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ESMO Open Jun 2024Low muscle mass (MM) predicts unfavorable outcomes in cancer. Protein intake supports muscle health, but oncologic recommendations are not well characterized. The...
Feasibility of two levels of protein intake in patients with colorectal cancer: findings from the Protein Recommendation to Increase Muscle (PRIMe) randomized controlled pilot trial.
BACKGROUND
Low muscle mass (MM) predicts unfavorable outcomes in cancer. Protein intake supports muscle health, but oncologic recommendations are not well characterized. The objectives of this study were to evaluate the feasibility of dietary change to attain 1.0 or 2.0 g/kg/day protein diets, and the preliminary potential to halt MM loss and functional decline in patients starting chemotherapy for stage II-IV colorectal cancer.
PATIENTS AND METHODS
Patients were randomized to the diets and provided individualized counseling. Assessments at baseline, 6 weeks, and 12 weeks included weighed 3-day food records, appendicular lean soft tissue index (ALSTI) by dual-energy X-ray absorptiometry to estimate MM, and physical function by the Short Physical Performance Battery (SPPB) test.
RESULTS
Fifty patients (mean ± standard deviation: age, 57 ± 11 years; body mass index, 27.3 ± 5.6 kg/m; and protein intake, 1.1 ± 0.4 g/kg/day) were included at baseline. At week 12, protein intake reached 1.6 g/kg/day in the 2.0 g/kg/day group and 1.2 g/kg/day in the 1.0 g/kg/day group (P = 0.012), resulting in a group difference of 0.4 g/kg/day rather than 1.0 g/kg/day. Over one-half (59%) of patients in the 2.0 g/kg/day group maintained or gained MM compared with 44% of patients in the 1.0 g/kg/day group (P = 0.523). Percent change in ALSTI did not differ between groups [2.0 g/kg/day group (mean ± standard deviation): 0.5% ± 4.6%; 1.0 g/kg/day group: -0.4% ± 6.1%; P = 0.619]. No differences in physical function were observed between groups. However, actual protein intake and SPPB were positively associated (β = 0.37; 95% confidence interval 0.08-0.67; P = 0.014).
CONCLUSION
Individualized nutrition counselling positively impacted protein intake. However, 2.0 g/kg/day was not attainable using our approach in this population, and group contamination occurred. Increased protein intake suggested positive effects on MM and physical function, highlighting the potential for nutrition to attenuate MM loss in patients with cancer. Nonetheless, muscle anabolism to any degree is clinically significant and beneficial to patients. Larger trials should explore the statistical significance and clinical relevance of protein interventions.
PubMed: 38935990
DOI: 10.1016/j.esmoop.2024.103604 -
Emerging Microbes & Infections Dec 2024Recurrent opportunistic infections (OIs) in patients with severely immunosuppressed AIDS remain an unresolved medical challenge despite advancements in antiretroviral...
Recurrent opportunistic infections (OIs) in patients with severely immunosuppressed AIDS remain an unresolved medical challenge despite advancements in antiretroviral therapy (ART). To address this gap, we developed an HLA-mismatched allogeneic adoptive immune therapy (AAIT) specifically targeting this patient population. The safety and efficacy of this novel therapeutic approach were preliminarily confirmed in our phase 1 trial. Subsequently, a multicenter, open-label, controlled, phase 2a trial was conducted to evaluate the efficacy of AAIT in combination with ART compared with the conventional ART-only regimen. No difference in the incidence of adverse events (AEs) was observed between the two groups at the 96-week follow-up. AAIT treatment improved CD4+ T cell recovery at weeks 72 (= 0.048) and 96 (= 0.024) compared to the Control Group. Additionally, stratified analysis of patients in the AAIT Group showed that donor/recipient sex mismatch was significantly associated with the likelihood of patients achieving an immunological response (OR = 8.667; 95% CI, 2.010-37.377; = 0.004). These findings suggest that AAIT serves as a promising adjunct therapy for improving the outcomes of patients with severely immunosuppressed AIDS. Further studies are needed to elucidate the immunological mechanisms underlying AAIT and identify the subpopulations that respond optimally to this therapeutic approach. This trial is registered at www.clinicaltrials.gov (NCT04098770). ClinicalTrials.gov identifier: NCT04098770. ClinicalTrials.gov identifier: NCT02651376.
Topics: Humans; Male; Female; Adult; Middle Aged; Immunotherapy, Adoptive; Immunocompromised Host; HLA Antigens; Acquired Immunodeficiency Syndrome; Treatment Outcome; AIDS-Related Opportunistic Infections; Transplantation, Homologous; CD4-Positive T-Lymphocytes; CD4 Lymphocyte Count
PubMed: 38935839
DOI: 10.1080/22221751.2024.2364744 -
PloS One 2024Highlighting minorities and crime survivors through public discourse is essential for their support and protection. However, advocating for minorities is challenging due...
