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.

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.

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.

Rehabilitation Support via Postcard (RSVP): A Randomised Controlled Trial of a Postcard to Promote Uptake of Cardiac Rehabilitation.

PURPOSE: The aim was to increase cardiac rehabilitation (CR) uptake using a novel intervention, Rehabilitation Support Via Postcard (RSVP), among patients with acute myocardial infarction discharged from two major hospitals in Hunter New England Local Health District (HNELHD), New South Wales, Australia. METHODS: The RSVP trial was evaluated using a two-armed randomised controlled trial design. Participants (N=430) were recruited from the two main hospitals in HNELHD, and enrolled and randomised to either the intervention (n=216) or control (n=214) group over a six-month period. All participants received usual care; however, the intervention group received postcards promoting CR attendance between January and July 2020. The postcard was ostensibly written as an invitation from the patient's admitting medical officer to promote timely and early uptake of CR. The primary outcome was CR attendance at outpatient HNELHD CR services in the 30-days post-discharge. RESULTS: Fifty-four percent (54%) of participants who received RSVP attended CR, compared to 46% in the control group; however this difference was not statistically significant (odds ratio [OR]=1.4, 95% confidence interval [CI]=0.9-2.0, p=0.11). Exploratory post-hoc analysis among four sub-groups (i.e., Indigeneity, gender, age and rurality), found that the intervention significantly increased attendance in males (OR=1.6, 95%CI=1.0-2.6, p=0.03) but had no significant impact on attendance for other sub-groups. CONCLUSIONS: While not statistically significant, postcards increased overall CR attendance by 8%. This strategy may be useful to increase attendance, particularly in men. Alternative strategies are necessary to increase CR uptake among women, Indigenous people, older people and people from regional and remote locations.

Adapted motivational interviewing for brief healthcare consultations: A systematic review and meta-analysis of treatment fidelity in real-world evaluations of behaviour change counselling.

BACKGROUND: Behaviour change counselling (BCC) is an adaptation of motivational interviewing (MI) designed to maximize the effectiveness of time-limited health behaviour change consultations. To improve intervention quality and understanding of treatment effects, it is recommended that evaluations of health behaviour change interventions incorporate existing fidelity frameworks (e.g. The National Institutes of Health [NIH] Behaviour Change Consortium) and ensure that treatment fidelity is assessed and reported. PURPOSE: This systematic review was designed to examine (a) adherence to NIH fidelity recommendations, (b) provider fidelity to BCC and (c) impact of these variables on the real-world effectiveness of BCC for adult health behaviours and outcomes. METHODS AND RESULTS: Searches of 10 electronic databases yielded 110 eligible publications describing 58 unique studies examining BCC delivered within real-world healthcare settings by existing providers. Mean study adherence to NIH fidelity recommendations was 63.31% (Range 26.83%-96.23%). Pooled effect size (Hedges g) for short-term and long-term outcomes was .19 (95% CI [.11, .27]) and .09 (95% CI [.04, .13]), respectively. In separate, random-effects meta-regressions, neither short-term nor long-term effect sizes were significantly modified by adherence to NIH fidelity recommendations. For the subgroup of short-term alcohol studies (n = 10), a significant inverse relationship was detected (Coefficient = -.0114, 95% CI [-.0187, -.0041], p = .0021). Inadequate and inconsistent reporting within the included studies precluded planned meta-regression between provider fidelity and BCC effect size. CONCLUSIONS: Further evidence is needed to clarify whether adherence to fidelity recommendations modifies intervention effects. Efforts to promote transparent consideration, evaluation and reporting of fidelity are urgently needed. Research and clinical implications are discussed.

'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.

Effectiveness and reporting of nutrition interventions in cardiac rehabilitation programmes: a systematic review.

