Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer.

Importance: The longitudinal experience of patients is critical to the development of interventions to identify and reduce financial hardship. Objective: To evaluate financial hardship over 12 months in patients with newly diagnosed colorectal cancer (CRC) undergoing curative-intent therapy. Design, Setting, and Participants: This prospective, longitudinal cohort study was conducted between May 2018 and July 2020, with time points over 12 months. Participants included patients at National Cance Institute Community Oncology Research Program sites. Eligibility criteria included age at least 18 years, newly diagnosed stage I to III CRC, not started chemotherapy and/or radiation, treated with curative intent, and able to speak English. Data were analyzed from December 2022 through April 2023. Main Outcomes and Measures: The primary end point was financial hardship, measured using the Comprehensive Score for Financial Toxicity (COST), which assesses the psychological domain of financial hardship (range, 0-44; higher score indicates better financial well-being). Participants completed 30-minute surveys (online or paper) at baseline and 3, 6, and 12 months. Results: A total of 450 participants (mean [SD] age, 61.0 [12.0] years; 240 [53.3%] male) completed the baseline survey; 33 participants (7.3%) were Black and 379 participants (84.2%) were White, and 14 participants (3.1%) identified as Hispanic or Latino and 424 participants (94.2%) identified as neither Hispanic nor Latino. There were 192 participants (42.7%) with an annual household income of $60 000 or greater. There was an improvement in financial hardship from diagnosis to 12 months of 0.3 (95% CI, 0.2 to 0.3) points per month (P < .001). Patients with better quality of life and greater self-efficacy had less financial toxicity. Each 1-unit increase in Functional Assessment of Cancer Therapy-General (rapid version) score was associated with an increase of 0.7 (95% CI, 0.5 to 0.9) points in COST score (P < .001); each 1-unit increase in self-efficacy associated with an increase of 0.6 (95% CI, 0.2 to 1.0) points in COST score (P = .006). Patients who lived in areas with lower neighborhood socioeconomic status had greater financial toxicity. Neighborhood deprivation index was associated with a decrease of 0.3 (95% CI, -0.5 to -0.1) points in COST score (P = .009). Conclusions and Relevance: These findings suggest that interventions for financial toxicity in cancer care should focus on counseling to improve self-efficacy and mitigate financial worry and screening for these interventions should include patients at higher risk of financial burden.

Utilization of Diagnostic Procedures After Lung Cancer Screening in the National Lung Screening Trial.

OBJECTIVE: To examine utilization patterns of diagnostic procedures after lung cancer screening among participants enrolled in the National Lung Screening Trial. METHODS: Using a sample of National Lung Screening Trial participants with abstracted medical records, we assessed utilization of imaging, invasive, and surgical procedures after lung cancer screening. Missing data were imputed using multiple imputation by chained equations. For each procedure type, we examined utilization within a year after the screening or until the next screen, whichever came first, across arms (low-dose CT [LDCT] versus chest X-ray [CXR]) and by screening results. We also explored factors associated with having these procedures using multivariable negative binomial regressions. RESULTS: After baseline screening, our sample had 176.5 and 46.7 procedures per 100 person-years for those with a false-positive and negative result, respectively. Invasive and surgical procedures were relatively infrequent. Among those who screened positive, follow-up imaging and invasive procedures were 25% and 34% less frequent in those screened with LDCT, compared with CXR. Postscreening utilization of invasive and surgical procedures was 37% and 34% lower at the first incidence screen compared with baseline. Participants with positive results at baseline were six times more likely to undergo additional imaging than those with normal findings. DISCUSSION: Use of imaging and invasive procedures to evaluate abnormal findings varied by screening modality, with a lower rate for LDCT than CXR. Invasive and surgical workup were less prevalent after subsequent screening examinations compared with baseline screening. Utilization was associated with older age but not gender, race or ethnicity, insurance status, or income.

Impact of Neck PET/CT Positivity on Survival Outcomes-Visual and Quantitative Assessment: Results From ACRIN 6685.