Highlighting minorities and crime survivors through public discourse is essential for their support and protection. However, advocating for minorities is challenging due to the fear of potential isolation from one's social circles. This reluctance contributes to the societal phenomenon known as the "spiral of silence," significantly impeding efforts to support socially vulnerable individuals. This study centers on a pivotal instance where the silence surrounding sexual abuse in the Japanese entertainment industry was disrupted, in which the late company president had allegedly abused idol trainees of the company for decades. Utilizing extensive data from news media and social media, the study probes the engagement dynamics of public attention to this scandal. Results indicate that users on social media provided earlier and greater coverage for this scandal compared to news media outlets. Furthermore, television demonstrated a significant delay in addressing this issue compared to other news media, such as tabloids, magazines, and online news. Regarding social media engagement, idol fans exhibited a more subdued response to the issue compared to the general public. Notably, fans more loyal to the company tended to be slower to mention the issue, with a higher likelihood of standing in defense of the perpetrators. Moreover, conflicting attitudes were observed within the fan communities, culminating in an observable "echo chamber" phenomenon. This paper presents a novel examination of the process of disruption of social silence and offers critical insights for aiding vulnerable individuals in environments dominated by an unacknowledged spiral of silence. This study is novel in that it suggests a reinterpretation of the "spiral of silence theory" in the age of social media, through a comprehensive analysis of relevant social media data and news media data. This contributes to the body of research that has analyzed the spiral of silence theory online.
Topics: Humans; Social Media; Japan; Sex Offenses; Mass Media; Industry; Female; East Asian People
PubMed: 38935809
DOI: 10.1371/journal.pone.0306104 -
PloS One 2024Chronic enteropathies are a common cause of morbidity in dogs and are associated with disruption of the normal gastrointestinal mucosal barrier. The objective of this...
Chronic enteropathies are a common cause of morbidity in dogs and are associated with disruption of the normal gastrointestinal mucosal barrier. The objective of this prospective study was to determine the association between measures of gastrointestinal dysbiosis and plasma concentrations of glucagon-like peptide-2, a hormone responsible for normal mucosal structure, in dogs with chronic enteropathies. Fecal 16S V4 rRNA gene sequencing and quantitative PCR via the dysbiosis index was performed on 16 healthy controls and 18 dogs with chronic enteropathy prior to and 1 month after initiation of individualized therapy. Fasting and post-prandial plasma GLP-2 concentrations were measured via ELISA in healthy dogs and chronic enteropathy dogs at both time points. Alpha and beta diversity indices, as well as bacterial population abundances were compared between groups and time-points. Principal component analysis combined with least squares regression was used to identify taxa contributing to glucagon-like peptide-2 variance among groups. While the dysbiosis index did not differ between healthy dogs and dogs with chronic enteropathy, 16S V4 genomic sequencing identified 47 operational taxonomic units that differed between the groups, all but 2 of which resolved following chronic enteropathy treatment. Principal component analysis identified 6 families and 19 genera that contributed to differences in glucagon-like peptide-2 concentrations between groups. Dysbiosis associated with chronic enteropathies in dogs may contribute to the observed lower plasma glucagon-like peptide-2 concentrations. Further research into mechanisms of microbiota impact on the enteroendocrine system is needed. Association between glucagon-like peptide-2 secretion and microbiome indices may help to guide research into future treatment strategies for dogs with chronic enteropathy.
Topics: Dogs; Animals; Glucagon-Like Peptide 2; Dysbiosis; Dog Diseases; Female; Male; Gastrointestinal Microbiome; Chronic Disease; Prospective Studies; Feces; RNA, Ribosomal, 16S; Intestinal Diseases
PubMed: 38935795
DOI: 10.1371/journal.pone.0305711 -
PloS One 2024Tools screening depression and anxiety developed using the Western biomedical paradigm are still used with First Nations Peoples globally, despite calls for...
A Delphi study and development of a social and emotional wellbeing screening tool for Australian First Nations Peoples living in the Torres Strait and Northern Peninsula Area of Australia.
