Five-Year Mortality Outcomes for Eating As Treatment (EAT), a Health Behavior Change Intervention to Improve Nutrition in Patients With Head and Neck Cancer: A Stepped-Wedge, Randomized Controlled Trial.

PURPOSE: Malnutrition affects up to 80% of patients with head and neck cancer (HNC) and is associated with higher burden of disease, poorer treatment outcomes, and greater mortality. The Eating As Treatment (EAT) intervention is a behavioral intervention previously demonstrated to be effective in improving nutritional status, depression, and quality of life in patients with HNC. This article examines the effects of the EAT intervention on 5-year mortality among participants. METHODS AND MATERIALS: A multicenter, stepped-wedge, randomized controlled trial was conducted in 5 Australian hospitals. Dietitians were trained to deliver EAT, a combination of motivational interviewing and cognitive behavior therapy strategies, to patients with HNC receiving radiation therapy. Secondary analyses of survival benefit on an intention-to-treat basis were performed. Differences in proportions of 5-year all-cause mortality between the control and EAT intervention arms were analyzed using multivariable logistic regression, and 5-year survival rates were analyzed using Cox proportional hazards regression. Analyses controlled for temporal effects (study duration), hospital site (clustering), and baseline nutritional status differences. RESULTS: Overall, there were 64 deaths in the 5 years after enrollment, 36 (24%) among those assigned to the control condition and 28 (18%) among those assigned to EAT. Logistic regression showed statistically significant reduced odds in favor of EAT (odds ratio, 0.33; 95% CI, 0.11-0.96), with an absolute risk reduction of 17% (95% CI, 0.01-0.33) and a relative risk reduction of 55% (95% CI, 0.22-0.92), resulting in a number needed to treat of 6 (95% CI, 4-13). Survival analysis revealed that risk of death was significantly reduced by the EAT intervention (hazard ratio, 0.39; 0.16-0.96). CONCLUSIONS: Participation in EAT provided a statistically and clinically meaningful survival benefit, likely via improved nutrition during radiation therapy. This survival benefit strengthens the finding of the main trial, showing that a behavioral intervention focused on nutrition could improve HNC outcomes. Replication studies using stepped-wedge designs for implementation into clinical practice may be warranted.

'Quitlink': Outcomes of a randomised controlled trial of peer researcher facilitated referral to a tailored quitline tobacco treatment for people receiving mental health services.

OBJECTIVE: The aim of this study was to test the effectiveness of a tailored quitline tobacco treatment ('Quitlink') among people receiving support for mental health conditions. METHODS: We employed a prospective, cluster-randomised, open, blinded endpoint design to compare a control condition to our 'Quitlink' intervention. Both conditions received a brief intervention delivered by a peer researcher. Control participants received no further intervention. Quitlink participants were referred to a tailored 8-week quitline intervention delivered by dedicated Quitline counsellors plus combination nicotine replacement therapy. The primary outcome was self-reported 6 months continuous abstinence from end of treatment (8 months from baseline). Secondary outcomes included additional smoking outcomes, mental health symptoms, substance use and quality of life. A within-trial economic evaluation was conducted. RESULTS: In total, 110 participants were recruited over 26 months and 91 had confirmed outcomes at 8 months post baseline. There was a difference in self-reported prolonged abstinence at 8-month follow-up between Quitlink (16%, n = 6) and control (2%, n = 1) conditions, which was not statistically significant (OR = 8.33 [0.52, 132.09] p = 0.131 available case). There was a significant difference in favour of the Quitlink condition on 7-day point prevalence at 2 months (OR = 8.06 [1.27, 51.00] p = 0.027 available case). Quitlink costs AU$9231 per additional quit achieved. CONCLUSION: The Quitlink intervention did not result in significantly higher rates of prolonged abstinence at 8 months post baseline. However, engagement rates and satisfaction with the 'Quitlink' intervention were high. While underpowered, the Quitlink intervention shows promise. A powered trial to determine its effectiveness for improving long-term cessation is warranted.

Situational anxiety in head and neck cancer: Rates, patterns and clinical management interventions in a regional cancer setting.

