Publications by authors named "Maria Pisu"

186 Publications

Evaluating meaningful levels of financial toxicity in gynecologic cancers.

Int J Gynecol Cancer 2021 Apr 15. Epub 2021 Apr 15.

Department of Obstetrics and Gynecology, The University of Alabama, Birmingham, Alabama, USA.

Objective: The Comprehensive Score for Financial Toxicity (COST) is a validated instrument measuring the economic burden experienced by patients with cancer. We evaluated the frequency of financial toxicity at different COST levels and stratified risk factors and associations with cost-coping strategies by financial toxicity severity.

Methods: We analyzed previously collected survey data of gynecologic oncology patients from two tertiary care institutions. Both surveys included the COST tool and questions assessing economic and behavioral cost-coping strategies. We adapted a proposed grading scale to define three groups: no/mild, moderate, and severe financial toxicity and used χ, Fisher's exact test, and Wilcoxon rank sum test to compare groups. We used Poisson regression to calculate crude and adjusted risk ratios for cost-coping strategies, comparing patients with moderate or severe to no/mild financial toxicity.

Results: Among 308 patients, 14.9% had severe, 32.1% had moderate, and 52.9% had no/mild financial toxicity. Younger age, non-white race, lower education, unemployment, lower income, use of systemic therapy, and shorter time since diagnosis were associated with worse financial toxicity (all p<0.05). Respondents with moderate or severe financial toxicity were significantly more likely to use economic cost-coping strategies such as changing spending habits (adjusted risk ratio (aRR) 2.7, 95% CI 1.8 to 4.0 moderate; aRR 3.6, 95% CI 2.4 to 5.4 severe) and borrowing money (aRR 5.5, 95% CI 1.8 to 16.5 moderate; aRR 12.7, 95% CI 4.3 to 37.1 severe). Those with severe financial toxicity also had a significantly higher risk of behavioral cost-coping through medication non-compliance (aRR 4.6, 95% CI 1.2 to 18.1).

Conclusions: Among a geographically diverse cohort of gynecologic oncology patients, nearly half reported financial toxicity (COST <26), which was associated with economic cost-coping strategies. In those 14.9% of patients reporting severe financial toxicity (COST <14) there was also an increased risk of medication non-compliance, which may lead to worse health outcomes in this group.
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http://dx.doi.org/10.1136/ijgc-2021-002475DOI Listing
April 2021

A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol.

Implement Sci 2021 Mar 11;16(1):25. Epub 2021 Mar 11.

School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.

Background: Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers.

Methods: Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor's Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15-27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms.

Discussion: This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices.

Trial Registration: Clinicaltrials.gov . NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1.
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http://dx.doi.org/10.1186/s13012-021-01086-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951124PMC
March 2021

Measuring Financial Distress and Quality of Life Over Time in Patients With Gynecologic Cancer-Making the Case to Screen Early in the Treatment Course.

JCO Oncol Pract 2021 Feb 17:OP2000907. Epub 2021 Feb 17.

Division of Preventive Medicine, Department of Internal Medicine, University of Alabama at Birmingham, Birmingham, AL.

Purpose: Our objective was to measure the trajectory of financial distress and to determine its relationship with quality of life (QOL) among patients with cancer.

Materials And Methods: We conducted a longitudinal survey of patients with gynecologic cancer starting a new line of systemic therapy at baseline, 3 months, and 6 months. Financial distress was measured using a Comprehensive Score for Financial Toxicity (COST) < 26, and QOL was measured using Functional Assessment of Cancer Therapy-General (FACT-G) with lower scores indicating worse responses. One-way repeated analysis of variances, generalized estimating equation models, and correlation coefficients were used to evaluate financial distress and QOL over time.

Results: There were 90 of 121 (74%) baseline participants with a 6-month follow-up. The average age was 60 years, 29% were African-American, 57% had an annual income < $40,000 in US dollars, and 6% were uninsured. At baseline, 54% of patients screened positive for financial distress, which was unchanged at 3 months (50%, = .27) but decreased at 6 months (46%, = .04) compared with baseline. There was no change in average COST (23.6, 25.1, 25.6; = .33) or FACT-G (70.8, 71.0, 72.8; = .68) over time. Less financial distress was moderately correlated with better QOL (r = 0.63, 0.61, 0.60) at each time point. The presence of financial distress was associated with a 16-point decrease in FACT-G QOL score over time.

Conclusion: Upfront screening with COST identified 90% of patients who experienced financial distress, and COST did not change significantly over time. More severe financial distress was moderately correlated with worse QOL, and its presence was associated with a clinically meaningful 16-point decrease in QOL.
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http://dx.doi.org/10.1200/OP.20.00907DOI Listing
February 2021

Determining patient needs to enhance exercise program implementation and uptake in rural settings for women after a cancer diagnosis.

Support Care Cancer 2021 Jan 25. Epub 2021 Jan 25.

University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.

Purpose: To qualitatively explore exercise barriers and facilitators experienced by rural female cancer survivors from the program interventionist and recipient perspective for the purpose of enhancing exercise program implementation and uptake in rural settings.

Methods: A descriptive qualitative study design was utilized. Focus groups were conducted prior to implementation of an evidence-based exercise program by a rural non-research cancer clinical site. Nineteen rural female cancer survivors (mean age = 61.7 ± 10.9 years) and 11 potential interventionists (mean age = 42.3 ± 15.3 years) completed focus groups (stratified by participant role). Focus groups were audio recorded, transcribed, coded, and analyzed using inductive thematic analysis with NVivo 11.

Results: Cancer survivors identified 12 barrier themes (cancer specific adverse effects, lack of support, lack of knowledge, perceived negative aspects of exercise, cost, lack of resources, motivation, inconvenience, lack of program flexibility, time, weather, safety) and eight facilitator themes (knowledge, ease of access, resources, awareness, cost, options, organized, fun) related to exercise. Interventionists identified seven barrier themes (cost, transportation, lack of cancer survivor and interventionist knowledge, fear, motivation, lack of support, lack of resources) and four facilitator themes (resources, support, knowledge, motivation). Narratives revealed differing role-specific perspectives on shared themes between survivors and interventionists as well as potential implementation strategies for enhancing exercise participation and exercise program uptake among rural female cancer survivors.

