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.

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.

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.

Head and neck cancer patient experience of a new dietitian-delivered health behaviour intervention: 'you know you have to eat to survive'.

PURPOSE: The aim of this study was to explore head and neck cancer (HNC) patient experiences of a novel dietitian delivered health behaviour intervention. METHODS: This study is a qualitative study which employed semi-structured individual interviews using open and axial coding and then final selective coding to organise the data. Patients with HNC who had participated in a dietitian delivered health behaviour intervention to reduce malnutrition were invited to discuss their experience of this intervention. Individual interviews were conducted, transcribed and analysed using grounded theory. RESULTS: Nine patients participated in the interviews. Four dimensions were identified in the initial coding process: 'information', which described patients' desire for tailored advice during their treatment; 'challenges of treatment experience', which described the difficulties related to treatment side effects; 'key messages: importance of eating and maintaining weight', which covered perceived integral messages delivered to patients by dietitians; and 'dietitian's approach' describing patient experiences of empathic and compassionate dietitians. Two overarching themes resulted from examining the connections and relationships between these dimensions: 'survival', a connection between eating and living; and 'support', describing the valued working partnership between dietitian and patient. CONCLUSIONS: Dimensions and themes overlapped with the qualitative literature on HNC patient experience of treatment. However, some themes, such as the empowerment of a message linking eating to survival, appeared unique to this study. Patients found this message to be delivered in a supportive manner that motivated change.

Why do oncology outpatients who report emotional distress decline help?

OBJECTIVE: Many patients who experience distress do not seek help, and little is known about the reasons for this. We explored the reasons for declining help among patients who had significant emotional distress. METHODS: Data were collected through QUICATOUCH screening at an Australian hospital. Oncology outpatients scoring 4 or more on the Distress Thermometer were asked if they would 'like help' with their distress. Those who declined help were asked their reasons. Demographic variables and a clinical measure of anxiety and depression (PSYCH-6) were used to identify factors associated with reasons for declining help. RESULTS: Of 311 patients with significant distress, 221 (71%) declined help. The most common reasons were 'I prefer to manage myself' (n = 99, 46%); 'already receiving help' (n = 52, 24%) and 'my distress is not severe enough' (n = 50, 23%). Younger patients and women were more likely to decline help and were more likely to already be receiving help. Distress score and PSYCH-6 scores were significantly lower among patients who rated their distress as not severe enough to require help. Nevertheless, there were patients who had maximal scores on distress and PSYCH in each group. CONCLUSIONS: Two common patient barriers to help with distress are a preference for self-help and a belief that distress is not sufficiently severe to warrant intervention. These beliefs were held by a sizeable proportion of individuals who reported very high levels of distress. Qualitative research and subsequent interventions for overcoming these barriers are required to obtain the most benefit from distress screening programs.

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.

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.

Predictors of desire for help in oncology outpatients reporting pain or distress.

OBJECTIVE: Although effective treatments for pain and distress are available, many patients do not access them. Improved understanding of patients' desire for help may improve uptake of services. METHODS: Data were collected as part of the QUICATOUCH screening program at an Australian regional hospital. Patients over threshold for pain were asked if they would like help with their pain and those over threshold for distress were asked if they would like help with their distress. Multivariate logistic regression analyses were conducted to identify independent predictors of desire for help. RESULTS: Of 305 patients over threshold for pain; 59% wanted help, increasing from 13% at a pain score of one to 90% at a pain score of 10. Of 274 patients over threshold for distress, 30% wanted help, increasing from 21% at a distress score of four to 41% at a distress score of 10. Pain score was the only significant independent predictor of desire for help with pain, with an odds ratio (OR) of 1.50 (95%CI 1.33-1.70) for every point increase in pain score. Distress score was the only significant independent predictor of desire for help with distress with an OR of 1.29 (95%CI 1.11-1.50) for every point increase in distress score. CONCLUSIONS: Although desire for help with pain and distress increased with respective symptom intensity, many patients indicated they did not want help with these symptoms. Patient reluctance to seek help may constitute a barrier to realising the full potential of screening programs in reducing pain and distress.

"You need something like this to give you guidelines on what to do": patients' and partners' use and perceptions of a self-directed coping skills training resource.

PURPOSE: This study aims to report on the acceptability of a self-directed coping skills intervention, called Coping-Together, for patients affected by cancer and their partners, including the strengths and limitations of the intervention design. METHODS: This initial version of Coping-Together included a series of four booklets, which aimed to provide practical coping strategies for the day-to-day management of common physical and psychosocial challenges. Thirty semi-structured interviews were conducted with 27 patients and/or 14 partners. Interviews were audiorecorded, transcribed verbatim, and analyzed for content. RESULTS: Participants endorsed the self-directed format, and the focus of Coping-Together on practical information was a feature that set it apart from other resources. The majority of participants interviewed felt that the proposed coping strategies were "doable"; however, only half of the participants reported learning new coping skills after reading the booklets. Additional benefits of reading the booklets were increasing awareness of challenges to prepare for, giving hope that something can help you "pull through", providing a sense of normality, connecting patients and partners to people and services, and complementing support received from health professionals. Despite the general acceptability of the intervention, some aspects of its design were criticized, including the workbook-like exercises, expectations about using the resource together, level of guidance provided, and amount of information included. In general, most participants felt that too much negative information was included, whereas more experiential information was desired. CONCLUSIONS: Preliminary evaluation of Coping-Together supported its practical approach and highlighted improvements to enhance its contribution to patient and partner coping.

'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.

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.

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.

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.

Effectiveness of QUICATOUCH: a computerised touch screen evaluation for pain and distress in ambulatory oncology patients in Newcastle, Australia.