INTRODUCTION: Research indicates that the immobilisation mask required for radiation therapy (RT) for head and neck cancers can provoke intense anxiety. However, little is known about the rates of this anxiety, whether it changes over a course of treatment and how it is managed in clinical practice. This study aimed to describe the rates and patterns of situational anxiety in patients undergoing RT for head and neck cancer and the use of anxiety management interventions in current clinical practice in a major regional cancer setting in New South Wales, Australia. METHODS: Situational anxiety rates and patterns were assessed at five time points using the State-Trait Anxiety Inventory prior to treatment planning (SIM), the first three treatment sessions (Tx 1, Tx 2 and Tx 3) and treatment 20 (Tx 20). Sessions were observed to record the use of general supportive interventions (music and support person) and anxiety-specific interventions (break from the mask, relaxation techniques and anxiolytic medication). Sociodemographic and clinical information was extracted from the medical record. RESULTS: One hundred and one patients were recruited. One-third had clinically significant anxiety at any of the first three time points (33.3-40%), and a quarter at Tx 3 (26.4%) and Tx 20 (23.4%). Of the sample, 55.4% had available data for categorisation into one of four pattern groups: 'No Anxiety' (46.4%); 'Decreasing Anxiety' (35.7%); 'Increasing Anxiety' (7.1%); and 'Stable High Anxiety' (10.7%). Most participants had social support present at SIM (53.5%) and listened to music during treatment (86.7-92.9%). Few participants received relaxation techniques alone (1.2-2.3%). Anxiolytic medication was provided for 10% of patients at some stage during the treatment journey and 5% required a break from the mask at SIM, with frequency decreasing throughout the treatment course. CONCLUSIONS: In this regional cancer setting, situational anxiety was common, but generally decreased throughout treatment. Some patients experience persistent or increasing anxiety, with up to 10% of patients receiving specific anxiety management interventions.

Outback Quit Pack: Feasibility trial of outreach smoking cessation for people in rural, regional, and remote Australia.

BACKGROUND: Tobacco smoking rates are higher in rural, regional, and remote (RRR) areas in Australia, and strategies to improve access to quit supports are required. This pilot study examined the feasibility of a smoking cessation intervention for people in RRR areas who smoke with the intention of using this data to design a powered effectiveness trial. METHODS: A randomised controlled trial (RCT) of the feasibility of a 12-week 'Outback Quit Pack' intervention consisting of mailout combination nicotine replacement therapy (NRT) and a proactive referral to Quitline, compared with a minimal support control (1-page smoking cessation support information mailout) was conducted between January and October 2021. Participants recruited via mailed invitation or Facebook advertising, were adults who smoked tobacco (≥10 cigarettes/day) and resided in RRR areas of New South Wales, Australia. Participants completed baseline and 12-week follow-up telephone surveys. Outcomes were feasibility of trial procedures (recruitment method; retention; biochemical verification) and acceptability of intervention (engagement with Quitline; uptake and use of NRT). RESULTS: Facebook advertising accounted for 97% of participant expressions of interest in the study (N = 100). Retention was similarly high among intervention (39/51) and control (36/49) participants. The intervention was highly acceptable: 80% of the intervention group had ≥1 completed call with Quitline, whilst Quitline made 3.7 outbound calls/participant (mean 14:05 mins duration). Most of the intervention group requested NRT refills (78%). No differences between groups in self-reported cessation outcomes. Biochemical verification using expired air breath testing was not feasible in this study. CONCLUSION: The Outback Quit Pack intervention was feasible and acceptable. Alternative methods for remote biochemical verification need further study. SO WHAT?: A powered RCT to test the effectiveness of the intervention to improve access to evidence-based smoking cessation support to people residing in RRR areas is warranted.

A systematic review of nonpharmacological interventions to reduce procedural anxiety among patients undergoing radiation therapy for cancer.