AIMS: Dietary modification is essential for the secondary prevention of cardiovascular disease. However, there are limited published evidence syntheses to guide practice in the cardiac rehabilitation (CR) setting. This systematic review's objective was to assess effectiveness and reporting of nutrition interventions to optimize dietary intake in adults attending CR. METHODS AND RESULTS: Randomized controlled trials (RCTs) of nutrition interventions within CR were eligible for inclusion and had to have measured change in dietary intake. MEDLINE, Embase, Emcare, PsycINFO, CINAHL, Scopus, and The Cochrane Library were searched from 2000 to June 2020, limited to publications in English. Evidence from included RCTs was synthesized descriptively. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool. This review is registered on PROSPERO; CRD42020188723. Of 13 048 unique articles identified, 11 were eligible. Randomized controlled trials were conducted in 10 different countries, included 1542 participants, and evaluated 29 distinct dietary intake outcomes. Five studies reported statistically significant changes in diet across 13 outcomes. Most nutrition interventions were not reported in a manner that allowed replication in clinical practice or future research. CONCLUSION: There is a gap in research testing high-quality nutrition interventions in CR settings. Findings should be interpreted in the light of limitations, given the overall body of evidence was heterogenous across outcomes and study quality; 6 of 11 studies were conducted more than 10 years old. Future research should investigate strategies to optimize and maintain nutrition improvements for patients attending CR. REGISTRATION: PROSPERO; CRD42020188723.

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.

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.

The Impact of Human Papillomavirus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) on Nutritional Outcomes.

BACKGROUND: Patients undergoing (chemo) radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) are at high risk of malnutrition during and after treatment. Malnutrition can lead to poor tolerance to treatment, treatment interruptions, poor quality of life (QOL) and potentially reduced survival rate. Human papillomavirus (HPV) is now known as the major cause of OPSCC. However, research regarding its effect on nutritional outcomes is limited. The aim of this study was to examine the relationship between HPV status and nutritional outcomes, including malnutrition and weight loss during and after patients' (chemo) radiotherapy treatment for OPSCC. Methods: This was a longitudinal cohort study comparing the nutritional outcomes of HPV-positive and negative OPSCC patients undergoing (chemo) radiotherapy. The primary outcome was nutritional status as measured using the Patient Generated-Subjective Global Assessment (PG-SGA). Secondary outcomes included loss of weight, depression, QOL and adverse events. Results: Although HPV-positive were less likely to be malnourished according to PG-SGA at the beginning of treatment, we found that the difference between malnutrition rates in response to treatment was not significantly different over the course of radiotherapy and 3 months post treatment. HPV-positive participants had significantly higher odds of experiencing >10% weight loss at three months post-treatment than HPV-negative participants (OR = 49.68, 95% CI (2.7, 912.86) p ≤ 0.01). Conclusions: The nutritional status of HPV positive and negative patients were both negatively affected by treatment and require similarly intense nutritional intervention. In acute recovery, HPV positive patients may require more intense intervention. At 3- months post treatment, both groups still showed nutritional symptoms that require nutritional intervention so ongoing nutritional support is essential.

Non-pharmacological approaches to procedural anxiety reduction for patients undergoing radiotherapy for cancer: systematic review protocol.

INTRODUCTION: Procedural anxiety relates to an affective state of anxiety or fear in relation to a medical procedure. Various treatment-related factors may elicit anxiety among oncology patients, including fear of diagnostic imaging (such as MRI scans) and impending treatment and medical procedures (such as chemotherapy and radiotherapy). It is common in oncology settings to manage acute anxiety relating to medical procedures with anxiolytic medication. However, pharmacological approaches are not suitable for many patients. Despite this, non-pharmacological interventions are infrequently used. The aim of this systematic review is to determine whether non-pharmacological interventions delivered prior to, or during, radiotherapy are effective in reducing procedural anxiety. METHODS AND ANALYSIS: Data sources will include the bibliographic databases CINAHL, MEDLINE, EMBASE, PsycINFO and Cochrane Central Register of Controlled trials (CENTRAL) (from inception onward). Eligible studies will include adult patients with cancer undergoing radiotherapy treatment. Included studies will be those which employ a non-pharmacological intervention, delivered within existing radiotherapy appointments, with the aim of reducing procedural anxiety related to radiotherapy. All research designs with a control or other comparison group will be included. The primary outcome will be change in levels of self-reported procedural anxiety. Secondary outcomes will be changes in scores on physiological measures of anxiety and/or changes in treatment completion and/or changes in treatment duration and/or changes in psychological distress. Two investigators will independently complete title and abstract screening, full-text screening, data extraction and assessment of methodological quality. If appropriate, a meta-analyses will be performed. Any important amendments to this protocol will be updated in the PROSPERO registration and documented in the resulting review publication. ETHICS AND DISSEMINATION: No ethical issues are anticipated from this review. The findings will be disseminated through peer-reviewed publication and at conferences by presentation. SYSTEMATIC REVIEW REGISTRATION: CRD42019112941.

