Institute Community Oncology Research Program Research Articles

Clinical and biological landscape of constitutional mismatch-repair deficiency syndrome: an International Replication Repair Deficiency Consortium cohort study.

Constitutional mismatch repair deficiency (CMMRD) syndrome is a rare and aggressive cancer predisposition syndrome. Because a scarcity of data on this condition contributes to management challenges and poor outcomes, we aimed to describe the clinical spectrum, cancer biology, and impact of genetics on patient survival in CMMRD. In this cohort study, we collected cross-sectional and longitudinal data on all patients with CMMRD, with no age limits, registered with the International Replication Repair Deficiency Consortium (IRRDC) across more than 50 countries. Clinical data were extracted from the IRRDC database, medical records, and physician-completed case record forms. The primary objective was to describe the clinical features, cancer spectrum, and biology of the condition. Secondary objectives included estimations of cancer incidence and of the impact of the specific mismatch-repair gene and genotype on cancer onset and survival, including after cancer surveillance and immunotherapy interventions. We analysed data from 201 patients (103 males, 98 females) enrolled between June 5, 2007 and Sept 9, 2022. Median age at diagnosis of CMMRD or a related cancer was 8·9 years (IQR 5·9-12·6), and median follow-up from diagnosis was 7·2 years (3·6-14·8). Endogamy among minorities and closed communities contributed to high homozygosity within countries with low consanguinity. Frequent dermatological manifestations (117 [93%] of 126 patients with complete data) led to a clinical overlap with neurofibromatosis type 1 (35 [28%] of 126). 339 cancers were reported in 194 (97%) of 201 patients. The cumulative cancer incidence by age 18 years was 90% (95% CI 80-99). Median time between cancer diagnoses for patients with more than one cancer was 1·9 years (IQR 0·8-3·9). Neoplasms developed in 15 organs and included early-onset adult cancers. CNS tumours were the most frequent (173 [51%] cancers), followed by gastrointestinal (75 [22%]), haematological (61 [18%]), and other cancer types (30 [9%]). Patients with CNS tumours had the poorest overall survival rates (39% [95% CI 30-52] at 10 years from diagnosis; log-rank p<0·0001 across four cancer types), followed by those with haematological cancers (67% [55-82]), gastrointestinal cancers (89% [81-97]), and other solid tumours (96% [88-100]). All cancers showed high mutation and microsatellite indel burdens, and pathognomonic mutational signatures. MLH1 or MSH2 variants caused earlier cancer onset than PMS2 or MSH6 variants, and inferior survival (overall survival at age 15 years 63% [95% CI 55-73] for PMS2, 49% [35-68] for MSH6, 19% [6-66] for MLH1, and 0% for MSH2; p<0·0001). Frameshift or truncating variants within the same gene caused earlier cancers and inferior outcomes compared with missense variants (p<0·0001). The greater deleterious effects of MLH1 and MSH2 variants as compared with PMS2 and MSH6 variants persisted despite overall improvements in survival after surveillance or immune checkpoint inhibitor interventions. The very high cancer burden and unique genomic landscape of CMMRD highlight the benefit of comprehensive assays in timely diagnosis and precision approaches toward surveillance and immunotherapy. These data will guide the clinical management of children and patients who survive into adulthood with CMMRD. The Canadian Institutes for Health Research, Stand Up to Cancer, Children's Oncology Group National Cancer Institute Community Oncology Research Program, Canadian Cancer Society, Brain Canada, The V Foundation for Cancer Research, BioCanRx, Harry and Agnieszka Hall, Meagan's Walk, BRAINchild Canada, The LivWise Foundation, St Baldrick Foundation, Hold'em for Life, and Garron Family Cancer Center.

Defining Practice Capacity for Cancer Care Delivery to Adolescents and Young Adults in the Community Setting: 2022 Landscape Assessment Results.

