JMIR Publications

ABSTRACT

Background:

Optimising recovery following breast cancer surgery is critical for restoring usual function, minimising complications and enabling timely initiation of adjuvant therapies. Enhanced Recovery After Surgery (ERAS) protocols are internationally endorsed recommendations and include patient-led behaviours such as early mobilisation, early oral intake of fluid and food, postoperative rehabilitation exercises, and multi-modal pain management. However, adherence to these behaviours is often suboptimal, and strategies to support patients are limited. Digital Health Interventions (DHIs) may offer scalable solutions.

Objective:

To assess the acceptability of the RecoverEsupport DHI, designed to increase adherence to patient-led ERAS recommendations across the perioperative period for breast cancer surgery; and assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate it.

Methods:

In this single-site, two-arm randomised pilot trial, participants having a mastectomy with or without implant-based reconstruction 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 (SUS), participant engagement rates, and willingness to recommend the intervention to others undergoing surgery. Descriptive analyses were conducted and outcomes compared to pre-specified targets and progression criteria.

Results:

Twenty-three participants were recruited (control n=12, intervention n=11), which was below the target of 70, while participant retention and data completeness were 100%, 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 SUS=83.2; target >68), 100% of participants logged in to the DHI at least once (target >75%), and 88% would recommend the program to others undergoing surgery (target >75%). According to pre-specified progression criteria, three of four 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 three acceptability targets were met.

Conclusions:

The RecoverEsupport intervention was acceptable, 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 RCT. Clinical Trial: This trial was prospectively registered with Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12624000417583.