Procedural anxiety is a concern for a number of patients undergoing radiation therapy. While procedural anxiety is often treated pharmacologically, there is a clinical need for effective alternative strategies for patients who are contraindicated from medication use, and those who prefer not to take unnecessary medications. OBJECTIVES: The primary objective was to assess the efficacy of nonpharmacological interventions delivered to adults with cancer, in the radiation oncology department, just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety. The secondary objectives were to assess the efficacy of these interventions in reducing physiological symptoms of procedural anxiety and anxiety-related treatment disruptions. DESIGN: Systematic review. DATA SOURCES: Electronic databases (MEDLINE, CINAHL, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials) were searched from inception up until February 2022. INCLUSION CRITERIA: Population: Adult patients with cancer undergoing external beam radiation therapy. INTERVENTION: Nonpharmacological interventions delivered within the radiation therapy department. Comparison: standard care controls, or standard care plus an alternative intervention. OUTCOMES: level of self-reported procedural anxiety (primary), physiological symptoms of anxiety (secondary) and measures of anxiety-related treatment disruptions (secondary). DATA EXTRACTION AND ANALYSIS: Two reviewers independently extracted data. A meta-analysis was originally planned but deemed not feasible as the studies could not be confidently pooled for meta-analysis, due to the variability in the interventions, study designs and the generally low number of studies. Therefore, a narrative synthesis is presented. RESULTS: Screening of 2363 records identified nine studies that met inclusion criteria: six studies of music interventions, two of video-based patient education and one of aromatherapy. Overall, three studies received a global rating of strong methodological quality and low risk of bias. Three studies reported a significant effect of the intervention on reducing the primary outcome of self-reported procedural anxiety: two music interventions (both strong methodological quality), and one video-based patient education (moderate methodological quality). One of the studies (a music intervention) also reported a significant reduction in the secondary outcome of physiological symptoms of procedural anxiety (systolic blood pressure). CONCLUSIONS: The evidence for nonpharmacological interventions delivered to adults with cancer just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety is limited, with very few well-designed studies. There is a need for interventions for procedural anxiety during radiation therapy to be evaluated through rigorous randomised controlled trials.

Smoking Cessation Interventions and Abstinence Outcomes for People Living in Rural, Regional, and Remote Areas of Three High-Income Countries: A Systematic Review.

INTRODUCTION: Tobacco smoking rates in high-income countries are greater in rural, regional, and remote (RRR) areas compared to cities. Yet, there is limited knowledge about interventions targeted to RRR smokers. This review describes the effectiveness of smoking cessation interventions for RRR smokers in supporting smoking abstinence. AIMS AND METHODS: Seven academic databases were searched (inception-June 2022) for smoking cessation intervention studies to include if they reported on RRR residents of Australia, Canada, or the United States, and short- (<6 months) or long-term (≥6 months) smoking abstinence outcomes. Two researchers assessed study quality, and narratively summarized findings. RESULTS: Included studies (n = 26) were primarily randomized control (12) or pre-post (7) designs, from the United States (16) or Australia (8). Five systems change interventions were included. Interventions included cessation education or brief advice, and few included nicotine monotherapies, cessation counseling, motivational interviewing, or cognitive behavioral therapy. Interventions had limited short-term effects on RRR smoking abstinence, decreasing markedly beyond 6 months. Short-term abstinence was best supported by contingency, incentive, and online cessation interventions, and long-term abstinence by pharmacotherapy. CONCLUSIONS: Cessation interventions for RRR smokers should include pharmacotherapy and psychological cessation counseling to establish short-term abstinence, and identify effective means of maintaining abstinence beyond 6 months. Contingency designs are a suitable vehicle for psychological and pharmacotherapy support for RRR people who smoke, and intervention tailoring should be explicitly considered. IMPLICATIONS: Smoking disproportionately harms RRR residents, who can encounter access barriers to smoking cessation support. High-quality intervention evidence and outcome standardization are still required to support long-term RRR smoking abstinence.

SMART recovery for youth: a small, exploratory qualitative study examining the potential of a mutual-aid, peer support addictive behaviour change program for young people.