Conclusion: Exploring multi-level stakeholder perspectives on cancer survivors' exercise needs and related strategies yields important information for organizations to consider when implementing exercise programs in rural contexts.
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http://dx.doi.org/10.1007/s00520-021-05990-8DOI Listing
January 2021

Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial.

Trials 2021 Jan 6;22(1):19. Epub 2021 Jan 6.

Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.

Background: HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora ("Better Family" in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples' HIV testing and counseling services to improve family health.

Methods: This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples' HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth.

Discussion: The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health.

Trial Registration: ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018.
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http://dx.doi.org/10.1186/s13063-020-04956-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788905PMC
January 2021

Social support and diabetes distress among adults with type 2 diabetes covered by Alabama Medicaid.

Diabet Med 2021 Apr 7;38(4):e14503. Epub 2021 Jan 7.

Division of Preventive Medicine, Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.

Aims: Diabetes distress affects approximately 36% of adults with diabetes and is associated with worse diabetes self-management and poor glycaemic control. We characterized participants' diabetes distress and studied the relationship between social support and diabetes distress.

Methods: In this cross-sectional study, we surveyed a population-based sample of adults with type 2 diabetes covered by Alabama Medicaid. We used the Diabetes Distress Scale assessing emotional burden, physician-related, regimen-related and interpersonal distress. We assessed participants' level of diabetes-specific social support and satisfaction with this support, categorized as low or moderate-high. We performed multivariable logistic regression of diabetes distress by level of and satisfaction with social support, adjusting for demographics, disease severity, self-efficacy and depressive symptoms.

Results: In all, 1147 individuals participated; 73% were women, 41% White, 58% Black and 3% Hispanic. Low level of or satisfaction with social support was reported by 11% of participants; 7% of participants had severe diabetes distress. Participants with low satisfaction with social support were statistically significantly more likely to have severe diabetes distress than those with moderate-high satisfaction, adjusted odds ratio 2.43 (95% CI 1.30, 4.54).

Conclusions: Interventions addressing diabetes distress in adults with type 2 diabetes may benefit from a focus on improving diabetes-specific social support.
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http://dx.doi.org/10.1111/dme.14503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7979501PMC
April 2021

Input from multiple stakeholder levels prioritizes targets for improving implementation of an exercise intervention for rural women cancer survivors.

Implement Sci Commun 2020 Nov 4;1(1):97. Epub 2020 Nov 4.

School of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, 1720 2nd Ave S, MT 614, Birmingham, AL, 35294-4410, USA.

Background: Although evidence-based interventions for increasing exercise among cancer survivors (CSs) exist, little is known about factors (e.g., implementation facilitators) that increase effectiveness and reach of such interventions, especially in rural settings. Such factors can be used to design implementation strategies. Hence, our study purpose was to (1) obtain multilevel perspectives on improving participation in and implementation of a multicomponent exercise behavior change intervention for rural women CSs and (2) identify factors important for understanding the context using the Consolidated Framework for Implementation Research (CFIR) for comparison across three levels (CSs, potential interventionists, community/organizational stakeholders).

Methods: We conducted three nominal group technique meetings with rural women CSs, three with community/organizational stakeholders, and one with potential interventionists. During each meeting, participants were asked to respond silently to one question asking what would make a multicomponent exercise intervention doable from intervention participation (CSs) or implementation (potential interventionists, stakeholders) perspectives. Responses were shared, discussed to clarify meaning, and prioritized by group vote. Data was deductively coded using CFIR.

Results: Mean age of CSs (n = 19) was 61.8 ± 11.1 years, community stakeholders (n = 16) was 45.9 ± 8.1 years, and potential interventionists (n = 7) was 41.7 ± 15.2 years. There was considerable consensus among CSs, potential interventionists, and stakeholders in terms of CFIR domains and constructs, e.g., "Design quality and packaging" (Innovation Characteristics), "Patients needs and resources" (Outer Setting), "Available resources" (Inner Setting), and "Engaging" (Process). However, participant-specific CFIR domains and constructs were also observed, e.g., CSs endorsed "Knowledge and beliefs about the intervention," "Individual stage of change," and "Self-efficacy" (Characteristics of Individuals); potential interventionists valued "Tension for change" (Inner Setting) and "Innovation participants" and "Key stakeholder" (Process); stakeholders emphasized "Goals and feedback" and "Network and communication" (Inner Setting), and "Planning" (Process). How the three participant levels conceptualized the CFIR constructs demonstrated both similarities and differences.

Conclusions: Multilevel input yielded diversity in type, relative priority, and conceptualization of implementation facilitators suggesting foci for future implementation strategy development and testing. Findings also reinforced the importance of multilevel implementation strategies for increasing exercise in an underserved, at-risk population.
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http://dx.doi.org/10.1186/s43058-020-00061-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640400PMC
November 2020

Telemedicine in rheumatology: a reliable approach beyond the pandemic.

Rheumatology (Oxford) 2021 01;60(1):366-370

Division of Rheumatology, University and IRCCS Policlinico S. Matteo, Pavia.

Objectives: The SARS-CoV-2 outbreak has imposed considerable restrictions on people's mobility, which affects the referral of chronically ill patients to health care structures. The emerging need for alternative ways to follow these patients up is leading to a wide adoption of telemedicine. We aimed to evaluate the feasibility of this approach for our cohort of patients with CTDs, investigating their attitude to adopting telemedicine, even after the pandemic.

Methods: We conducted a telephonic survey among consecutive patients referred to our CTD outpatients' clinic, evaluating their capability and propensity for adopting telemedicine and whether they would prefer it over face-to-face evaluation. Demographical and occupational factors were also collected, and their influence on the answers has been evaluated by a multivariate analysis.

Results: A total of 175 patients answered our survey (M/F = 28/147), with a median age of 62.5 years [interquartile range (IQR) 53-73]. About 80% of patients owned a device allowing video-calls, and 86% would be able to perform a tele-visit, either alone (50%) or with the help of a relative (36%). Telemedicine was considered acceptable by 78% of patients and 61% would prefer it. Distance from the hospital and patient's educational level were the strongest predictive factors for the acceptance of telemedicine (P < 0.05), whereas age only affected the mastering of required skills (P < 0.001).

