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Background Higher weight individuals report experiencing weight‐based stigma in the healthcare setting; within the cancer continuum, the most robust evidence exists for cancer screening. More research is needed to understand whether and how higher weight patients experience weight stigma during cancer treatment. Methods We conducted semi‐structured interviews with 15 breast and 15 cervical cancer survivors diagnosed 2017–2019 in Iowa who had a pre‐diagnosis body mass index of 30+ kg/m2 calculated from their driver's license height and weight. Interviews focused on whether individuals perceived being treated differently because of their weight in daily life, in healthcare, or during cancer treatment. Data were coded using a combination of inductive and deductive approaches, and analyzed using a multi‐phase thematic analysis. Results Almost all interviewees reported positive experiences during cancer treatment; several described their weight as never being an issue. Some identified weight stigma during cancer diagnosis or treatment that resulted in delayed diagnoses or changes in treatment. Many interviewees described situations where their weight was discussed negatively during cancer treatment, but most did not identify these as stigmatizing because their providers were only “concerned about [their] health.” Additional themes developed included experiencing environmental stigma, the discussion of cancer recurrence by providers only as it related to weight, and misconceptions of the causes and consequences of obesity. Conclusions While several participants did not feel that their weight impacted cancer treatment, some reported experiences of weight stigma pre‐diagnosis and during treatment. When individuals noted their weight was discussed during treatment, internalized bias may have impacted whether they considered these discussions stigmatizing.

Introduction Cancer is rare in adolescents and young adults (AYA), but these patients have seen little improvement in survival in contrast to most other age groups. Furthermore, participation in research by AYAs is typically low. We conducted a study to examine the feasibility of recruiting a population-based sample of AYA survivors to examine issues of treatment and health outcomes. Methods Individuals diagnosed in 2007–08 and age 15–39 at the time of diagnosis with acute lymphocytic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, germ cell cancer or sarcoma were identified by 7 Surveillance, Epidemiology, and End-Results (SEER) cancer registries, mailed surveys within 14 months after diagnosis and again a year later, and had medical records reviewed. Results 525 (43%) of the eligible patients responded, 39% refused and 17% were lost to follow-up. Extensive efforts were required for most potential respondents (87%). 76% of respondents completed the paper rather than online survey version. In a multivariate model, age, cancer site, education and months from diagnosis to the first mailing of the survey were not associated with participation, although males ( p  < 0.01), Hispanics and non-Hispanic blacks ( p  < 0.001) were less likely to participate. 91% of survivors completing the initial survey completed the subsequent survey. Discussion Despite the response rate, those who participated adequately reflected the population of AYA cancer survivors. The study demonstrates that cancer registries are valuable foundations for conducting observational, longitudinal population-based research on AYA cancer survivors. Implications for Cancer Survivors Achieving a reasonable response rate in this population is possible, but requires extensive resources.

Purpose Overweight and obesity are risk factors for several cancers; however, population-based cancer registries do not routinely collect data on body mass index (BMI). This study evaluated the utility of supplementing cancer registry data with BMI data derived from driver’s license records. Methods We linked self-reported height and weight data from driver’s license records to directly measured values, obtained via medical record abstraction, in a sample of 712 adult Iowa residents with cancer diagnosed during 2007–2012. Matched BMI values were subjected to a comprehensive evaluation of quantitative and categorical measures of agreement between data sources. Results Driver’s license issue dates preceded diagnosis dates in 60.7% of cases, with time lags ranging from 3.0 years pre-diagnosis to 2.9 years post-diagnosis. Statistical analysis of agreement between continuous BMI values and ordinal BMI categories yielded an overall intraclass correlation estimate of 0.79 (95% confidence interval [CI] 0.77, 0.82) and an overall weighted kappa estimate of 0.63 (95% CI 0.59, 0.68), respectively. Subgroup analyses indicated reduced reliability among obesity-related cancers, particularly multiple myeloma, ovarian cancer, and pancreatic cancer. Neither measurement order nor time lag significantly affected agreement between BMI values. Conclusions These findings suggest that self-reported driver’s license data provide a reasonable approximation of BMI, but are less precise than interview- and questionnaire-based methods. Furthermore, the degree of bias is seemingly unaffected by measurement order and time lag, but appears to become more pronounced as BMI itself increases.