BACKGROUND: SMART (Self-Management and Recovery Training) Recovery is a mutual-aid program informed by cognitive behaviour therapy and motivational interviewing that provides support for a range of addictive behaviours. SMART Recovery has not been adapted to target young people with addictive behaviours despite the potential to overcome important barriers affecting youth engagement in other addiction programs. This study aimed to engage young people and SMART Recovery facilitators in qualitative interviews and focus groups to explore the potential of such a program and gain specific insights for its development. METHODS: We conducted qualitative interviews and a focus group with five young people (aged between 14 and 24 years) and eight key stakeholders (including seven SMART Recovery facilitators) to obtain recommendations on how best to reach, engage, and support young people with addictive behaviours in a tailored SMART Recovery program. Qualitative data was transcribed and analysed using iterative categorization. RESULTS: Five key themes were identified when developing and delivering youth-targeted SMART Recovery. [1] 'Discussing personal experiences to promote a shared identity' refers to the benefits of creating a forum where personal stories are used to connect with others and validate one's experiences. [2] 'Flexible and patient approach' emphasises a preference for facilitators to take a more gentle, less direct approach that allows for discussion beyond addictive behaviours. [3] 'Balancing information and skills with the space for discussion' acknowledges that youth want to connect in a variety of ways, beyond discussion of addictive behaviours, and that they wish to lead skill sharing and development. [4] 'Conveying a community for youth through language' highlighted the need to focus on connecting youth and to avoid the use of generic language to engage young people. [5] 'Group logistics and competing demands' refers to the logistical considerations of implementing a group program for youth that takes into account their competing demands and group accessibility. CONCLUSION: The findings point to considerations for developing youth specific mutual-aid groups, in particular a youth-targeted SMART Recovery program, such as by ensuring the conversation is youth-led and with an informal and flexible approach to guide group discussion.

Implementing Smoking Cessation Interventions for Tobacco Users Within Oncology Settings: A Systematic Review.

Importance: Patients with cancer who continue to smoke tobacco experience greater treatment-related complications, higher risk of secondary cancers, and greater mortality. Despite research to improve smoking cessation care within clinical oncology, implementation of proposed interventions within routine care remains challenging. Objective: To identify and recommend implementation strategies for smoking cessation interventions associated with improved screening, advice-giving, and referral for tobacco users recently diagnosed with cancer, as well as shifting smoking behaviors and attitudes in this patient population. Evidence Review: MEDLINE, CINAHL, Embase, and PsycINFO databases, as well as Google Scholar, were searched for articles published before September 7, 2020, using terms related to cancer, smoking cessation, and implementation science. Outcomes of interest were study characteristics, implementation strategies, and outcome measures (screening, advice, referral, abstinence rates, and attitudes). The Cochrane Risk of Bias Tool for randomized and nonrandomized studies was used to assess bias. The review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline and Synthesis Without Meta-analysis (SWiM) guideline. Implementation strategies were categorized according to Expert Recommendations for Implementing Change (ERIC) study taxonomy. A systematic analysis was conducted focusing on studies with low or moderate risk of bias due to high heterogeneity in outcome measurement. Findings: In total, 6047 records were screened, yielding 43 articles (10 randomized clinical trials and 33 nonrandomized studies). Four strategies were associated with improved screening, advice-giving, and referral: (1) supporting clinicians, (2) training implementation stakeholders (including clinicians), (3) changing the infrastructure, and (4) developing stakeholder interrelationships. Conclusions and Relevance: In this systematic review, supporting clinicians by providing cessation care through a trained tobacco specialist was identified as important for achieving short-term abstinence and changing attitudes among patients with cancer. Combined with a theoretical framework and stakeholder involvement, these strategies provide the basis for successful implementation of cessation support; this systematic review serves as an illustration of the methodological application and synthesis of implementation studies and other medical conditions more generally.

'Having the mask on didn't worry me until they clamped my head down so I wouldn't move': A qualitative study exploring anxiety in patients with head and neck cancer during radiation therapy.