Conclusion: Telemedicine is a viable approach to be considered for routine follow-up of chronic patients, even beyond the pandemic. Our data showed that older patients would be willing to use this approach, although a proper guide for them would be required.
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http://dx.doi.org/10.1093/rheumatology/keaa554DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499691PMC
January 2021

Treatment Decision Making and Financial Toxicity in Women With Metastatic Breast Cancer.

Clin Breast Cancer 2021 Feb 6;21(1):37-46. Epub 2020 Jul 6.

University of Alabama School of Medicine, University of Alabama at Birmingham, Birmingham, AL; Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, AL.

Introduction: Oncologists have increasingly been proponents of shared decision making (SDM) to enhance patient outcomes and reduce unnecessary health care spending. However, its effect on patient out-of-pocket costs is unknown. This study investigated the relationship between patient preferences for SDM and financial toxicity (FT) in patients with metastatic breast cancer (MBC).

Patients And Methods: This cross-sectional study utilized surveys of women aged ≥ 18 with MBC who received care at two academic hospitals in Alabama from 2017 to 2019. Patients self-reported their SDM preference (Control Preferences Scale) and FT (Comprehensive Score for Financial Toxicity [COST] tool; 11-item scale, with lower scores indicating worse FT). Effect sizes were calculated using the proportion of variance explained (R) or Cramer's V. Differences in FT by SDM preference were estimated using mixed models clustered by site and treating medical oncologist.

Results: In 95 women with MBC, 44% preferred SDM, 29% preferred provider-driven decision making, and 27% preferred patient-driven decision making. Patients preferring SDM were more often college educated (53% vs. 39%; V = 0.12) with an income greater than $40,000/y (55% vs. 43%; V = 0.18). Overall median COST was 22 (interquartile range, 16-29). After adjusting for patient demographic and clinical characteristics, patients preferring patient-driven decision making trended toward worse FT (COST 17: 95% confidence interval, 12-22) compared to those preferring SDM (COST 19: 95% confidence interval, 15-23) and those preferring provider-driven decision making (COST 22: 95% confidence interval, 17-27).

Conclusion: Patients preferring more patient-driven decision making reported worse FT, although differences did not reach statistical significance. Further research is needed to understand this relationship.
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http://dx.doi.org/10.1016/j.clbc.2020.07.002DOI Listing
February 2021

How, When, and With Whom Should Cost of Care Conversations Occur? Preferences of Two Distinct Cancer Survivor Groups.

JCO Oncol Pract 2020 09 7;16(9):e912-e921. Epub 2020 May 7.

Kaiser Permanente Washington Health Research Institute, Seattle, WA.

Purpose: Cost of care (CoC) conversations should occur routinely in oncology practice. However, patient preferences about with whom, when, and how to have these conversations are missing and preferences may vary across patient populations.

Methods: We performed a secondary qualitative analysis of quotes from interviews with 28 cancer survivors from two health care settings (Kaiser Permanente Washington and O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham [UABCCC]). A targeted approach searched for three constructs: (1) Who should have CoC conversations with patients? (2) When should CoC conversations occur? and (3) How should CoC conversations happen?

Results: Interviewees were similar in age and education, but UABCCC participants had more racial/ethnic minority representation and financial distress. Within each construct, themes were similar across both groups. As to who should have CoC conversations, we found that (1) providers' main role is medical care, not CoC; and (2) care team staff members are a more appropriate choice to address CoC needs. About the question of when, we found that (3) individuals have strong convictions about when and if they want to discuss CoC; and (4) CoC information and resources need to be available when patients are ready. About the question of how, themes were (5) provide estimates of anticipated out-of-pocket costs and insurance coverage; (6) provide reassurance, sympathy, and concrete solutions; and (7) because of their sensitivity, conduct CoC conversations in a comfortable, private space.

Conclusion: These findings offer general guidance as to who should conduct CoC conversations and when and how they should occur, with applicability across different patient populations.
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http://dx.doi.org/10.1200/JOP.19.00726DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489481PMC
September 2020

Location as Destiny: Identifying Geospatial Disparities in Radiation Treatment Interruption by Neighborhood, Race, and Insurance.

Int J Radiat Oncol Biol Phys 2020 07 29;107(4):815-826. Epub 2020 Mar 29.

Department of Radiation Oncology, University of Tennessee Health Science Center, Memphis, Tennessee; Division of Radiation Oncology, University of Texas, M.D. Anderson Cancer Center, Houston, Texas; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee. Electronic address:

Purpose: Radiation therapy interruption (RTI) worsens cancer outcomes. Our purpose was to benchmark and map RTI across a region in the United States with known cancer outcome disparities.

Methods And Materials: All radiation therapy (RT) treatments at our academic center were cataloged. Major RTI was defined as ≥5 unplanned RT appointment cancellations. Univariate and multivariable logistic and linear regression analyses identified associated factors. Major RTI was mapped by patient residence. A 2-sided P value <.0001 was considered statistically significant.

Results: Between 2015 and 2017, a total of 3754 patients received RT, of whom 3744 were eligible for analysis: 962 patients (25.8%) had ≥2 RT interruptions and 337 patients (9%) had major RTI. Disparities in major RTI were seen across Medicaid versus commercial/Medicare insurance (22.5% vs 7.2%; P < .0001), low versus high predicted income (13.0% vs 5.9%; P < .0001), Black versus White race (12.0% vs 6.6%; P < .0001), and urban versus suburban treatment location (12.0% vs 6.3%; P < .0001). On multivariable analysis, increased odds of major RTI were seen for Medicaid patients (odds ratio [OR], 3.35; 95% confidence interval [CI], 2.25-5.00; P < .0001) versus those with commercial/Medicare insurance and for head and neck (OR, 3.74; 95% CI, 2.56-5.46; P < .0001), gynecologic (OR, 3.28; 95% CI, 2.09-5.15; P < .0001), and lung cancers (OR, 3.12; 95% CI, 1.96-4.97; P < .0001) compared with breast cancer. Major RTI was mapped to urban, majority Black, low-income neighborhoods and to rural, majority White, low-income regions.

Conclusions: Radiation treatment interruption disproportionately affects financially and socially vulnerable patient populations and maps to high-poverty neighborhoods. Geospatial mapping affords an opportunity to correlate RT access on a neighborhood level to inform potential intervention strategies.
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http://dx.doi.org/10.1016/j.ijrobp.2020.03.016DOI Listing
July 2020

A telephone-based education and support intervention for Rural Breast Cancer Survivors: a randomized controlled trial comparing two implementation strategies in rural Florida.