Assessing Adherence, Competence and Differentiation in a Stepped-Wedge Randomised Clinical Trial of a Complex Behaviour Change Intervention.

BACKGROUND: A key challenge in behavioural medicine is developing interventions that can be delivered adequately (i.e., with fidelity) within real-world consultations. Accordingly, clinical trials should (but tend not to) report what is actually delivered (adherence), how well (competence) and the distinction between intervention and comparator conditions (differentiation). PURPOSE: To address this important clinical and research priority, we apply best practice guidelines to evaluate fidelity within a real-world, stepped-wedge evaluation of "EAT: Eating As Treatment", a new dietitian delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. METHODS: Dietitians (n = 18) from five Australian hospitals delivered a period of routine care and following a randomly determined order each site received training and began delivering the EAT Intervention. A 20% random stratified sample of audio-recorded consultations (control n = 196; intervention n = 194) was coded by trained, independent, raters using a study specific checklist and the Behaviour Change Counselling Inventory. Intervention adherence and competence were examined relative to apriori benchmarks. Differentiation was examined by comparing control and intervention sessions (adherence, competence, non-specific factors, and dose), via multiple linear regression, logistic regression, or mixed-models. RESULTS: Achievement of adherence benchmarks varied. The majority of sessions attained competence. Post-training consultations were clearly distinct from routine care regarding motivational and behavioural, but not generic, skills. CONCLUSIONS: Although what level of fidelity is "good enough" remains an important research question, findings support the real-world feasibility of integrating EAT into dietetic consultations with HNC patients and provide a foundation for interpreting treatment effects.

Not seeing the forest for the trees: a systematic review of comprehensive distress management programs and implementation strategies.

PURPOSE OF REVIEW: Clinically significant distress is common in patients with cancer and if untreated can be associated with adverse outcomes. This article offers a review of current approaches to implementing and reporting the minimum components of distress screening and management interventions in cancer services. RECENT FINDINGS: Twenty-two relevant published articles were identified from January 2018 to February 2020. The reporting of recommended minimum components of distress screening and management interventions in these articles was not consistent. The majority of studies used validated tools to conduct initial screening. However, recommendations were either not reported or not followed regarding subsequent pathway components, secondary assessment, referral pathways linked to screening results and rescreening. The majority of studies did not include a description of the implementation of the distress screening program. A small number of studies described a comprehensive set of implementation strategies. SUMMARY: Distress screening and management interventions in cancer are an important component of comprehensive cancer care. To improve patient outcomes and guide researchers and services to identify effective models, studies must include and evaluate minimum recommended components and implementation strategies. Addressing these limitations with high-quality, robust interventions is vital for advancing the implementation of effective distress management.

Gastrostomy dependency trends over 15 years of patients at a large tertiary referral center following the insertion of a prophylactic gastrostomy for chemoradiation for mucosal head and neck cancer.

AIM: The routine use of prophylactic percutaneous endoscopic gastrostomy (PEG) tubes for nutrition support during radical chemoradiation for head and neck cancer has been suggested to result in PEG dependency. This research aimed to determine the rates of gastrostomy dependency at the Calvary Mater Newcastle (CMN) where PEGs are routinely used and to identify potentially modifiable risk factors. METHODS: All patients with head and neck cancer planned for curative chemoradiation with a prophylactic PEG inserted were included in this review. Medical records of 250 patients treated between 2000 and 2015 were examined. RESULTS: Overall, eight patients (3%) were unable to wean. At 12 months following treatment, 16 patients (6%) still required PEG tubes for feeding. A greater T extent (T4 or synchronous head and neck tumors) and number of days Nil By Mouth (NBM) remained as significant independent risk factors for PEG dependency at 12 months (Textent OR 6.96 P < .001; NBM OR 1.01 P = .004) and overall (Textent OR8.04 P = .02; NBM OR1.01 P = .001). Associations with NBM were investigated, which demonstrated that patients had less NBM days with intensity-modulated radiation therapy (IMRT) (ß-13.3, P = .007) and seeing a speech pathologist during treatment (ß-11.9, P = .026). More NBM days were associated with tumors with greater T extent (ß+22; P < .001). CONCLUSION: The routine use of prophylactic PEGs has not resulted in significant rates of PEG dependency at the CMN. Seeing a speech pathologist during treatment and IMRT may decrease time NBM, which was identified as a potentially modifiable risk factor for PEG dependency.

