Feasibility of precision smoking treatment in a low-income community setting: results of a pilot randomized controlled trial in The Southern Community Cohort Study.

BACKGROUND: The feasibility of precision smoking treatment in socioeconomically disadvantaged communities has not been studied. METHODS: Participants in the Southern Community Cohort Study who smoked daily were invited to join a pilot randomized controlled trial of three smoking cessation interventions: guideline-based care (GBC), GBC plus nicotine metabolism-informed care (MIC), and GBC plus counseling guided by a polygenic risk score (PRS) for lung cancer. Feasibility was assessed by rates of study enrollment, engagement, and retention, targeting > 70% for each. Using logistic regression, we also assessed whether feasibility varied by age, sex, race, income, education, and attitudes toward precision smoking treatment. RESULTS: Of 92 eligible individuals (79.3% Black; 68.2% with household income < $15,000), 67 (72.8%; 95% CI 63.0-80.9%) enrolled and were randomized. Of these, 58 (86.6%; 95% CI 76.4-92.8%) engaged with the intervention, and of these engaged participants, 43 (74.1%; 95% CI 61.6-83.7%) were retained at 6-month follow-up. Conditional on enrollment, older age was associated with lower engagement (OR 0.83, 95% CI 0.73-0.95, p = 0.008). Conditional on engagement, retention was significantly lower in the PRS arm than in the GBC arm (OR 0.18, 95% CI 0.03-1.00, p = 0.050). No other selection effects were observed. CONCLUSIONS: Genetically informed precision smoking cessation interventions are feasible in socioeconomically disadvantaged communities, exhibiting high enrollment, engagement, and retention irrespective of race, sex, income, education, or attitudes toward precision smoking treatment. Future smoking cessation interventions in this population should take steps to engage older people and to sustain participation in interventions that include genetic risk counseling. TRIAL REGISTRATION: ClinicalTrials.gov No. NCT03521141, Registered 27 April 2018, https://www. CLINICALTRIALS: gov/study/NCT03521141.

A comprehensive assessment of the prolonged febrile neutropenia evaluation in pediatric oncology patients.

BACKGROUND: Pediatric oncology patients with prolonged (≥96 hours) febrile neutropenia (absolute neutrophil count < 500/µL) often undergo an evaluation for invasive fungal disease (IFD) and other infections. Current literature suggests that beta-D-glucan (BDG), galactomannan, bronchoalveolar lavage (BAL), and computed tomography (CT) scans (sinus, chest, and abdomen/pelvis) may help determine a diagnosis in this population. METHODS: In a retrospective cohort study of all cancer/stem cell transplant patients (diagnosed 2005-2019) from one pediatric hospital, all episodes with prolonged febrile neutropenia or IFD evaluations (defined as sending a fungal biomarker or performing a CT scan to assess for infection) were identified. RESULTS: In total, 503 episodes met inclusion criteria and 64% underwent IFD evaluations. In total, 36.4% of episodes documented an infection after initiation of prolonged febrile evaluation, most commonly Clostridioides difficile colitis (6.4%) followed by a true bacterial bloodstream infection (BSI) (5.2%), proven/probable IFD (4.8%), and positive respiratory pathogen panel (3.6%). There was no difference in sinus CTs showing sinusitis (74% vs 63%, p = 0.46), whereas 32% of abdomen/pelvis CTs led to a non-IFD diagnosis, and 25% of chest CTs showed possible pneumonia. On chest CT, the positive predictive value (PPV) for IFD was 19% for nodules and 14% for tree and bud lesions. BDG had a PPV of 25% for IFD and GM 50%. BAL diagnosed IFD once and pneumocystis jirovecii pneumonia twice. CONCLUSIONS: Chest CTs and abdomen/pelvis CTs provide clinically relevant information during the prolonged febrile neutropenia evaluation, whereas BDG, galactomannan, BAL, and sinus CTs have less certain utility.

Posttraumatic stress symptoms and financial toxicity among adolescent and young adult oncology patients and their caregivers at cancer diagnosis.

BACKGROUND: Adolescent and young adult oncology (AYAO) patients and caregivers may experience significant psychosocial dysfunction and financial toxicity. Understanding early risk factors is critical to improving survivorship trajectories. METHODS: The authors conducted a cross-sectional study of baseline survey data from a prospective cohort of AYAO patient-caregiver dyads enrolled within 1 month of medical oncology treatment initiation. Posttraumatic stress symptoms (PTSS) were measured by the Impacts of Events Scale-Revised, and financial toxicity was measured with the Comprehensive Score (COst). The authors fit models of linear association between PTSS, financial toxicity, and other end points and pairwise associations of PTSS and financial toxicity within dyads. RESULTS: The analytic cohort contained 41 patients, 37 caregivers, and 34 complete dyads. Clinically-concerning PTSS were observed among patients (44%) and caregivers (52%). The median COst scores were 20.0 for patients (quartiles, 12.5-29.5) and 22.0 for caregivers (quartiles, 12.8-26.0), which were consistent with high financial toxicity (patients, 46%; caregivers, 44%). PTSS were positively associated with financial toxicity (P = .013 for patients, P = .039 for caregivers), subjective distress (P < .001 for all), depressive (P < .001 for all) and anxiety symptoms (P = .005 for patients, P = .024 for caregivers), and poorer quality of life (P < .001 for patients, P = .003 for caregivers). A significant paired association was not found in PTSS (Pearson correlation coefficient [PCC], 0.23; 95% confidence interval [CI], -0.15 to 0.56). Financial toxicity was positively associated within dyads (PCC, 0.65; 95% CI, 0.36-0.83). CONCLUSIONS: At diagnosis, AYAO patients and caregivers exhibit substantial PTSS, which are associated with greater financial toxicity and other psychosocial distress.