INTRODUCTION: FDG PET/CT was prospectively studied in 287 cN0 head and neck cancer patients in ACRIN 6685, and additional analysis of neck FDG uptake upon recurrence-free survival (RFS) and overall survival (OS) was performed. PATIENTS AND METHODS: Two hundred eight had analyzable data. Survival analysis was performed to compare RFS and OS based on neck FDG visual assessment (VA) and SUV max . For SUV max , the optimal thresholds were calculated using conditional inference trees on a randomly selected 70% training data set and validated using the remaining 30% of data. Kaplan-Meier curves with log-rank tests were generated for the patient groups based on VA and optimal SUV max thresholds, and the hazards ratios (HRs) and 95% confidence intervals (CIs) were also calculated. Hypothesis testing was set at a significance level of 0.05. RESULTS: A total of 73.9% of bilateral cN0 and 50.0% of unilateral cN0 were alive at the end of the study with the remaining being dead or lost to follow-up. Overall survival median follow-up time was 24.0 months (interquartile range, 15.8-25.3; range, 0-37.0). A total of 63.3% of bilateral cN0 and 42.5% of unilateral cN0 patients remained disease free during the study. Recurrence-free survival median follow-up time was 23.9 months (interquartile range, 12.4-25.2; range, 0-35.6). Visual assessment of necks by our panel of radiologists was significantly associated with RFS (HR [95% CI], 2.30 [1.10-4.79]; P = 0.02), but not with OS (HR [95% CI], 1.64 [0.86-3.14]; P = 0.13). The optimal SUV max thresholds were 2.5 for RFS and 5.0 for OS. For SUV max assessment, applying the optimal thresholds to the 30% test data yielded HRs (95% CIs) of 2.09 (0.61-7.14; P = 0.23) for RFS and 3.42 (1.03-11.41; P = 0.03) for OS. The SUV max threshold of 5.0 was significantly associated with RFS (HR [95% CI], 5.92 [1.79-19.57]; P < 0.001). CONCLUSIONS: Neck FDG uptake by VA is significant for RFS. An SUV max threshold of 5.0 is significantly associated with OS and RFS.

Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0].

BACKGROUND: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings. METHODS/DESIGN: This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes. DISCUSSION: This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.

FDG-PET/CT and Pathology in Newly Diagnosed Head and Neck Cancer: ACRIN 6685 Trial, FDG-PET/CT cN0.

OBJECTIVE: FDG-PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography) is effective to assess for occult neck nodal disease. We report risks and patterns of nodal disease based on primary site and nodal level from data on the dissected cN0 per the results from ACRIN 6685. STUDY DESIGN: Prospective nonrandomized enrollment included participants with first-time head and neck squamous cell carcinoma and at least 1 cN0 neck side to be dissected. SETTING: Twenty-four ACRIN-certified centers internationally (American College of Radiology Imaging Network). METHODS: A total of 287 participants were enrolled. Preoperative FDG-PET/CT findings were centrally reviewed and compared with pathology. Incidence, relative risk, pattern of lymph node involvement, and impact upon neck dissection were reported. RESULTS: An overall 983 nodal levels were dissected (n = 261 necks, n = 203 participants). The highest percentages of ipsilateral positive nodes by primary location and nodal level were oral cavity (level I, 17/110, 15.5%), pharynx (level II, 6/30, 20.0%), and larynx (level VI, 1/3, 33.3%). CONCLUSION: Levels at greatest risk for nodal disease in cN0 in terms of ipsilateral neck dissection are level I (oral cavity), II (pharynx), and VI (larynx). These data should be considered when treating patients presenting with cN0. This is the first study to comprehensively report the incidence, location, and risk of metastases in cN0 in the FDG-PET/CT era.

Micronodules Detected on Computed Tomography During the National Lung Screening Trial: Prevalence and Relation to Positive Studies and Lung Cancer.

