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  1. Article: Effect of Chemotherapy on the Gut Microbiome of Breast Cancer Patients During the First Year of Treatment.

    Wu, Anna H / Vigen, Cheryl / Tseng, Chiuchen / Garcia, Agustin A / Spicer, Darcy

    Breast cancer (Dove Medical Press)

    2022  Volume 14, Page(s) 433–451

    Abstract: Introduction: There is accumulating information of the effects of chemotherapy and weight changes on the gut microbiome of breast cancer patients.: Methods: In this 1-year follow-up study, we investigated gut microbiome of 33 breast cancer patients ... ...

    Abstract Introduction: There is accumulating information of the effects of chemotherapy and weight changes on the gut microbiome of breast cancer patients.
    Methods: In this 1-year follow-up study, we investigated gut microbiome of 33 breast cancer patients who donated fecal samples at baseline and after completion of treatment. We compared alpha diversity and mean taxa abundance at baseline and absolute taxa abundance changes (final-baseline) by treatment (16 neoadjuvant [neoADJ], 13 adjuvant [ADJ], 4 no chemotherapy [noC]) and specific chemotherapy agent using Wilcoxon rank sum and negative binomial mixed model (NBMM) analysis.
    Results: All four gut alpha diversity measures changed in association with chemotherapy treatment; they increased in the neoADJ (+16.4% OTU
    Conclusion: Results from this pilot longitudinal study support an effect of chemotherapy, particularly neoADJ on the gut microbiome of breast cancer patients even after adjustment for weight changes. Further investigations are needed to confirm these findings in larger studies and with longer follow-up and to assess the impact of these microbiome changes on patient outcome.
    Language English
    Publishing date 2022-12-09
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2520722-2
    ISSN 1179-1314
    ISSN 1179-1314
    DOI 10.2147/BCTT.S305486
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Experiences of a Multiethnic Cohort of Patients Enrolled in a Financial Reimbursement Program for Cancer Clinical Trials.

    Medina, Sheyla P / Zhang, Sylvia / Nieves, Elena / Dornsife, Dana L / Johnson, Robert / Spicer, Darcy / Borno, Hala T

    JCO oncology practice

    2023  Volume 19, Issue 5, Page(s) e801–e810

    Abstract: Purpose: Financial reimbursement programs (FRPs) offset out-of-pocket (OOP) expenses from therapeutic clinical trial (TCT) participation. The study explores patients' experience in TCTs after enrollment in a FRP at two academic medical centers, ... ...

    Abstract Purpose: Financial reimbursement programs (FRPs) offset out-of-pocket (OOP) expenses from therapeutic clinical trial (TCT) participation. The study explores patients' experience in TCTs after enrollment in a FRP at two academic medical centers, including barriers and opportunities to improve trial participation.
    Methods: From May 2019 to January 2020, adults diagnosed with cancer and eligible for TCTs and FRP were recruited from the Improving Patient Access to Cancer Clinical Trials randomized trial at the University of California San Francisco and University of Southern California. Patients with income ≤ 700% of national poverty guidelines were eligible. Semistructured interviews were conducted in patients' preferred language. Qualitative analysis was performed by site and preferred language by two independent coders.
    Results: Of 65 trial patients, 53 participated (38%, University of California San Francisco; 62%, USC). The median age was 59 (IQR, 46-65) years, and 58% were female. Nearly half (49%) identified as Latinx/Hispanic compared with 32% non-Hispanic White, 10% Asian, 4% Black, 1% Native American, and 4% Others. A third were non-English speakers, 42% had college education or more, and 55% were retired/unemployed. Most common malignancies were gastrointestinal (42%), breast (19%), and genitourinary (13%), and 66% had metastatic disease. Patients experienced long travel time (1-4.5 hours) among 57% and financial toxicity from OOP costs (68%). High acceptability of the FRP was reported (81%). Although 30% of patients reported willingness to discuss finances of cancer treatment/trial with physicians, majority (87%) preferred discussion with social workers or TCT staff. Proposed modifications to TCTs included decentralization, recruitment strategies, voucher structure, and established rates for OOP expenses.
    Conclusion: Patients' experience with TCTs reveal financial and logistical stressors that may be lessened by the Improving Patient Access to Cancer Clinical Trial reimbursement program. FRPs may address inequities in clinical trial access among low-income and diverse populations.
    MeSH term(s) Adult ; Female ; Humans ; Male ; Middle Aged ; Academic Medical Centers ; Hispanic or Latino ; Neoplasms/therapy ; Reimbursement Mechanisms ; Health Expenditures ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2023-02-17
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 3028198-2
    ISSN 2688-1535 ; 2688-1527
    ISSN (online) 2688-1535
    ISSN 2688-1527
    DOI 10.1200/OP.22.00429
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  3. Article ; Online: Overcoming endocrine resistance in metastatic hormone receptor-positive breast cancer.