Background: Adolescents and young adults (AYAs) commonly receive cancer care in the community setting, but the availability of treatment options, resources, and support services for this population is not well known. The National Cancer Institute Community Oncology Research Program (NCORP) funds a network of practices whose mission is to increase access to cancer care and clinical trials in the community setting. We describe our interdisciplinary methodological approach to identify and characterize NCORP practices where AYAs receive cancer care. Methods: NCORP practices completed a cross-sectional Landscape Assessment to describe resources and practice characteristics. We established an interdisciplinary team of stakeholders to analyze the Landscape Assessment data relating to AYAs. Through an iterative process, we assessed NCORP practice responses to questions assessing AYA cancer care capacity, determined a threshold to define practices treating AYAs, and characterized these practices. Results: We determined that practices provide cancer care to AYAs if the following criteria were met: (1) endorsed having an AYA program (n = 20), (2) AYAs comprised ≥5% of annual cancer cases (n = 55), or (3) the practice treated ≥50 AYA cancer cases annually (n = 70). Of 271 NCORP practices, 100 (37%) met any criteria, whereas 87 (32%) did not; 84 (31%) could not be classified due to missing or unknown data. Conclusion: Using an interdisciplinary process, we define practices that treat AYAs in the community. We posit a uniform approach to examine resources and practice capacity for AYAs receiving cancer care across the United States to guide future AYA-focused cancer care delivery research development.

SWOG S1820: A pilot randomized trial of the Altering Intake, Managing Bowel Symptoms Interventionin Survivors of Rectal Cancer.

Survivors of rectal cancer experience persistent bowel dysfunction after treatments. Dietary interventions may be an effective approach for symptom management and posttreatment diet quality. SWOG S1820 was a pilot randomized trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention for bowel dysfunction in survivors of rectal cancer. Ninety-three posttreatment survivors were randomized to the AIMS-RC group (N=47) or the Healthy Living Education attention control group (N=46) after informed consent and completion of a prerandomization run-in. Outcome measures were completed at baseline and at 18 and 26weeks postrandomization. The primary end point was total bowel function score, and exploratory end points included low anterior resection syndrome (LARS) score, quality of life, dietary quality, motivation, self-efficacy, and positive/negative affect. Most participants were White and college educated, with a mean age of 55.2years and median time since surgery of 13.1months. There were no statistically significant differences in total bowel function score by group, with the AIMS-RC group demonstrating statistically significant improvements in the exploratory end points of LARS (p=.01) and the frequency subscale of the bowel function index (p=.03). The AIMS-RC group reported significantly higher acceptability of the study. SWOG S1820 did not provide evidence of benefit from the AIMS-RC intervention relative to the attention control. Select secondary end points did demonstrate improvements. The study was highly feasible and acceptable for participants in the National Cancer Institute Community Oncology Research Program. Findings provide strong support for further refinement and effectiveness testing of the AIMS-RC intervention.

Characteristics of Health Care Settings Where Adolescents and Young Adults Receive Care for ALL.

Individuals diagnosed with cancer between 15 and 39 years (adolescent and young adult [AYA]) face unique vulnerability. Detail is lacking about care delivery for these patients, especially those with ALL. We address these knowledge gaps by describing AYA ALL care delivery details at National Cancer Institute Community Oncology Research Program (NCORP) (sub)affiliates by model of care. Participating institutions treated at least one AYA with ALL from 2012 to 2016. Study-specific criteria were used to determine the number of unique clinical facilities (CFs) per NCORP and their model of care (adult/internal medicine [IM], pediatric, mixed [both]). Surveys completed by NCORPs for each CF by model of care captured size, resources, services, and communication. Among 84 participating CFs (adult/IM, n=47; pediatric, n=15; mixed, n=24), 34% treated 5-10 AYAs with ALL annually; adult/IM CFs more often treated <5 (adult/IM, 60%; pediatric, 40%; mixed, 29%). Referral decisions were commonly driven by an age/diagnosis combination (58%), with frequent ALL-specific age minimums (87%) or maximums (80%). Medical, navigational, and social work services were similar across models while psychology was available at more pediatric CFs (pediatric, 80%; adult/IM, 40%; mixed, 46%-54%). More pediatric or mixed CFs reported oncologists interacting with pediatric/adult counterparts via tumor boards (pediatric, 93%; adult/IM, 26%; mixed, 96%) or initiating contact (pediatric, 100%; adult/IM, 77%; mixed 96%); more pediatric CFs reported an affiliated counterpart (pediatric, 53%; adult, 19%). Most CFs reported no AYA-specific resources (79%) or meetings (83%-98%). System-level aspects of AYA ALL care delivery have not been examined previously. At NCORPs, these characteristics differ by models of care. Additional work is ongoing to investigate the impact of these facility-level factors on guideline-concordant care in this population. Together, these findings can inform a system-level intervention for diverse practice settings.