INTRODUCTION: In the National Lung Screening Trial (NLST) all cases with a 4-mm nodule (micronodule) and no other findings were classified as a negative study. The prevalence and malignant potential of micronodules in the NLST is evaluated to understand if this classification was appropriate. METHODS AND MATERIALS: In the NLST a total of 53,452 participants were enrolled with 26,722 undergoing low-dose computed tomography (CT) screening. To determine whether a micronodule developed into a lung cancer, a list from the NLST database of those participants who developed lung cancer and had a micronodule recorded was selected. The CT images of this subset were reviewed by experienced, fellowship-trained thoracic radiologists (R.F.M., C.C., P.M.B., and D.R.A.), all of whom participated as readers in the NLST. RESULTS: There were 26,722 participants who underwent CT in the NLST, of which 11,326 (42%) participants had at least one CT with a micronodule. Five thousand five hundred sixty (49%) of these participants had at least one positive CT examination, of which 409 (3.6%) subsequently were diagnosed with lung cancer. Of the 409 lung cancer cases with a micronodule recorded, there were 13 cases in which a micronodule developed into lung cancer. Considering the 13 cases, they represent 1.2% (13 of 1089) of the lung cancers diagnosed in the CT arm of the NLST and 0.11% (13 of 11,326) of the total micronodule cases. Additionally they represent 0.23% (13 of 5560) of the micronodule and at least one positive CT examination cases and 3.2% (13 of 409) of the micronodule cases diagnosed with lung cancer. The average size of the nodule at baseline (recorded as maximum diameter by perpendicular diameter) was 3.0 × 2.5 mm (ranges 2 x 4 mm and 2 x 4 mm) and at the positive CT the nodule was 11.1 × 8.6 mm (ranges, 6 x 20 mm and 5 x 14 mm); a difference of average change in size of 8.1 × 6.1 mm. The average number of days from first CT with a micronodule recorded to positive CT was 459 days (range, 338 - 723 days), the mean time from first CT with micronodule to lung cancer diagnosis was 617 days (range, 380 - 1140 days) and the mean time from positive CT to lung cancer diagnosis was 160 days (range, 18 - 417 days). Histologically, there was one small cell carcinoma and 12 non-small cell with stages of IA in 8 (62%), stage IB in 2 (15%), and 1 each stage IIIA, IIIB, and IV. The overall survival of NSCLC cases with a micronodule was not significantly different than the survival of the CT subset diagnosed with NSCL (p = 0.36). CONCLUSIONS: Micronodules are common among lung cancer-screened participants and are capable of developing into lung cancer; however, following micronodules by annual CT screening surveillance is appropriate and does not impact overall survival or outcome.

Lung Cancer Screening in the National Cancer Institute Community Oncology Research Program: Availability and Service Organization.

PURPOSE: Annual low-dose CT (LDCT) for lung screening in high-risk individuals decreases both lung cancer-specific mortality and all-cause mortality. Community oncology practice networks constituting the National Cancer Institute Community Oncology Research Program (NCORP) conduct clinical trials across the cancer spectrum. The authors report access to and characteristics of LDCT screening for lung cancer in these community oncology practices. METHODS: A landscape capacity assessment was conducted in 2017 across the NCORP network. The primary outcome was the proportion of adult oncology practice groups offering LDCT lung screening on site. The secondary outcomes were the proportion of those screening services (1) with radiologist participation in service management and (2) offered at ACR Designated Lung Cancer Screening Centers. RESULTS: Fifty-two percent of components and subcomponents responded to at least some portion of the assessment, representing 217 practice groups. Analyzing the 211 adult oncology practice groups responding to the primary question, 73% offered lung screening services on site. Radiologists participated in managing 69% of these services. Forty-seven percent were offered in ACR Designated Lung Cancer Screening Centers. Minority and underserved practice groups were less likely to offer lung screening; however, this association dissipated when analyses focused on practices within the United States. Safety net and Critical Access Hospital designation increased the likelihood of screening availability. CONCLUSIONS: The majority of community oncology practice groups within the NCORP offered lung screening on site, although radiologist participation in service management and ACR Lung Cancer Screening Center designation, markers of service quality, were more variable.

Multicenter Trial of [18F]fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Staging of Head and Neck Cancer and Negative Predictive Value and Surgical Impact in the N0 Neck: Results From ACRIN 6685.

PURPOSE: The objective of this study was to determine the negative predictive value (NPV) of positron emission tomography (PET)/computed tomography (CT) for the clinically N0 neck on the basis of neck dissection. METHODS: Participants with newly diagnosed, first-time, head and neck squamous cell carcinoma (HNSCC) and at least one clinically N0 neck side for which dissection was planned were included. A total of 287 participants were prospectively enrolled from 23 American College of Radiology Imaging Network-qualified institutions. PET/CT was compared with findings at neck dissection. RESULTS: PET/CT scans and pathology findings were available for 270 N0 neck sides from 212 participants. For visual assessment, the NPV specific to the clinical-N0 sides was 0.868 (95% CI, 0.803 to 0.925). For dichotomized maximum standardized uptake value, the NPVs specific to the nodal basins were 0.940 (95% CI, 0.928 to 0.952) and 0.937 (95% CI, 0.925 to 0.949) at prespecified cutoffs of 2.5 and 3.5, respectively. The optimal cutoff maximum standardized uptake value was determined to be 1.8, with an NPV of 0.942 (95% CI, 0.930 to 0.953). The PET/CT-informed surgical treatment plan was changed in 51 of 237 participants (22%) compared with the PET/CT-blinded surgical plan. In 34 participants (14%), this led to planned dissection of additional nodal levels. In 12 participants (5%), this led to fewer planned dissected nodal levels. Negative PET/CT scans in N0 necks was true negative in 87% and false negative in 13%. CONCLUSION: [18F]fluorodeoxyglucose-PET/CT has high NPV for the N0 neck in T2 to T4 HNSCC. The surgical treatment plans on the basis of PET/CT findings may be changed in approximately 22% of this group. These findings suggest that [18F]fluorodeoxyglucose-PET/CT may assist the clinician in deciding on the best therapy for the clinically N0 neck in HNSCC. Well-designed clinical trials should be performed to test the outcome of omitting neck dissection by using PET/CT.