A cross-sectional audit of current practices and areas for improvement of distress screening and management in Australian cancer services: is there a will and a way to improve?

BACKGROUND: It is unknown how many distressed patients receive the additional supportive care recommended by Australian evidence-based distress management guidelines. The study identifies the (1) distress screening practices of Australian cancer services; (2) barriers to improving practices; and (3) implementation strategies which are acceptable to service representatives interested in improving screening practices. METHOD: Clinic leads from 220 cancer services were asked to nominate an individual involved in daily patient care to complete a cross-sectional survey on behalf of the service. Questions related to service characteristics; screening and management processes; and implementation barriers. Respondents indicated which implementation strategies were suitable for their health service. RESULTS: A total of 122 representatives participated from 83 services (51%). The majority of respondents were specialist nurses or unit managers (60%). Approximately 38% of representatives' services never or rarely screen; 52% who screen do so for all patients; 55% use clinical interviewing only; and 34% follow referral protocols. The most common perceived barriers were resources to action screening results (74%); lack of time (67%); and lack of staff training (66%). Approximately 65% of representatives were interested in improving practices. Of the 8 implementation strategies, workshops (85%) and educational materials (69%) were commonly selected. Over half (59%) indicated a multicomponent implementation program was preferable. CONCLUSIONS: Although critical gaps across all guideline components were reported, there is a broad support for screening and willingness to improve. Potential improvements include additional services to manage problems identified by screening, more staff time for screening, additional staff training, and use of patient-report measures.

Adapted motivational interviewing for brief healthcare consultations: protocol for a systematic review and meta-analysis of treatment fidelity in real-world evaluations of behaviour change counselling.

INTRODUCTION: Treatment fidelity is an important and often neglected component of complex behaviour change research. It is central to understanding treatment effects, especially for evaluations conducted outside of highly controlled research settings. Ensuring that promising interventions can be delivered adequately (ie, with fidelity) by real-world clinicians within real-world settings is an essential step in developing interventions that are both effective and 'implementable'. Whether this is the case for behaviour change counselling, a complex intervention developed specifically for maximising the effectiveness of real-world consultations about health behaviour change, remains unclear. To improve our understanding of treatment effects, best practice guidelines recommend the use of strategies to enhance, monitor and evaluate what clinicians deliver during patient consultations. There has yet to be a systematic evaluation of whether and how these recommendations have been employed within evaluations of behaviour change counselling, nor the impact on patient health behaviour and/or outcome. We seek to address this gap. METHODS AND ANALYSIS: Methods are informed by published guidelines. Ten electronic databases (Medline, PubMed, EMBASE, PsycINFO, CINAHL Complete, ScienceDirect, Taylor and Francis; Wiley, ProQuest and Open Grey) will be searched for published and unpublished articles that evaluate behaviour change counselling within real-world clinical settings (randomised and non-randomised). Eligible papers will be rated against the National Institute of Health fidelity framework. A synthesis, evaluation and critical overview of fidelity practices will be reported and linear regression used to explore change across time. Random-effect meta-regression is planned to explore whether fidelity (outcomes reported and methods used) is associated with the impact of behaviour change counselling. Standardised effect sizes will be calculated using Hedges' g (continuous outcomes) and ORs (binary/dichotomous outcomes). ETHICS AND DISSEMINATION: No ethical issues are foreseen. Findings will be disseminated via journal publication and conference presentation(s). PROSPERO REGISTRATION NUMBER: CRD42019131169.

Therapeutic Alliance Between Dietitians and Patients With Head and Neck Cancer: The Effect of Training in a Health Behavior Change Intervention.

