RecoverEsupport-A Digital Health Intervention for Recovery After Breast Cancer Surgery: Feasibility and Acceptability Outcomes from a Pilot Randomized Controlled Trial.

内容摘要

Optimizing recovery following breast cancer surgery is critical for restoring usual function, minimizing complications, and enabling timely initiation of adjuvant therapies. Enhanced Recovery After Surgery protocols are internationally endorsed recommendations and include patient-led behaviors such as early mobilization, early oral intake of fluids and food, postoperative rehabilitation exercises, and multimodal pain management. However, adherence to these behaviors is often suboptimal, and strategies to support patients are limited. Digital health interventions (DHIs) may offer scalable solutions. The aim of the study is to assess the acceptability of the RecoverEsupport Breast DHI, designed to increase adherence to patient-led Enhanced Recovery After Surgery recommendations across the perioperative period for breast cancer surgery, and to assess the feasibility of conducting a randomized controlled trial to evaluate it. In this single-site, 2-arm randomized pilot trial, conducted at a major cancer hospital in New South Wales, Australia, between July 2024 and October 2025, participants were consecutively recruited from the surgical list at the study site, supplemented by referrals from surgeons' private rooms, and included individuals having a mastectomy with or without implant-based reconstruction. Participants were allocated to usual care (control) or usual care plus the RecoverEsupport DHI (intervention). Trial feasibility outcomes included participant recruitment, retention, data completeness, and postoperative safety (adverse events). Intervention acceptability was assessed via the System Usability Scale, participant engagement rates, and willingness to recommend the intervention to others undergoing surgery. Descriptive analyses were conducted, and outcomes were compared to prespecified targets and progression criteria. In total, 23 participants were recruited (control: n=12, intervention: n=11), which was below the target of 70, while participant retention and data completeness were 100% (23/23), both exceeding the targets. No grade 3+ adverse events occurred; minor grade 2 events occurred in both groups. Acceptability outcomes exceeded targets: usability was high (mean System Usability Scale score 83.2, SD 17.7; target >68), 100% (11/11; target >75%) of participants logged in to the DHI at least once, and 88% (10/11; target >75%) would recommend the program to others undergoing surgery. According to prespecified progression criteria, 3 of 4 feasibility targets were met, indicating that a revised recruitment strategy would be required before proceeding. The restrictive eligibility criteria may have contributed to the lower than expected recruitment rate. All 3 acceptability targets were met. The RecoverEsupport intervention was acceptable and safe and had high participant engagement. The trial processes were feasible; however, recruitment barriers, including restrictive eligibility criteria, highlight the need for more robust and integrated recruitment strategies to enable progression to a fully powered randomized controlled trial.