Table 1.

Methodologic Challenges and Approaches in Conducting a Multi-Site Randomized Clinical Trial of Massage Therapy in Hospice

Challenge	Approach
Obtaining an adequate and appropriate sample
Inclusion/exclusion criteria	- Reflected the parameters of the study: Adults, diagnosed with advanced cancer, had at least moderate pain, life expectancy of at least 3 weeks, cognitively able to consent to treatment and respond to study questions.
	- Ensured patient safety: Excluded patients who had a potential for bleeding or who were on anticoagulant therapy, and patients presenting with an unstable spine or who were at high risk for fractures.
	- Minimized the effect of intervening variables on the outcomes: Excluded patients who had received massage therapy during the 4 weeks prior to study enrollment.
Sample size	- Ensured sufficient statistical power to detect real differences in outcomes: Accounted for high attrition rate (estimated at 30%) in this population.
Participant recruitment and retention	- Set explicit monthly accrual goals for each site based on hospice census - Monitored accrual and distributed monthly reports tracking the progress of each site.
	- Offered incentives and rewards to those sites meeting their accrual goals and to the most productive sites.
	- Regularly communicated the intent, importance, and procedures of the study via regular conference calls, site visits, and attendance at local hospice interdisciplinary team meetings.
	- Distributed study information flyers for care providers and patients/families.
Minimizing withdrawal	- Carefully emphasized during the consent process the 50-50 chance of receiving massage therapy.
	- Offered a post-study massage session for participants randomized to the control arm.
	- Chose an active control arm.
Training and retaining study teams at each site
Training teams at a distance	- Two large training sessions held in Colorado for original study sites.
	- Additional on-site training sessions for new sites with extensive training manual and video.
	- Review and remediation of study procedures and protocol for sites with extended lag time between training and enrollment.
	- To address significant team member turnover, a train-the-trainer model was employed so that on-site team members could train new or replacement members. Consistency and reliability of these new or replacement members was maintained by verbal tests over the phone to check knowledge and competence with study protocol.
	- Touch providers often shadowed a more experienced member until reaching comfort with the protocol.
Ongoing quality assurance and communication	- Site visits conducted at least once a year to monitor adherence to study protocol, respond to any questions, encourage and thank the teams, and to collect best practices from each site.
	- Monthly conference calls with study sites to reinforce best practices in recruitment, adherence to study protocol, and collective problem-solving.
	- One research team member assigned to each study site as the primary contact.