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.

Use of Medicare Benefit Scheme mental health services in young people who experienced self-harm and/or suicidal behaviours: Data from the Young Minds Matter survey.

OBJECTIVES: To examine healthcare utilisation patterns in a sample of young people with self-reported experiences of self-harm and/or suicidal behaviours. METHODS: A national survey examining mental health in a nationally representative sample of young Australians aged 12-17 years, linked to routinely collected healthcare and dispensing data. For respondents that self-reported experience of self-harm, suicidal ideation, suicidal plan and/or suicide attempt, we assessed attendance at a Medicare Benefits Scheme (MBS) subsidised MH service or non-MH general practitioner (GP) attendance at three time periods: 1) ever, 2) in the 12 months prior to completing the survey and 3) after completing the survey until 31 Dec 2015. We also assessed correlates associated with attendance and non-attendance at a MH service. RESULTS: The study included 311 young people. MH services were attended in the 12 months before the survey by 38.3% with attempted suicide, 28.7% with a suicidal plan, 28.9% with suicidal ideation and 29.4% with self-harm. MH treatment administered by a GP was the most common MH service (25%); followed treatment by psychologist (15%) and psychiatrist (5%). Attendance at a MH service was observed highest alongside more severe self-reported depression. CONCLUSIONS: Potential underutilisation of MBS MH services by young people with self-harm and/or suicidal behaviours.

ALSUntangled # 69: astaxanthin.

ALSUntangled reviews alternative and off-label treatments for people living with amyotrophic lateral sclerosis (PALS). Here we review astaxanthin which has plausible mechanisms for slowing ALS progression including antioxidant, anti-inflammatory, and anti-apoptotic effects. While there are no ALS-specific pre-clinical studies, one verified "ALS reversal" occurred in a person using a combination of alternative therapies which included astaxanthin. There have been no trials of astaxanthin in people living with ALS. Natural astaxanthin appears to be safe and inexpensive. Based on the above information, we support further pre-clinical and/or clinical trials of astaxanthin in disease models and PALS, respectively, to further elucidate efficacy.

ALSUntangled #68: ozone therapy.

ALSUntangled reviews alternative and off-label treatments for people living with amyotrophic lateral sclerosis (PALS). Here we review ozone therapy. Ozone therapy has possible mechanisms for slowing ALS progression based on its antioxidant, anti-inflammatory, and mitochondrial effects. A non-peer-reviewed report suggests that ozone treatment may slow progression in a mTDP-43 mouse model of ALS. One verified "ALS reversal" occurred on a cocktail of alternative treatments including ozone. There are no ALS trials using ozone to treat PALS. There can be potentially serious side effects associated with ozone therapy, depending on the dose. Based on the above information, we support an investigation of ozone therapy in ALS cell or animal models but cannot yet recommend it as a treatment in PALS.

Characteristics of suicide decedents with no federally funded mental health service contact in the 12 months before death in a population-based sample of Australians 45 years of age and over.

INTRODUCTION: More than half of suicide decedents have no contact with mental health services 12 months before death. It is uncertain if they have different characteristics than decedents who use mental health services. METHODS: A case-series design. Participants 45 years and older, who died by suicide (2006-2018). Comparisons were made between those who did and did not have contact with mental health services, using individually linked data from federal services in the Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS). RESULTS: Of 186 cases, 71% had no contact with mental health services. Physical health services were used equally by 75%. Psychiatric medication use was uncommon, except for antidepressants, 50% with mental health service contact and 20% with no contact. Older age, lower income, involuntarily unemployed, firearms as suicide method, greater physical disability, less functional impairment due to emotional problems and lesser proportions with mental illness, were associated with no contact with mental health services. CONCLUSIONS: For suicide prevention, middle-older aged adults may have less requirement for mental health intervention, and greater requirement for the development of complementary interventions focused on physical health and social issues, which are not necessarily best delivered by clinical mental health services.

ALSUntangled #60: light therapy.

ALSUntangled reviews alternative and off-label treatments for people with ALS. Here we review light therapy. We show that it has theoretically plausible mechanisms, three flawed pre-clinical data, studies, and one incompletely documented case report supporting its use. We explain why further studies are needed to determine whether any specific light therapy protocol can help people with ALS.

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).

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.

