5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment.

BACKGROUND: Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer. METHODS: The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0-10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups. DISCUSSION: The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines. TRIAL REGISTRATION: IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023.

MITIG.RA: study protocol of a tailored psychological intervention for managing fatigue in rheumatoid arthritis randomized controlled trial.

BACKGROUND: Despite remarkable medical advances in the treatment of rheumatoid arthritis (RA), a subset of patients fails to achieve complete clinical remission, as the Patient Global Assessment (PGA) of disease activity remains above 1, even after the inflammatory process is brought under control. This so-called state of 'PGA-near-remission' negatively impacts individuals' functioning and potentiates inadequate care. Fatigue is a distressing and disabling symptom frequently reported by patients in PGA-near-remission, and its management remains challenging. While classic cognitive-behavioural interventions show some benefits in managing fatigue, there is potential for improvement. Recently, contextual-cognitive behavioural therapies (CCBT), like mindfulness, acceptance, and compassion-based interventions, have shown promising results in fatigue-associated disorders and their determinants. This study primarily aims to examine the efficacy of the Compassion and Mindfulness Intervention for RA (MITIG.RA), a novel intervention combining different components of CCBT, compared to treatment-as-usual (TAU) in the management of RA-associated fatigue. Secondary aims involve exploring whether MITIG.RA produces changes in the perceived impact of disease, satisfaction with disease status, levels of depression, and emotion-regulation skills. METHODS: This is a single center, two-arm parallel randomized controlled trial. Patients will be screened for eligibility and willingness to participate and will be assessed and randomized to the experimental (MITIG.RA + TAU) or control condition (TAU) using computer randomization. MITIG.RA will be delivered by a certified psychologist and comprises eight sessions of 2 h, followed by two booster sessions. Outcomes will be assessed through validated self-report measures, including fatigue (primary outcome), perceived impact of disease, depressive symptoms, mindfulness, self-compassion, safety, and satisfaction (secondary outcomes). Assessment will take place at baseline, post-intervention, before the first and second booster sessions (weeks 12 and 20, respectively), and at 32 and 44 weeks after the interventions' beginning. DISCUSSION: We expect MITIG.RA to be effective in reducing levels of RA-associated fatigue. Secondarily, we hypothesize that the experimental group will show improvements in the overall perceived impact of disease, emotional distress, and emotion regulation skills. Our findings will contribute to determine the benefits of combining CCBT approaches for managing fatigue and associated distress in RA. TRIAL REGISTRATION: ClinicalTrials.gov NCT05389189. Registered on May 25, 2022.

Symptom burden, fatigue, sleep quality and perceived social support in hemodialysis patients with musculoskeletal discomfort: a single center experience from Egypt.

BACKGROUND AND AIMS: Musculoskeletal disorders (MSDs) are commonly encountered in hemodialysis (HD) patients. However, the causes linked to these disorders are still partially defined. The aim of this study was to determine the frequency of MSDs and their relationship to a variety of clinico-social characteristics such as sleep quality, mood disorders, fatigue, and social support, in addition to the patients' clinical and therapeutic profile. METHOD: The study included 94 patients on maintenance HD. Clinical and Sociodemographic data was gathered. To investigate the prevalence and trends of MSDs, the Nordic Musculoskeletal Questionnaire (NMQ-E) was employed. Patients completed the modified Edmonton Symptom Assessment System, Pittsburgh Sleep Quality Index (PSQI), multidimensional Fatigue Inventory (MFI-20), and Perceived Social Support from Family Scales. Univariate and multivariate regression analysis were used to assess the determinants of MSDs. RESULTS: The patients' mean age was 49.73 and 59.6% were males. Seventy-two percent of patients were afflicted by MSDs. Knee pain (48.9%), low back pain (43.6%), shoulder pain (41.6%), hip/thigh pain (35.1%), and neck pains (35.1%) were the most reported MSD domains. Pain (p = 0.001), fatigue (p = 0.01), depression (p = 0.015), and anxiety (p = 0.003) scores were substantially higher in patients with MSDs. Furthermore, patients with MSDs engaged in less physical activity (p = 0.02) and perceived less social support (p = 0.029). Patients with MSDs had lower subjective sleep quality, daytime dysfunction domains, and global PSQI scores (p = 0.02, 0.031, 0.036, respectively). Female gender (p = 0.013), fatigue (p = 0.012), depression (p = 0.014), anxiety (p = 0.004), lower activity (p = 0.029), and PSQI score (0.027), use of erythropoiesis-stimulating agents (ESAs), antihypertensive drugs, calcium and Iron supplementation were all significantly associated with MSDs. At the multivariable regression model, administration of ESAs (p = 0.017) and pain score (p = 0.040) were the only independent variables associated with the outcome. CONCLUSION: MSDs are quite common among HD patients. Female gender, pain, fatigue, depression, anxiety, reduced activity, poor sleep quality, and use of ESAs are all significantly associated with MSDs in HD patients. Patients with MSD perceived less social support compared to the other group. Patients treated with antihypertensive drugs, calcium and iron supplements were more likely to suffer MSDs.