INTRODUCTION: More than 20% of patients undergoing radiation therapy for head and neck cancer report anxiety specifically related to the immobilisation mask, a tight-fighting mask patients are required to wear for the duration of each treatment session. However, limited research has investigated this from the patient perspective. The aim of this study was to better understand patient experiences of mask anxiety during head and neck cancer radiation therapy and to explore patient attitudes toward potential strategies that may reduce mask anxiety during this treatment. METHODS: Five patients with head and neck cancer, who had self-reported mask anxiety during radiation therapy, participated in semi-structured, qualitative interviews exploring their experiences of anxiety and suggestions for reducing anxiety. A codebook thematic analysis was conducted. RESULTS: Six main themes were identified: (1) triggers of anxiety; (2) adjusting to radiation therapy; (3) education about the mask; (4) coping; (5) motivation and (6) improving the patient experience. CONCLUSION: Findings from these interviews provide valuable insight into how and when healthcare providers may be able to assist patients to manage mask anxiety. Recommendations include increased communication from health care providers; delivery of visual information to improve patient preparedness; exposure/opportunities to interact with the masks prior to treatment commencing and increased control of music/soundtrack selection. However, a limitation of this study is the small sample size and further research is warranted.

Building staff capability, opportunity, and motivation to provide smoking cessation to people with cancer in Australian cancer treatment centres: development of an implementation intervention framework for the Care to Quit cluster randomised controlled trial.

Few rigorous studies provide a clear description of the methodological approach of developing an evidence-based implementation intervention, prior to implementation at scale. This study describes the development, mapping, rating, and review of the implementation strategies for the Care to Quit smoking cessation trial, prior to application in nine cancer services across Australia. Key stakeholders were engaged in the process from conception through to rating, reviewing and refinement of strategies and principles. An initial scoping review identified 21 barriers to provision of evidence-based smoking cessation care to patients with cancer, which were mapped to the Theoretical Domains Framework and Behaviour Change Wheel (BCW) to identify relevant intervention functions. The mapping identified 26 relevant behaviour change techniques, summarised into 11 implementation strategies. The implementation strategies were rated and reviewed against the BCW Affordability, Practicality, Effectiveness and cost-effectiveness, Acceptability, Side-effects/safety, and Equity criteria by key stakeholders during two interactive workshops to facilitate a focus on feasible interventions likely to resonate with clinical staff. The implementation strategies and associated intervention tools were then collated by form and function to provide a practical guide for implementing the intervention. This study illustrates the rigorous use of theories and frameworks to arrive at a practical intervention guide, with potential to inform future replication and scalability of evidence-based implementation across a range of health service settings. Supplementary Information: The online version contains supplementary material available at 10.1007/s10742-022-00288-6.

The value of compassionate support to address smoking: A qualitative study with people who experience severe mental illness.

Introduction: People experiencing severe mental illness (SMI) smoke at much higher rates than the general population and require additional support. Engagement with existing evidence-based interventions such as quitlines and nicotine replacement therapy (NRT) may be improved by mental health peer worker involvement and tailored support. This paper reports on a qualitative study nested within a peer researcher-facilitated tobacco treatment trial that included brief advice plus, for those in the intervention group, tailored quitline callback counseling and combination NRT. It contextualizes participant life experience and reflection on trial participation and offers insights for future interventions. Methods: Qualitative semi-structured interviews were conducted with 29 participants in a randomized controlled trial (intervention group n = 15, control group n = 14) following their 2-month (post-recruitment) follow-up assessments, which marked the end of the "Quitlink" intervention for those in the intervention group. Interviews explored the experience of getting help to address smoking (before and during the trial), perceptions of main trial components including assistance from peer researchers and tailored quitline counseling, the role of NRT, and other support received. A general inductive approach to analysis was applied. Results: We identified four main themes: (1) the long and complex journey of quitting smoking in the context of disrupted lives; (2) factors affecting quitting (desire to quit, psychological and social barriers, and facilitators and reasons for quitting); (3) the perceived benefits of a tailored approach for people with mental ill-health including the invitation to quit and practical resources; and (4) the importance of compassionate delivery of support, beginning with the peer researchers and extended by quitline counselors for intervention participants. Subthemes were identified within each of these overarching main themes. Discussion: The findings underscore the enormity of the challenges that our targeted population face and the considerations needed for providing tobacco treatment to people who experience SMI. The data suggest that a tailored tobacco treatment intervention has the potential to assist people on a journey to quitting, and that compassionate support encapsulating a recovery-oriented approach is highly valued. Clinical trial registration: The Quitlink trial was registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines.