J Cancer Surviv 2020 08 10;14(4):494-503. Epub 2020 Mar 10.

School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.

Purpose: To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivors (RBCS) in which education was delivered early or after the support component.

Methods: Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S) and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods.

Results: Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, and 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (mean (standard deviation): SF-36 PCS, 44.88 (10.6) vs. 45.08 (10.6); MCS, 49.45 (11.1) vs. 48.1 (11.9); CES-D, 10.11 (9.8) vs. 10.86 (10.5); POMS-SF, 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS, 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen's d, - 0.22; 95% CI, - 0.38, - 0.06) and POMS (Cohen's d, 0.23; 95% CI, 0.07, 0.39) for EE-S vs. S-DE.

Conclusions: The implementation strategies were equivalent.

Implications For Cancer Survivors: Enhancing support may be considered before delivering not-in-person interventions to RBCS.
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http://dx.doi.org/10.1007/s11764-020-00866-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7365751PMC
August 2020

Insurance status and head and neck radiotherapy interruption disparities in the Mid-Southern United States.

Head Neck 2020 08 6;42(8):2013-2020. Epub 2020 Mar 6.

Department of Radiation Oncology, University of Tennessee Health Science Center, College of Medicine, Memphis, Tennessee, USA.

Background: Relationships between health insurance coverage and radiotherapy (RT) interruption rates in patients with head and neck (H&N) cancer remain unclear.

Methods: We performed a retrospective cohort study at our academic center. Days of RT interruption for individual patients were tabulated, analyzed for explanatory variables, and geographically mapped.

Results: 894 of 7526 (11.9%) scheduled treatment days were interrupted, impacting 149 of 216 (69%) patients. Medicaid/uninsured patients experienced a 7.3 day mean interruption (SD = 9.9) vs 3.4 days (SD = 5.2) for Medicare/private patients (P < .001). RT interruption was predicted by insurance status in multivariate analysis (P = .008). Higher RT interruption rates overlapped geospatially with low predicted median household income and racial minority neighborhoods.

Conclusion: Unplanned treatment interruptions are a key source for H&N RT quality shortfalls in Medicaid/uninsured patients. This is the first geographic benchmarking of H&N RT delivery disparities across a complete metropolitan region, and will guide interventions studies to reduce interruption risk.
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http://dx.doi.org/10.1002/hed.26128DOI Listing
August 2020

Correction: Association of baseline inflammatory biomarkers with cancer mortality in the REGARDS cohort.

Oncotarget 2020 Feb 18;11(7):758. Epub 2020 Feb 18.

Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.

[This corrects the article DOI: 10.18632/oncotarget.27108.].
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http://dx.doi.org/10.18632/oncotarget.27480DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7041933PMC
February 2020

Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors.

BMJ Open 2020 02 13;10(2):e036864. Epub 2020 Feb 13.

Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA

Introduction: Many breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors' optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors.

Methods And Analysis: This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors' activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later.

Ethics And Dissemination: Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals.

Trial Registration Number: NCT03915548; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-036864DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044873PMC
February 2020

Health Insurance Literacy and Financial Hardship in Women Living With Metastatic Breast Cancer.

JCO Oncol Pract 2020 06 29;16(6):e529-e537. Epub 2020 Jan 29.

Division of Hematology and Oncology, The University of Alabama at Birmingham School of Medicine, Birmingham, AL.

Purpose: In patients with metastatic breast cancer (MBC), low health insurance literacy may be associated with adverse material conditions, psychological response, and coping behaviors because of financial hardship (FH). This study explored the relationship between health insurance literacy and FH in women with MBC.

Methods: This cross-sectional study used data collected from 84 women receiving MBC treatment at 2 southeastern cancer centers. Low health insurance literacy was defined as not knowing premium or deductible costs. FH was defined by lifestyle changes as a result of medical expenses, financial toxicity, and medical care modifications attributable to cost. Mean differences were calculated using Cramer's V. Associations between health insurance literacy and FH were estimated with adjusted linear models.

Results: Half of the surveyed patients had low health insurance literacy, 26% were underinsured, 45% had private insurance, 39% had Medicare, and 15% had Medicaid. Patients with low health insurance literacy more often reported borrowing money (19% 4%; V = 0.35); an inability to pay for basic necessities like food, heat, or rent (10% 4%; V = 0.18); and skipping a procedure (8% 1%; V = 0.21), medical test (7% 0%; V = 0.30), or treatment (4% 0%; V = 0.20) compared with patients with high health insurance literacy. Median Comprehensive Score for Financial Toxicity was 23 (interquartile range, 17-29). In adjusted models, health insurance literacy was not associated with financial toxicity.

Conclusion: Low health insurance literacy was common in women receiving MBC treatment. Additional research to increase health insurance literacy could lessen undesirable material FH and unnecessary behavioral FH associated with cancer-related care.
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http://dx.doi.org/10.1200/JOP.19.00563DOI Listing
June 2020

Cost-effectiveness of CYP2C19-guided antiplatelet therapy in patients with acute coronary syndrome and percutaneous coronary intervention informed by real-world data.

Pharmacogenomics J 2020 10 11;20(5):724-735. Epub 2020 Feb 11.

Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.

Current guidelines recommend dual antiplatelet therapy (DAPT) consisting of aspirin and a P2Y12 inhibitors following percutaneous coronary intervention (PCI). CYP2C19 genotype can guide DAPT selection, prescribing ticagrelor or prasugrel for loss-of-function (LOF) allele carriers (genotype-guided escalation). Cost-effectiveness analyses (CEA) are traditionally grounded in clinical trial data. We conduct a CEA using real-world data using a 1-year decision-analytic model comparing primary strategies: universal empiric clopidogrel (base case), universal ticagrelor, and genotype-guided escalation. We also explore secondary strategies commonly implemented in practice, wherein all patients are prescribed ticagrelor for 30 days post PCI. After 30 days, all patients are switched to clopidogrel irrespective of genotype (nonguided de-escalation) or to clopidogrel only if patients do not harbor an LOF allele (genotype-guided de-escalation). Compared with universal clopidogrel, both universal ticagrelor and genotype-guided escalation were superior with improvement in quality-adjusted life years (QALY's). Only genotype-guided escalation was cost-effective ($42,365/QALY) and demonstrated the highest probability of being cost-effective across conventional willingness-to-pay thresholds. In the secondary analysis, compared with the nonguided de-escalation strategy, although genotype-guided de-escalation and universal ticagrelor were more effective, with ICER of $188,680/QALY and $678,215/QALY, respectively, they were not cost-effective. CYP2C19 genotype-guided antiplatelet prescribing is cost-effective compared with either universal clopidogrel or universal ticagrelor using real-world implementation data. The secondary analysis suggests genotype-guided and nonguided de-escalation may be viable strategies, needing further evaluation.
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http://dx.doi.org/10.1038/s41397-020-0162-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7417282PMC
October 2020

Race, Socioeconomic Status, and Health-Care Access Disparities in Ovarian Cancer Treatment and Mortality: Systematic Review and Meta-Analysis.