OBJECTIVE: To describe the change in pain and distress over time to demonstrate the effectiveness of the QUICATOUCH program in an outpatient oncology population. METHODS: Descriptive study of the first 29 months of the QUICATOUCH program (13 736 assessments for 5775 patients). A longitudinal cohort design was used to examine the patients with three or more assessments (8129 assessments for 1778 patients). Effectiveness of this complex intervention (repeated assessment, clinician report and referral to speciality psycho-oncology service) was examined using: reduction in proportion over threshold for pain and distress, predictors of mean pain and distress scores and comparison of the number of new patients treated by the psycho-oncology service during the study and in the preceding 29 months. RESULTS: Pain and distress declined during the study. The risk of being over threshold at endpoint was reduced for pain (odds ratio (OR) 0.70, confidence interval (CI) 95% 0.60-0.81) and for distress (OR 0.58 CI 95% 0.49-0.68) with baseline as referent level. Three variables predicted the mean pain: clinic type, current radiotherapy treatment and distress score; and five predicted mean distress: time, gender, clinic type, age and pain score. There was an increase of 40% (533v747) in new patients treated by the psycho-oncology service. CONCLUSIONS: The QUICATOUCH assessment for pain and distress was implemented into usual clinical practice with reasonable coverage of patients for modest cost. It was effective in monitoring the patients over time, contributed to a reduction in pain and distress, whilst appropriately increasing the number of new patients reaching psychological treatment as part of the clinical service.

Baseline depression predicts malnutrition in head and neck cancer patients undergoing radiotherapy.

PURPOSE: Poor nutritional status is common and associated with mortality and morbidity in patients with head and neck cancer (HNC). While there are several established clinical risk factors for poor nutritional status during HNC radiotherapy, the complete aetiology is not known. The association of malnutrition with psychological factors has been recognised in other chronic illnesses but has not been studied in HNC patients who have higher levels of malnutrition and psychological disorder than many other patient populations. METHOD: Patients with HNC were assessed at three time points: week 1 of radiotherapy treatment (T1, n = 72), end of radiotherapy treatment (T2, n = 64) and 4 weeks post-radiotherapy treatment (T3, n = 58). Nutritional outcome was measured using the Patient-Generated Subjective Global Assessment, and psychological factors measured were depression, anxiety and adjustment style. RESULTS: Linear mixed models indicated that a model containing the variables time, tumour site and baseline depression best explained malnutrition at T2 and T3 (-2 restricted log likelihood = 695.42). The clinical risk factors: cancer stage, number of radiotherapy fractionations, a PEG feeding tube, availability of a care giver and dietitian's informal clinical assessment did not predict later nutritional status. CONCLUSIONS: Depression is a modifiable risk factor for malnutrition among HNC patients undergoing radiation therapy, offering the potential to ameliorate malnutrition in this group. While the nature of any causal relationship between depression and malnutrition in HNC is yet to be understood, the utility of a short depression screen in predicting malnutrition has been demonstrated and could be adopted in clinical practice.

Interventions for increasing fruit and vegetable consumption in children aged 5 years and under.

BACKGROUND: Insufficient consumption of fruits and vegetables in childhood increases the risk of future chronic diseases including cardiovascular disease. OBJECTIVES: To assess the effectiveness, cost-effectiveness and associated adverse events of interventions designed to increase the consumption of fruit and/or vegetables amongst children aged five years and under. SEARCH METHODS: The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 2, 2010, MEDLINE (1950 to 2010 April week 4), EMBASE (1947 to 2010 week 18), CINAHL (up to 12 May 2010), PsycINFO (up to 12 May 2010) and Proquest Dissertations and Theses (up to February 2011) were searched to identify eligible trials, as well as electronic trial registers (also up to February 2011). The reference lists of included trials were reviewed and handsearches of three international nutrition journals were also performed. Authors of all included trials were contacted in order to identify further potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs), including cluster-randomised controlled trials, of any intervention primarily targeting fruit and/or vegetable consumption among children aged five years and under and incorporating a biochemical or dietary assessment of fruit and/or vegetable consumption. Two review authors independently screened the titles and abstracts of identified papers. A third review author with expertise in review methodology resolved any disagreements regarding study eligibility. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias of the included studies. A third reviewer resolved disagreements between review authors. Fixed-effect models were used to perform meta-analysis for the primary review outcomes where a sufficient number of trials with suitable data and homogeneity were identified. MAIN RESULTS: Five trials, with 13 trial arms and 3967 participants were included in the review. Two trials examined the impact of specific feeding practices (e.g. repeated food exposure) in increasing child intake of a target vegetable. Two trials assessed the effectiveness of home visiting programs implemented in disadvantaged communities and one trial investigated the effect of a preschool-based intervention in increasing child fruit and vegetable intake. Risk of bias of included studies was low although three of the five trials were judged to be at high risk of performance bias. Meta-analysis of two trials examining repeated food exposure versus a no intervention comparison found no significant difference in target vegetable consumption in the short term (mean difference (MD) 1.37, 95% confidence interval (CI) -2.78 to 5.52). Coupling repeated food exposure with a tangible non-food or social reward, was effective in increasing targeted vegetable consumption in the short term based on one trial. Home visiting programs provided to disadvantaged groups did not significantly increase overall fruit intake in the short term (standardised mean difference (SMD) 0.01, 95% CI -0.09 to 0.11). Similarly, a multi-component preschool-based intervention failed to significantly increase child consumption of vegetables, but did report a small significant increase in mean child consumption of fruit, six months following baseline assessment. None of the trials investigated intervention cost-effectiveness or reported information regarding any adverse events or unintended adverse consequences of the intervention. AUTHORS' CONCLUSIONS: Despite the importance of encouraging fruit and vegetable consumption among children aged five years and under, this review identified few randomised controlled trials investigating interventions to achieve this.

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 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.

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.