Adapting Peer Researcher Facilitated Strategies to Recruit People Receiving Mental Health Services to a Tobacco Treatment Trial.

Introduction: One of the most challenging aspects of conducting intervention trials among people who experience severe mental illness (SMI) and who smoke tobacco, is recruitment. In our parent "QuitLink" randomized controlled trial (RCT), slower than expected peer researcher facilitated recruitment, along with the impact of COVID-19 pandemic restrictions, necessitated an adaptive recruitment response. The objectives of the present study were to: (i) describe adaptive peer researcher facilitated recruitment strategies; (ii) explore the effectiveness of these strategies; (iii) investigate whether recruitment strategies reached different subgroups of participants; and (iv) examine the costs and resources required for implementing these strategies. Finally, we offer experience-based lessons in a Peer Researcher Commentary. Methods: People were included in the RCT if they smoked at least 10 cigarettes a day and were accessing mental health support from the project's two partnering mental health organizations in Victoria, Australia. The majority of people accessing these services will have been diagnosed with SMI. Recruitment occurred over 2 years. We began with peer facilitated recruitment strategies delivered face-to-face, then replaced this with direct mail postcards followed by telephone contact. In the final 4 months of the study, we began online recruitment, broadening it to people who smoked and were accessing support or treatment (including from general practitioners) for mental health and/or alcohol or other drug problems, anywhere in the state of Victoria. Differences between recruitment strategies on key participant variables were assessed. We calculated the average cost per enrolee of the different recruitment approaches. Results: Only 109 people were recruited from a target of 382: 29 via face-to-face (March 2019 to April 2020), 66 from postcards (May 2020 to November 2020), and 14 from online (November to December 2020 and January to March 2021) strategies. Reflecting our initial focus on recruiting from supported independent living accommodation facilities, participants recruited face-to-face were significantly more likely to be living in partially or fully supported independent living (n = 29, <0.001), but the samples were otherwise similar. After the initial investment in training and equipping peer researchers, the average cost of recruitment was AU$1,182 per participant-~US$850. Face-to-face recruitment was the most expensive approach and postcard recruitment the least (AU$1,648 and AU$928 per participant). Discussion: Peer researcher facilitated recruitment into a tobacco treatment trial was difficult and expensive. Widely dispersed services and COVID-19 restrictions necessitated non-face-to-face recruitment strategies, such as direct mail postcards, which improved recruitment and may be worthy of further research. Clinical Trial Registration: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines. The trial sponsor was the University of Newcastle, NSW, Australia.

Smoking and other health factors in patients with head and neck cancer.

BACKGROUND: Information on smoking and other health factors in head and neck cancer (HNC) patients throughout treatment, follow-up and survivorship is limited. This study explores patterns of multiple health factors during radiotherapy (RT) and naturalistic long-term follow-up in a convenience sample of patients with HNC. METHODS: Smoking, alcohol use and depression were measured at baseline, 4 and 12 weeks post RT for a sub-group of 99 patients who participated in a randomised controlled trial and completed long-term follow-up. These factors plus healthy eating, physical activity and fatigue are also reported from the long-term follow-up component. Smoking was measured by self-report and biochemically, whilst all other variables were by self-report. Where variables were assessed at multiple time points logistic mixed effects regression models determined within-person changes over time. RESULTS: There were important discrepancies between self-reported (4-7%) and biochemically verified (13-29%) rates of smoking. Rates of smoking and hazardous alcohol intake were significantly increased at follow-up compared to baseline. Depression rates were observed to be higher at end of RT compared to baseline. At long-term follow-up, fatigue was common and co-occurred with suboptimal healthy eating and hazardous alcohol use. CONCLUSION: Clinically important levels of smoking and alcohol consumption post RT in this sample suggest possible targets for intervention beyond treatment into long-term follow-up of patients.

Behavioral Interventions to Reduce Cardiovascular Risk Among People with Severe Mental Disorder.

