Methodological challenges in conducting a multi-site randomized clinical trial of massage therapy in hospice.
Study Goal
The researchers aimed to evaluate the efficacy of massage therapy for reducing pain in advanced cancer patients receiving palliative care or hospice services.
Results Summary
The study successfully enrolled 380 participants across 15 sites, with a lower-than-anticipated withdrawal rate (27%). Successful implementation relied on organizational commitment, strong leadership, and effective communication among study teams.
Population
Patients with advanced cancer in palliative care or hospice settings.
Effective Dosage
Not specified
Duration
36 months (total study period; intervention duration not specified)
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
massage therapy | decrease | pain | patients with advanced cancer in palliative care/hospice settings | - | decreasing | #1 |
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.