Subclinical hypothyroidism: Let the evidence be your guide.

Patient age, time of day, and supplement use influence screening results; repeat testing is advised. Avoid treating to improve mood, cognition, fatigue, or quality of life.

Utilizing EEG and fNIRS for the detection of sleep-deprivation-induced fatigue and its inhibition using colored light stimulation.

Drowsy driving is a common, but underestimated phenomenon in terms of associated risks as it often results in crashes causing fatalities and serious injuries. It is a challenging task to alert or reduce the driver's drowsy state using non-invasive techniques. In this study, a drowsiness reduction strategy has been developed and analyzed using exposure to different light colors and recording the corresponding electrical and biological brain activities. 31 subjects were examined by dividing them into 2 classes, a control group, and a healthy group. Fourteen EEG and 42 fNIRS channels were used to gather neurological data from two brain regions (prefrontal and visual cortices). Experiments shining 3 different colored lights have been carried out on them at certain times when there is a high probability to get drowsy. The results of this study show that there is a significant increase in HbO of a sleep-deprived participant when he is exposed to blue light. Similarly, the beta band of EEG also showed an increased response. However, the study found that there is no considerable increase in HbO and beta band power in the case of red and green light exposures. In addition to that, values of other physiological signals acquired such as heart rate, eye blinking, and self-reported Karolinska Sleepiness Scale scores validated the findings predicted by the electrical and biological signals. The statistical significance of the signals achieved has been tested using repeated measures ANOVA and t-tests. Correlation scores were also calculated to find the association between the changes in the data signals with the corresponding changes in the alertness level.

Assessment of depression, anxiety and fatigue in Tunisian patients in recovery from colon cancer and their impact on quality of life.

PURPOSE: Colon cancer survivors can experience several post-treatment consequences that include fatigue and often report severe psychological illnesses such as depression or anxiety. There is little published quantitative data on the quality of life and psychological well-being associated with the health of Tunisian colon cancer survivors. METHODS: A total of 60 recovering colon cancer patients underwent a structured interview, which included the Hospital Anxiety and Depression (HADS) scale, the Piper fatigue scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). RESULTS: Patients were 59.26 years old on average. The median length of remission was 33.3 months. Surgery was performed on all patients, followed by 96.7% adjuvant chemotherapy. 15.1% of study participants were in the severe category for the depression score and 10% were in this category for the anxiety score. Ninety-one percent reported pathological fatigue scores on the Piper scale. However, only 8.33% were experiencing severe fatigue. According to the QLQ-C30 assessment, the overall quality of life was slightly impaired with an overall average score of 79.54 ± 16.98. Anxiety, depression and fatigue negatively affect global health outcomes and all their dimensions. CONCLUSION: Even in the recovery phase, colon cancer patients can see their quality of life deteriorate. It comes out of their psychological experience and their physical life. It is, therefore, crucial to provide greater attention to these patients for holistic and multi-disciplinary care.

A case-control analysis of the associations between Fibromyalgia Syndrome and Osteoporosis.