Enhancing Cancer care of rural dwellers through telehealth and engagement (ENCORE): protocol to evaluate effectiveness of a multi-level telehealth-based intervention to improve rural cancer care delivery.

BACKGROUND: Despite lower cancer incidence rates, cancer mortality is higher among rural compared to urban dwellers. Patient, provider, and institutional level factors contribute to these disparities. The overarching objective of this study is to leverage the multidisciplinary, multispecialty oncology team from an academic cancer center in order to provide comprehensive cancer care at both the patient and provider levels in rural healthcare centers. Our specific aims are to: 1) evaluate the clinical effectiveness of a multi-level telehealth-based intervention consisting of provider access to molecular tumor board expertise along with patient access to a supportive care intervention to improve cancer care delivery; and 2) identify the facilitators and barriers to future larger scale dissemination and implementation of the multi-level intervention. METHODS: Coordinated by a National Cancer Institute-designated comprehensive cancer center, this study will include providers and patients across several clinics in two large healthcare systems serving rural communities. Using a telehealth-based molecular tumor board, sequencing results are reviewed, predictive and prognostic markers are discussed, and treatment plans are formulated between expert oncologists and rural providers. Simultaneously, the rural patients will be randomized to receive an evidence-based 6-week self-management supportive care program, Cancer Thriving and Surviving, versus an education attention control. Primary outcomes will be provider uptake of the molecular tumor board recommendation and patient treatment adherence. A mixed methods approach guided by the Consolidated Framework for Implementation Research that combines qualitative key informant interviews and quantitative surveys will be collected from both the patient and provider in order to identify facilitators and barriers to implementing the multi-level intervention. DISCUSSION: The proposed study will leverage information technology-enabled, team-based care delivery models in order to deliver comprehensive, coordinated, and high-quality cancer care to rural and/or underserved populations. Simultaneous attention to institutional, provider, and patient level barriers to quality care will afford the opportunity for us to broadly share oncology expertise and develop dissemination and implementation strategies that will enhance the cancer care delivered to patients residing within underserved rural communities. TRIAL REGISTRATION: Clinicaltrials.gov , NCT04758338 . Registered 17 February 2021 - Retrospectively registered, http://www.clinicaltrials.gov/.

Transforming a Face-to-Face Legacy Intervention to a Web-Based Legacy Intervention for Children With Advanced Cancer.

Research is needed to examine new and innovative web-based intervention delivery methods that are feasible, cost-effective, and acceptable to children and their families to increase access to palliative care services in the home and community. Our previous work included the development of a legacy intervention using face-to-face digital storytelling for children with cancer that showed feasibility and strong promise to improve child outcomes. However, face-to-face intervention delivery techniques limited our recruitment, thus decreasing sample size and potential access to broader populations. Here we present the systematic steps of the development of a web-based legacy intervention for children (7-17 years of age) with relapsed or refractory cancer and their parent caregivers. Counts and frequencies for parent (n = 81) reports on satisfaction surveys are presented and parent suggestions for future work. Results suggest the web-based legacy intervention is feasible and acceptable, with parent-perceived beneficial outcomes for the child, parent, and family. Results provide a foundation for web-based intervention development in palliative care and the implementation of a theoretically grounded intervention to reduce suffering of seriously ill children and their family members, thereby advancing the science of symptom management in vulnerable palliative care populations.

Knowledge of diagnosis, treatment history, and risk of late effects among childhood cancer survivors and parents: The impact of a survivorship clinic.

