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