BACKGROUND: Fibromyalgia syndrome (FMS) is characterized by widespread musculoskeletal pain and tenderness with associated neuropsychological symptoms such as fatigue, unrefreshing sleep, cognitive dysfunction, anxiety, and depression. Osteoporosis is defined as a reduction of bone density. Previous studies to determine an association of FMS with osteoporosis showed mixed results, partially due to small sample sizes and lack of statistical power. OBJECTIVES: To evaluate the association of FMS with osteoporosis. METHODS: We conducted a case-control study utilizing the database from Israel's largest health maintenance organization. FMS patients were compared to age- and sex-matched controls. Data were analyzed using chi-square and t-tests. Multivariable logistic regression models assessed the association between osteoporosis and FMS. Spearman's rho test was used for correlation. RESULTS: We utilized data from 14,296 FMS patients and 71,324 age- and sex-matched controls. Spearman's rho test showed a significant correlation between FMS and osteoporosis (correlation coefficient 0.55, P < 0.001). A logistic regression for osteoporosis showed an odds ratio [OR] of 1.94 (95% confidence interval [95%CI] 1.83-2.06, P < 0.001) for FMS compared to controls and found higher body mass index to be slight protective (OR 0.926, 95%CI 0.92-0.93, P < 0.001). CONCLUSIONS: There is a significant correlation between FMS and osteoporosis. Early detection of predisposing factors for osteoporosis in FMS patients and implementation of suitable treatments and prevention measures (such as dietary supplements, resistance or weight bearing exercise, and bone-mineral enhancing pharmacological therapy) may reduce both occurrence rate and severity of osteoporosis and its complications, such as fractures.

A review of the content and psychometric properties of cancer-related fatigue (CRF) measures used to assess fatigue in intervention studies.

PURPOSE: Cancer-related fatigue (CRF) is a common and debilitating consequence of cancer and its treatment. Numerous supportive care interventions have been developed to alleviate CRF; however, the diversity of outcome measures used to assess CRF limits comparability of findings. We aimed to evaluate the content and psychometric properties of measures used to assess CRF in interventions targeting fatigue, to inform the selection of suitable measures in future research. METHODS: Included measures were identified from a systematic review of interventions targeting CRF. General characteristics of each measure were extracted, and item content was assessed against domains specified by the National Comprehensive Cancer Network (NCCN) definition of CRF. Psychometric properties were evaluated against COnsensus-based Standards for the selection of heath Measurement INstruments (COSMIN) criteria. RESULTS: Of 54 measures identified, 25 met inclusion criteria. Seventeen were fatigue-specific and eight a fatigue subscale or single item within a broader measure. Only 14 (56%) were specifically developed for cancer populations. Content coverage according to the NCCN CRF definition ranged from 0 to 75%. Evidence for fulfilment of COSMIN criteria in cancer populations ranged from 0 to 93%, with only five measures meeting > 70% of the COSMIN criteria. CONCLUSION: The Piper Fatigue Scale-Revised had good content coverage, but did not comprehensively address COSMIN criteria. The EORTC-FA12 and FACIT/FACT-F had excellent psychometric properties, with each capturing different aspects of fatigue. Ultimately, the choice of CRF measure should be guided by the research question and the CRF domains most relevant to the particular research context.

Cancer-Related Fatigue Outcome Measures in Integrative Oncology: Evidence for Practice and Research Recommendations.

Cancer-related fatigue (CRF) is one of the most common symptoms across the cancer continuum and is often underreported and undertreated. Defined as a distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or its treatment, CRF includes physical, emotional, cognitive, and spiritual dimensions. Patient-reported outcome (PRO) measures are the most widely used tool to screen for and assess fatigue and the associated negative impacts on quality of life. However, selecting subjective CRF measures can be complex. This has resulted in the availability of and inconsistent use of numerous PROs, limiting the ability to cross-compare outcomes clinically and within research. To address this, the PROs that are most widely reported in the literature are recommended to support the standardization of a core set of validated measures. The National Comprehensive Cancer Network single-item tool for clinical significance is recommended for quick use in clinical environments; the Brief Fatigue Inventory allows for fast, easy, helpful cutoffs on severity threshold for triage, and measures both severity and interference with daily functioning; while the MD Anderson Symptom Inventory allows for multisymptomatic assessment. In addition, a fundamental consideration for any PRO use is the administrative burden on the patient and clinician. In this review, we aim to summarize current, validated PROs specific to CRF to aid clinicians and researchers in patient care and in study design and implementation. We conclude with suggestions for future directions in CRF research that can increase the possibility for long-term impact on future guidelines of fatigue management.

Post-COVID-19 fatigue: the contribution of cognitive and neuropsychiatric symptoms.

