The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors

BACKGROUND: Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. OBJECTIVE: This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. METHODS: To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. RESULTS: The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. CONCLUSIONS: Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31976

The prevalence, age distribution and comorbidity of personality disorders in Australian women

OBJECTIVE: We aimed to describe the prevalence and age distribution of personality disorders and their comorbidity with other psychiatric disorders in an age-stratified sample of Australian women aged ⩾25 years. METHODS: Individual personality disorders (paranoid, schizoid, schizotypal, histrionic, narcissistic, borderline, antisocial, avoidant, dependent, obsessive-compulsive), lifetime mood, anxiety, eating and substance misuse disorders were diagnosed utilising validated semi-structured clinical interviews (Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Non-patient Edition and Structured Clinical Interview for DSM-IV Axis II Personality Disorders). The prevalence of personality disorders and Clusters were determined from the study population ( n = 768), and standardised to the Australian population using the 2011 Australian Bureau of Statistics census data. Prevalence by age and the association with mood, anxiety, eating and substance misuse disorders was also examined. RESULTS: The overall prevalence of personality disorders in women was 21.8% (95% confidence interval [CI]: 18.7, 24.9). Cluster C personality disorders (17.5%, 95% CI: 16.0, 18.9) were more common than Cluster A (5.3%, 95% CI: 3.5, 7.0) and Cluster B personality disorders (3.2%, 95% CI: 1.8, 4.6). Of the individual personality disorders, obsessive-compulsive (10.3%, 95% CI: 8.0, 12.6), avoidant (9.3%, 95% CI: 7.1, 11.5), paranoid (3.9%, 95% CI: 3.1, 4.7) and borderline (2.7%, 95% CI: 1.4, 4.0) were among the most prevalent. The prevalence of other personality disorders was low (⩽1.7%). Being younger (25-34 years) was predictive of having any personality disorder (odds ratio: 2.36, 95% CI: 1.18, 4.74), as was being middle-aged (odds ratio: 2.41, 95% CI: 1.23, 4.72). Among the strongest predictors of having any personality disorder was having a lifetime history of psychiatric disorders (odds ratio: 4.29, 95% CI: 2.90, 6.33). Mood and anxiety disorders were the most common comorbid lifetime psychiatric disorders. CONCLUSIONS: Approximately one in five women was identified with a personality disorder, emphasising that personality disorders are relatively common in the population. A more thorough understanding of the distribution of personality disorders and psychiatric comorbidity in the general population is crucial to assist allocation of health care resources to individuals living with these disorders

Personalised cancer follow-up: risk stratification, needs assessment or both?

First paragraph: There are approximately 2 million people now living with or beyond cancer in the UK (Maddams et al, 2009) and this number is increasing. Cancer survivors can experience physical, psychological and social consequences as a result of the disease and the treatments received (Jefford et al, 2008; Foster et al, 2009). The effects may be immediate, some of which will resolve and others may persist and become long-term. Late effects can also occur and the interval between the end of treatment and onset can range from a few weeks (e.g. lymphoedema after axillary node removal) to several years (e.g. heart disease following radiotherapy to the chest area). Problems will be individual to each patient due to a unique combination of circumstances including the site and stage of the cancer, the type of treatment(s) given, the age of the patient, genetic factors, concomitant co-morbidities, family and social circumstances, and personality traits

Brief Engagement and Acceptance Coaching for Community and Hospice Settings (the BEACHeS Study): Protocol for the development and pilot testing of an evidence-based psychological intervention to enhance wellbeing and aid transition into palliative care

Background: Cancer affects millions of individuals globally, with a mortality rate of over eight million people annually. Although palliative care is often provided outside of specialist services, many people require, at some point in their illness journey, support from specialist palliative care services, for example, those provided in hospice settings. This transition can be a time of uncertainty and fear and there is a need for effective interventions to meet the psychological and supportive care needs of people with cancer that cannot be cured. While Acceptance and Commitment Therapy (ACT) has been shown to be effective across diverse health problems, robust evidence for its effectiveness in palliative cancer populations is not extensive. Method: This mixed-methods study uses a single-case experimental design with embedded qualitative interviews to pilot test a novel intervention for this patient group. Between 14 and 20 patients will be recruited from two hospices in England and Scotland. Participants will receive five face-to-face manualised sessions with a psychological therapist. Sessions are structured around teaching core ACT skills (Openness, Awareness and Engagement) as a way to deal effectively with challenges of transition into specialist palliative care services. Outcome measures include: cancer-specific quality of life (primary outcome) and distress (secondary outcome), which are assessed alongside measures of psychological flexibility. Daily diary outcome assessments will be taken for key measures, alongside more detailed weekly self-report, through baseline, intervention and one-month follow-up phases. After follow-up, participants will be invited to take part in a qualitative interview to understand their experience of taking part, and acceptability and perceived effectiveness of the intervention and its components. Discussion: This study is the first investigation of using ACT with terminally ill patients at the beginning of their transition into palliative treatment. Using in-depth single-case approaches, we will refine and manualise intervention content by the close of the study for use in follow-up research trials. Our long-term goal is then to test the intervention as delivered by non-psychologist specialist palliative care practitioners thus broadening the potential relevance of the approach