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

The longitudinal experience of patients is critical to the development of interventions to identify and reduce financial hardship. To evaluate financial hardship over 12 months in patients with newly diagnosed colorectal cancer (CRC) undergoing curative-intent therapy. 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. 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. 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). 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.

Defining the Role of the Advanced Practice Provider Within the National Cancer Institute Community Oncology Research Program.

Oncology advanced practice providers (APPs), including nurse practitioners, clinical nurse specialists, physician assistants, and clinical pharmacists, contribute significantly to quality cancer care. Understanding the research-related roles of APPs in the National Cancer Institute's (NCI) Community Oncology Research Program (NCORP) could lead to enhanced protocol development, trial conduct, and accrual. The 2022 NCORP Landscape Assessment Survey asked two questions about the utilization and roles of APPs in the NCORP. A total of 271 practice groups completed the 2022 survey, with a response rate of 90%. Of the 259 nonpediatric exclusive practice groups analyzed in this study, 92% used APPs for clinical care activities and 73% used APPs for research activities. APPs most often provided clinical care for patients enrolled in trials (97%), followed by assistance with coordination (65%), presenting/explaining clinical trials (59%), screening patients (49%), ordering investigational drugs (37%), and consenting participants (24%). Some groups reported APPs as an enrolling investigator (18%) and/or participating in institutional oversight/selection of trials (15%). Only 5% of NCORP sites reported APPs as a site primary investigator for trials, and very few (3%) reported APPs participating in protocol development. Practice groups report involving APPs in clinical research within the NCORP network; however, opportunities for growth exists. As team-based care has enhanced clinical practice in oncology, this same approach can be used to enhance successful research. Suggested strategies include supporting APP research-related time, recognition, and education. The findings of this survey and subsequent recommendations may be applied to all adult oncology practices that participate in clinical research.

Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial

Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 30 to 60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. This 6-site, subject and assessor-blinded randomized clinical trial (RCT) was designed to assess 1) preliminary efficacy (ie, alpha pre-specified at .2) of a wearable, app-controlled, transcutaneous electrical nerve stimulation (TENS) device for chronic CIPN and 2) feasibility of conducting a confirmatory trial within the National Cancer Institute Community Oncology Research Program (NCORP) (NCT 04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were individual symptoms assessed daily (via 0–10 numeric rating scales). The primary analysis was an analysis of covariance (outcome: EORTC-CIPN20, fixed effect: arm, covariates: baseline EORTC-CIPN20 and site). Secondary analyses used a similar analysis of covariance models (excluding site) for each symptom on subgroups of subjects with ≥4 out of 10 for that symptom at baseline. 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. The difference between groups in the EORCT-CIPN20 at the endpoint (placebo-active) was 1.05 (95% Confidence Interval: −.56, 2.67; P = .199). The difference between groups for the individual symptoms was as follows: hot/burning pain: 1.37 (−.33, 3.08; P = .112), sharp/shooting pain: 1.21 (−.37, 2.79; P = .128), cramping: 1.35 (−.32, 3.02; P = .110), tingling: .23 (−.61, 1.08; P = .587), numbness: .27 (−.51, 1.05; P = .492). An RCT of an app-controlled TENS device for chronic CIPN with excellent retention is feasible in the NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN. A confirmatory RCT of TENS for painful CIPN is highly warranted. PerspectiveDaily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial. Future confirmatory trial is warranted.