    D'Souza, Anishka / Spicer, Darcy / Lu, Janice

    Journal of hematology & oncology

    2018  Volume 11, Issue 1, Page(s) 80

    Abstract: Endocrine therapy has historically formed the basis of treatment of metastatic hormone receptor-positive breast cancer. The development of endocrine resistance has led to the development of newer endocrine drug combinations. Use of the CDK4/6 inhibitors ... ...

    Abstract Endocrine therapy has historically formed the basis of treatment of metastatic hormone receptor-positive breast cancer. The development of endocrine resistance has led to the development of newer endocrine drug combinations. Use of the CDK4/6 inhibitors has significantly improved progression-free survival in this group of patients. There are multiple studies of the use of P13K inhibitors and mTOR inhibitors for use as subsequent lines of therapy, particularly for endocrine resistance. The optimal sequencing of therapy should be based on medical comorbidities, prior adjuvant therapies, quality of life, side-effect profile, and disease-free interval.
    MeSH term(s) Breast Neoplasms/drug therapy ; Breast Neoplasms/mortality ; Breast Neoplasms/pathology ; Cyclin-Dependent Kinase 4/antagonists & inhibitors ; Cyclin-Dependent Kinase 6/antagonists & inhibitors ; Drug Resistance, Neoplasm/drug effects ; Endocrine System/chemistry ; Humans ; Molecular Targeted Therapy/methods ; Protein Kinase Inhibitors/therapeutic use ; Receptor Protein-Tyrosine Kinases/antagonists & inhibitors ; Survival Analysis
    Chemical Substances Protein Kinase Inhibitors ; Receptor Protein-Tyrosine Kinases (EC 2.7.10.1) ; Cyclin-Dependent Kinase 4 (EC 2.7.11.22) ; Cyclin-Dependent Kinase 6 (EC 2.7.11.22)
    Language English
    Publishing date 2018-06-11
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2429631-4
    ISSN 1756-8722 ; 1756-8722
    ISSN (online) 1756-8722
    ISSN 1756-8722
    DOI 10.1186/s13045-018-0620-6
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  4. Article ; Online: Evaluation of markers of immunity in different metastatic immune microenvironments suggests more suppression within breast to liver metastases in breast cancer.

    Hsu, Robert / Al-Zubeidy, Batul / Flores, Daniel / Nazarian, Ari / Baugh, Aaron / Gonzalez, Edgar / Castanon, Sofi / Xiu, Joanne / Kang, Irene / Spicer, Darcy / Lenz, Heinz Josef / Dara, Lily / Ademuyiwa, Foluso O / Korn, W Michael / Irshad, Sheeba / Chan, Isaac S / Roussos Torres, Evanthia T

    Breast cancer research and treatment

    2024  

    Abstract: Purpose: Programmed death receptor ligand-1 (PD-L1) expression and tumor mutational burden (TMB) are approved screening biomarkers for immune checkpoint inhibition (ICI) in advanced triple negative breast cancer. We examined these biomarkers along with ... ...

    Abstract Purpose: Programmed death receptor ligand-1 (PD-L1) expression and tumor mutational burden (TMB) are approved screening biomarkers for immune checkpoint inhibition (ICI) in advanced triple negative breast cancer. We examined these biomarkers along with characterization of the tumor microenvironment (TME) between breast tumors (BrTs), axillary metastases (AxMs), liver metastases (LvMs), non-axillary lymph node metastases, and non-liver metastases to determine differences related to site of metastatic disease.
    Methods: 3076 unpaired biopsies from breast cancer patients were analyzed using whole transcriptome sequencing and NextGen DNA depicting TMB within tumor sites. The PD-L1 positivity was determined with VENTANA PD-L1 (SP142) assay. The immune cell fraction within the TME was calculated by QuantiSeq and MCP-counter.
    Results: Compared to BrT, more LvM samples had a high TMB (≥ 10 mutations/Mb) and fewer LvM samples had PD-L1
    Conclusions: LvMs are less likely to express PD-L1
    Language English
    Publishing date 2024-04-20
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 604563-7
    ISSN 1573-7217 ; 0167-6806
    ISSN (online) 1573-7217
    ISSN 0167-6806
    DOI 10.1007/s10549-024-07295-w
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  5. Article ; Online: Breast cancer and neurotransmitters: emerging insights on mechanisms and therapeutic directions.

