Skip to main content

Table 1 Assessments of study feasibility

From: Mechanical suppression of osteolytic bone metastases in advanced breast cancer patients: a randomised controlled study protocol evaluating safety, feasibility and preliminary efficacy of exercise as a targeted medicine

Measures Time of collection
Recruitment and completion
 - Referred patients Trial completion
 - Eligible patients Trial completion
 - Enrolled patients Trial completion
 - Eligibility rate Trial completion
 - Recruitment rate Trial completion
 - Trial completions Trial completion
 - Patient withdrawals Trial completion
 - Patient drop-outs Trial completion
 - Trial contamination Trial completion
Patient safety (control arm)
 - Number of adverse events Tri-weekly record
 - Severity of adverse events Tri-weekly record
 - Number of skeletal complications Tri-weekly record
Patient safety (intervention arm)
 - Number of adverse events At each exercise session
 - Severity of adverse events At each exercise session
 - Number of skeletal complications At each exercise session
Program tolerance (intervention arm)
 - Pre-sessional bone pain At each exercise session
 - Pre-sessional fatigue At each exercise session
 - Sessional rating of perceived exertion At each exercise session
 - Sessional tolerance At each exercise session
Program adherence (intervention arm)
 - Number of completed sessions Post intervention
 - Number of missed sessions Post intervention
Program compliance (intervention arm)
 - Prescribed vs. actual exercise completed (for each exercise mode). Post intervention
 - Percent of total volume completed (for each exercise mode). Post intervention