Cardiovascular disease (CVD) is the leading cause of death among people with severe mental disorder (SMD). CVD risk factors occur at the individual, health system, and socio-environmental levels and contribute not only to high rates of CVD but also to worsening mental health. While acknowledging this wider context, this review focuses on behavioral interventions for seven CVD risk behaviors-smoking, physical inactivity, excessive alcohol consumption, low fruit and vegetable intake, inadequate sleep, poor social participation, and poor medication adherence-that are common among people with SMD. We survey recent meta-reviews of the literature and then review additional key studies to provide clinical recommendations for behavioral interventions to reduce CVD risk among people with SMD. A transdiagnostic psychological approach from the start of mental health treatment, drawing upon multidisciplinary expertise to address multiple risk behaviors, is recommended.

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 pregnant women attending treatment for substance use disorders: A systematic review.

BACKGROUND AND AIMS: Up to 95% of pregnant women seeking treatment for alcohol and other drug (AOD) use smoke tobacco. Previous reviews indicate few effective smoking cessation treatments for this group. This updated review aimed to identify and measure the efficacy of smoking cessation interventions trialled among pregnant women in AOD treatment settings who smoke tobacco. METHODS: A narrative synthesis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Studies involving psychological, behavioural or pharmacological interventions used to treat tobacco use, including electronic nicotine delivery systems, for pregnant women of any age, who smoked tobacco and were seeking/receiving treatment, or in post-treatment recovery for AOD concerns, were reviewed. MEDLINE, PsycINFO, CINAHL, EMBASE and ProQuest databases, grey literature and reference lists were searched, and field experts were contacted for unpublished study data. The Effective Public Health Practice Project tool assessed study quality. The review was pre-registered with PROSPERO no. CRD42018108777. RESULTS: Seven interventions (two randomised controlled trials, two single-arm pilot studies, two program evaluations and one causal comparative study) treating 875 women were identified. All were United States (US)-based and targeted women with drug dependence, but not alcohol dependence. Three interventions used contingency management, five provided behavioural counselling, and one offered nicotine replacement therapy. All reported reductions in cigarette consumption; one contingency management-based study demonstrated higher abstinence rates compared with controls at treatment-end that were not maintained at follow-up. Four of six studies were rated as methodologically weak and one unpublished study was not rated. CONCLUSIONS: Conclusions about the efficacy of smoking interventions for pregnant women with alcohol and other drug concerns who also smoke tobacco are hindered by the paucity of available data and poor methodological quality of included studies.

A qualitative study investigating Australian cancer service outpatients' experience of distress screening and management: what is the personal relevance, acceptability and improvement opportunities from patient perspectives?

PURPOSE: People diagnosed with cancer experience high distress levels throughout diagnosis, treatment, and survivorship. Untreated distress is associated with poor outcomes, including worsened quality of life and higher mortality rates. Distress screening facilitates need-based access to supportive care which can optimize patient outcomes. This qualitative interview study explored outpatients' perceptions of a distress screening process implemented in an Australian cancer center. METHODS: Adult, English-speaking cancer outpatients were approached to participate in face-to-face or phone interviews after being screened by a clinic nurse using the distress thermometer (DT). The piloted semi-structured interview guide explored perceptions of the distress screening and management process, overall well-being, psychosocial support networks, and improvement opportunities for distress processes. Thematic analysis was used. RESULTS: Four key themes were identified in the 19 interviews conducted. Distress screening was found to be generally acceptable to participants and could be conducted by a variety of health professionals at varied time points. However, some participants found "distress" to be an ambiguous term. Despite many participants experiencing clinical distress (i.e., DT ≥ 4), few actioned referrals; some noted a preference to manage and prevent distress through informal support and well-being activities. Participants' diverse coping styles, such as positivity, acceptance, and distancing, also factored into the perceived value of screening and referrals. CONCLUSION AND IMPLICATIONS: Screening models only measuring severity of distress may not be sufficient to direct care referrals, as they do not consider patients' varying coping strategies, external support networks, understanding of distress terminology, and motivations for accessing supportive care services.