The purpose of this study was to compare breast cancer patients' self-report and surveillance, epidemiology, and end results (SEER) abstract data regarding type of treatment received (radiation, chemotherapy, and hormonal therapies). Patients 65 years of age or older diagnosed during 1999–2001 with stage I–II breast cancer and treated with conserving surgery were identified from the Iowa SEER registry; 307 (41% of those eligible) completed telephone interviews. SEER-registry abstract data also were obtained. Agreement between self-reports and SEER data varied by type of treatment, with almost perfect agreement for chemotherapy (kappa = 0.93) and moderate to substantial agreement for ever use of hormonal therapy (kappa = 0.61), receipt of radiation therapy (kappa = 0.60), and current use of hormonal therapy (kappa = 0.54). If the SEER data are assumed to be the “gold standard,” the sensitivity was generally high (>87%) for all types of treatment. Specificity varied according to type of treatment: highest for chemotherapy (98.4%) and lowest for radiation therapy (49.0%). Predictive values positive and negative were above 75% across type of treatment. Using self-reported data was an acceptable alternative to reviewing medical records for documenting some types of breast cancer treatment.

Patients with non-small-cell lung cancer (NSCLC) and ALK rearrangements generally have a progression-free survival of 8–11 months while on treatment with the ALK inhibitor crizotinib. However, resistance inevitably develops, with the brain a common site of progression. More potent ALK inhibitors with consistently demonstrable CNS activity and good tolerability are needed urgently. Alectinib is a novel, highly selective, and potent ALK inhibitor that has shown clinical activity in patients with crizotinib-naive ALK-rearranged NSCLC. We did a phase 1/2 study of alectinib to establish the recommended phase 2 dose of the drug and examine its activity in patients resistant or intolerant to crizotinib. We enrolled patients with ALK-rearranged NSCLC who progressed on or were intolerant to crizotinib. We administered various oral doses of alectinib (300–900 mg twice a day) during the dose-escalation portion of the study (phase 1), to ascertain the recommended dose for phase 2. We used Response Evaluation Criteria in Solid Tumors criteria (version 1.1) to investigate the activity of alectinib in all patients with a baseline scan and at least one post-treatment scan (CT or MRI), with central radiological review of individuals with brain metastases. We assessed safety in all patients who received at least one dose of alectinib. Here, we present data for the phase 1 portion of the study, the primary objective of which was to establish the recommended phase 2 dose; phase 2 is ongoing. This trial is registered at ClinicalTrials.gov, number NCT01588028. 47 patients were enrolled. Alectinib was well tolerated, with the most common adverse events being fatigue (14 [30%]; all grade 1–2), myalgia (eight [17%]; all grade 1–2), and peripheral oedema (seven [15%] grade 1–2, one [2%] grade 3). Dose-limiting toxic effects were recorded in two patients in the cohort receiving alectinib 900 mg twice a day; one individual had grade 3 headache and the other had grade 3 neutropenia. The most common grade 3–4 adverse events were increased levels of γ-glutamyl transpeptidase (two [4%]), a reduction in the number of neutrophils (two [4%]), and hypophosphataemia (two [4%]). Three patients reported four grade 4 serious adverse events that were deemed unrelated to alectinib: acute renal failure; pleural effusion and pericardial effusion; and brain metastasis. At data cut-off (median follow-up 126 days [IQR 84–217]), 44 patients could be assessed for activity. Investigator-assessed objective responses were noted in 24 (55%) patients, with a confirmed complete response in one (2%), a confirmed partial response in 14 (32%), and an unconfirmed partial response in nine (20%). 16 (36%) patients had stable disease; the remaining four (9%) had progressive disease. Of 21 patients with CNS metastases at baseline, 11 (52%) had an objective response; six (29%) had a complete response (three unconfirmed) and five (24%) had a partial response (one unconfirmed); eight (38%) patients had stable disease and the remaining two (10%) had progressive disease. Pharmacokinetic data indicated that mean exposure (AUC0–10) after multiple doses of alectinib (300–600 mg twice a day) was dose-dependent. Alectinib was well tolerated, with promising antitumour activity in patients with ALK-rearranged NSCLC resistant to crizotinib, including those with CNS metastases. On the basis of activity, tolerability, and pharmacokinetic data, we chose alectinib 600 mg twice a day as the recommended dose for phase 2. Chugai Pharmaceuticals, F Hoffmann La-Roche.

