Predictors of chronic fatigue syndrome and mood disturbance after acute infection

Prospective cohort studies following individuals from acute infections have documented a prevalent post-infective fatigue state meeting diagnostic criteria for chronic fatigue syndrome (CFS) – that is, a post-infective fatigue syndrome (PIFS). The Dubbo Infection Outcomes Study (DIOS) was a prospective cohort following individuals from acute infection with Epstein-Barr virus (EBV), Ross River virus (RRV), or Q fever through to assessment of caseness for CFS designated by physician and psychiatrist assessments at 6 months. Previous studies in DIOS have revealed that functional genetic polymorphisms in both immunological (pro- and anti-inflammatory cytokines) and neurological (the purinergic receptor, P2X7) genes are associated with both the severity of the acute infection and subsequent prolonged illness. Principal components analysis was applied to self-report data from DIOS to describe the severity and course of both the overall illness and concurrent mood disturbance. Associations between demographics and acute infection characteristics, with prolonged illness course as well as the PIFS outcome were examined using multivariable statistics. Genetic haplotype-driven functional variations in the neuropeptide Y (NPY) gene previously shown to be associated with brain responses to stress, and to trait anxiety were also examined as predictors. The sample included 484 subjects (51% female, median age 32, IQR 19–44), of whom 90 (19%) met diagnostic criteria for CFS at 6 months. Participants with greater overall illness severity and concurrent mood disturbance in the acute illness had a more prolonged illness severity (HR = 0.39, 95% CI: 0.34–0.46, p 0.05). Severe acute infective illnesses predicted prolonged illness, prolonged mood disturbance and PIFS. These factors may facilitate early intervention to manage both PIFS and mood disturbances

Practical suggestions for harms reporting in exercise oncology : the Exercise Harms Reporting Method (ExHaRM)

The volume of high-quality evidence supporting exercise as beneficial to cancer survivors has grown exponentially; however, the potential harms of exercise remain understudied. Consequently, the trade-off between desirable and undesirable outcomes of engaging in exercise remains unclear to clinicians and people with cancer. Practical guidance on collecting and reporting harms in exercise oncology is lacking. We present a harms reporting protocol developed and refined through exercise oncology trials since 2015. Development of the Exercise Harms Reporting Method (ExHaRM) was informed by national and international guidelines for harms reporting in clinical trials involving therapeutic goods or medical devices, with adaptations to enhance applicability to exercise. The protocol has been adjusted via an iterative process of implementation and adjustment through use in multiple exercise oncology trials involving varied cancer diagnoses (types: breast, brain, gynaecological; stages at diagnosis I–IV; primary/ recurrent), and heterogeneous exercise intervention characteristics (face to face/telehealth delivery; supervised/unsupervised exercise). It has also involved the development of terms (such as, adverse outcomes, which capture all undesirable physical, psychological, social and economic outcomes) that facilitate the harms assessment process in exercise. ExHaRM involves: step 1: Monitor occurrence of adverse outcomes through systematic and non-systematic surveillance; step 2: Assess and record adverse outcomes, including severity, causality, impact on intervention and type; step 3: Review of causality by harms panel (and revise as necessary); and step 4: Analyse and report frequencies, rates and clinically meaningful details of all-cause and exercise-related adverse outcomes. ExHaRM provides guidance to improve the quality of harms assessment and reporting immediately, while concurrently providing a framework for future refinement. Future directions include, but are not limited to, standardising exercise-specific nomenclature and methods of assessing causality

elearning improves allied health professionals\u27 knowledge and confidence to manage medically unexplained chronic fatigue states: A randomized controlled trial

Objectives: To evaluate the impact of eLearning by allied health professionals on improving the knowledge and confidence to manage people with medically unexplained chronic fatigue states (FS). Methods: Using a parallel randomized controlled trial design, participants were randomized 1:1 to a 4-week eLearning or wait-list control group. Knowledge and self-reported confidence in clinical skills to implement a therapeutic intervention for patients with FS were assessed at baseline, post-intervention and follow-up. Secondary outcomes (adherence and satisfaction with online education, knowledge retention) were also assessed. Data was analyzed using intention-to-treat. Results: There were 239 participants were randomized (eLearning n = 119, control n = 120), of whom 101 (85%) eLearning and 107 (89%) control participants completed baseline assessments and were included in the analysis. Knowledge (out of 100) improved significantly more in the eLearning group compared to the control group [mean difference (95% CI) 8.6 (5.9 to 11.4), p \u3c 0.001]. Knowledge was reduced in the eLearning group at follow-up but was still significantly higher than baseline [6.0 (3.7 to 8.3), p \u3c 0.001]. Median change (out of 5) in confidence in clinical skills to implement the FS intervention was also significantly greater in the eLearning group compared to the control group [knowledge: eLearning (1.2), control (0); clinical skills: eLearning (1), control (0.1); both p \u3c 0.001)]. Average time spent on the eLearning program was 8.8 h. Most participants (80%) rated the lesson difficulty as at the “right level”, and 91% would recommend it to others. Conclusions: eLearning increased knowledge and confidence to manage FS amongst allied health professionals and was well-accepted. Registration: ACTRN12616000296437 https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370222&isReview=true

