Impact of the COVID-19 Pandemic Mitigation Strategies on Cancer Treatment Trials: A Meta-Analysis of Industry and National Cancer Institute Studies.

Purpose: The onset of the COVID-19 pandemic in early 2020 disrupted the conduct of cancer clinical trials. In response, federal agencies allowed more flexibility for trial recruitment and patient follow-up. A key question is whether the benefits of adopting these strategies outweigh the potential detriments to quality metrics.

Nivolumab-AVD Versus Brentuximab Vedotin-AVD in Older Patients With Advanced-Stage Classic Hodgkin Lymphoma Enrolled on S1826.

Older patients with classic Hodgkin lymphoma (cHL) have inferior survival compared with younger patients. We report a subset analysis of older patients (60 years and older) enrolled in the phase three S1826 trial conducted by SWOG that randomly assigned patients with newly diagnosed advanced-stage (III-IV) cHL to six cycles of nivolumab (N)-AVD or brentuximab vedotin (BV)-AVD. Of 103 enrolled patients 60 years and older, 99 were eligible.

Emerging Strategies for Drug-Based Cancer Risk Reduction.

Chemoprevention has emerged as a promising strategy to reduce cancer incidence by using pharmacologic agents that interrupt the carcinogenesis process. This review discusses emerging insights and recent advancements in chemoprevention, emphasizing novel approaches in several cancer types. Specifically, we examine breast cancer prevention, focusing on optimized endocrine therapy dosing to enhance adherence and minimize adverse effects while maintaining efficacy.

Addressing Challenges in Research Aimed at Reducing Financial Toxicity Among Cancer Patients and Caregivers: An Example From the CREDIT Study (SWOG S1912CD).

IntroductionCancer-related financial hardship is pervasive, impacting both patients and caregivers, making it crucial to address financial hardship at the household level. The CREDIT (S1912CD) study was designed to enroll and randomize cancer patients and spousal caregivers as dyads to proactive financial navigation compared to usual care. The study faced several challenges to recruitment.

S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE).

NCT06203600.

Cancer in rural America: Improving access to clinical trials and quality of oncologic care.

Individuals from rural areas in the United States suffer higher rates of morbidity and mortality from cancer than their urban counterparts. This review is based on the idea that equity-the elimination of unnecessary and preventable differences between groups of individuals-should underlie access to cancer care resources for patients from rural areas. Access to cancer clinical trials serves as the framework for identifying and understanding barriers in access to quality oncologic care.

Overcoming challenges of recruiting cancer patients into clinical trials: insights from a randomized trial of app-based smoking cessation interventions.

Behavioral clinical trials among cancer patients often fail to meet recruitment goals - especially for underrepresented groups. Comparing recruitment strategies on participant accrual and cost can inform the use of cost-effective recruitment strategies for enrollment of diverse populations of cancer patients. In this study, we compared social media, internet sites, and clinic-based recruitment on accrual, cost, and characteristics of cancer patients (i.

Healthcare utilization in the departments of obstetrics and gynecology during the first two years of the COVID-19 pandemic: time series analysis in Jining, China.

Introduction: Healthcare utilization in China decreased precipitously during the initial outbreak of the COVID-19 pandemic, and women were disproportionately affected. As the COVID-19 pandemic has proven to be far more pervasive and persistent than many first surmised, a vital question is whether the utilization of non-COVID related healthcare has remained low under China's dynamic zero-COVID policy. This study aimed to estimate the initial and enduring collateral effects of the COVID-19 pandemic on the utilization of obstetrics and gynecology care at a tertiary hospital in Jining, Shandong Province, China.

Health Care Contact Days for Older Adults Enrolled in Cancer Clinical Trials.

Importance: Contact days-days with health care contact outside the home-are a measure of how much of a patient's life is consumed by health care. Clinical trials, with a more uniform patient mix and protocolized care, provide a unique opportunity to assess whether burdens differ by individuals' sociodemographic backgrounds.

Objective: To characterize patterns of contact days for older adults with cancer participating in clinical trials.

When to adjust for multiplicity in cancer clinical trials.

Interpreting cancer clinical trial results often depends on addressing issues of multiplicity. When testing multiple hypotheses, unreliable findings can occur by chance due to the inflation of the type I error rate, the probability of mistakenly rejecting the null hypothesis when the null hypothesis is true. In this setting, researchers may often set the type I error rate (or the alpha level) low to limit false positive findings and the interpretation of a causal relationship where none exists.

Design and analysis considerations for investigating patient subgroups of interest within cancer clinical trials.

Examining treatment effects in subgroups of patients defined by demographic, genetic, or clinical characteristics is increasingly of interest given the pursuit of personalized medicine and the importance of representation and equity in treatment decisions. The magnitude or even the direction of the treatment effect may vary across subgroups, and these differential treatment effects could have clinical implications. Subgroup analyses require caution in their interpretation, however, because of the high probability of a false-positive or false-negative conclusion.

Best practices and pragmatic approaches for patient-reported outcomes and quality of life measures in cancer clinical trials.

Patient-reported outcomes (PROs) are often collected in cancer clinical trials. Data obtained from trials with PROs are essential in evaluating participant experiences relating to symptoms, financial toxicity, or health-related quality of life. Although most features of clinical trial design, implementation, and analyses apply to trials with PROs, several considerations are unique.

Practical design considerations for cluster randomized controlled trials: lessons learned in community oncology research.

Cancer care delivery research trials conducted within the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) routinely implement interventions at the practice or provider level, necessitating the use of cluster randomized controlled trials (cRCTs). The intervention delivery requires cluster-level randomization instead of participant-level, affecting sample size calculation and statistical analyses to incorporate correlation between participants within a practice. Practical challenges exist in the conduct of these cRCTs due to unique trial network infrastructures, including the possibility of unequal participant accrual totals and rates and staggered study initiation by clusters, potentially with differences between randomized arms.

Cancer clinical trial participation in socioeconomically vulnerable patients; A risk model to aid in targeted interventions.

Background: In patients with cancer, those with lower incomes are less likely to participate in clinical trials. A broad-based evaluation of variables that could contribute to this disparity has not been conducted.

Methods: We used data from Health Information National Trends Survey (HINTS) databases for survey years 2014, 2017, and 2020, the survey years that included questions about whether patients with cancer participated in a clinical trial.

Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial.

Background: The phase III RxPONDER trial has affected treatment for node-positive (1-3), hormone receptor-positive, HER2-negative breast cancer with a 21-gene recurrence score (RS) less than 26. We investigated how these findings apply to different racial and ethnic groups within the trial.

Methods: The trial randomly assigned women to endocrine therapy (ET) or to chemotherapy plus ET.

National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.

Purpose: National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC).

Methods: The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year.

Socioeconomic Deprivation and Health Care Use in Patients Enrolled in SWOG Cancer Clinical Trials.

Importance: Reducing acute care use is an important strategy for improving value. Patients with cancer are at risk for unplanned emergency department (ED) visits and hospital stays (HS). Clinical trial patients have homogeneous treatment; despite this, structural barriers to care may independently impact acute care use.

Impact of Broadening Trial Eligibility Criteria on the Inclusion of Patients With Brain Metastases in Cancer Clinical Trials: Time Series Analyses for 2012-2022.

Purpose: In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US Food and Drug Administration (ASCO/FoCR/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of exclusions regarding patients with brain metastases changed over time in relation to these recommendations.

Methods: Trial eligibility criteria were abstracted from ClinicalTrials.