IntroductionOral pirfenidone reduces lung function decline and mortality in patients with idiopathic pulmonary fibrosis (IPF). Systemic exposure can have significant side effects, including nausea, rash, photosensitivity, weight loss and fatigue. Reduced doses may be suboptimal in slowing disease progression.MethodsThis phase 1b, randomised, open-label, dose–response trial at 25 sites in six countries (Australian New Zealand Clinical Trials Registry (ANZCTR) registration number ACTRN12618001838202) assessed safety, tolerability and efficacy of inhaled pirfenidone (AP01) in IPF. Patients diagnosed within 5 years, with forced vital capacity (FVC) 40%–90% predicted, and intolerant, unwilling or ineligible for oral pirfenidone or nintedanib were randomly assigned 1:1 to nebulised AP01 50 mg once per day or 100 mg two times per day for up to 72 weeks.ResultsWe present results for week 24, the primary endpoint and week 48 for comparability with published trials of antifibrotics. Week 72 data will be reported as a separate analysis pooled with the ongoing open-label extension study. Ninety-one patients (50 mg once per day: n=46, 100 mg two times per day: n=45) were enrolled from May 2019 to April 2020. The most common treatment-related adverse events (frequency, % of patients) were all mild or moderate and included cough (14, 15.4%), rash (11, 12.1%), nausea (8, 8.8%), throat irritation (5, 5.5%), fatigue (4, 4.4%) and taste disorder, dizziness and dyspnoea (three each, 3.3%). Changes in FVC % predicted over 24 and 48 weeks, respectively, were −2.5 (95% CI −5.3 to 0.4, −88 mL) and −4.9 (−7.5 to −2.3,–188 mL) in the 50 mg once per day and 0.6 (−2.2 to 3.4, 10 mL) and −0.4 (−3.2 to 2.3, −34 mL) in the 100 mg two times per day group.DiscussionSide effects commonly associated with oral pirfenidone in other clinical trials were less frequent with AP01. Mean FVC % predicted remained stable in the 100 mg two times per day group. Further study of AP01 is warranted.Trial registration numberACTRN12618001838202 Australian New Zealand Clinical Trials Registry.

Integrated nutrition and health programs seek to reduce undernutrition by educating child caregivers about infant feeding and care. Data on the quality of program implementation and consequent effects on infant feeding practices are limited. This study evaluated the effectiveness of enhancing a nutrition and health program on breastfeeding and complementary-feeding practices in rural India. Utilizing a quasi-experimental design, one of the implementing districts of a Cooperative for Assistance and Relief Everywhere (CARE) nutrition and health program was randomly selected for enhanced services and compared with a district receiving the Government of India's standard nutrition and health package alone. A cohort of 942 mother-child dyads was longitudinally followed from birth to 18 months. In both districts, the evaluation focused on responses to services delivered by community-based nutrition and health care providers [anganwadi workers (AWWs) and auxiliary nurse midwives (ANMs)]. The CARE enhanced program district showed an improvement in program coverage indicators (e.g., contacts, advice) through outreach visits by both AWWs (28.8-59.8% vs. 0.7-12.4%; all p<0.05) and ANMs (8.6-46.2% vs. 6.1-44.2%; <0.05 for ages ≥6 months). A significantly higher percentage of child caregivers reported being contacted by the AWWs in the CARE program district (20.5-45.6% vs. 0.3-21.6%; p<0.05 for all ages except at 6months). No differences in ANM household contacts were reported. Overall, coverage remained low in both areas. Less than a quarter of women received any infant feeding advice in the intervention district. Earlier and exclusive breastfeeding improved with increasing number or quality of visits by either level of health care provider (OR: 2.04-3.08, p = <0.001), after adjusting for potentially confounding factors. Socio-demographic indicators were the major determinants of exclusive breastfeeding up to 6 month and age-appropriate complementary-feeding practices thereafter in the program-enhanced but not comparison district. An enhanced nutrition and health intervention package improved program exposure and associated breastfeeding but not complementary-feeding practices, compared to standard government package. ClinicalTrials.gov NCT00198835.