Is fidelity to a complex behaviour change intervention associated with patient outcomes? Exploring the relationship between dietitian adherence and competence and the nutritional status of intervention patients in a successful stepped-wedge randomised clinical trial of eating as treatment (EAT).

BACKGROUND: Behavioural medicine is characterised by findings for the effectiveness and efficacy of complex behaviour change interventions. Comparatively, scant attention has been paid to key intervention components or mechanisms of action. Evaluating relationships between process variables (fidelity) and intervention effects is central to addressing this imbalance. Accordingly, in the current study, we sought to explore the magnitude and direction of effect between fidelity predictors (dietitian adherence and competence) and intervention effects (patient nutritional status) during the intervention phase of a real-world, stepped-wedge evaluation of 'EAT: Eating As Treatment'. METHODS: The EAT clinical trial was conducted within five major Australian hospitals located in Queensland, Western Australia, Victoria and South Australia between 2013 and 2016. EAT is a dietitian-delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Dietitian adherence and competence ratings were derived from a 20% random sample of audio-recorded dietetic consultations (n=194) conducted after dietitians (n=18) were trained in EAT. Sessions were coded by trained, independent, coders using a study checklist, the Behaviour Change Counselling Index (BECCI) and items from the Cognitive Therapy Scale-Revised (CTS-R). Patient nutritional status was measured using the Patient-Generated Subjective Global Assessment (PGSGA). RESULTS: Dietitian adherence to a written nutrition plan (ß=7.62, 95% CI=0.65 to 14.58, p=0.032), dietitian adherence to behaviour change counselling (ß=0.69, 95% CI =0.02 to 1.38, p=0.045) and competence in delivering behaviour change counselling (ß=3.50, 95% CI =0.47 to 6.53, p=0.024) were significant predictors of patient nutritional status. Dietitian adherence and competence ratings were higher during consultations with intervention patients at greater risk of malnutrition. CONCLUSIONS: This study contributes new insights into the relationship between fidelity and treatment outcome by demonstrating that dietitian adherence and competence is greater when working with more challenging patients. This is likely central to the demonstrated success of the EAT intervention in reducing malnutrition and highlights the importance of ensuring that providers are adequately equipped to flexibly integrate intervention elements according to patient need. TRIAL REGISTRATION: This study is a process analysis of a stepped-wedge randomised controlled trial prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12613000320752 ; Date of registration 21/03/2013).

Care to Quit: a stepped wedge cluster randomised controlled trial to implement best practice smoking cessation care in cancer centres.

BACKGROUND: Cigarette smoking in people with cancer is associated with negative treatment-related outcomes including increased treatment toxicity and complications, medication side effects, decreased performance status and morbidity. Evidence-based smoking cessation care is not routinely provided to patients with cancer. The purpose of this study is to determine the effectiveness of a smoking cessation implementation intervention on abstinence from smoking in people diagnosed with cancer. METHODS: A stepped wedge cluster randomised design will be used. All sites begin in the control condition providing treatment as usual. In a randomly generated order, sites will move to the intervention condition. Based on the Theoretical Domains Framework, implementation of Care to Quit will include (i) building the capability and motivation of a critical mass of key clinical staff and identifying champions; and (ii) identifying and implementing cessation care models/pathways. Two thousand one hundred sixty patients with cancer (diagnosed in the prior six months), aged 18+, who report recent combustible tobacco use (past 90 days or in the 30 days prior to cancer diagnosis) and are accessing anti-cancer therapy, will be recruited at nine sites. Assessments will be conducted at baseline and 7-month follow-up. The primary outcome will be 6-month abstinence from smoking. Secondary outcomes include biochemical verification of abstinence from smoking, duration of quit attempts, tobacco consumption, nicotine dependence, provision and receipt of smoking cessation care, mental health and quality of life and cost effectiveness of the intervention. DISCUSSION: This study will implement best practice smoking cessation care in cancer centres and has the potential for wide dissemination. TRIAL REGISTRATION: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN ( ACTRN12621000154808 ) prior to the accrual of the first participant and will be updated regularly as per registry guidelines.