LAUSR

Simple Summary The compelling evidence demonstrating the benefits of exercise to cancer survivors is biased towards ‘more well’ patients undertaking exercise interventions in tightly controlled (highly supervised) conditions. The aim of this trial was to evaluate the safety, feasibility, and effect of a 12-week exercise intervention delivered under ‘real-world’ conditions (that is, with low-level supervision, defined as five sessions across 12 weeks) compared with the same exercise intervention delivered under high-level supervision (20 sessions across 12 weeks). The understudied, less well women with breast cancer were the target population; that is, women with stage II or higher disease at diagnosis, and at least one comorbidity or treatment-related side-effect. The results showed that exercise was safe and feasible for this understudied breast cancer subgroup, and, while women who received the exercise intervention with low-level supervision experienced improvements in quality of life and physical function, greater gains in strength and exercise self-efficacy were observed for women who had the exercise intervention delivered via high-level supervision. Future research will determine whether the extra benefit gained through higher supervision levels lead to longer term quality of life and survival benefits. Abstract The aim of this comparative, effectiveness trial was to evaluate the safety, feasibility and effect of an exercise intervention delivered via low-level versus high-level supervision. The target population were women who were diagnosed with ≥stage II breast cancer, had ≥ one comorbidity and/or persistent treatment-related side-effects, and were insufficiently physically active. Sixty women (50 ± 9 years) were randomized to the low-supervision group (n = 30) or high-supervision group (n = 30). The low-supervision group participated in a 12-week, individually-tailored exercise intervention supported by five supervised sessions with an exercise professional. The high-supervision group participated in the same exercise intervention but received 20 supervised sessions across the 12-week period. The target weekly dosage of 600 metabolic equivalent minutes of exercise per week (MET-mins/wk) and the session content, such as safety and behaviour change topics, were standardized between the groups. The primary outcomes were intervention safety, defined as the number, type, and severity of exercise-related adverse events (e.g., musculoskeletal injury or exacerbated treatment-related side effects), and feasibility, which was defined as compliance to target exercise dosage. The effect of the intervention on quality of life, physical activity, self-efficacy, fitness, and strength was also assessed (pre- and post-intervention, and at 12-week follow-up). The intervention was safe, with no exercise-related adverse events of grade 3 or above in either group. Both groups reported high compliance to the target exercise dosage (median MET-mins/wk: High = 817; Low = 663), suggesting the exercise intervention was feasible, irrespective of supervision level. Improvements in quality of life, physical activity and fitness were observed post-intervention and maintained at follow-up for both groups (p < 0.05). Only the high-supervision group showed clinically-relevant improvements in strength and self-efficacy at post-intervention (p < 0.05). Individually-targeted exercise delivered under high- or low-levels of supervision is safe, feasible and beneficial for women with stage II+ breast cancer. Future research needs to assess whether the greater gains observed in the group who received higher supervision may contribute to longer term maintenance of physical activity levels and overall health benefits. Australian and New Zealand Clinical Trials Registry: ACTRN12616000547448.