Seasonal and Ontogenetic Changes in Movement Patterns of Sixgill Sharks

Understanding movement patterns is fundamental to population and conservation biology. The way an animal moves through its environment influences the dynamics of local populations and will determine how susceptible it is to natural or anthropogenic perturbations. It is of particular interest to understand the patterns of movement for species which are susceptible to human activities (e.g. fishing), or that exert a large influence on community structure, such as sharks.We monitored the patterns of movement of 34 sixgill sharks Hexanchus griseus using two large-scale acoustic arrays inside and outside Puget Sound, Washington, USA. Sixgill sharks were residents in Puget Sound for up to at least four years before making large movements out of the estuary. Within Puget Sound, sixgills inhabited sites for several weeks at a time and returned to the same sites annually. Across four years, sixgills had consistent seasonal movements in which they moved to the north from winter to spring and moved to the south from summer to fall. Just prior to leaving Puget Sound, sixgills altered their behavior and moved twice as fast among sites. Nineteen of the thirty-four sixgills were detected leaving Puget Sound for the outer coast. Three of these sharks returned to Puget Sound.For most large marine predators, we have a limited understanding of how they move through their environment, and this clouds our ability to successfully manage their populations and their communities. With detailed movement information, such as that being uncovered with acoustic monitoring, we can begin to quantify the spatial and temporal impacts of large predators within the framework of their ecosystems

Natural variation in life history and aging phenotypes is associated with mitochondrial DNA deletion frequency in Caenorhabditis briggsae

<p>Abstract</p> <p>Background</p> <p>Mutations that impair mitochondrial functioning are associated with a variety of metabolic and age-related disorders. A barrier to rigorous tests of the role of mitochondrial dysfunction in aging processes has been the lack of model systems with relevant, naturally occurring mitochondrial genetic variation. Toward the goal of developing such a model system, we studied natural variation in life history, metabolic, and aging phenotypes as it relates to levels of a naturally-occurring heteroplasmic mitochondrial <it>ND5 </it>deletion recently discovered to segregate among wild populations of the soil nematode, <it>Caenorhabditis briggsae</it>. The normal product of <it>ND5 </it>is a central component of the mitochondrial electron transport chain and integral to cellular energy metabolism.</p> <p>Results</p> <p>We quantified significant variation among <it>C. briggsae </it>isolates for all phenotypes measured, only some of which was statistically associated with isolate-specific <it>ND5 </it>deletion frequency. We found that fecundity-related traits and pharyngeal pumping rate were strongly inversely related to <it>ND5 </it>deletion level and that <it>C. briggsae </it>isolates with high <it>ND5 </it>deletion levels experienced a tradeoff between early fecundity and lifespan. Conversely, oxidative stress resistance was only weakly associated with <it>ND5 </it>deletion level while ATP content was unrelated to deletion level. Finally, mean levels of reactive oxygen species measured <it>in vivo </it>showed a significant non-linear relationship with <it>ND5 </it>deletion level, a pattern that may be driven by among-isolate variation in antioxidant or other compensatory mechanisms.</p> <p>Conclusions</p> <p>Our findings suggest that the <it>ND5 </it>deletion may adversely affect fitness and mitochondrial functioning while promoting aging in natural populations, and help to further establish this species as a useful model for explicit tests of hypotheses in aging biology and mitochondrial genetics.</p

Effects of experiment start time and duration on measurement of standard physicological variables

Duration and start time of respirometry experiments have significant effects on the measurement of basal values for several commonly measured physiological variables (metabolic rate, evaporative water loss and body temperature). A longer measurement duration reduced values for all variables for all start times, and this was an effect of reduced animal activity rather than random sampling. However, there was also an effect of circadian rhythm on the timing of minimal physiological values. Experiment start time had a significant effect on time taken to reach minimal values for all variables, ranging from 4:00 h ± 38 min (body temperature, start time 23:00 h) to 8:54 h ± 52 min (evaporative water loss, start time 17:00 h). It also influenced the time of day that minimal values were obtained, ranging from 22:24 h ± 40 min (carbon dioxide production, start time 15:00 h) to 06:00 h ± 57 min (oxygen consumption, start time 23:00 h), and the minimum values measured. Consequently both measurement duration and experiment start time should be considered in experimental design to account for both a handling and a circadian effect on the animal’s physiology. We suggest that experiments to measure standard physiological variables for small diurnal birds should commence between 17:00 h and 21:00 h, and measurement duration should be at least 9 h

Specialist palliative and end-of-life care for patients with cancer and SARS-CoV-2 infection: a European perspective

Background: Specialist palliative care team (SPCT) involvement has been shown to improve symptom control and end-of-life care for patients with cancer, but little is known as to how these have been impacted by the COVID-19 pandemic. Here, we report SPCT involvement during the first wave of the pandemic and compare outcomes for patients with cancer who received and did not receive SPCT input from multiple European cancer centres. Methods: From the OnCovid repository (N = 1318), we analysed cancer patients aged ⩾18 diagnosed with COVID-19 between 26 February and 22 June 2020 who had complete specialist palliative care team data (SPCT+ referred; SPCT− not referred). Results: Of 555 eligible patients, 317 were male (57.1%), with a median age of 70 years (IQR 20). At COVID-19 diagnosis, 44.7% were on anti-cancer therapy and 53.3% had ⩾1 co-morbidity. Two hundred and six patients received SPCT input for symptom control (80.1%), psychological support (54.4%) and/or advance care planning (51%). SPCT+ patients had more ‘Do not attempt cardio-pulmonary resuscitation’ orders completed prior to (12.6% versus 3.7%) and during admission (50% versus 22.1%, p < 0.001), with more SPCT+ patients deemed suitable for treatment escalation (50% versus 22.1%, p < 0.001). SPCT involvement was associated with higher discharge rates from hospital for end-of-life care (9.7% versus 0%, p < 0.001). End-of-life anticipatory prescribing was higher in SPCT+ patients, with opioids (96.3% versus 47.1%) and benzodiazepines (82.9% versus 41.2%) being used frequently for symptom control. Conclusion: SPCT referral facilitated symptom control, emergency care and discharge planning, as well as high rates of referral for psychological support than previously reported. Our study highlighted the critical need of SPCTs for patients with cancer during the pandemic and should inform service planning for this population