JNCI Cancer Spectr 2019 Dec 9;3(4):pkz084. Epub 2019 Oct 9.

See the Notes section for the full list of authors' affiliations.

Background: Ovarian cancer remains a leading cause of death from gynecological malignancies. Race, socioeconomic status (SES), and access to health care are important predictors of quality treatment and survival. We provide a systematic review and meta-analysis on the role of these predictors on disparities in ovarian cancer treatment and mortality.

Methods: Using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched PubMed, EMBASE, and Scopus for relevant articles published between January 2000 and March 2017. We selected studies published in the United States that evaluated the role of race, SES, or health-care access on disparities in ovarian cancer treatment or survival. Pooled relative risk (RR) and 95% confidence intervals (CIs) were calculated for each outcome using a random-effects model.

Results: A total of 41 studies met the inclusion criteria for systematic review. In meta-analysis, there was a 25% decrease (RR = 0.75, 95% CI = 0.66 to 0.84) in receipt of adherent ovarian cancer treatment and 18% increased risk (RR = 1.18, 95% CI = 1.11 to 1.26) of mortality for blacks compared to whites. Receipt of adherent ovarian cancer treatment was 15% lower (RR = 0.85, 95% CI = 0.77 to 0.94) in the lowest vs highest SES group and 30% lower (RR = 0.70, 95% CI = 0.58 to 0.85) among patients at lower vs higher hospital volumes.

Conclusion: We found consistent and strong evidence for continued lack of quality ovarian cancer treatment and higher mortality among ovarian cancer patients who are black, are of low SES, and/or have poor access to care. Interventions focused on these groups targeting specific barriers to care are needed to reduce disparities in ovarian cancer treatment and mortality.
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http://dx.doi.org/10.1093/jncics/pkz084DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899434PMC
December 2019

Cerebellar continuous theta burst stimulation reduces levodopa-induced dyskinesias and decreases serum BDNF levels.

Neurosci Lett 2020 01 25;716:134653. Epub 2019 Nov 25.

Department of Medical Science and Public Health, Section of Neurology, University of Cagliari, Italy.

Patients with Parkinson's Disease (PD) experience bothersome motor fluctuations and Levodopa-induced Dyskinesias (LIDs). Cerebellar continuous theta burst stimulation (cTBS) was used as an inhibitory protocol of repetitive transcranial magnetic stimulation (rTMS) to reduce LIDs in PD patients. The influence of Val66Met polymorphism of Brain Derived Neurotrophic Factor (BDNF) gene on the therapeutic response to cTBS was investigated and the serum levels of BDNF were measured before and after treatment. Eleven patients were exposed to a session of cTBS and sham stimulation (one week apart) after the administration of 125 % of their usual morning dose of Levodopa and LIDs were video-recorded and evaluated at different time points (0, 15, 30, 45, 60, 90 min after Levodopa). Cerebellar cTBS significantly reduced LIDs with respect to sham stimulation and decreased serum BDNF levels. These effects were evident in the Val66Val group (7 subjects) but not in the Val66Met group (4 subjects). These data confirm the efficacy of cerebellar cTBS in reducing LIDs in PD patients and show that the clinical effect is accompanied by a decrease in serum BDNF levels. Moreover, they suggest that BDNF Val66Met polymorphism may influence the clinical and biological response to cTBS.
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http://dx.doi.org/10.1016/j.neulet.2019.134653DOI Listing
January 2020

Extensive financial hardship among gynecologic cancer patients starting a new line of therapy.

Gynecol Oncol 2020 02 23;156(2):271-277. Epub 2019 Nov 23.

Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Alabama at Birmingham, Birmingham, AL, United States of America.

Objective: Our objective was to evaluate the three domains of financial hardship (psychological response, material conditions, and coping behaviors) among gynecologic cancer patients receiving treatment.

Methods: We conducted a single-institution survey of gynecologic cancer patients starting a new line of therapy for primary or recurrent disease. Psychological response was measured using Comprehensive Score for Financial Toxicity, with score < 26 indicating financial distress. We measured material conditions by patient-reported changes in employment or spending and coping behaviors by patient-reported medication non-adherence. We performed descriptive statistics, bivariate analysis, and multivariate logistic regression.

Results: Among 121 participants, the mean age was 59 years, 28% were African-American, 50% reported income < $40,000, 74% had private insurance, 20% had only public insurance, and 7% were uninsured. Sixty-five (54%) participants screened positive for financial distress. Age < 65 years (aOR 2.61, 95% CI 1.04-6.52) and income < $40,000 (aOR 3.41, 95% CI 1.28-9.09) were associated with increased odds of screening positive for financial distress. Participants with financial distress were significantly more likely to report material hardship, including losing wages (46% vs. 18%, p < 0.01), not paying bills on time (40% vs. 7%, p < 0.01), and borrowing money (39% vs. 4%, p < 0.01). Financial distress was not associated with coping behaviors, such as not taking (6% vs. 2%, p = 0.37) or refilling medications (5% vs. 2%, p = 0.62).

Conclusions: Financial distress affects over half of gynecologic cancer patients starting a new line of treatment and is associated with material hardship. Younger age and lower income can be used to identify patients at increased risk.
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http://dx.doi.org/10.1016/j.ygyno.2019.11.022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7018550PMC
February 2020

Guideline Discordance and Patient Cost Responsibility in Medicare Beneficiaries With Metastatic Breast Cancer.

J Natl Compr Canc Netw 2019 10;17(10):1221-1228

Division of Hematology and Oncology.