Tools screening depression and anxiety developed using the Western biomedical paradigm are still used with First Nations Peoples globally, despite calls for cross-cultural adaption. Recent work by this research team found that tools used to screen for depression and anxiety were inappropriate for use with Australian First Nations Peoples living in the Torres Strait and Northern Peninsula Area of Australia. The objective of this Delphi study, the second phase of a broader four-phase project, was to gain consensus from an expert mental health and/or social and emotional wellbeing (SEWB) panel to inform the development of an appropriate screening tool. This Delphi study took place between March and May 2023. Three sequential rounds of anonymous online surveys delivered using QualtricsTM were planned, although only two were needed to reach 75% consensus. The first round sought consensus on whether a new screening tool needed to be developed or whether existing tools could be used. The second round achieved consensus. Twenty-eight experts (47% response rate) participated across the two Delphi rounds. In the second round, 83% of these experts agreed or strongly agreed that a new screening tool, using the holistic First Nations concept of social and emotional wellbeing, be developed. Ninety-four percent of them agreed that it should take a Yarning approach. These findings enabled the development of a new SEWB screening tool that adopted a Yarning (narrative) approach designed for use in primary care and geriatric settings in the region. The new tool has four different Yarning areas: Community engagement and behaviour; Stress worries; Risk; and Feeling strong. Guidelines for tool use are integrated as well as Summary and Recommendation sections. At a macro-level this project responds to the need for new screening tools that are underpinned by First Nations worldviews.
Topics: Adult; Female; Humans; Male; Middle Aged; Anxiety; Australia; Delphi Technique; Depression; Emotions; Mass Screening; Mental Health; Surveys and Questionnaires; Australian Aboriginal and Torres Strait Islander Peoples
PubMed: 38935759
DOI: 10.1371/journal.pone.0306316 -
PloS One 2024Among the consequences of systemic racism in health care are significant health disparities among Black/African American individuals with comorbid physical and mental...
Among the consequences of systemic racism in health care are significant health disparities among Black/African American individuals with comorbid physical and mental health conditions. Despite decades of studies acknowledging health disparities based on race, significant change has not occurred. There are shockingly few evidence-based antiracism interventions. New paradigms are needed to intervene on, and not just document, racism in health care systems. We are developing a transformative paradigm for new antiracism interventions for primary care settings that integrate mental and physical health care. The paradigm is the first of its kind to integrate community-based participatory research and systems science, within an established model of early phase translation to rigorously define new antiracism interventions. This protocol will use a novel application of systems sciences by combining the qualitative systems sciences methods (group model building; GMB) with quantitative methods (simulation modeling) to develop a comprehensive and community-engaged view of both the drivers of racism and the potential impact of antiracism interventions. Community participants from two integrated primary health care systems will engage in group GMB workshops with researchers to 1) Describe and map the complex dynamic systems driving racism in health care practices, 2) Identify leverage points for disruptive antiracism interventions, policies and practices, and 3) Review and prioritize a list of possible intervention strategies. Advisory committees will provide feedback on the design of GMB procedures, screen potential intervention components for impact, feasibility, and acceptability, and identify gaps for further exploration. Simulation models will be generated based on contextual factors and provider/patient characteristics. Using Item Response Theory, we will initiate the process of developing core measures for assessing the effectiveness of interventions at the organizational-systems and provider levels to be tested under a variety of conditions. While we focus on Black/African Americans, we hope that the resulting transformative paradigm can be applied to improve health equity among other marginalized groups.
Topics: Humans; Primary Health Care; Health Equity; Racism; Black or African American; Community-Based Participatory Research; Healthcare Disparities; Antiracism
PubMed: 38935743
DOI: 10.1371/journal.pone.0306185 -
PloS One 2024Front-of-package labels indicating a product's environmental footprint (i.e., eco-score labels) offer promise to shift consumers towards more sustainable food choices.... (Randomized Controlled Trial)
Randomized Controlled Trial
Front-of-package labels indicating a product's environmental footprint (i.e., eco-score labels) offer promise to shift consumers towards more sustainable food choices. This study aimed to understand whether eco-score labels impacted consumers' perceptions of environmental sustainability and intentions to purchase sustainable and unsustainable foods. US parents (n = 1,013) completed an online experiment in which they were shown 8 food products (4 sustainable and 4 unsustainable). Participants were randomized to a control (n = 503, barcode on product packaging) or eco-score label group (n = 510, eco-score label on product packaging). The eco-score label was color-coded with a grade of A-F based on the product's environmental footprint, where "A" indicates relative sustainability and "F" indicates relative unsustainability. Participants rated each product's environmental sustainability and their future likelihood of purchase. We used multilevel mixed-effects linear regression models and examined moderation by product category and sociodemographic characteristics. The eco-score label lowered perceived sustainability of unsustainable products by 13% in relative terms or -0.4 in absolute terms (95% CI -0.5, -0.3; p<0.001). The eco-score label increased perceived sustainability of sustainable products by 16% in relative terms or 0.6 in absolute terms (95% CI 0.5, 0.7, p<0.001). Effects on purchase intentions were smaller, with a 6% decrease for unsustainable products (p = 0.001) and an 8% increase for sustainable products (p<0.001). For unsustainable products, the effect of eco-score labels on sustainability perceptions was greater for older adults, men, participants with higher educational attainment, and participants with higher incomes. For sustainable products, the effect of ecolabels on sustainability perceptions was greater for those with higher educational attainment. Eco-score labels have the potential to direct consumers towards more sustainable products. Future studies should investigate eco-score label effectiveness on behavioral outcomes.