BACKGROUND: The relationship between a clinician and their client-the "therapeutic alliance" is a robust predictor of outcome in healthcare settings; yet, few interventions to improve alliance have been tested. Motivational interviewing is a client-centered approach that embodies many principles and strategies consistent with a strong therapeutic alliance. PURPOSE: To examine whether alliance is enhanced by training dietitians to deliver a motivational interviewing informed health behavior change intervention ("Eating as Treatment"; EAT) as part of routine consultations with patients with head and neck cancer. The predictive ability of motivational interviewing techniques was also assessed. METHODS: A secondary analysis of the EAT stepped-wedge cluster-randomized controlled trial was conducted. Patients with head and neck cancer undergoing radiotherapy (n = 307) were treated by radiotherapy dietitians (n = 29) during the control (Treatment as Usual) or intervention (EAT) phase. Alliance was rated during the first and final weeks of radiotherapy, and again 4 and 12 weeks post-radiotherapy. Dietetic sessions were audiotaped. Week one sessions were objectively rated for dietitians' use of motivational interviewing techniques. RESULTS: Generalized linear-mixed effects regressions found no effect of EAT on dietitian-rated alliance (p = .237). After excluding outliers, patient-rated alliance was 0.29 points lower after EAT training (p = .016). Post hoc analyses revealed lower patient ratings on perceived support and dietitian confidence. Hierarchical multiple regressions found that no specific motivational interviewing techniques predicted patient-rated alliance. Dietitian acknowledgment of patient challenges was related to dietitian-rated alliance (ß =.15, p =.035). CONCLUSIONS: Patient and dietitian ratings of alliance were high after EAT training, but not significantly improved. Further research is needed to better understand the differential impact of intervention training and delivery on patient and clinician ratings of therapeutic alliance. CLINICAL TRIAL INFORMATION: Trial registration number ACTRN12613000320752.

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03).

PURPOSE: Malnutrition in head and neck cancer (HNC) treatment is common and associated with poorer morbidity and mortality outcomes. This trial aimed to improve nutritional status during radiation therapy (RT) using a novel method of training dietitians to deliver psychological techniques to improve nutritional behaviors in patients with HNC. METHODS AND MATERIALS: This trial used a stepped-wedge, randomized controlled design to assess the efficacy of the Eating As Treatment (EAT) program. Based on motivational interviewing and cognitive behavioral therapy, EAT was designed to be delivered by oncology dietitians and integrated into their clinical practice. During control steps, dietitians provided treatment as usual, before being trained in EAT and moving into the intervention phase. The training was principles based and sought to improve behavior-change skills rather than provide specific scripts. Patients recruited to the trial (151 controls, 156 intervention) were assessed at 4 time points (the first and the final weeks of RT, and 4 and 12 weeks afterward). The primary outcome was nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment. RESULTS: Patients who received the EAT intervention had significantly better scores on the primary outcome of nutritional status at the critical end-of-treatment time point (ß = -1.53 [-2.93 to -.13], P = .03). Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life. Although results were not statistically significant, patients who received the intervention had fewer and shorter unplanned hospital admissions. CONCLUSIONS: This trial is the first of its kind to demonstrate the effectiveness of a psychological intervention to improve nutrition in patients with HNC who are receiving RT. The intervention provides a means to ameliorate malnutrition and the important related outcomes and consequently should be incorporated into standard care for patients receiving RT for HNC.

Interventions to improve screening and appropriate referral of patients with cancer for psychosocial distress: systematic review.

OBJECTIVES: The primary aim of the review was to determine the effectiveness of strategies to improve clinician provision of psychosocial distress screening and referral of patients with cancer. DESIGN: Systematic review. DATA SOURCES: Electronic databases (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO and Cumulative Index to Nursing and Allied Health Literature (CINAHL)) were searched until July 2016. INCLUSION CRITERIA: Population: adult patients with cancer and clinical staff members. INTERVENTION: any strategy that aimed to improve the rate of routine screening and referral for detected distress of patients with cancer. Comparison: no intervention controls, 'usual' practice or alternative interventions. OUTCOME: (primary) any measure of provision of screening and/or referral for distress, (secondary) psychosocial distress, unintended adverse effects. DESIGN: trials with or without a temporal comparison group, including randomised and non-randomised trials, and uncontrolled pre-post studies. DATA EXTRACTION AND ANALYSIS: Two review authors independently extracted data. Heterogeneity across studies precluded quantitative assessment via meta-analysis and so a narrative synthesis of the results is presented. RESULTS: Five studies met the inclusion criteria. All studies were set in oncology clinics or departments and used multiple implementation strategies. Using the Grades of Recommendation, Assessment, Development and Evaluation, the overall rating of the certainty of the body of evidence reported in this review was assessed as very low. Three studies received a methodological quality rating of weak and two studies received a rating of moderate. Only one of the five studies reported a significant improvement in referrals. CONCLUSIONS: The review identified five studies of predominantly poor quality examining the effectiveness of strategies to improve the routine implementation of distress screening and referral for patients with cancer. Future research using robust research designs, including randomised assignment, are needed to identify effective support strategies to maximise the potential for successful implementation of distress screening and referral for patients with cancer. PROSPERO REGISTRATION NUMBER: CRD42015017518.