Individualised, targeted step count intervention following gastrointestinal cancer surgery: the Fit-4-Home randomised clinical trial

Background: To determine the effectiveness of an individualised, daily targeted step count intervention and usual care compared with usual care alone on improving surgical and patient reported outcomes. Methods: The Fit-4-Home trial was a pragmatic, randomised controlled trial conducted from April 2019 to February 2021. Patients undergoing elective surgery for liver, stomach or pancreatic cancer in two Australian hospitals were recruited. Participants were randomly allocated to receive an individualised, targeted step count intervention and usual care (intervention) or usual care alone (control). A wearable activity tracker was provided to the intervention group to monitor their daily step count target. Primary outcome was the length of stay in the gastrointestinal ward. Secondary outcomes included postoperative complication rates, discharge destination, quality of life, physical activity, pain, fatigue, distress and hospital re-admission within 30 days. Outcome measures were compared between groups using non-parametric statistics. Results: Of the 96 patients recruited, 47 were randomised to the intervention group and 49 were randomised to the control group. The median (interquartile) length of stay in the ward was 7 days (5.0–13.0) in the intervention group and 7 days (5.0– 12.0) in the control group (p = 0.330). Fatigue scores were worse in the intervention group when compared to control (p = 0.018). No other differences between groups were observed. Conclusions: An individualised, daily targeted step count intervention and usual care did not confer additional benefits in reducing the length of stay in the ward compared to usual care alone for patients undergoing gastrointestinal cancer surgery. Trial Registration: Registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12619000194167).