Medicinal Cannabis: A Survey Among Health Care Providers in Washington State

INTRODUCTION: Washington State allows marijuana use for medical (since 1998) and recreational (since 2012) purposes. The benefits of medicinal cannabis (MC) can be maximized if clinicians educate patients about dosing, routes of administration, side effects, and plant composition. However, little is known about clinicians' knowledge and practices in Washington State. METHODS: An anonymous online survey assessed providers' MC knowledge, beliefs, clinical practices, and training needs. The survey was disseminated through health care providers' professional organizations in Washington State. Descriptive analysis compared providers who had and had not authorized MC for patients. Survey results informed the approach and content of an online training on best clinical practices of MC. RESULTS: Four hundred ninety-four health care providers responded to the survey. Approximately two-third were women, aged 30 to 60 years, and working in family or internal medicine. More than half of the respondents were legally allowed to write MC authorizations per Washington State law, and 27% of those had issued written MC authorizations. Overall, respondents reported low knowledge and comfort level related to recommending MC. Respondents rated MC knowledge as important and supported inclusion of MC training in medical/health provider curriculum. Most Washington State providers have not received education on scientific basis of MC or training on best clinical practices of MC. Clinicians who had issued MC authorizations were more likely to have received MC training than those who had not issued MC authorization. DISCUSSION: The potential of MCs to benefit some patients is hindered by the lack of comfort of clinicians to recommend it. Training opportunities are badly needed to address these issues.

Complementary and Alternative Therapies in Amyotrophic Lateral Sclerosis.

Given the severity of their illness and lack of effective disease-modifying agents, it is not surprising that most patients with amyotrophic lateral sclerosis (ALS) consider trying complementary and alternative therapies. Some of the most commonly considered alternative therapies include special diets, nutritional supplements, cannabis, acupuncture, chelation, and energy healing. This article reviews these in detail. The authors also describe 3 models by which physicians may frame discussions about alternative therapies: paternalism, autonomy, and shared decision making. Finally, the authors review a program called ALSUntangled, which uses shared decision making to review alternative therapies for ALS.

Eating As Treatment (EAT) study protocol: a stepped-wedge, randomised controlled trial of a health behaviour change intervention provided by dietitians to improve nutrition in patients with head and neck cancer undergoing radiotherapy.

INTRODUCTION: Maintaining adequate nutrition for Head and Neck Cancer (HNC) patients is challenging due to both the malignancy and the rigours of radiation treatment. As yet, health behaviour interventions designed to maintain or improve nutrition in patients with HNC have not been evaluated. The proposed trial builds on promising pilot data, and evaluates the effectiveness of a dietitian-delivered health behaviour intervention to reduce malnutrition in patients with HNC undergoing radiotherapy: Eating As Treatment (EAT). METHODS AND ANALYSIS: A stepped-wedge cluster randomised design will be used. All recruitment hospitals begin in the control condition providing treatment as usual. In a randomly generated order, oncology staff at each hospital will receive 2 days of training in EAT before switching to the intervention condition. Training will be supplemented by ongoing supervision, coaching and a 2-month booster training provided by the research team. EAT is based on established behaviour change counselling methods, including motivational interviewing, cognitive-behavioural therapy, and incorporates clinical practice change theory. It is designed to improve motivation to eat despite a range of barriers (pain, mucositis, nausea, reduced or no saliva, taste changes and appetite loss), and to provide patients with practical behaviour change strategies. EAT will be delivered by dietitians during their usual consultations. 400 patients with HNC (nasopharynx, hypopharynx, oropharynx, oral cavity or larynx), aged 18+, undergoing radiotherapy (>60 Gy) with curative intent, will be recruited from radiotherapy departments at 5 Australian sites. Assessments will be conducted at 4 time points (first and final week of radiotherapy, 4 and 12 weeks postradiotherapy). The primary outcome will be a nutritional status assessment. ETHICS AND DISSEMINATION: Ethics approval from all relevant bodies has been granted. Study findings will be disseminated widely through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12613000320752.

Pilot Randomized Trial Comparing Intersession Scheduling of Biofeedback Results to Individuals with Chronic Pain: Influence on Psychologic Function and Pain Intensity.

OBJECTIVE: The objective of this study was to compare the effectiveness of two biofeedback schedules on long-term improvement in physical and psychologic reactivity to chronic nonmalignant pain. DESIGN: This study is a prospective, randomized pilot trial. METHODS: Twenty adults with chronic pain engaged in heart rate variability (HRV) biofeedback training for nine sessions with HRV presented visually. Two groups, formed by random assignment, were compared: The faded feedback group received concurrent visual HRV biofeedback in session 1, with the amount of biofeedback systematically reduced for ensuing sessions so that, by session 9, the participants were controlling HRV without external feedback. The full feedback group received visual HRV biofeedback continuously across all sessions. Outcome measures assessed at baseline, immediately after the program, and 3 mos after the program included pain intensity, fear-avoidance beliefs, and self-report physical functioning. Use of biofeedback skills was also assessed 3 mos after the program. Nominal variables were analyzed with χ. Continuous measures were analyzed with repeated-measures analyses of variance. RESULTS: The faded feedback schedule resulted in greater use of biofeedback skills at 3 mos and improved pain intensity and fear-avoidance beliefs after the program and at 3 mos. Physical functioning did not differ between groups. CONCLUSIONS: Systematically reducing the frequency of external visual feedback during HRV biofeedback training was associated with reduced reactivity to chronic pain. Results of this pilot study should be confirmed with a larger randomized study.