BACKGROUND: Childhood cancer survivors are at risk for treatment-related adverse health outcomes, known as late effects. Through matched and longitudinal cohorts, we assessed the impact of survivorship care on patient and parent knowledge of treatment history and associated health risks. PROCEDURE: Childhood cancer survivors were recruited from a single-institution survivorship clinic and matched with survivors receiving routine follow-up care (controls) on diagnosis, age, and time off therapy. One hundred seventy-four participants completed telephone interviews assessing knowledge of diagnosis, treatment history, and risk of late effects. Additionally, 48 new survivorship patients were followed longitudinally with serial interviews for 18 months. RESULTS: In the case-control study, survivorship participants were more likely than controls to correctly report their diagnosis (98% vs. 90%, P = 0.039) and indicate a previous discussion of risk of late effects (99% vs. 62%, P<0.0001). Compared to controls, survivorship participants were 13% more sensitive reporting chemotherapeutics (95%CI 2.8-23.7%, P = 0.013) and 12% more sensitive reporting late effect risk (95%CI 7.3-16.6%, P<0.0001). In the longitudinal cohort, participants were 7% more sensitive reporting chemotherapeutics (95%CI 5.4-10.8%, P < 0.001) and 9% more sensitive reporting late effect risk (95%CI 5.6-23.8%, P<0.001) at 3 months compared to baseline. In regression analysis, baseline knowledge correlated with subsequent interview performance, and time since survivorship visit correlated with decreased knowledge of late effects, but not diagnosis or treatment history. CONCLUSIONS: Survivorship care was associated with increased knowledge of diagnosis, treatment history, and risk of late effects in both cohorts. Knowledge of late effects decreases with time, suggesting the need for additional educational strategies.

Second neoplasms in survivors of childhood cancer: findings from the Childhood Cancer Survivor Study cohort.

PURPOSE: To review the reports of subsequent neoplasms (SNs) in the Childhood Cancer Survivor Study (CCSS) cohort that were made through January 1, 2006, and published before July 31, 2008, and to discuss the host-, disease-, and therapy-related risk factors associated with SNs. PATIENTS AND METHODS: SNs were ascertained by survivor self-reports and subsequently confirmed by pathology findings or medical record review. Cumulative incidence of SNs and standardized incidence ratios for second malignant neoplasms (SMNs) were calculated. The impact of host-, disease-, and therapy-related risk factors was evaluated by Poisson regression. RESULTS: Among 14,358 cohort members, 730 reported 802 SMNs (excluding nonmelanoma skin cancers). This represents a 2.3-fold increase in the number of SMNs over that reported in the first comprehensive analysis of SMNs in the CCSS cohort, which was done 7 years ago. In addition, 66 cases of meningioma and 1,007 cases of nonmelanoma skin cancer were diagnosed. The 30-year cumulative incidence of SMNs was 9.3% and that of nonmelanoma skin cancer was 6.9%. Risk of SNs remains elevated for more than 20 years of follow-up for all primary childhood cancer diagnoses. In multivariate analyses, risks differ by SN subtype, but include radiotherapy, age at diagnosis, sex, family history of cancer, and primary childhood cancer diagnosis. Female survivors whose primary childhood cancer diagnosis was Hodgkin's lymphoma or sarcoma and who received radiotherapy are at particularly increased risk. Analyses of risk associated with radiotherapy demonstrated different dose-response curves for specific SNs. CONCLUSION: Childhood cancer survivors are at a substantial and increasing risk for SNs, including nonmelanoma skin cancer and meningiomas. Health care professionals should understand the magnitude of these risks to provide individuals with appropriate counseling and follow-up.

Models of care for survivors of childhood cancer.

With improvements in therapy for childhood cancer, the expectation that most childhood cancer patients will survive and enter adulthood is a reality. There is clear evidence that survivors are at risk for adverse health-related long-term sequelae associated with their cancer and its treatment, requiring appropriate health care resources. What is less clear is how this health care should optimally be delivered. We review the functional and operational needs for long-term follow-up for childhood cancer survivors and present alternatives for models of care. Programs for childhood cancer survivors should provide mechanisms for monitoring and management of late effects, as well as support and advocacy for addressing psychosocial issues, health education, and assistance with financial concerns. Access to research is an important component as clinical care and research are integrally related. A multidisciplinary model that provides continuity of care throughout the disease course is optimal, providing transitions from acute anti-neoplastic therapy to follow-up and primary care, as well as from pediatric care to adult-oriented care. There is no single best model of care for all childhood cancer survivors. In evaluating different models, considerations include available resources as well as the particular cancer population being served. Not all survivors require the same level of services and the service level requirement for individual patients may change with time. As outcome research progresses for childhood cancer survivors, methodological issues of optimal health care delivery for this population deserve to be the subject of such research.

Issues and challenges in palliative care for children with cancer.

Although the majority of children with cancer are cured of their illness, the children who die from their disease or complications require special care at the end of life. We present special issues and challenges unique to pediatric palliative care and suggest ways in which we can face these issues and address the challenges. The care must be family centered and balance the needs of the health-care system, the child, and the family. The way in which the care is delivered, the services provided, and the place in which that care is given are not carved into a simple protocol. Quality of life is an important concept that is often overlooked. Educational initiatives for patients, families, health-care providers, and third-party payers are essential. Reimbursement for palliative care services presents a large barrier to provision of appropriate services to all children and families in need. Hypothesis-driven research must be developed to help us learn more about how best to deliver end-of-life care to children and their families.