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.

Smoking cessation interventions for people living in rural and remote areas: a systematic review protocol.

INTRODUCTION: Smoking rates among people living in rural and remote areas are higher and quit rates are lower over the past 10 years compared with people living in suburban and urban areas. Higher smoking rates contribute to greater tobacco-related disease and morbidity in rural and remote areas. Physical and social isolation, greater exposure to pro-tobacco marketing, pro-tobacco social norms, and lower socioeconomic and educational levels are contributing to these higher smoking rates and lower quit rates. Smoking cessation interventions for people in rural and remote areas have been conducted, however little is known about their effectiveness or their mechanisms of action as well as the quality of such research. Behaviour change techniques (BCTs) are mechanisms of action derived from behaviour change theory, such as goal setting and reward. Improved understanding of the contribution of BCTs for smoking cessation in the rural and remote population will support future intervention development. We aim to review the literature on smoking cessation interventions for people living in rural and remote areas to inform evidence about intervention effectiveness and mechanisms of action. METHODS AND ANALYSIS: We will conduct a systematic review using seven scientific databases (EMBASE, MedLine, PsycINFO, CINAHL, Cochrane, Informit Health and Scopus). We will include peer-reviewed journal articles published in English that examine a smoking cessation intervention delivered to people living in rural and remote areas in the USA, Canada and Australia. We will examine outcome data relating to intervention effectiveness (eg, point prevalence abstinence or continuous abstinence), as well as the BCTs used in included interventions and their relationship with intervention outcomes. We will also assess the feasibility, acceptability and quality of research interventions of included articles, and provide graded recommendations based on the review outcomes. Data will be synthesised using narrative approaches and interpreted using content analysis. ETHICS AND DISSEMINATION: Ethics was not required for this systematic review. The results will be disseminated through peer-reviewed publication and at conferences by presentations. PROSPERO REGISTRATION NUMBER: 177398.