Institute Community Oncology Research Program Research Articles

Baseline characteristics of parents enrolled in ACCL20N1CD: Financial distress during treatment for pediatric acute lymphoblastic leukemia (ALL) in the US.

220 Background: Personal costs of childhood cancer can contribute to disparities in health outcomes. The purpose of ACCL20N1CD is to examine trajectories of parental costs and the associated financial distress, cost coping behaviors, and household material hardships (HMH) during treatment for pediatric ALL. Objective is to report baseline characteristics of the parents and their households. Methods: The study used a prospective cohort design with repeated measures. Setting was Children’s Oncology Group (COG) practices at National Cancer Institute Community Oncology Research Program (NCORP) institutions. Parents who use English or Spanish, and have children newly diagnosed with ALL treated at COG NCORP practices were eligible. Parents were asked to complete surveys at 3 time points, including baseline (T1; during induction and <7 days after planned induction remission evaluation). Surveys included items about (a) parent socio‐economic status, financial distress measured by 8-item Personal Wellness Scale (PFWS), and cost coping behaviors, and (b) HMH. Factors related to high PFWS scores were evaluated by logistic regression. Results: Of 104 evaluable parents, most were female (83.7%), white (65.4%), non-Hispanic (48.1%), partnered (79.8%), > high school diploma (93.3%), used English (84.6%), worked full (48.1%) or part (5.8%) time, and paid for their child’s care with public insurance (57.7%). Median household income=$50,000 (Inter-Quartile Range/IQR 20,000-100,000) for 4 (IQR 4-5) people. Not including wages lost due to caregiving, out of pocket payments for medical care + other ALL-related costs in the prior month >15% of monthly income for 51.9% of households, which is considered financially catastrophic. 24.0% of households lacked food stability; 21% had housing insecurity. Conclusions: At baseline, sizeable proportions of parents exhibit high out of pocket costs, high financial distress level, and multiple cost coping behaviors with implications for future health and individual and household quality of life.

Exploring the reliability and validity of clinically-relevant outcome measures for chemotherapy-induced peripheral neuropathy.

To explore the reliability and validity of clinically-relevant outcome measures for balance (i.e., The Short Physical Performance Battery [SPPB] - Balance Subscale) and sensation (i.e., monofilament threshold testing) for use in clinical trials of chemotherapy-induced peripheral neuropathy (CIPN). Adult, post-treatment cancer survivors (N = 142) who had reported ≥ 4/10 CIPN symptom severity following neurotoxic chemotherapy were recruited from six National Cancer Institute Community Oncology Research Program (NCORP) sites associated with the University of Rochester Cancer Center NCORP Research Base. Participants completed the monofilament threshold test at the screening and baseline time points (i.e., one week apart), while the Quality of Life Questionnaire-CIPN20, Treatment-Induced Neuropathy Assessment Scale, and SPPB - Balance Subscale were completed at baseline. Test-retest reliability of the monofilament threshold testing scores was assessed using the Intraclass Correlation Coefficient (ICC). The convergent validity among monofilament threshold testing, SPPB - Balance Subscale, and CIPN patient-reported outcome (PRO) scores at baseline was assessed using Spearman's correlation. Ceiling effects were observed for SPPB-Balance Subscale scores as 113 (79.6%) respondents reported the highest score. Agreement between the screening and baseline monofilament threshold testing scores was moderate (ICC = 0.65). Monofilament threshold testing (rs Range: 0.14 - 0.21) and SPPB Balance Subscale scores (rs Range: -0.36 - -0.22) showed largely low correlations with all PRO measures. Monofilament threshold testing demonstrated moderate test-retest reliability, but low convergent validity with CIPN PROs, while the SPPB - Balance Subscale demonstrated low convergent validity with CIPN PROs and ceiling effects (i.e., highest possible score) among post-treatment cancer survivors with CIPN. Future research is needed to identify promising measures of balance and sensation loss for use in clinical trials that complement CIPN PROs to aid in the identification of clinically relevant treatments for CIPN. NCT04367490 [April 29, 2020].

Self-Reported Financial Difficulties Among Patients with Multiple Myeloma and Chronic Lymphocytic Leukemia Treated at U.S. Community Oncology Clinics (Alliance A231602CD).