    Jayachandran, Priya / Battaglin, Francesca / Strelez, Carly / Lenz, Annika / Algaze, Sandra / Soni, Shivani / Lo, Jae Ho / Yang, Yan / Millstein, Joshua / Zhang, Wu / Shih, Jean C / Lu, Janice / Mumenthaler, Shannon M / Spicer, Darcy / Neman, Josh / Roussos Torres, Evanthia T / Lenz, Heinz-Josef

    Oncogene

    2023  Volume 42, Issue 9, Page(s) 627–637

    Abstract: Exploring the relationship between various neurotransmitters and breast cancer cell growth has revealed their likely centrality to improving breast cancer treatment. Neurotransmitters play a key role in breast cancer biology through their effects on the ... ...

    Abstract Exploring the relationship between various neurotransmitters and breast cancer cell growth has revealed their likely centrality to improving breast cancer treatment. Neurotransmitters play a key role in breast cancer biology through their effects on the cell cycle, epithelial mesenchymal transition, angiogenesis, inflammation, the tumor microenvironment and other pathways. Neurotransmitters and their receptors are vital to the initiation, progression and drug resistance of cancer and progress in our biological understanding may point the way to lower-cost and lower-risk antitumor therapeutic strategies. This review discusses multiple neurotransmitters in the context of breast cancer. It also discusses risk factors, repurposing of pharmaceuticals impacting neurotransmitter pathways, and the opportunity for better integrated models that encompass exercise, the intestinal microbiome, and other non-pharmacologic considerations. Neurotransmitters' role in breast cancer should no longer be ignored; it may appear to complicate the molecular picture but the ubiquity of neurotransmitters and their wide-ranging impacts provide an organizing framework upon which further understanding and progress against breast cancer can be based.
    MeSH term(s) Humans ; Female ; Breast Neoplasms/metabolism ; Neurotransmitter Agents/metabolism ; Epithelial-Mesenchymal Transition ; Tumor Microenvironment
    Chemical Substances Neurotransmitter Agents
    Language English
    Publishing date 2023-01-18
    Publishing country England
    Document type Journal Article ; Review ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 639046-8
    ISSN 1476-5594 ; 0950-9232
    ISSN (online) 1476-5594
    ISSN 0950-9232
    DOI 10.1038/s41388-022-02584-4
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    Zs.A 2218: Show issues Location:
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  6. Article ; Online: Implementation of a Multisite Financial Reimbursement Program in Cancer Clinical Trials Integrated With Patient Navigation: A Pilot Randomized Clinical Trial.

    Borno, Hala T / Zhang, Li / Zhang, Sylvia / Lin, Tracy K / Skafel, Andrea / Nieves, Elena / Dornsife, Dana / Johnson, Robert / Rhoads, Kim / Small, Eric / Spicer, Darcy

    JCO oncology practice

    2022  Volume 18, Issue 6, Page(s) e915–e924

    Abstract: Purpose: Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical ... ...

    Abstract Purpose: Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical Trials, a pilot feasibility study investigating the efficacy of offering a financial reimbursement program (FRP) during a therapeutic clinical trial discussion with or without additional outreach in improving patient enrollment.
    Methods: Study participants for this study were recruited at two National Cancer Institute-designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019. Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial. Participants were randomly assigned 1:1 to receive no follow-up (usual care) or a follow-up telephone call to facilitate FRP utilization stratified by study site. The target enrollment was 132 patients, with 66 patients in each study arm. The primary outcome was the consent rate to the multisite interventional study on the FRP among participants enrolling in clinical trials.
    Results: The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019. No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms. The most common reason for not enrolling in a clinical trial was due to ineligibility determined through screening procedures (75%).
    Conclusion: The current study observed that implementation of FRP at CCCs is feasible and serves a diverse patient population. Future studies will measure the impact of programs on overall clinical trial accrual and among racial/ethnic minorities.
    MeSH term(s) Adult ; Feasibility Studies ; Humans ; National Cancer Institute (U.S.) ; Neoplasms/epidemiology ; Neoplasms/therapy ; Patient Navigation ; Pilot Projects ; United States
    Language English
    Publishing date 2022-02-23
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 3028198-2
    ISSN 2688-1535 ; 2688-1527
    ISSN (online) 2688-1535
    ISSN 2688-1527
    DOI 10.1200/OP.21.00328
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    Zs.A 7198: Show issues Location:
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  7. Article: Disease characterization in liquid biopsy from HER2-mutated, non-amplified metastatic breast cancer patients treated with neratinib.