Recruitment of informal caregivers into research studies in community oncology practices: Results from the 2022 NCI Community Oncology Research Program (NCORP) Landscape Committee Assessment.

219 Background: Understanding experiences of community oncology practices in recruiting informal (unpaid/family) caregivers into research studies can inform resources and strategies to improve their enrollment. In this study, we aimed to describe the recruitment of informal caregivers for research studies in community oncology practices. Methods: The 2022 cross-sectional Landscape Assessment of National Cancer Institute Community Oncology Research Program (NCORP) assessed research capacity among network oncology practices. The University of Rochester Cancer Center (URCC) NCORP Research Base used these data to examine factors associated with the recruitment of informal caregivers into research studies in community oncology practices, adjusting for region of the country, practice ownership type, and total number of oncologists in logistic regression analyses. Results: Information was available from 517 discrete practices representing 271 practice groups. After excluding those serving pediatric patients exclusively (n=12) and missing information on recruitment of informal caregivers (n=1), 258 practice groups were included in final analyses. The practice groups had on average 20 oncologists [standard deviation (SD) 28.8]. Over 70% of practice groups (190/258) had advanced practice providers (APPs) involved in clinical research activities. Less than one third of practice groups (30%, 78/258) had experience recruiting informal caregivers of oncology patients for research studies. Informal caregivers were recruited in the following settings: medical oncology (97%, 76/78), radiation oncology (24%, 19/78), survivorship clinic (14%, 11/78), and surgical oncology (10%, 8/78). On multivariable analysis, having a greater number of oncologists [odds ratio (OR) 2.40, 95% Confidence Interval (95% CI) 1.23 - 4.67] and having APPs involved in clinical research activities (OR 2.32, 95% CI 1.13 - 4.76) were positively associated with experience recruiting informal caregivers for research studies. Conclusions: Most community oncology practices did not have experience recruiting informal caregivers of oncology patients, which may reflect limited research in this area. Future research should explore barriers for recruiting informal caregivers into research studies, especially in practices that may have fewer resources such as small community oncology practices or those without APPs involved in research activities.

Assessment of financial screening and navigation capabilities at National Cancer Institute community oncology clinics.

Cancer-related financial hardship is a side effect of cancer diagnosis and treatment, and affects both patients and caregivers. Although many oncology clinics have increased financial navigation services, few have resources to proactively provide financial counseling and assistance to families affected by cancer before financial hardship occurs. As part of an ongoing randomized study testing a proactive financial navigation intervention, S1912CD, among sites of the National Cancer Institute Community Oncology Research Program (NCORP), we conducted a baseline survey to learn more about existing financial resources available to patients and caregivers. The NCORP sites participating in the S1912CD study completed a required 10-question survey about their available financial resources and an optional 5-question survey that focused on financial screening and navigation workflow and challenges prior to starting recruitment. The proportion of NCORP sites offering financial navigation services was calculated and responses to the optional survey were reviewed to determine current screening and navigation practices and identify any challenges. Most sites (96%) reported offering financial navigation for cancer patients. Sites primarily identified patients needing financial assistance through social work evaluations (78%) or distress screening tools (76%). Sites revealed challenges in addressing financial needs at the outset and through diagnosis, including lack of proactive screening and referral to financial navigation services as well as staffing challenges. Although most participating NCORP sites offer some form of financial assistance, the survey data enabled identification of gaps and challenges in providing services. Utilizing community partners to deliver comprehensive financial navigation guidance to cancer patients and caregivers may help meet needs while reducing site burden.

Information Technology and Telemedicine Services in Community Oncology Practices.