Background: Treatment for metastatic breast cancer (MBC) that is not concordant with the NCCN Guidelines for Breast Cancer has been associated with higher healthcare utilization and payer costs. However, a significant knowledge gap exists regarding the impact of guideline-discordant care on patient cost responsibility. This study examined this question among patients with MBC in the year postdiagnosis.

Methods: This retrospective cohort study used data from the SEER-Medicare linked database from 2000 through 2013. Guideline discordance, defined by year-specific NCCN Guidelines, was assessed for first-line antineoplastic treatment and grouped into discrete categories. Patient cost responsibility (deductibles, coinsurance, copayments) in women with MBC were summed for all medical care received in the year postdiagnosis. The difference in patient cost responsibility by guideline discordance status was estimated using linear mixed-effect models.

Results: Of 3,709 patients with MBC surviving at least 1 year postdiagnosis, 17.6% (n=651) received guideline-discordant treatment. Median cost responsibility in the year postdiagnosis for patients receiving guideline-discordant treatment was $7,421 (interquartile range [IQR], $4,359-$12,983) versus $5,171 (IQR, $3,006-$8,483) for those receiving guideline-concordant care. In adjusted models, guideline-discordant treatment was significantly associated with $1,841 higher patient costs in the first year from index diagnosis date (95% CI, $1,280-$2,401) compared with guideline-concordant care. Patient cost responsibility differed by category of guideline discordance, with those receiving nonapproved bevacizumab having the highest cost responsibility (β=$3,330; 95% CI, $1,711-$4,948).

Conclusions: Deviations from current treatment guidelines may have implications on patient healthcare cost responsibility. Additional research is needed to fully understand the mechanisms underlying how guideline deviation leads to greater costs for patients with MBC.
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http://dx.doi.org/10.6004/jnccn.2019.7316DOI Listing
October 2019

Healthy lifestyle discussions between healthcare providers and older cancer survivors: Data from 12 cancer centers in the Southeastern United States.

Cancer Med 2019 11 30;8(16):7123-7132. Epub 2019 Sep 30.

UAB Comprehensive Cancer Center, Birmingham, AL, USA.

Background: Little is known about the prevalence of healthy lifestyle (HLS) discussions between providers and older cancer survivors.

Methods: We utilized cross-sectional data from older cancer survivors (≥65 years) seen at 12 southeastern cancer centers during 2013-2015. Data on demographics, time since diagnosis, weight, height, and healthy behaviors were collected. Respondents were asked if providers (oncologists, other physicians, and/or nurses) discussed exercise, healthy diet, weight management, and/or smoking cessation during clinical encounters. Descriptive statistics and bivariate associations between HLS topics and survivor characteristics were calculated.

Results: Among 1460 cancer survivors, mean age was 74 years (SD 6), most were white (81%), and >1 year postdiagnosis (84%). The majority (71%) reported discussing at least one of three HLS topics (exercise 49%, healthy diet 53%, vegetable consumption 28%); 17% received counseling on all three. Weight loss was recommended to 33% of overweight/obese survivors and smoking cessation to 85% of current smokers. Oncologists and nurses discussed HLS less frequently compared to other physicians. Younger survivors (65-74 years) received recommendations for exercise, weight loss, and tobacco cessation more often than older survivors (≥75 years). Compared to white respondents, minorities reported discussions on all topics more often except for tobacco cessation. Excluding tobacco cessation, survivors with recent cancer diagnoses (<1 year) reported HLS discussions more often than survivors >1 year postdiagnosis.

Conclusion: Despite the American Cancer Society's recommendations, older survivors reported a low prevalence of HLS discussions with their providers, with some variation by demographic groups. Strategies are needed to promote these important discussions in this population.
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http://dx.doi.org/10.1002/cam4.2568DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6853832PMC
November 2019

Association of baseline inflammatory biomarkers with cancer mortality in the REGARDS cohort.

Oncotarget 2019 Aug 6;10(47):4857-4867. Epub 2019 Aug 6.

Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.

This study examines the association between inflammatory biomarkers and risk of cancer mortality by race. Data were obtained from 1,856 participants in the prospective REGARDS cohort who were cancer-free at baseline, and analyzed in relation to cancer mortality prospectively. Biomarkers were log-transformed and categorized into tertiles due to non-normal distributions, and Cox proportional hazard regression models were utilized to compute hazard ratios with 95% confidence intervals using robust sandwich methods. Individuals in the highest tertile of IL-6 had over a 12-fold increased risk of cancer mortality (HR: 12.97, 95% CI: 3.46-48.63); those in the highest tertile of IL-8 had over a 2-fold increased risk of cancer mortality (HR: 2.21, 95% CI: 0.86-5.71), while those in the highest tertile of IL-10 had over a 3-fold increased risk of cancer mortality (HR: 3.06, 95% CI: 1.35-6.89). In race-stratified analysis, each unit increase in IL-6 was associated with increased risk of cancer mortality among African-Americans (HR: 3.88, 95% CI: 1.17-12.88) and Whites (5.25, 95% CI: 1.24-22.31). If replicated in larger, racially diverse prospective cohorts, these results suggest that cancer patients may benefit from clinical or lifestyle approaches to regulate systemic inflammation as a cancer prevention strategy.
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http://dx.doi.org/10.18632/oncotarget.27108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6690671PMC
August 2019

Fertility outcome after medically treated pyometra in dogs.

J Vet Sci 2019 Jul;20(4):e39

Società Veterinaria "Il Melograno" Srl, 21018 Sesto Calende, Varese, Italy.