Re-branding cannabis: the next generation of chronic pain medicine?

The field of pain medicine is at a crossroads given the epidemic of addiction and overdose deaths from prescription opioids. Cannabis and its active ingredients, cannabinoids, are a much safer therapeutic option. Despite being slowed by legal restrictions and stigma, research continues to show that when used appropriately, cannabis is safe and effective for many forms of chronic pain and other conditions, and has no overdose levels. Current literature indicates many chronic pain patients could be treated with cannabis alone or with lower doses of opioids. To make progress, cannabis needs to be re-branded as a legitimate medicine and rescheduled to a more pharmacologically justifiable class of compounds. This paper discusses the data supporting re-branding and rescheduling of cannabis.

Pain location and functioning in persons with spinal cord injury.

BACKGROUND: The influence of pain location and extent on functioning in persons with spinal cord injury (SCI) and chronic pain is not well understood. OBJECTIVE: To investigate the correlations between pain location and extent to determine which pain domains may be important to assess and potentially target in treating chronic pain in SCI populations. DESIGN: Prospective, observational study. SETTING: University medical center. PARTICIPANTS: A total of 259 persons with an SCI and chronic pain. METHODS: Postal mail survey questionnaire. MAIN OUTCOME MEASUREMENTS: Pain sites, pain extent (number of sites), pain intensity in specific body locations, pain interference, and physical and psychological functioning. RESULTS: A positive association between pain extent and intensity with pain interference (r = 0.33, P < .01) and a negative association with psychological functioning were noted in the study sample (r = -0.21, P < .01). Pain intensity in the lower back and legs (r = 0.55, P < .01) and a number of other sites showed strong associations with patient functioning. Correlation with psychological functioning was significant but weaker (r = -0.22, P < .01 for the lower back and legs). Ambulatory status had only a small moderating effect on the associations between pain intensity in specific sites and pain interference and no effect on psychological functioning. CONCLUSIONS: The findings support the importance of assessing pain intensity at specific locations as a part of a thorough evaluation of chronic pain, as well as the importance of addressing pain at multiple sites, when managing pain in persons with an SCI.

From 32 ounces to zero: a medical geographic study of dispensing a cultivated batch of "plum" cannabis flowers to medical marijuana patients in Washington State.

The medicinal use of cannabis is a growing phenomenon in the U.S. predicated on the success of overcoming specific spatial challenges and establishing particular human-environment relationships. This article takes a medical geographic "snapshot" of an urban site in Washington State where qualifying chronically ill and debilitated patients are delivered locally produced botanical cannabis for medical use. Using interview, survey, and observation, this medical geographic research project collected information on the social space of the particular delivery site and tracked the production cost, reach, and health value of a 32-ounce batch of strain-specific medical cannabis named "Plum" dispensed over a four-day period. A convenience sample of 37 qualifying patients delivered this batch of cannabis botanical medicine was recruited and prospectively studied with survey instruments. Results provide insight into patients' self-rated health, human-plant relationships, and travel-to-clinic distances. An overall systematic geographic understanding of the medical cannabis delivery system gives a grounded understanding of the lengths that patients and care providers go, despite multiple hurdles, to receive and deliver treatment with botanical cannabis that relieves diverse symptoms and improves health-related quality-of-life.

Considerations for neuropathic pain conditions in life care planning.

Significant progress has been made in assessing and managing neuropathic pain. Newer, more effective treatments with minimal side effects are available. Despite advances in treatments, neuropathic pain remains a multifaceted phenomenon that can be difficult to alleviate. Diagnosis, mechanisms of injury, and treatment recommendations are critical components of life care plans for patients with neuropathic pain. A clear understanding of the underlying issues and careful coordination with neurologists and other treatment providers are key to providing optimal life care plans. Understanding that pain treatments vary over time and by individual patient is integral to comprehensive life care planning.

Distress, coping, and drug law enforcement in a series of patients using medical cannabis.

Patients using medical cannabis in the United States inhabit a conflicting medicolegal space. This study presents data from a dispensary-based survey of patients using medical cannabis in the state of Washington regarding cannabis-specific health behaviors, levels of psychological distress, stress regarding marijuana criminality, past experiences with drug law enforcement, and coping behaviors. Thirty-seven subjects were enrolled in this study, and all but three completed survey materials. The median index of psychological distress, as measured by the Behavioral Symptom Inventory, was nearly 2.5 times higher than that found in a general population sample but one third less than that found in an outpatient sample. The subjects reported a moderate amount of stress related to the criminality of marijuana, with 76% reporting previous exposure to 119 separate drug law enforcement tactics in total. The subjects reported a wide range of coping methods, and their responses to a modified standardized survey showed the confounding influence of legality in assessing substance-related disorders.