Biofeedback Enabled CALM (BeCALM)—the feasibility of biofeedback on procedural anxiety during radiation therapy: study protocol for a pilot randomised controlled trial

Introduction Patients undergoing treatment for cancer who require radiation therapy (RT) report anxiety specifically relating to the RT procedure. Procedural anxiety can be detrimental to treatment delivery, causing disruptions to treatment sessions, or treatment avoidance. Acute procedural anxiety is most commonly managed with anxiolytic medication. There is a need for effective, non-pharmacological interventions for patients not suitable for, or who prefer to avoid, anxiolytic medication. The primary objectives of this pilot trial are to evaluate the: (1) feasibility of conducting the Biofeedback Enabled CALM (BeCALM) intervention during RT treatment sessions; (2) acceptability of the BeCALM intervention among patients; and (3) acceptability of the BeCALM intervention among radiation therapists. The secondary objective of this pilot trial is to examine the potential effectiveness of the BeCALM intervention delivered by radiation therapists to reduce procedural anxiety during RT. Methods and analysis This is a pilot randomised controlled trial. A researcher will recruit adult patients with cancer (3-month recruitment period) scheduled to undergo RT and meeting eligibility criteria for procedural anxiety at the Calvary Mater Hospital, Newcastle (NSW), Australia. Participants will be randomly assigned to receive treatment as usual or the BeCALM intervention (biofeedback plus brief breathing techniques). The primary outcomes are feasibility (measured by recruitment, retention rates and percentage of treatment sessions in which the intervention was successfully delivered); radiation therapists perceived feasibility and acceptability (survey responses); and patient perceived acceptability (survey responses). Secondary outcome is potential effectiveness of the intervention (as measured by the State Trait Anxiety Inventory—State subscale; the Distress Thermometer; and an analysis of treatment duration). Ethics and dissemination The study protocol has received approval from Hunter New England Health Human Research Ethics Committee (2021/ETH11356). The results will be disseminated via peer-reviewed publications, as well as presentation at relevant conferences. Trial registration number ACTRN12621001742864.