Cystic endometrial hyperplasia-pyometra complex (CEH/P) is a challenge in canine reproduction. Present study aimed to assess fertility after medical treatment. One-hundred-seventy-four bitches affected by CEH/P received aglepristone on days 1, 2, 8, then every 7 days until blood progesterone < 1.2 ng/mL; cloprostenol was administered on days 3 to 5. Records were grouped according to bodyweight (BW): small (< 10 kg, n = 33), medium (10 ≥ BW < 25 kg, n = 44), large (25 ≥ BW < 40 kg, n = 52), and giant bitches (BW ≥ 40 kg, n = 45). Age; success rate; aglepristone treatments number; relapse, pregnancy rates; diagnosis-relapse, -first, -last litter intervals; litters number after treatment, and LS were analyzed by ANOVA. Overall age was 5.14 ± 1.75 years, without difference among groups. Treatment was 100% successful, without difference in treatments number (4.75 ± 1.18), relapse (15/174, 8.62%) and pregnancy (129/140 litters, 92.14%) rates, intervals diagnosis-relapse (409.63 ± 254.9 days) or -last litter (418.62 ± 129.03 days). The interval diagnosis-first litter was significantly shorter (163.52 ± 51.47 days) and longer (225.17 ± 90.97 days) in small and giant bitches, respectively. Overall, 1.47 ± 0.65 litters were born after treatment. Expected LS was achieved in each group, as shown by ΔLS (actual-expected LS by breed, overall -0.40 ± 1.62) without differences among groups. Concluding, CEH/P affects younger dogs than previously described. Relapses were rarer than previously reported. Medical treatment with aglepristone+cloprostenol is effective and safe, preserving subsequent fertility, as demonstrated by negligible changes in LS.
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http://dx.doi.org/10.4142/jvs.2019.20.e39DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6669203PMC
July 2019

Hypofractionated radiation in older women with breast cancer.

Breast J 2019 11 29;25(6):1206-1213. Epub 2019 Jul 29.

University of Alabama at Birmingham, Birmingham, Alabama.

Background: American Society of Radiation Oncology Choosing Wisely campaign recommends hypofractionated radiation and against routine use of intensity-modulated radiation therapy (IMRT) in early-stage estrogen receptor-positive breast cancer. We analyzed guideline recommendation adherence and financial implications in a modern Medicare cohort of women treated across the southeastern United States.

Methods: Our study population comprised Medicare patients over 65 years of age with breast cancer diagnosis from 12 cancer centers in the Southeast United States with stage 0-II breast treated with lumpectomy from 2012 to 2015. Hypofractionation was defined as 4 or fewer weeks of radiation treatments. Factors associated with utilization of hypofractionation and IMRT were identified using Poisson regression. Median costs during radiation treatments were compared for hypofractionation and IMRT.

Results: In older women (median age 71), 75% were treated with conventional fractionation, and 20% received IMRT. Hypofractionated women were more likely to have a positive estrogen(ER) or progestorone(PR) receptor status, lower comorbidity scores, and be treated at a high volume center (all P < 0.05). IMRT was utilized in 20% of patients and was more common in women treated with conventional fractionation (P < 0.001). Positive ER/PR status (P < 0.001) and utilization of hormonal blockade (P = 0.02) were associated with increased utilization of IMRT.

Conclusion: In an older cohort of patients with early-stage breast cancer, a majority were treated with conventional fractionated radiation, while approximately 20% were treated with IMRT. Both of which were associated with increased cost relative to hypofractionation.
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http://dx.doi.org/10.1111/tbj.13444DOI Listing
November 2019

Beyond efficacy: a qualitative organizational perspective on key implementation science constructs important to physical activity intervention translation to rural community cancer care sites.

J Cancer Surviv 2019 Aug 27;13(4):537-546. Epub 2019 Jun 27.

Washington University in St. Louis, 1 Brookings Dr, St. Louis, MO, 63130, USA.

Purpose: To identify constructs relevant to implementation of evidence-based physical activity (PA) behavior change interventions for rural women cancer survivors from an organizational perspective.

Methods: During the development of a PA intervention implementation toolkit, 11 potential interventionists and 19 community and organizational stakeholders completed focus groups stratified by role. Narratives were audio recorded, transcribed, and coded for Consolidated Framework for Implementation Research (CFIR) constructs.

Results: Multiple CFIR constructs were identified: Implementation Process (i.e., Engaging, Reflecting and Evaluating), Intervention Characteristics (i.e., Design Quality and Packaging, Cost, Evidence Strength and Quality, Adaptability, Complexity), Inner Setting (i.e., Implementation Readiness, Implementation Climate, Structural Characteristics), Outer Setting (i.e., Patient Needs and Resources, Cosmopolitanism), and Characteristics of Individuals (i.e., Knowledge and Beliefs, Stage of Change). Narratives identified rural implementation barriers (e.g., transportation) and facilitators (e.g., community-oriented). Unique needs of the cancer survivor (e.g., coping during cancer treatment and long-term effects on physical abilities) were emphasized as important barriers potentially addressed through Adaptability and Readiness implementation strategies. Narratives identified multi-level (i.e., individual-, organizational-, and community-level) strategies for targeting the identified constructs.

Conclusions: Fourteen CFIR constructs emerged as potentially important for organizations to consider when implementing PA interventions. Constructs were integrated into our implementation toolkit and research testing their potential mechanisms of action when implementing PA interventions in rural settings is warranted.

Implications: Strategies that target the identified constructs may enhance the implementation of PA programs for rural cancer survivors. Cancer survivors can facilitate these efforts by partnering with their health care providers and community organizations.

Implications For Cancer Survivors: Organizations promoting physical activity programs for cancer survivors must overcome implementation barriers including but not limited to cost, necessary expertise, and lack of awareness. Cancer survivors can facilitate these efforts by partnering with their health care providers, cancer center, and local community organizations to raise awareness and champion these efforts. It will "take a village", with cancer survivors being their own best advocate, to bring physical activity promotion to a broad range of cancer survivors.
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http://dx.doi.org/10.1007/s11764-019-00773-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6679742PMC
August 2019

Are preconceptional stressful experiences crucial elements for the aetiology of autism spectrum disorder? Insights from an animal model.

Neuropharmacology 2019 10 25;157:107686. Epub 2019 Jun 25.

Department of Life and Environment Sciences and Center of Excellence for Neurobiology of Dependence, University of Cagliari, Cagliari, Italy; Center of Excellence for Neurobiology of Dependence, University of Cagliari, Cagliari, Italy.