We described information technology support and use of telemedicine for cancer care and research purposes at community oncology practices within the National Cancer Institute Community Oncology Research Program (NCORP). We used data from the NCORP 2017 and 2022 Landscape Assessments. Separate logistic regression models were used to assess factors associated with the use of telemedicine for delivery of cancer care in 2017 and for research purposes in 2022 (cancer care delivery not assessed in 2022). Information was available from 210 and 259 practice groups excluding pediatric-only groups in 2017 and 2022, respectively. In 2017, 30% of practice groups used telemedicine for delivery of cancer care; half of these (15% overall) could use telemedicine for research purposes. In 2022, telemedicine was used for research purposes in 73% of practice groups. In multivariable models, self-identifying as a safety-net hospital was associated with a lower odd of telemedicine use for delivery of cancer care (adjusted odds ratio [AOR], 0.39; 95% CI, 0.17 to 0.93), whereas affiliation with a designated critical access hospital was associated with a higher odd of telemedicine use for delivery of cancer care (AOR, 2.29; 95% CI, 1.10 to 4.76). Having a general survivorship clinic (AOR, 1.92; 95% CI, 1.04 to 3.54) and number of oncology providers (increase per 10 providers; AOR, 1.32; 95% CI, 1.05 to 1.65) were associated with telemedicine use for research purposes. Almost one third of NCORP practice groups used telemedicine for cancer care delivery in 2017. In 2022, there is high capacity among NCORP practices (almost three-quarters) to use telemedicine for research purposes, especially among practices with a general survivorship clinic and a greater provider number.

Website and social media presence for National Cancer Institute Community Oncology Research Program (NCORP) sites.

e23009 Background: The National Cancer Institute Community Oncology Research program (NCORP) is a network which brings cancer clinical trials and care to patients within their own communities. Currently, NCORP consists of 46 sites throughout the United States which receive grant funding through the NCI. We aim to describe the scope of social media use and NCORP dedicated websites. We also aim to describe the correlation between media usage and funding. Methods: We searched NCORP websites and online search engines to identify the social media presence of different NCORP sites. Facebook, Instagram, LinkedIn, and Twitter were the social media sites chosen. Additionally, we searched for NCORP dedicated websites that were separate and distinct from the host institution. We were able to gather public data outlining the total funding received by each site in a three-year span (2019-2021) using the NIH RePORTER. Data was summarized using descriptive statistics. Results: A total of 15 out of 46 sites were determined to have a social media presence, 11 out of 46 sites had NCORP dedicated websites, and 7 out of 46 had both a social media presence and a dedicated website. The social media sites used for the NCORPs were as follows Facebook 8, Twitter 5, LinkedIn 3, and Instagram 1. The content information within the 11 dedicated websites were as follows clinical trials 9, newsletters 2, and provider information 8. All 11 websites had the NCI watermark badge (100% of NCORP websites). The average three-year funding for NCORP sites utilizing social media was $5,371,610. The average three-year funding for NCORP sites without social media was $4,230,552. The average three-year funding for NCORP sites utilizing dedicated websites was $4,681,708. The average three-year funding for NCORP sites without dedicated websites was 4,584,321. There was no statistical significance between funding and websites or social media accounts. Conclusions: NCORPs have an opportunity to disseminate high quality reliable information about cancer clinical trials that meet the need of patients and clinical care providers. However, NCORP sites are rarely a distinct voice on social media or with dedicated websites. Sites may not have resources for this type of communication or may promote the work of NCORP through the communication channels of the host institution(s). Sites with websites or social media accounts had higher average funding. However, this was not significant. Whether social media and NCORP dedicated websites contribute meaningfully to the work of NCI clinical trials remains to be seen and is beyond the scope of this investigation.