To estimate the proportion and correlates of self-reported financial difficulty among patients with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL). 23 U.S. community and minority oncology practice sites affiliated with the National Cancer Institute Community Oncology Research Program (NCORP). 521 patients (≥18 years) with MM or CLL were consented and 416 responded to a survey (completion rate=79.8%). Respondents had a MM diagnosis (74.0%), an associate degree or higher (53.4%), were White (89.2%), insured (100%) and treated with clinician-administered drugs (68.0%). Observational, prospective, protocol-based survey administered in 2019-2020. Financial difficulty was assessed using a single-item standard measure, the EORTC QLQC30: "Has your physical condition or medical treatment caused you financial difficulties in the past year?" and using an 'any-or-none' composite measure of 22 items assessing financial difficulty, worries and the use of cost-coping strategies. Multivariable logistic regression models assessed the association between financial difficulty, diagnosis, and socioeconomic and treatment characteristics. 16.8% reported experiencing financial difficulty using the single-item measure and 60.3% using the composite measure. Most frequently endorsed items in the composite measure were financial worry about having to pay large medical bills related to cancer and difficulty paying medical bills. Financial difficulty using the single-item measure was associated with having MM versus CLL (adjusted odds ratio [aOR], 0.34; 95% CI, 0.13-0.84; P=.02), having insurance other than Medicare (aOR, 2.53; 95% CI, 1.37-4.66; P=.003), being non-White (aOR, 2.21; 95% CI, 1.04-4.72; P=.04), and having a high school education or below (aOR, 0.36; 95% CI, 0.21-0.64; P=.001). Financial difficulty using the composite measure was associated with having a high school education or below (aOR, 0.62; 95% CI, 0.41-0.94; P=.03). U.S. patients with blood cancer report financial difficulty, especially those with low socio-economic status. Evidence-based and targeted interventions are needed.

Recruitment of informal caregivers into community oncology research studies: results from the 2022 Landscape Assessment.

Understanding the experiences of community oncology practices in recruiting informal (unpaid/family) caregivers into research studies can inform strategies to improve caregiver enrollment. We used data from the 2022 National Cancer Institute Community Oncology Research Program (NCORP) Landscape Assessment to describe the experience of recruiting informal caregivers for research studies in community oncology practices. Among 258 practice groups, only one-third (30%, 78/258) reported prior experience recruiting informal caregivers for research studies. In multivariable logistic analyses, having a greater number of oncology providers (increase per 10 providers, adjusted odds ratio [AOR] 1.16, 95% CI 1.03-1.31) and having advanced practice providers (APPs) involved in research (AOR 2.17, 95% CI 1.05-4.48) were significantly associated with prior experience recruiting caregivers. In conclusion, many community oncology practices lack caregiver recruitment experience and may benefit from education, integration of APPs/caregiver stakeholders in research infrastructure, and/or other strategies to improve caregiver recruitment.

Changes in S100 calcium-binding protein β (S100β) and cognitive function from pre- to post-chemotherapy among women with breast cancer

Many patients with cancer experience cancer-related cognitive decline (CRCD). Previous studies have shown that elevated S100β, a calcium-binding protein commonly found in glial cells, can exhibit neurotoxic effects, including disruption of the blood-brain barrier (BBB). We studied changes in S100β levels in patients with breast cancer receiving chemotherapy, and the relationship to changes in cognitive function. A total of 505 women with breast cancer (mean (sd) age; 53.4 (53.6)) and 336 age-matched controls without cancer (52.8 (10.3)) were included from a nationwide study as part of the National Cancer Institute Community Oncology Research Program (NCORP). Both groups provided blood samples and completed neurocognitive assessments within 7 days before the patients with breast cancer received their first chemotherapy dose (pre-chemotherapy; T1) and within 1 month of their last chemotherapy administration (post-chemotherapy; T2). Utilizing a linear mixed model, multivariate linear regressions, and Spearman rank correlations (rs), we investigated longitudinal changes in serum S100β concentrations and their relationships to changes in neurocognitive outcomes over time. We observed an increase in S100β for patients with breast cancer (p = 0.002), but not for controls without cancer over time (p = 0.683). Additionally, we identified subtle relationships between increases in serum S100β and worsening in cognitive performance on the Backward Counting test (rs = 0.11, p = 0.041) and self-reported FACT-Cog Perceived Cognitive Abilities (rs = −0.10, p = 0.025). Regression analyses adjusted for age, race, body-mass index (BMI), education, menopausal status, anxiety, and depression revealed a trend remained for the relationship of S100β with Backward Counting. In conclusion, we found that patients with breast cancer experience a significant increase in concentration of serum S100β over the course of chemotherapy. This increase is correlated with worsening in some neurocognitive outcomes from pre-to post-chemotherapy, with trending results remaining following adjustment for covariates.