A systematic review and meta-analysis of the safety, feasibility and effect of exercise in women with stage II+ breast cancer

To systematically evaluate the safety, feasibility and effect of exercise among women with stage II+ breast cancer.CINAHL, Cochrane, Ebscohost, MEDLINE, Pubmed, ProQuest Health and Medical Complete, ProQuest Nursing and Allied Health Source, Science Direct and SPORTDiscus were searched for articles published prior to March 1, 2017.Randomised, controlled, exercise trials involving at least 50% of women diagnosed with stage II+ breast cancer were included.Risk of bias was assessed and adverse event severity was classified using the Common Terminology Criteria. Feasibility was evaluated by computing median (range) recruitment, withdrawal and adherence rates. Meta-analyses were performed to evaluate exercise safety and effects on health outcomes only. The influence of intervention characteristics (mode, supervision, duration and timing) on exercise outcomes were also explored.There were no differences in adverse events between exercise and usual care (risk difference

Exercise during chemotherapy for ovarian cancer (ECHO) trial : design and implementation of a randomised controlled trial

Introduction Epidemiological evidence supports an association between higher levels of physical activity and improved cancer survival. Trial evidence is now needed to demonstrate the effect of exercise in a clinical setting. The Exercise during CHemotherapy for Ovarian cancer (ECHO) trial is a phase III, randomised controlled trial, designed to determine the effect of exercise on progression-free survival and physical well-being for patients receiving first-line chemotherapy for ovarian cancer. Methods and analysis Participants (target sample size n=500) include women with newly diagnosed primary ovarian cancer, scheduled to receive first-line chemotherapy. Consenting participants are randomly allocated (1:1) to either the exercise intervention (plus usual care) or usual care alone, with stratification for recruitment site, age, stage of disease and chemotherapy delivery (neoadjuvant vs adjuvant). The exercise intervention involves individualised exercise prescription with a weekly target of 150 minutes of moderate-intensity, mixed-mode exercise (equivalent to 450 metabolic equivalent minutes per week), delivered for the duration of first-line chemotherapy through weekly telephone sessions with a trial-trained exercise professional. The primary outcomes are progression-free survival and physical well-being. Secondary outcomes include overall survival, physical function, body composition, quality of life, fatigue, sleep, lymphoedema, anxiety, depression, chemotherapy completion rate, chemotherapy-related adverse events, physical activity levels and healthcare usage. Ethics and dissemination Ethics approval for the ECHO trial (2019/ETH08923) was granted by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Zone) on 21 November 2014. Subsequent approvals were granted for an additional 11 sites across Queensland, New South Wales, Victoria and the Australian Capital Territory. Findings from the ECHO trial are planned to be disseminated via peer-reviewed publications and international exercise and oncology conferences

Chronic fatigue syndrome: progress and possibilities

Chronic fatigue syndrome (CFS) is a prevalent condition affecting about one in 100 patients attending primary care. There is no diagnostic test, validated biomarker, clear pathophysiology or curative treatment. The core symptom of fatigue affects both physical and cognitive activities, and features a prolonged post-activity exacerbation triggered by tasks previously achieved without difficulty. Although several different diagnostic criteria are proposed, for clinical purposes only three elements are required: recognition of the typical fatigue; history and physical examination to exclude other medical or psychiatric conditions which may explain the symptoms; and a restricted set of laboratory investigations. Studies of the underlying pathophysiology clearly implicate a range of different acute infections as a trigger for onset in a significant minority of cases, but no other medical or psychological factor has been reproducibly implicated. There have been numerous small case–control studies seeking to identify the biological basis of the condition. These studies have largely resolved what the condition is not: ongoing infection, immunological disorder, endocrine disorder, primary sleep disorder, or simply attributable to a psychiatric condition. A growing body of evidence suggests CFS arises from functional (non-structural) changes in the brain, but of uncertain character and location. Further functional neuroimaging studies are needed. There is clear evidence for a genetic contribution to CFS from family and twin studies, suggesting that a large scale genome-wide association study is warranted. Despite the many unknowns in relation to CFS, there is significant room for improvement in provision of the diagnosis and supportive care. This may be facilitated via clinician education

Reflexive intervention development : using qualitative research to inform the development of an intervention for women with metastatic breast cancer

