initials: J
authors.lastname: Kutner
authors.forename: Marlaine
authors.initials: M
authors.lastname: Smith
authors.forename: Karen
authors.initials: K
authors.lastname: Mellis
authors.forename: Sue
authors.initials: S
authors.lastname: Felton
authors.forename: Traci
authors.initials: T
authors.lastname: Yamashita
authors.forename: Lisa
authors.initials: L
authors.lastname: Corbin
mesh_terms: D003120:Colorado; D017051:Hospice Care; D006801:Humans; D008405:Massage; D009369:Neoplasms / Q000150:complications / Q000451:nursing; D010146:Pain / Q000209:etiology / Q000451:nursing; D010166:Palliative Care / Q000379:methods; D011340:Problem Solving; D012107:Research Design