OPEN: optimising patient experience in head and neck radiotherapy, a phase 3 randomised control trial comparing open versus closed face masks.

PURPOSE/

OBJECTIVE

The use of open face masks provides a potential patient centred alternative to traditional closed masks. This prospective trial aims to determine whether open masks combined with surface guided radiotherapy (SGRT) can deliver accurate radiotherapy without compromising setup accuracy and a more comfortable patient experience, by comparing three head and neck radiotherapy immobilisation systems: the standard closed 5‑point mask without SGRT, versus two SGRT‑supported systems using open 3‑point or open 5‑point masks.

MATERIALS AND

METHODS

Non-claustrophobic patients receiving radical radiotherapy were randomized (1:1:1) to standard closed 5-point masks (no SGRT), or SGRT-supported 3-point open or 5-point open masks. Setup accuracy was evaluated via daily CBCT and SGRT. Secondary analysis included: 1) patient distress levels (GHQ-12), 2) mask stability and clinical utility of SGRT monitoring for intrafraction motion, and 3) impact on resources.

RESULTS

Two hundred and thirty patients were randomised from January 2024 to May 2025. Arm A patients (34.2%) received closed-face masks, Arm B (35.7%) three-point open-face masks, and Arm C (30.2%) five-point open-face masks. Significant differences in inter‑fraction motion were observed only in the longitudinal axis, where the closed‑mask cohort (Arm A) demonstrated larger shifts compared with both open‑mask arms (P < 0.001). No other significant variations were observed in the vertical, lateral, or rotational axes between arms. At treatment completion patient experience metrics, including tolerability, overall experience and distress, were significantly more favourable for both open-mask cohorts compared to closed masks (p < 0.01).

CONCLUSION

This randomised trial of open masks versus a standard closed mask, demonstrates improved patient experience and equivalent setup accuracy supporting the adoption of open‑mask SGRT‑based immobilisation as a new patient centred solution.