Feasibility and effect of a physical activity counselling session with or without provision of an activity tracker on maintenance of physical activity in women with breast cancer - A randomised controlled trial.

Objectives: The SAFE-Maintain study sought to evaluate the effect and acceptability of a physical activity counselling (PAC) session, versus a PAC session plus provision of a Fitbit (Charge HR®; PAC+F), on maintenance of physical activity levels 12 weeks following participation in a supervised exercise intervention.

Design: Fifty-two women with stage II+breast cancer who had recently (within the previous 7 days) completed a 12-week supervised exercise program were randomised to the PAC or PAC+F group.

Methods: Physical activity levels, including weekly minutes of total physical activity (min/week), daily step count (steps/day), and weekly minutes of moderate to vigorous physical activity (MVPA, min/week), were assessed using the Active Australia survey and Actigraph® GT3X+ accelerometers. Self-reported outcomes were assessed at baseline and 12-week follow-up, while objectively-measured outcomes were only available at 12-week follow-up.

Results: Compared with the PAC group, the PAC+F group had higher self-reported MVPA and self-reported total activity (between-group mean difference: 78.2 [95% CI=-8.3, 164.9] min/week, p<0.01, and 171.9 [95% CI=46.1, 297.8] min/week, p<0.01, respectively) at 12-week follow-up. Higher objectively-assessed MVPA (p=0.03) and steps/day (p=0.07) at 12-week follow-up was also observed in the PAC+F group compared with the PAC group. Most (>80%) of the PAC+F group reported high levels of Fitbit use and considered the device to be beneficial for physical activity maintenance.

Conclusions: Findings suggest that activity trackers show promise as an effective, feasible and acceptable approach to support physical activity maintenance following completion of a supervised exercise intervention.

Trial Registration: Prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, Trial registration number: ACTRN12616000954426).