Topics: Humans; Male; Consumer Behavior; Female; Adult; Food Labeling; Intention; Middle Aged; United States; Conservation of Natural Resources; Food Preferences; Young Adult; Perception; Choice Behavior; Adolescent
PubMed: 38935699
DOI: 10.1371/journal.pone.0306123 -
PloS One 2024The present study investigated how life stress and sleep disturbance impact depressive symptoms among Chinese (N = 185) and Japanese (N = 464) workers. Based on a...
The present study investigated how life stress and sleep disturbance impact depressive symptoms among Chinese (N = 185) and Japanese (N = 464) workers. Based on a hypothesis that sleep disturbance can cause depression, a statistical model is established, expecting that work-related life stress indirectly increases depressive symptoms by worsening sleep disturbance rather than initiating depression directly. The study also examined the buffering effects of social support on depression. The extent of depressive symptoms, sleep disturbance symptoms (insomnia, hypersomnia, and nightmare), work-related stressors, and available social support were measured. The result revealed that the extent of depression was equivalent for both groups, but the Chinese reported more stress, less social support, and more severe sleep disturbance symptoms than the Japanese. Despite those differences, the statistical model fitted both groups well, suggesting that addressing sleep disturbance at the earliest opportunity can effectively prevent depression onset for workers.
Topics: Humans; Depression; Male; Female; Adult; Sleep Wake Disorders; Japan; Middle Aged; China; Stress, Psychological; Social Support; Asian People; Occupational Stress; East Asian People
PubMed: 38935694
DOI: 10.1371/journal.pone.0305936 -
PloS One 2024Breast cancer health disparities are linked to clinical-pathological determinants, socioeconomic inequities, and biological factors such as genetic ancestry. These...
Breast cancer health disparities are linked to clinical-pathological determinants, socioeconomic inequities, and biological factors such as genetic ancestry. These factors collectively interact in complex ways, influencing disease behavior, especially among highly admixed populations like Colombians. In this study, we assessed contributing factors to breast cancer health disparities according to genetic ancestry in Colombian patients from a national cancer reference center. We collected non-tumoral paraffin embedded (FFPE) blocks from 361 women diagnosed with breast cancer at the National Cancer Institute (NCI) to estimate genetic ancestry using a 106-ancestry informative marker (AIM) panel. Differences in European, Indigenous American (IA) and African ancestry fractions were analyzed according to potential sources of breast cancer health disparities, like etiology, tumor-biology, treatment administration, and socioeconomic-related factors using a Kruskal-Wallis test. Our analysis revealed a significantly higher IA ancestry among overweight patients with larger tumors and those covered by a subsidized health insurance. Conversely, we found a significantly higher European ancestry among patients with smaller tumors, residing in middle-income households, and affiliated to the contributory health regime, whereas a higher median of African ancestry was observed among patients with either a clinical, pathological, or stable response to neoadjuvant treatment. Altogether, our results suggest that the genetic legacy among Colombian patients, measured as genetic ancestry fractions, may be reflected in many of the clinical-pathological variables and socioeconomic factors that end up contributing to health disparities for this disease.
Topics: Humans; Female; Colombia; Breast Neoplasms; Middle Aged; Adult; Health Status Disparities; White People; Aged; Socioeconomic Factors
PubMed: 38935662
DOI: 10.1371/journal.pone.0306037 -
JAMA Network Open Jun 2024Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence.
OBJECTIVE
To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET.
DESIGN, SETTING, AND PARTICIPANTS
This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year.
INTERVENTIONS
Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team.
MAIN OUTCOMES AND MEASURES
The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms.
RESULTS
Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants.
CONCLUSIONS AND RELEVANCE
This RCT found that a remote monitoring app with alerts to the patient's care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03592771.
Topics: Humans; Female; Breast Neoplasms; Middle Aged; Medication Adherence; Antineoplastic Agents, Hormonal; Mobile Applications; Aged; Text Messaging; Adult; Chemotherapy, Adjuvant
PubMed: 38935379
DOI: 10.1001/jamanetworkopen.2024.17873