Telemedicine services in community oncology practices.

e13678 Background: Telemedicine services have grown tremendously due to the COVID-19 pandemic. We described the use of telemedicine for research purposes at community oncology practices. Methods: We utilized results from the National Cancer Institute Community Oncology Research Program 2017 and 2022 Landscape Surveys, which were designed to understand cancer delivery research capacity in community oncology practices. We used multivariable logistic regression to examine factors associated use of telemedicine for research purpose in 2022, adjusting for region, practice ownership type, and number of oncology providers. Results: Information was available from 504 and 685 discrete practices in 2017 and 2022, respectively. These represent 210 and 259 practice groups; practice groups serving only pediatric patients were excluded. Mean numbers of oncology providers at the practice group level were 18 (IQR 5-21) and 20 (IQR 7-22) in 2017 and 2022, respectively. Over 90% of practice groups reported having outpatient electronic health records and patient portal in both years. In 2022, IT service was available onsite in 71%. In 2017, 31% of practice groups utilized telemedicine for delivery of cancer care and 15% can utilize telemedicine for research purposes. In 2022, telemedicine was used for research purposes in 73% of practice groups. Specifically, telemedicine was used for collection of patient-reported outcomes (54%), delivery of health care interventions (47%), consent (39%), conduct of qualitative interviews (32%), delivery of behavioral interventions (30%), collection of biometric data (e.g., weight, blood pressure) (14%), and collection of neurocognitive testing data (12%). One-third of all practice groups (35%) did not have internet-abled devices available for patients, 53% had them onsite, and 2% had them on site and for patients to take home. On multivariable analysis, a greater number of oncology providers was associated with greater use of telemedicine for research purposes (every 10-unit increase, AOR 1.31, 95% CI 1.04-1.64). Conclusions: From 2017 to 2022, there has been an increased use of telemedicine for research purposes, though its use varies across practices. Bigger practice groups were more likely to use telemedicine for research purpose. Cancer care delivery research that incorporates telemedicine should consider implementing site-specific and standardized resources. [Table: see text]

The 2022 NCI Community Oncology Research Program (NCORP) Landscape Committee Assessment: Methods and participating practice group characteristics.

e13517 Background: The National Cancer Institute Community Oncology Research Program (NCORP) Landscape Assessment (funding support from 2UG1CA189824) provides important information about available services and capacity to engage in research among the 46 NCORP sites (encompassing ~1000 discrete clinics). We describe the methods for conducting the Landscape Assessment and present practice group characteristics. Methods: The Landscape Committee included representation from all NCORP research bases and community NCORP site members. The 2022 assessment was updated from the 2017 assessment after a network-wide request for questions. All items were reviewed for relevance, question quality, applicability to community sites, and data collection burden. The 2022 assessment update included an expanded range of topics (e.g., social determinants of health screening, pediatric and AYA services, fertility preservation services). After an initial pilot phase, the final assessment was distributed to NCORP affiliate/sub-affiliates via representatives designated by the participating sites. Data were collected April-June, 2022. Results: 271 NCORP practice groups rostered and provided demographics for 517 individual sites (98% response from NCORP sites; 52% of discrete clinics). 70 practice groups (26%) represented multiple NCORP clinics, with a median of 4 clinics (IQR: 2-7 sites). Practice groups were located in the Midwest (42%), South (30%), West (18%) and Northeast (10%). Treatment was provided to adults only at 83% of groups, 12% treated adults and children, and 5% provided only pediatric care. 28% were independently owned and 64% were owned by large regional health systems; 28% participated in the Center for Medicare and Medicaid Services Oncology Care Model. Cancer treatment services were provided in the hospital setting for 73%, freestanding practices in 49%, and 64% at inpatient clinics. The median number of annual cancer cases was 875 (IQR: 453-2,004). Practice groups reported on average most new patients were White (79%), followed by Black (13%), Asian (2.5%), and Native Hawaiian/Pacific Islander (0.64%). 10% were identified as Hispanic ethnicity. Provider availability to recruit patients for research varied by provider type (95% medical oncology; 73% radiation oncology; 47% general surgery/surgical oncology; 38% gynecology oncology; 21% uro-oncology; 19% neuro-oncology; 15% pediatric oncology; &amp; 7% orthopedic surgical oncology). Conclusions: The Landscape assessment was successfully updated and administered in 2022 with a high response rate. Results provide updated information about community site infrastructure and capacity to conduct research among NCORP clinics. Detailed results are available to investigators by request for concept development and to help identify affiliate/sub-affiliate sites to participate in studies.