    Shishido, Stephanie N / Masson, Rahul / Xu, Liya / Welter, Lisa / Prabakar, Rishvanth Kaliappan / D' Souza, Anishka / Spicer, Darcy / Kang, Irene / Jayachandran, Priya / Hicks, James / Lu, Janice / Kuhn, Peter

    NPJ breast cancer

    2022  Volume 8, Issue 1, Page(s) 22

    Abstract: Metastatic breast cancer (mBC) patients have a high risk of progression and face poor prognosis overall, with about one third (34%) surviving five years or more. In rare instances (2-4% of cases) patients with mBC have ERBB2 (HER2) activating mutations ... ...

    Abstract Metastatic breast cancer (mBC) patients have a high risk of progression and face poor prognosis overall, with about one third (34%) surviving five years or more. In rare instances (2-4% of cases) patients with mBC have ERBB2 (HER2) activating mutations but are ERBB2 non-amplified. Neratinib is a potent, irreversible inhibitor that binds HER2 and inhibits downstream signaling. We used the previously validated high-definition single cell assay (HDSCA) workflow to investigate the clinical significance of the liquid biopsy in ERBB2 mutant, non-amplified, post-menopausal mBC patients starting neratinib and fulvestrant combination therapy. Characterization with a comprehensive liquid biopsy methodology (HDSCA) included genomic analysis of both the cell-free DNA (cfDNA) and single circulating tumor cells (CTCs) to monitor tumor evolution and identify potential mutational variants unique to the patient's clinical response. A limited series of five sequentially enrolled patients presented here were from the MutHER ( https://www.clinicaltrials.gov , NCT01670877) or SUMMIT ( https://www.clinicaltrials.gov , NCT01953926) trials. Patients had an average of 5.4 lines of therapy before enrollment, variable hormone receptor status, and ERBB2 mutations at diagnosis and during treatment. CTC enumeration alone was not sufficient to predict clinical response. Treatment pressure was shown to lead to an observable change in CTC morphology and genomic instability (GI), suggesting these parameters may inform prognosis. Single cell copy number alteration (CNA) analysis indicated that the persistence or development of a clonal population of CTCs during treatment was associated with a worse response. Hierarchical clustering analysis of the single cells across all patients and timepoints identified distinct aberrant regions shared among patients, comprised of 26 genes that are similarly affected and may be related to drug resistance. Additionally, the genomic analysis of the cfDNA, identified new mutations in ERBB2, PIK3CA, and TP53 that arose likely due to treatment pressure in a patient with poor response, further providing insights on the dynamics of the cancer genome over the course of therapy. The data presented in this small cohort study demonstrates the feasibility of real-time molecular profiling of the cellular and acellular fractions of the liquid biopsy using the HDSCA methodology. Additional studies are necessary to determine the potential use of morphometric and genomic analysis as a prognostic tool to advance personalized oncology.
    Language English
    Publishing date 2022-02-18
    Publishing country United States
    Document type Journal Article
    ISSN 2374-4677
    ISSN 2374-4677
    DOI 10.1038/s41523-022-00390-5
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  8. Article ; Online: Gut microbiome associations with breast cancer risk factors and tumor characteristics: a pilot study.

    Wu, Anna H / Tseng, Chiuchen / Vigen, Cheryl / Yu, Yang / Cozen, Wendy / Garcia, Agustin A / Spicer, Darcy

    Breast cancer research and treatment

    2020  Volume 182, Issue 2, Page(s) 451–463

    Abstract: Objective: To investigate the association between gut microbiome with breast tumor characteristics (receptor status, stage and grade) and known breast cancer risk factors.: Methods: In a pilot cross-sectional study of 37 incident breast cancer ... ...