Autism spectrum disorders (ASD) are a group of neurodevelopmental disorders characterized by changes in social interactions, impaired language and communication, fear responses and presence of repetitive behaviours. Although the genetic bases of ASD are well documented, the recent increase in clinical cases of idiopathic ASD indicates that several environmental risk factors could play a role in ASD aetiology. Among these, maternal exposure to psychosocial stressors during pregnancy has been hypothesized to affect the risk for ASD in offspring. Here, we tested the hypothesis that preconceptional stressful experiences might also represent crucial elements in the aetiology of ASD. We previously showed that social isolation stress during adolescence results in a marked decrease in the brain and plasma concentrations of progesterone and in the quality of maternal care that these female rats later provide to their young. Here we report that male offspring of socially isolated parents showed decreased agonistic behaviour and social transmission of flavour preference, impairment in reversal learning, increased seizure susceptibility, reduced plasma oxytocin levels, and increased plasma and brain levels of BDNF, all features resembling an ASD-like phenotype. These alterations came with no change in spatial learning, aggression, anxiety and testosterone plasma levels, and were sex-dependent. Altogether, the results suggest that preconceptional stressful experiences should be considered as crucial elements for the aetiology of ASD, and indicate that male offspring of socially isolated parents may be a useful animal model to further study the neurobiological bases of ASD, avoiding the adaptations that may occur in other genetic or pharmacologic experimental models of these disorders.
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http://dx.doi.org/10.1016/j.neuropharm.2019.107686DOI Listing
October 2019

Time-restricted feeding delays the emergence of the age-associated, neoplastic-prone tissue landscape.

Aging (Albany NY) 2019 06;11(11):3851-3863

Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.

Aging increases the risk of cancer partly through alterations in the tissue microenvironment. Time-restricted feeding (TRF) is being proposed as an effective strategy to delay biological aging. In the present studies, we assessed the effect of long-term exposure to TRF on the emergence of the age-associated, neoplastic-prone tissue landscape. Animals were exposed to either feeding (ALF) or TRF for 18 months and then transplanted with hepatocytes isolated from pre-neoplastic nodules. Both groups were continued ALF and the growth of transplanted cells was evaluated 3 months later. A significant decrease in frequency of larger size clusters of pre-neoplastic hepatocytes was seen in TRF-exposed group compared to controls. Furthermore, TRF modified several parameters related to both liver and systemic aging towards the persistence of a younger phenotype, including a decrease in liver cell senescence, diminished fat accumulation and up-regulation of SIRT1 in the liver, down-regulation of plasma IGF-1, decreased levels of plasma lipoproteins and up-regulation of hippocampal brain-derived growth factor (BDNF).These results indicate that TRF was able to delay the onset of the neoplastic-prone tissue landscape typical of aging. To our knowledge, this is the first investigation to describe a direct beneficial effect of TRF on early phases of carcinogenesis.
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http://dx.doi.org/10.18632/aging.102021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6594823PMC
June 2019

Impact of Travel Time on Health Care Costs and Resource Use by Phase of Care for Older Patients With Cancer.

J Clin Oncol 2019 08 11;37(22):1935-1945. Epub 2019 Jun 11.

1University of Alabama at Birmingham, Birmingham, AL.

Purpose: Many community cancer clinics closed between 2008 and 2016, with additional closings potentially expected. Limited data exist on the impact of travel time on health care costs and resource use.

Methods: This retrospective cohort study (2012 to 2015) evaluated travel time to cancer care site for Medicare beneficiaries age 65 years or older in the southeastern United States. The primary outcome was Medicare spending by phase of care (ie, initial, survivorship, end of life). Secondary outcomes included patient cost responsibility and resource use measured by hospitalization rates, intensive care unit admissions, and chemotherapy-related hospitalization rates. Hierarchical linear models with patients clustered within cancer care site (CCS) were used to determine the effects of travel time on average monthly phase-specific Medicare spending and patient cost responsibility.

Results: Median travel time was 32 (interquartile range, 18-59) minutes for the 23,382 included Medicare beneficiaries, with 24% of patients traveling longer than 1 hour to their CCS. During the initial phase of care, Medicare spending was 14% higher and patient cost responsibility was 10% higher for patients traveling longer than 1 hour than those traveling 30 minutes or less. Hospitalization rates were 4% to 13% higher for patients traveling longer than 1 hour versus 30 minutes or less in the initial (61 54), survivorship (27 26), and end-of-life (310 286) phases of care (all < .05). Most patients traveling longer than 1 hour were hospitalized at a local hospital rather than at their CCS, whereas the converse was true for patients traveling 30 minutes or less.

Conclusion: As health care locations close, patients living farther from treatment sites may experience more limited access to care, and health care spending could increase for patients and Medicare.
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http://dx.doi.org/10.1200/JCO.19.00175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6804875PMC
August 2019

High health care costs in minority groups of older US Medicare beneficiaries with epilepsy.

Epilepsia 2019 07 6;60(7):1462-1471. Epub 2019 Jun 6.

Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama.

Objective: To examine health care costs in diverse older Medicare beneficiaries with epilepsy.

Methods: Using 2008-2010 claims data, we conducted a longitudinal cohort study of a random sample of Medicare beneficiaries augmented for minority representation. Epilepsy cases (n = 36 912) had ≥1 International Classification of Diseases, Ninth Edition (ICD-9) 345.x or ≥2 ICD-9 780.3x claims, and ≥1 antiepileptic drug (AED) in 2009; new cases (n = 3706) had no seizure/epilepsy claims nor AEDs in the previous 365 days. Costs were measured by reimbursements for all care received. High cost was defined as follow-up 1-year cost ≥ 75th percentile. Logistic regressions examined association of high cost with race/ethnicity, adjusting for demographic, clinical, economic, and treatment quality factors. In cases with continuous 2-year data, we obtained costs in two 6-month periods before and two after the index event.

Results: Cohort was ~62% African Americans (AAs), 11% Hispanics, 5% Asians, and 2% American Indian/Alaska Natives. Mean costs in the follow-up were ~$30 000 (median = $11 547; new cases, mean = $44 642; median = $25 008). About 19% white compared to 27% AA cases had high cost. AA had higher odds of high cost in adjusted analyses (odds ratio [OR] = 1.20, 95% confidence interval [CI] = 1.11-1.29), although this was only marginally significant when adjusting for AED adherence (OR = 1.09, 95% CI = 1.01-1.18, P = 0.03). Factors associated with high cost included ≥1 comorbidity, neurological care, and low AED adherence. Costs were highest at ~$17 000 in the 6 months immediately before and after the index event (>$29 000 for new cases).

Significance: The financial sequelae of epilepsy among older Americans disproportionally affect minorities. Studies should examine contributors to high costs.
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http://dx.doi.org/10.1111/epi.16051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6685539PMC
July 2019