Availability of palliative specialty care for adults in community oncology: Results from the 2022 NCORP landscape assessment.

e24125 Background: Palliative care promotes timely symptom management, and care planning and improves quality of life in oncology patients. About 60% of community oncology practices sampled in 2015 had outpatient palliative care. This study updates estimates of palliative care resources in community oncology. Methods: Questions from the 2022 Landscape Assessment of National Cancer Institute Community Oncology Research Program (NCORP) (funding provided by 2UG1CA189824) assessed the availability of specialist palliative care providers and ancillary care services, including utilization of advanced practice providers (APPs). Descriptive statistics describe availability of providers and services. Multivariable logistic regression was used to identify practice characteristics associated with palliative care specialist availability in 2022. Differences in rates of palliative care specialists, outpatient palliative care, APPs and patient portal use between 2015 and 2022 assessment results were assessed using Chi-Square tests, assuming independent time snapshots of general population characteristics. Results: Most community oncology practices sampled in 2015 had palliative care specialists (76%) and 62% of practices reported having outpatient palliative care. Of the 259 non-pediatric exclusive NCORP practice groups included in the 2022 analyses (Table 1), significantly more had palliative care specialists (86%; p = 0.003) and offered palliative care in the outpatient setting (76%; p = 0.001). Most practices utilized APPs (92%) and had a patient portal (95%), while only 41% had a survivorship clinic. Multivariable analyses demonstrated practices with more adult oncology providers (OR = 1.03, p = 0.039) and those with a designated survivorship clinic (OR = 3.16, p = 0.001), were significantly more likely to have specialty palliative care in the outpatient setting. Conclusions: More practices reported availability of palliative care specialists and outpatient services in community oncology practices in 2022 compared to 2015, with more oncology providers being associated with increased odds of having outpatient specialty palliative care in 2022. Smaller community oncology practices with fewer providers may need support to expand their capacity to provide palliative care. [Table: see text]

Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD).

Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning. We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients. Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient. We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research.

The Optimizing Lung Screening Trial (WF-20817CD): Multicenter Randomized Effectiveness Implementation Trial to Increase Tobacco Use Cessation for Individuals Undergoing Lung Screening

One-half of all people who undergo lung cancer screening (LCS) currently use tobacco. However, few published studies have explored how to implement effective tobacco use treatment optimally during the LCS encounter. Was the Optimizing Lung Screening intervention (OaSiS) effective at reducing tobacco use among patients undergoing LCS in community-based radiology facilities? The OaSiS study (National Cancer Institute [NCI] Protocol No.: WF-20817CD) is an effectiveness-implementation hybrid type II cluster randomized trial of radiology facilities conducted in partnership with the Wake Forest National Cancer Institute Community Oncology Research Program research base. We randomly assigned 26 radiology facilities in 20 states to the intervention or usual care group. Staff at intervention facilities implemented a variety of strategies targeting the clinic and care team. Eligible patient participants were aged 55 to 77 years undergoing LCS and currently using tobacco. Of 1,094 who completed a baseline survey (523 intervention group, 471 control group) immediately before the LCS appointment, 956 completed the 6-month follow-up (86%retention rate). Fifty-four percent of those who reported not using tobacco at 6months completed biochemical verification via mailed cotinine assay. Generalized estimating equation marginal models were used in an intention-to-treat analysis to predict 7-day tobacco use abstinence. The average self-reported abstinence among participants varied considerably across facilities (0%-27%). Despite a significant increase in average cessation rate over time (0%at baseline to approximately 13%at 6months; P< .0001), tobacco use did not differ by trial group at 14days (OR, 0.96; 95%CI, 0.46-1.99; P= .90), 3months (OR, 1.17; 95%CI, 0.69-1.99; P= .56), or 6months (OR, 0.97; 95%CI, 0.65-1.43; P= .87). The OaSiS trial participants showed a significant reduction in tobacco use over time, but no difference by trial arm was found. ClinicalTrials.gov; No.: NCT03291587; URL: www. gov.