Medical Care Costs Were Similar Across the Low-dose Computed Tomography and Chest X-Ray Arms of the National Lung Screening Trial Despite Different Rates of Significant Incidental Findings.

BACKGROUND: The National Lung Screening Trial (NLST) reported lung cancer and all-cause mortality reductions for low-dose computed tomography (LDCT) versus chest x-ray (CXR) screening. Although LDCT lung screening has received a grade B from the United States Preventive Services Task Force and is a covered service under most health plans, concerns remain on the costs engendered by screening, and the impact of the high rate of significant incidental finding (SIF) detection on those costs. METHODS: We linked American College of Radiology Imaging Network NLST and Medicare fee-for-service claims data for participants from 23 sites for 2002-2009. We performed participant-level analyses using generalized linear regression models to estimate the adjusted annual mean of the 3-year total medical costs per person in each study arm and within screen outcome categories (ever positive with abnormalities suspicious for lung cancer, always negative for abnormalities suspicious for lung cancer, but with SIFs, and always negative without SIFs). RESULTS: The adjusted annual mean total per person costs were not significantly different between screening arms [LDCT, $11,029 (95% confidence interval, $10,107-$11,951); CXR, $10,905 (95% confidence interval, $10,059-$11,751)], despite higher proportions of individuals with SIFs in the LDCT versus the CXR arm (18% vs. 4%; P<0.0001). CONCLUSIONS: We found little difference in total annual per person costs between LDCT-screened and CXR-screened Medicare participants, despite the higher number of SIFs in the LDCT arm of the study.

Capacity for Cancer Care Delivery Research in National Cancer Institute Community Oncology Research Program Community Practices: Availability of Radiology and Primary Care Research Partners.

PURPOSE: Cancer care spans the spectrum from screening and diagnosis through therapy and into survivorship. Delivering appropriate care requires patient transitions across multiple specialties, such as primary care, radiology, and oncology. From the program's inception, the National Cancer Institute Community Oncology Research Program (NCORP) sites were tasked with conducting cancer care delivery research (CCDR) that evaluates structural, organizational, and social factors, including care transitions that determine patient outcomes. The aim of this study is to describe the capacity of the NCORP to conduct multidisciplinary CCDR that includes radiology and primary care practices. METHODS: The NCORP includes 34 community and 12 minority and underserved community sites. The Landscape Capacity Assessment was conducted in 2015 across these 46 sites, composed of the 401 components and subcomponents designated to conduct CCDR. Each respondent had the opportunity to designate an operational practice group, defined as a group of components and subcomponents with common care practices and resources. The primary outcomes were the proportion of adult oncology practice groups with affiliated radiology and primary care practices. The secondary outcomes were the proportion of those affiliated radiology and primary care groups that participate in research. RESULTS: Eighty-seven percent of components and subcomponents responded to at least some portion of the assessment, representing 230 practice groups. Analyzing the 201 adult oncology practice groups, 85% had affiliated radiologists, 69% of whom participate in research. Seventy-nine percent had affiliated primary care practitioners, 31% of whom participate in research. Institutional size, multidisciplinary group practice, and ownership by large regional or multistate health systems was associated with research participation by affiliated radiology and primary care groups. Research participation by these affiliated specialists was not significantly different between the community and the minority and underserved community sites. CONCLUSIONS: Research relationships exist between the majority of community oncology sites and affiliated radiology practices. Research relationships with affiliated primary care practices lagged. NCORP as a whole has the opportunity to encourage continued and expanded engagement where relationships exist. Where no relationship exists, the NCORP can encourage recruitment, particularly of primary care practices as partners.