Fatigue in its many forms of physical, mental, and psychosocial exhaustion is a common symptom of post-COVID-19 condition, also known as "Long COVID." Persistent fatigue in COVID-19 patients is frequently accompanied by cognitive dysfunction and neuropsychiatric symptoms; however, less is known about the relationships between these components of post-COVID-19 condition and fatigue itself. Consequently, the present study sought to (1) distinguish the types of fatigue experienced by participants, and (2) investigate whether cognitive deficits across various domains and neuropsychiatric conditions predicted these different types of fatigue. The study included 136 COVID-19 patients referred for neuropsychological evaluation due to cognitive complaints 8 months on average after SARS-CoV-2 infection. Measures included self-reported fatigue (physical, cognitive, and psychosocial), neuropsychiatric questionnaires (assessing symptoms of depression, anxiety, apathy, and executive functioning), a comprehensive neuropsychological assessment, and self-reported quality of life and everyday functioning. Results showed that reports of clinical significant fatigue were pervasive in our sample (82.3% of participants), with physical fatigue rated highest on average relative to the subscale maximum. Elevated levels of apathy, anxiety, and executive dysfunction in neuropsychiatric measures along with executive and attentional difficulties on cognitive tests were found to be consistently important predictors among different types of fatigue. This implicates both cognitive and neuropsychiatric symptoms as predictors of fatigue in post-COVID-19 condition, and stresses the importance of a holistic approach in assessing and considering potential treatment for COVID-19 patients experiencing fatigue.

Effects of progressive muscle relaxation therapy with home exercise on pain, fatigue, and stress in subjects with fibromyalgia syndrome: A pilot randomized controlled trial.

BACKGROUND: Fibromyalgia is accompanied by symptoms of fatigue, depression, sleep disorders, and physical and mental stress [1]. It is a difficult-to-treat disorder because its exact causes are unknown. OBJECTIVE: This study aimed to examine the effect of progressive muscle relaxation therapy (PMRT) on pain, fatigue, and stress in patients with fibromyalgia syndrome. METHODS: Thirty-seven patients with fibromyalgia syndrome (age: 20-65 years) were randomly allocated to the PMRT group (n1= 18, 2 men and 16 women) or non-PMRT group (n2= 19, 2 men and 17 women). The PMRT group received PMRT twice a week for 8 weeks and the non-PMRT group received conventional physical therapies such as electro-stimulation and heat therapies during this period. The outcome was evaluated before and after 8 week sofintervention using the Visual Analogue Scale, Multidimensional Assessment of Fatigue, Perceived Stress Scale, and measurement of the blood pressure and pulse rate. RESULTS: Pain and fatigue significantly decreased in the PMRT group compared with the non-PMRT group (both P< 0.001). In addition, perceived stress (P< 0.001), systolic blood pressure (P< 0.001), diastolic blood pressure (P< 0.05), and pulse rate (P< 0.001) significantly decreased in the PMRT group compared with the non-PMRT group. CONCLUSIONS: The findings indicate that progressive muscle relaxation therapy is a viable rehabilitative therapy for pain, fatigue, and stress symptoms in patients with fibromyalgia syndrome.

Systematic review of cancer-related fatigue instruments in breast cancer patients.

OBJECTIVE: Fatigue is having high prevalence and increased acknowledgment of negative effect on the patient's well-being which has resulted in fatigue being important research variable in breast cancer patients. The recent development shows greater receptivity of health professionals to assessing cancer-related fatigue (CRF). In this review, an attempt has been made to identify CRF instruments which have been used in breast cancer patients with the detailed description about the instruments and their psychometric properties. METHOD: A search was conducted from January 2000 to April 2020 from electronic databases such as PubMed, Cochrane, Embase, and Google Scholar. The studies were included if the instrument was used to measure fatigue in breast cancer patients and its description and psychometric properties reported in breast cancer patients. The search was limited to studies in the English language and use of English version of instruments. RESULTS: Among 34 CRF instruments, 9 instruments were included according to inclusion and exclusion criteria. From nine instruments, six were multidimensional, two were unidimensional, and one instrument was quality-of-life (QOL) subscale. All the scales have showed accepted reliability and validity in breast cancer patients. A minimal clinically important difference was available for Multidimensional Fatigue Symptom Inventory - Short Form, Brief Fatigue Inventory, Piper Fatigue Scale - Revised, FACIT Fatigue scale, and Fatigue symptom inventory instruments. SIGNIFICANCE OF RESULTS: This review will help healthcare providers who are dealing with breast cancer patients to acknowledge and better understand what their patients are experiencing. The most appropriate tool will allow healthcare providers to use for holistic assessment of CRF. The instrument will help them to monitor their patient's condition or treatment progress, so it can be incorporated into treatment decisions for better management of fatigue.