    Abstract Objective: To investigate the association between gut microbiome with breast tumor characteristics (receptor status, stage and grade) and known breast cancer risk factors.
    Methods: In a pilot cross-sectional study of 37 incident breast cancer patients, fecal samples collected prior to chemotherapy were analyzed by 16S ribosomal RNA (rRNA) gene-based sequencing protocol. Alpha diversity and specific taxa by tumor characteristics and breast cancer risk factors were tested by Wilcoxon rank sum test, and by differential abundance analysis, using a zero-inflated negative binomial regression model with adjustment for total counts, age and race/ethnicity.
    Results: There were no significant alpha diversity or phyla differences by estrogen/progesterone receptor status, tumor grade, stage, parity and body mass index. However, women with human epidermal growth factor receptor 2 positive (HER2+) (n = 12) compared to HER2- (n = 25) breast cancer showed 12-23% lower alpha diversity [number of species (OTU) p = 0.033, Shannon index p = 0.034], lower abundance of Firmicutes (p = 0.005) and higher abundance of Bacteroidetes (p = 0.089). Early menarche (ages ≤ 11) (n = 11) compared with later menarche (ages ≥ 12) (n = 26) was associated with lower OTU (p = 0.036), Chao1 index (p = 0.020) and lower abundance of Firmicutes (p = 0.048). High total body fat (TBF) (> 46%) (n = 12) compared to lower (≤ 46%) TBF was also associated with lower Chao 1 index (p = 0.011). There were other significant taxa abundance differences by HER2 status, menarche age, as well as other tumor and breast cancer risk factors.
    Conclusions and relevance: Further studies are needed to identify characteristics of the human microbiome and the interrelationships between breast cancer hormone receptor status and established breast cancer risk factors.
    MeSH term(s) Adult ; Age Factors ; Aged ; Bacteroidetes/genetics ; Bacteroidetes/isolation & purification ; Biomarkers, Tumor/metabolism ; Body Mass Index ; Breast/pathology ; Breast Neoplasms/epidemiology ; Breast Neoplasms/pathology ; Breast Neoplasms/physiopathology ; Cross-Sectional Studies ; DNA, Bacterial/isolation & purification ; Feces/microbiology ; Female ; Firmicutes/genetics ; Firmicutes/isolation & purification ; Gastrointestinal Microbiome/physiology ; Humans ; Menarche/physiology ; Middle Aged ; Parity/physiology ; Pilot Projects ; RNA, Ribosomal, 16S/genetics ; Receptor, ErbB-2/metabolism ; Receptors, Estrogen/metabolism ; Receptors, Progesterone/metabolism ; Risk Factors
    Chemical Substances Biomarkers, Tumor ; DNA, Bacterial ; RNA, Ribosomal, 16S ; Receptors, Estrogen ; Receptors, Progesterone ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1)
    Language English
    Publishing date 2020-05-28
    Publishing country Netherlands
    Document type Journal Article ; Observational Study
    ZDB-ID 604563-7
    ISSN 1573-7217 ; 0167-6806
    ISSN (online) 1573-7217
    ISSN 0167-6806
    DOI 10.1007/s10549-020-05702-6
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  9. Article ; Online: Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis.

    Dieli-Conwright, Christina M / Courneya, Kerry S / Demark-Wahnefried, Wendy / Sami, Nathalie / Norris, Mary K / Fox, Frank S / Buchanan, Thomas A / Spicer, Darcy / Bernstein, Leslie / Tripathy, Debu

    Sleep

    2021  Volume 44, Issue 10

    Abstract: Study objectives: Poor sleep quality affects nearly one-third of breast cancer survivors and is associated with insulin resistance. The purpose of this secondary analysis was to examine the effects of a 16-week exercise intervention on patient-reported ... ...