There is growing consensus around the limited attention given to documenting the process of intervention development, specifically the role of qualitative research. In this article, we seek to describe a missing piece of this process: how qualitative research, and related methodologies and theories, informs intervention development. We use our research as a case study of “reflexive intervention development.” We begin by describing our interview study, consisting of 23 in-depth interviews with women diagnosed with metastatic breast cancer, and go on to detail our methodological framework and research team. We then explain how this interview study directly informed our development of the intervention materials, allowing us to attend carefully to language and its potential implications for women. We conclude by inviting researchers to reflect on the knowledge production process that is inherent in intervention development to consider not only their role in this process but also the role of qualitative research

Reflexive intervention development: using qualitative research to inform the development of an intervention for women with metastatic breast cancer

There is growing consensus around the limited attention given to documenting the process of intervention development, specifically the role of qualitative research. In this article, we seek to describe a missing piece of this process: how qualitative research, and related methodologies and theories, informs intervention development. We use our research as a case study of "reflexive intervention development." We begin by describing our interview study, consisting of 23 in-depth interviews with women diagnosed with metastatic breast cancer, and go on to detail our methodological framework and research team. We then explain how this interview study directly informed our development of the intervention materials, allowing us to attend carefully to language and its potential implications for women. We conclude by inviting researchers to reflect on the knowledge production process that is inherent in intervention development to consider not only their role in this process but also the role of qualitative research

Physical activity and exercise in women with ovarian cancer: A systematic review

Objective: A consistent body of evidence supports participating in physical activity (PA) post-cancer diagnosis as beneficial to function, quality-of-life and potentially survival. However, diagnosis of late stage disease, poor prognosis, receipt of high doses of adjuvant therapy and presence of severe acute and persistent treatment-related side-effects may alter how these findings translate to women with ovarian cancer. Therefore, the objectives of this review were to (I) describe PA levels post-diagnosis of ovarian cancer, (II) explore the relationship between PA levels and health outcomes, and (III) evaluate the effect of exercise interventions for women with ovarian cancer. Methods: PubMed, EMBASE, Scopus and CINAHL were systematically searched to December 31, 2019. Two independent reviewers assessed articles for eligibility. Studies were eligible if they evaluated the relationship between PA levels or an exercise intervention and health outcomes following ovarian cancer. Methodological quality was assessed by two independent reviewers using the Joanna Briggs Institute Critical Appraisal Tools. Descriptive statistics were used to collate relevant data. Results: 34 articles were eligible for inclusion. Results demonstrated that most women decrease PA from pre- to post-diagnosis and remain insufficiently active following diagnosis. Higher levels of PA were associated with higher health-related quality-of-life (HRQOL), and lower levels of anxiety and depression. Exercise appears safe and feasible during and following treatment and leads to improvements in HRQOL, fatigue and additional physical and psychological outcomes. Conclusions: Findings suggest that PA is relevant to health outcomes for women with ovarian cancer. Interventions that aid women to stay or become sufficiently active, including through exercise interventions during or following treatment have potential to improve the lives of those with ovarian cancer. Future work evaluating targeted interventions that can accommodate disease-specific challenges is now required to ensure scientific findings can translate into improved ovarian cancer care.</p

Feasibility and effect of a physical activity counselling session with or without provision of an activity tracker on maintenance of physical activity in women with breast cancer — A randomised controlled trial

Objectives: The SAFE-Maintain study sought to evaluate the effect and acceptability of a physical activity counselling (PAC) session, versus a PAC session plus provision of a Fitbit (Charge HR®; PAC + F), on maintenance of physical activity levels 12 weeks following participation in a supervised exercise intervention. Design: Fifty-two women with stage II + breast cancer who had recently (within the previous 7 days) completed a 12-week supervised exercise program were randomised to the PAC or PAC + F group. Methods: Physical activity levels, including weekly minutes of total physical activity (min/week), daily step count (steps/day), and weekly minutes of moderate to vigorous physical activity (MVPA, min/week), were assessed using the Active Australia survey and Actigraph® GT3X+ accelerometers. Self-reported outcomes were assessed at baseline and 12-week follow-up, while objectively-measured outcomes were only available at 12-week follow-up. Results: Compared with the PAC group, the PAC + F group had higher self-reported MVPA and self-reported total activity (between-group mean difference: 78.2 [95% CI = −8.3, 164.9] min/week, p 80%) of the PAC + F group reported high levels of Fitbit use and considered the device to be beneficial for physical activity maintenance. Conclusions: Findings suggest that activity trackers show promise as an effective, feasible and acceptable approach to support physical activity maintenance following completion of a supervised exercise intervention. Trial registration: Prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, Trial registration number: ACTRN12616000954426)