Practice review: Evidence-based and effective management of fatigue in patients with advanced cancer.

BACKGROUND: Fatigue affects most patients living with advanced cancer and is a symptom that healthcare professionals can find difficult to manage. AIM: To provide healthcare professionals with a pragmatic overview of approaches to management of fatigue in patients with advanced cancer that are commonly recommended by guidelines and to evaluate evidence underpinning them. DESIGN: Scoping review methodology was used to determine the strength of evidence supporting use of interventions recommended in management of fatigue in patients with advanced cancer. DATA SOURCES: National or international guidelines were examined if they described the management of fatigue in adult cancer patients and were written within the last 6 years (2015-2021) in English. The Cochrane Database of Systematic Reviews (January 2011-December 2021) was searched for 'cancer' AND 'fatigue' in title, abstract or keywords. A PubMed search was also made. RESULTS: Evidence indicates physical exercise interventions are effective and patients may benefit from energy conservation tactics. Evidence does not support use of psychostimulants such as methylphenidate. Limited data were found on efficacy of corticosteroids, psychological interventions, nutritional intervention, sleep optimization or complementary therapies for management of fatigue in advanced cancer. CONCLUSION: We recommend regular assessment, review and acknowledgement of the impact of fatigue. Exercise and energy conservation should be considered. Pharmacological interventions are not endorsed as a routine approach. Many interventions currently recommended by guidelines are not supported by a robust evidence base and further research on their efficacy is required.

TANGO: effect of tango Argentino on cancer-associated fatigue in breast cancer patients-study protocol for a randomized controlled trial.

BACKGROUND: The majority of breast cancer patients suffer from persistent impairments after completion of their primary oncological therapy. Cancer-related fatigue (CRF) in particular is a multidimensional syndrome having a profound negative impact on the quality of life. To counter CRF symptoms, physical activities are suggested as first-line interventions, mind-body therapies have been shown to be effective, and music therapy can also reduce anxiety and stress in breast cancer patients. Tango therapy that combines various elements can have an impact on physical, psychological, and cognitive abilities and could therefore have a beneficial effect on breast cancer patients. The purpose of this study is to investigate whether a 6-week tango module is suited as a therapeutic approach for people after primary breast cancer therapy to favorably influence their quality of life, especially CRF levels. METHODS: Sixty patients with a diagnosis for stage I-III breast cancer 12-48 months before enrollment and with CRF (age > 18) will be recruited and randomized 1:1 to a tango or a waiting-list group. Movement concepts using elements of Argentine tango (self-awareness, musical and spatial perception, self-perception, playfulness, shared experience) will be examined with the participants during six consecutive weekly 1-h tango sessions. The primary outcome will be the improvement of CRF (German version of the Cancer Fatigue Scale), and the secondary outcomes will be the improvement in sleep quality (Pittsburgh Sleep Quality Index) and quality of life (EORTC-QLQ-C30). Patient-reported outcomes will be measured at baseline and 6 weeks later; follow-up will be performed 6, 12, and 24 months after baseline. An evaluation will be performed by means of descriptive data analyses. DISCUSSION: Argentine tango, as a music-based movement therapy, can influence different skills and may improve several outcomes. The therapeutic use of Argentine tango in the care of breast cancer patients has not yet been reported. It is anticipated that participants receiving the tango module will have improved CRF, sleep, and quality of life scores compared to a waitlist control. TRIAL REGISTRATION: German Clinical Trials Registry (DRKS) DRKS00021601 . Retrospectively registered on 21 August 2020.

Possible Bioenergetic Biomarker for Chronic Cancer-Related Fatigue.