Undernutrition below two years of age remains a major public health problem in India. We conducted an evaluation of an integrated nutrition and health program that aimed to improve nutritional status of young children by improving breast and complementary feeding practices over that offered by the Government of India's standard nutrition and health care program. In Uttar Pradesh state, through multi-stage cluster random sampling, 81 villages in an intervention district and 84 villages in a comparison district were selected. A cohort of 957 third trimester pregnant women identified during house-to-house surveys was enrolled and, following childbirth, mother-child dyads were followed every three months from birth to 18 months of age. The primary outcomes were improvements in weight-for-age and length-for-age z scores, with improved breastfeeding and complementary feeding practices as intermediate outcomes. Optimal breastfeeding practices were higher among women in intervention than comparison areas, including initiating breastfeeding within one hour of delivery (17.4% vs. 2.7%, p<0.001), feeding colostrum (34.7% vs. 8.4%, p<0.001), avoiding pre-lacteals (19.6% vs. 2.1%, p<0.001) and exclusively breastfeeding up to 6 months (24.1% vs. 15.3%, p = 0.001). However, differences were few and mixed between study arms with respect to complementary feeding practices. The mean weight-for-age z-score was higher at 9 months (-2.1 vs. -2.4, p = 0.0026) and the prevalence of underweight status was lower at 12 months (58.5% vs. 69.3%, p = 0.047) among intervention children. The prevalence of stunting was similar between study arms at all ages. Coefficients to show the differences between the intervention and comparison districts (0.13 cm/mo) suggested significant faster linear growth among intervention district infants at earlier ages (0-5 months). Mothers participating in the intervention district were more likely to follow optimal breast, although not complementary feeding practices. The program modestly improved linear growth in earlier age and weight gain in late infancy. Comprehensive nutrition and health interventions are complex; the implementation strategies need careful examination to improve feeding practices and thus impact growth. The trial was registered with ClinicalTrials.gov, NCT00198835.

Background Treatment of a child who has an anxiety disorder usually begins with the question of which treatment to start first, medication or psychotherapy. Both have strong empirical support, but few studies have compared their effectiveness head-to-head, and none has investigated what to do if the treatment tried first isn’t working well—whether to optimize the treatment already begun or to add the other treatment. Methods This is a single-blind Sequential Multiple Assignment Randomized Trial (SMART) of 24 weeks duration with two levels of randomization, one in each of two 12-week stages. In Stage 1, children will be randomized to fluoxetine or Coping Cat Cognitive Behavioral Therapy (CBT). In Stage 2, remitters will continue maintenance-level therapy with the single-modality treatment received in Stage 1. Non-remitters during the first 12 weeks of treatment will be randomized to either [1] optimization of their Stage 1 treatment, or [2] optimization of Stage 1 treatment and addition of the other intervention. After the 24-week trial, we will follow participants during open, naturalistic treatment to assess the durability of study treatment effects. Patients, 8–17 years of age who are diagnosed with an anxiety disorder, will be recruited and treated within 9 large clinical sites throughout greater Los Angeles. They will be predominantly underserved, ethnic minorities. The primary outcome measure will be the self-report score on the 41-item youth SCARED (Screen for Child Anxiety Related Disorders). An intent-to-treat analysis will compare youth randomized to fluoxetine first versus those randomized to CBT first (“Main Effect 1”). Then, among Stage 1 non-remitters, we will compare non-remitters randomized to optimization of their Stage 1 monotherapy versus non-remitters randomized to combination treatment (“Main Effect 2”). The interaction of these main effects will assess whether one of the 4 treatment sequences (CBT➔CBT; CBT➔med; med➔med; med➔CBT) in non-remitters is significantly better or worse than predicted from main effects alone. Discussion Findings from this SMART study will identify treatment sequences that optimize outcomes in ethnically diverse pediatric patients from underserved low- and middle-income households who have anxiety disorders. Trial registration This protocol, version 1.0, was registered in ClinicalTrials.gov on February 17, 2021 with Identifier: NCT04760275 .