Clinical practice guideline recommendation summaries for pediatric oncology health care professionals: A qualitative study.

To develop a summary format of clinical practice guideline (CPG) recommendations to improve understandability among health care professionals. We developed a summary format based on current research and used the "Think Aloud" technique in one-on-one cognitive interviews to iteratively improve it. Interviews of health care professionals from Children's Oncology Group-member, National Cancer Institute Community Oncology Research Program sites were conducted. After every five interviews (a round), responses were reviewed, and changes made to the format until it was well understood and no new, substantive suggestions for revision were raised. We took a directed (deductive) approach to content analysis of the interview notes to identify concerns related to recommendation summary usability, understandability, validity, applicability and visual appeal. During seven rounds of interviews with 33 health care professionals, we identified important factors that influenced understandability. Participants found understanding weak recommendations more challenging than strong recommendations. Understanding was improved when the term 'conditional' recommendation was used instead of 'weak' recommendation. Participants found a Rationale section to be very helpful but desired more information when a recommendation entailed a practice change. In the final format, the recommendation strength is clearly indicated in the title, highlighted, and defined within a text box. The rationale for the recommendation is in a column on the left, with supporting evidence on the right. In a bulleted list, the Rationale section describes the benefits and harms and additional factors, such as implementation, that were considered by the CPG developers. Each bullet under the supporting evidence section indicates the level of evidence with an explanation and the supporting studies with hyperlinks when applicable. A summary format to present strong and conditional recommendations was created through an iterative interview process. The format is straightforward, making it easy for organizations and CPG developers to use it to communicate recommendations clearly to intended users.

Increasing socioeconomically disadvantaged patients’ engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial

IntroductionSocioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may...

Clinical Trial Enrollment, Ineligibility, and Reasons for Decline in Older vs Younger Patients With Cancer in the National Cancer Institute Community Oncology Research Program

This cross-sectional study assesses differences in clinical trial participation among older vs younger adults with cancer.

Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment

BackgroundStatins taken for cardiovascular indications by patients with breast cancer and lymphoma during doxorubicin treatment may attenuate left ventricular ejection fraction (LVEF) decline, but the effect of statins on LVEF among patients with no cardiovascular indications is unknown.MethodsA double-blind, placebo-controlled, 24-month randomized trial of 40 mg of atorvastatin per day administered to patients with breast cancer and lymphoma receiving doxorubicin was conducted within the National Cancer Institute Community Oncology Research Program across 31 sites in the United States. At pretreatment and then 6 and 24 months after initiating doxorubicin, we assessed left ventricular (LV) volumes, strain, mass, and LVEF through cardiac magnetic resonance imaging, along with cognitive function and serum markers of inflammation. The primary outcome was the difference in 24-month LVEF between placebo and treatment groups, adjusted for pretreatment LVEF.ResultsA total of 279 participants were enrolled in the trial. Participants had a mean (±SD) age of 49±12 years; 92% were women; and 83% were White. The mean (±SD) LVEF values were 61.7±5.5% before treatment and 57.4±6.8% at 24 months in the placebo group and 62.6±6.4% before treatment and 57.7±5.6% at 24 months in the atorvastatin group. On the basis of a multiple imputed data set for missing data and adjusted for each individual’s pretreatment LVEF, 24-month declines in LVEF averaged 3.3±0.6 percentage points and 3.2±0.7 percentage points, for those randomly assigned to placebo versus statins, respectively (P=0.93). Across both treatment arms, similar percentages of individuals experienced changes of more than 10 percentage points in LVEF, LV strain, LV mass, cognition, and inflammation biomarkers, including among those with greater than 90% drug compliance.ConclusionsIn patients with breast cancer and lymphoma with no existing indication for statin therapy, prospective statin administration did not affect LVEF declines 2 years after doxorubicin. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01988571.)