BACKGROUND: Cancer-related fatigue (CRF) is a highly prevalent, debilitating, and persistent symptom experienced by patients receiving cancer treatments. Up to 71% of men with prostate cancer receiving radiation therapy experience acute and persistent CRF. There is neither an effective therapy nor a diagnostic biomarker for CRF. This pilot study aimed to discover potential biomarkers associated with chronic CRF in men with prostate cancer receiving radiation therapy. METHODS: We used a longitudinal repeated-measures research design. Twenty men with prostate cancer undergoing radiation therapy completed all study visits. CRF was evaluated by a well-established and validated questionnaire, the Patient-Reported Outcomes Measurement Information System for Fatigue (PROMIS-F) Short Form. In addition, peripheral blood mononuclear cells were harvested to quantify ribonucleic acid (RNA) gene expression of mitochondria-related genes. Data were collected before, during, on completion, and 24 months postradiation therapy and analyzed using paired t-tests and repeated-measures analysis of variance. RESULTS: The mean of the PROMIS-F T score was significantly increased over time in patients with prostate cancer, remaining elevated at 24 months postradiation therapy compared to baseline. A significant downregulated BC1 ubiquinol-cytochrome c reductase synthesis-like (BCS1L) was observed over time during radiation therapy and at 24 months postradiation therapy. An increased PROMIS-F score was trended with downregulated BCS1L in patients 24 months after completing radiation therapy. DISCUSSION: This is the first evidence to describe altered messenger RNA for BCS1L in chronic CRF using the PROMIS-F measure with men receiving radiation therapy for prostate cancer. CONCLUSION: Our results suggest that peripheral blood mononuclear cell messenger RNA for BCS1L is a potential biomarker and therapeutic target for radiation therapy-induced chronic CRF in this clinical population.

Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes.

BACKGROUND: Yoga is a meditative movement therapy focused on mind-body awareness. The impact of yoga on health-related quality of life (HRQOL) outcomes in patients with chemotherapy-induced peripheral neuropathy (CIPN) is unclear. METHODS: We conducted a pilot randomized wait-list controlled trial of 8 weeks of yoga (n = 21) versus wait-list control (n = 20) for CIPN in 41 breast and gynecological cancer survivors with persistent moderate to severe CIPN. HRQOL endpoints were Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI). The Treatment Expectancy Scale (TES) was administered at baseline. We estimated mean changes and 95% confidence intervals (CIs) from baseline to weeks 8 and 12 and compared arms using constrained linear mixed models. RESULTS: At week 8, HADS anxiety scores decreased -1.61 (-2.75, -0.46) in the yoga arm and -0.32 (-1.38, 0.75) points in the wait-list control arm (p = 0.099). At week 12, HADS anxiety scores decreased -1.42 (-2.57, -0.28) in yoga compared to an increase of 0.46 (-0.60, 1.53) in wait-list control (p = 0.017). There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait-list control. Baseline TES was significantly higher in yoga than in wait-list control (14.9 vs. 12.7, p = 0.019). TES was not associated with HADS anxiety reduction and HADS anxiety reduction was not associated with CIPN pain reduction. CONCLUSIONS: Yoga may reduce anxiety in patients with CIPN. Future studies are needed to confirm these findings. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03292328.

Assessment and Management of Cognitive Symptoms in Patients With Brain Tumors.

Cognitive symptoms occur in almost all patients with brain tumors at varying points in the disease course. Deficits in neurocognitive function may be caused by the tumor itself, treatment (surgery, radiation, or chemotherapy), or other complicating factors (e.g., seizures, fatigue, mood disturbance) and can have a profound effect on functional independence and quality of life. Assessment of neurocognitive function is an important part of comprehensive care of patients with brain tumors. In the neuro-oncology clinic, assessment may include cognitive screening tools and inquiry into subjective cognitive function. Neuropsychological assessment is an important adjunct to identify cognitive symptoms and can be used as an opportunity to intervene through transformative feedback and treatment planning. Preventative measures can be taken to reduce cognitive side effects of treatment, such as awake craniotomies with intraoperative mapping during neurosurgery or prophylactic measures during radiation therapy (e.g., hippocampal avoidance, neuroprotectant treatment with memantine). Rehabilitative therapies, including cognitive rehabilitation and computerized cognitive exercise, are options for managing cognitive problems in an individualized manner. Pharmacotherapy, including use of stimulant medications and acetylcholinesterase inhibitors, has shown benefits for patients with brain tumors when tailored to an individual's cognitive profile. Identification and management of co-occurring issues, such as sleep disturbance, fatigue, and depression, can also improve neurocognitive function. There are promising therapies under development that may provide new options for treatment in the future. Integrating careful assessment and treatment of cognition throughout the disease course for patients with brain tumors can improve functional outcomes and quality of life.

Moxibustion for treating cancer-related fatigue: A multicenter, assessor-blinded, randomized controlled clinical trial.