    Abstract Study objectives: Poor sleep quality affects nearly one-third of breast cancer survivors and is associated with insulin resistance. The purpose of this secondary analysis was to examine the effects of a 16-week exercise intervention on patient-reported sleep quality among breast cancer survivors and assess whether changes in patient-reported sleep quality were associated with cardiometabolic biomarkers. We explored Hispanic ethnicity as a moderator of the effects of exercise on patient-reported sleep quality.
    Methods: Breast cancer survivors who were overweight or obese were randomized to exercise (n = 50) or usual care (n = 50). The 16-week intervention included aerobic and resistance exercise. Patient-reported sleep quality (Pittsburgh Sleep Quality Index [PSQI]) and biomarkers of cardiometabolic health were assessed at baseline and post-intervention. Within- and between-group differences were assessed using general linear models repeated-measures analyses of variance and mixed-model repeated-measure analysis, respectively. Associations between changes in PSQI and cardiometabolic biomarkers were computed using Pearson correlations. Linear mixed-models were used to evaluate effect modification by ethnicity.
    Results: Participants were 52 ± 10.4 years old, and over half were of Hispanic ethnicity. As compared to usual care, PSQI global scores improved significantly in the exercise group (mean between-group difference -2.2; 95% CI -3.2 to -0.6). Change in PSQI was inversely associated with changes in all cardiometabolic biomarkers (p < 0.01) among the exercise group. Ethnicity was found to moderate the effects of exercise training on global sleep quality (p < 0.001).
    Conclusions: An aerobic and resistance exercise intervention effectively improved patient-reported sleep quality in breast cancer survivors. Hispanic ethnicity as a moderator showed greater improvement in patient-reported sleep indicating Hispanic versus non-Hispanic breast cancer survivors may derive larger sleep benefits.
    Clinical trail information: NCT01140282.
    MeSH term(s) Adult ; Biomarkers ; Breast Neoplasms/complications ; Breast Neoplasms/therapy ; Cancer Survivors ; Cardiovascular Diseases ; Exercise ; Female ; Humans ; Middle Aged ; Obesity/complications ; Obesity/therapy ; Overweight/therapy ; Patient Reported Outcome Measures ; Quality of Life ; Resistance Training ; Sleep
    Chemical Substances Biomarkers
    Language English
    Publishing date 2021-04-26
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 424441-2
    ISSN 1550-9109 ; 0161-8105
    ISSN (online) 1550-9109
    ISSN 0161-8105
    DOI 10.1093/sleep/zsab111
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  10. Article ; Online: Accelerating cancer clinical trial recruitment through a financial reimbursement program integrated with patient navigation: an interrupted time series analysis.

    Borno, Hala T / Lin, Tracy Kuo / Zhang, Sylvia / Skafel, Andrea / Lalanne, Alyssa / Dornsife, Dana / Johnson, Robert / Spicer, Darcy / Small, Eric J / Rhoads, Kim F

    Journal of cancer policy

    2021  Volume 30, Page(s) 100305

    Abstract: Background: Cancer treatment clinical trials face major challenges with patient recruitment. Strategies to address patient indirect costs associated with clinical trial participation may accelerate accrual overall. The current study examined the effect ... ...

    Abstract Background: Cancer treatment clinical trials face major challenges with patient recruitment. Strategies to address patient indirect costs associated with clinical trial participation may accelerate accrual overall. The current study examined the effect of the IMproving Patient Access to Clinical Trials (IMPACT) intervention on patient accrual to cancer treatment clinical trials at an academic medical center. The IMPACT intervention was an onsite patient navigator combined with a financial reimbursement program to address patient out of pocket costs and began on September 2018.
    Methods: This analysis measured frequency of patient enrollment in cancer treatment clinical trials and available cancer treatment clinical trials per month between January 1, 2016 and March 31, 2020. An interrupted time-series analysis (ITSA) was conducted to estimate changes in patient enrollment attributable to the IMPACT intervention.
    Results: During the study period, a mean of 69 patients enrolled in clinical trials per month (standard deviation (SD = 13), with 27 (SD = 7) in early phase vs 41 (SD = 12) in late phase clinical trials. The number of available clinical trials per month was 51 (SD = 2) overall, with 23 (SD = 1) in early phase vs 28 (SD = 1) in late phase context. A total of 3470 patients were enrolled in cancer treatment clinical trials during the evaluated time period, the majority of whom were men (1895, 55 %) and racially white (2267, 65 %). A statistically significant increase in the number of patients accrued as compared to the pre-intervention trend was observed; with approximately 1 additional patient accrued per month, with a larger effect on increase patient accrual for late phase clinical trials.
    Discussion: This study observed that the IMPACT intervention accelerated clinical trial recruitment, especially among late phase clinical trials. Future research will examine strategies to leverage this infrastructure to optimize recruitment among underrepresented patients.
    Policy summary: To improve clinical trial recruitment and ensure that trial results are representative of a diverse population it is critical for health policies consider patient out-of-pocket costs and potential reimbursement to alleviate financial burden associated with clinical trial participation. Furthermore, policies for facilitating clinical trial recruitment and participant retention should budget for and incorporate a navigation component to assist patients who may not be familiar with the healthcare system and available financial assistance.
    MeSH term(s) Female ; Health Expenditures ; Humans ; Interrupted Time Series Analysis ; Male ; Neoplasms/therapy ; Patient Navigation ; Patient Selection
    Language English
    Publishing date 2021-09-04
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2213-5383
    ISSN (online) 2213-5383
    DOI 10.1016/j.jcpo.2021.100305
    Database MEDical Literature Analysis and Retrieval System OnLINE

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