Fit4Surgery: A pilot randomized controlled trial to assess the feasibility of prehabilitation prior to debulking surgery for ovarian cancer

Fit4Surgery:一项评估卵巢癌减瘤手术前康复可行性的试点随机对照试验

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Abstract

OBJECTIVES: To assess the feasibility of enrolling women with ovarian cancer in a randomized controlled trial (RCT) of a home-based, patient-tailored physical activity prehabilitation program (Fit4Surgery, F4S) and assess adherence while estimating effects on patient-reported outcomes (PROs), frailty, and physical function. METHODS: Thirty patients aged ≥60 with ovarian cancer, scheduled for neoadjuvant chemotherapy and surgery, were randomized 2:1 to Fit4Surgery or educational control. The intervention group received a Fitbit, access to the F4S app, and weekly coaching calls. Controls received educational calls and access to the Cancer.Net app. The primary outcome was feasibility, defined as >80 % evaluability and adherence. Daily steps and PROs were compared using paired t-tests or Wilcoxon rank sum tests. RESULTS: Of 74 patients approached, 32 consented and 30 were randomized. Average age was 69.7 years (range 60-81). Ninety percent of patients completed both baseline and pre-surgical assessments. Patients wore their FitBit on 94 % of days, attended 97 % of coaching calls, and engaged with the F4S app on 80 % of days. Patients reached personal step goals on 49 % of days, while 77.8 % of patients increased their daily steps over the intervention, with an average increase of 1804 steps per day (37 % increase, p = 0.01). Patient-reported physical function (p = 0.09) and frailty-related metrics, including energy levels (p = 0.01) and weekly walks (p = 0.02) improved in the F4S group, while no differences were detected in surgical outcomes. CONCLUSIONS: Fit4Surgery was feasible with high engagement and adherence. Patients demonstrated increased daily step count and positive trends in PROs, frailty, and physical function.

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