Cancer-related fatigue (CRF) is one of the most common chronic symptoms experienced by cancer patients. As moxibustion is a popular traditional therapy for managing fatigue, it can be an alternative strategy to treat CRF as well. Therefore, we rigorously designed a full-scale, multicenter, assessor-blinded, randomized controlled trial to evaluate the efficacy and safety of moxibustion treatment for CRF. Ninety-six subjects suffering from CRF were recruited and randomly assigned to moxibustion group, sham moxibustion group, or usual care group. Both the moxibustion group and the sham group received moxibustion treatment for 8 weeks and the usual care group did not. Brief fatigue inventory (BFI) score and Functional Assessment of Cancer Therapy-Fatigue score were used to assess CRF at baseline and weeks 5, 9, and 13. Questionnaires for the assessment of cognitive impairment, quality of life, and Cold-Heat and Deficiency-Excess patterns were also evaluated. BFI scores significantly decreased in moxibustion group compared to the usual care group (mean difference of -1.92, p < 0.001 at week 9 and mean difference of -2.36, p < 0.001 at week 13). Although the sham group also showed significant improvement during the treatment period, only the moxibustion group showed improvement after 4 weeks of follow-up period (mean difference of -1.06, p < 0.001). There were no serious adverse events. Our findings confirmed the efficacy and safety of moxibustion for CRF compared to usual care. We also found that moxibustion has a prolonged treatment effect during 4 weeks of follow-up period.

Effect of Mindfulness Training on Fatigue and Recovery in Elite Volleyball Athletes: A Randomized Controlled Follow-Up Study.

Volleyball is a team sport with high physical and perceptual-cognitive demand, hence, increasing the perception of physical and mental fatigue during a competition. To alleviate fatigue (physical and mental), mindfulness and music have been proposed. The aim of this study was to analyze the effect of mindfulness-based mental versus music training on mental fatigue, physical fatigue, and recovery in elite competitive female volleyball athletes using a randomized two-controlled study with follow-up. Participants were 30 elite female Brazilian volleyball athletes. Athletes were randomly assigned to the following groups: 1) mindfulness-based mental training group (MBMT); 2) music-based training group (MBT); or 3) control group (CG). Three variables were evaluated as follows: 1) recovery based on total quality recovery; 2) mental fatigue visual analog scale; and 3) physical fatigue visual analog scale. Regarding recovery, there was no difference between the MBMT, MBT, and CG groups (p > 0.05). A difference in mental fatigue was noted between MBT and CG at follow-up [F(2,26) = 5.71, p = 0.009; large]. Regarding physical fatigue, there was no difference between the MBMT, MBT, and CG groups (p > 0.05). The mindfulness intervention effectively attenuated the mental fatigue caused by competition in volleyball athletes. These results will assist coaches and staff in providing fatigue management and reinforce the applicability of mental training in sports.

Exploring the Use of Two Brief Fatigue Screening Tools in Cancer Outpatient Clinics.

PURPOSE: Cancer fatigue guidelines recommend routine fatigue screening, with further assessment for people reporting moderate to severe fatigue. There is neither a gold-standard, nor a broadly accepted screening method, and knowledge about the impact of screening on care processes is limited. This study aimed to explore the feasibility of 2 fatigue screening methods and current clinical practice in cancer outpatient clinics. METHODS: Hospital outpatients attending cancer clinics during 1 week completed a five-item survey: a numeric scale for current tiredness, 2 categorical pictorial scales rating tiredness last week and the impact of fatigue (Fatigue Pictogram), screening tool preference and help needed for survey completion. Participant demographics and fatigue documentation by clinical staff for that appointment were extracted from medical records. Analyses used descriptive statistics. Groups were compared using appropriate statistical tests. RESULTS: Over 75% of participants rated their fatigue consistently as mild or significant on both screening tools. Of 1709 eligible outpatients, 533 (31%) completed the survey. Records were audited for 430 (81%) identifiable participants. Over half of the participants reported moderate or severe tiredness either "now" (237, 57%) and/or "last week" (226, 53%). Clinician documentation of fatigue seldom matched self-reports. Fatigue was rated as severe by 103 participants (24%), yet was noted in only 21 (20%) of these individuals' clinical notes. Both screening tools were equally preferred. CONCLUSION: The numeric rating scale and Fatigue Pictogram are equally applicable for screening fatigue in cancer outpatient care. There is a high prevalence of clinically significant fatigue in a hospital outpatient setting that is not documented. Adequate care pathways for further management should be established alongside fatigue screening.