Longitudinal patterns of patient-reported cognitive impairment in patients with non-Hodgkin lymphoma (NHL) treated with chemotherapy: A group-based trajectory analysis of a nationwide community-based cohort.

7071 Background: Cognitive problems are an important clinical concern for cancer patients. We previously published that patients with lymphoma experienced worsening in cognitive functions and perceived function from pre-to post-treatment. Limited data exists in NHL, importantly previously reported group means of cognitive function may not capture interindividual heterogeneity. Therefore, we identified distinct subgroups of NHL patients with similar trajectories of cognitive function over time and investigated potential predictors. Methods: We included 181 NHL patients receiving chemotherapy (mean age [SD]: 59.0 [11.8]; 63.5% male; 54% diffuse large B-cell, 22% follicular lymphoma) enrolled in the National Cancer Institute Community Oncology Research Program. Cognitive function was assessed by the patient-reported Functional Assessment of Cancer-Therapy-Cognitive Function (total score and perceived cognitive impairment [PCI]) prior to chemotherapy (T1), after chemotherapy (T2), and 6 months following T2 (T3). Patient and cancer characteristics were collected through questionnaires or medical records at T1. We utilized group-based trajectory modeling (GBTM) to identify latent clusters of individuals with similar cognitive function patterns over time. Model selection and assessment were based on the Bayes factor, group size, model diagnostics, and clinical interpretability. Multinomial logistic regression models were identified characteristics associated with group membership. Results: Four groups were identified by GBTM: Group A had high perceived impairment, which decreased at T2 and remained high at T3 (n=17, 9.4%); Group B had moderate perceived impairment, with a continuous decline at T2 and T3 (n=21, 11.6%); Group C had low perceived impairment and remained stable at T2 and T3 (n=95, 52.5%); Group D had moderate perceived impairment, without changes at T2 and T3 (n=48, 26.5%). Similar trajectory groups were identified for the PCI subscale. Compared to ≥ some college education, ≤ high school was associated with an increased odds of membership in Group D relative to Group C (OR 3.45, 95% CI 1.44, 8.30). Patients with a higher fatigue score (MFSI) were more likely to report worse cognitive impairment (Group A vs. C: OR 1.10, 95% CI 1.07, 1.14; Group B vs. C: OR 1.05, 95% CI 1.02, 1.08; Group D vs. C: 1.05, 95% CI 1.03, 1.07). Stage, lymphoma subtype, and treatment regimen were not associated with group membership. Conclusions: Our analysis revealed that patients with perceived impairment experienced stable impairment or further decline over time, which is associated with education and fatigue; a subgroup of patients did not experience cognitive worsening. These data help identify patients with different patterns of cognitive impairment to inform personalized interventions.

Clinical Practice Guideline-Inconsistent Management of Fertility Preservation in Pediatric Cancer Patients in Community Settings: A Children's Oncology Group Study.

Background: The primary objective was to measure adherence to clinical practice guideline (CPG) recommendations for fertility preservation (FP) in pediatric cancer patients treated in National Cancer Institute Community Oncology Research Program (NCORP) sites. Secondary objectives were to describe factors such as site size associated with CPG-inconsistent care delivery and cryopreservation completion. Methods: This retrospective, multicenter study included patients 15 to 21 years old with a first cancer diagnosis from January 2014 through December 2015 who were previously enrolled to a Children's Oncology Group (COG) study and received care at a participating NCORP site. Patients were randomly selected from a list generated by the COG for chart review by participating sites. Primary outcome was care delivery that was inconsistent with a strong CPG recommendation on FP, namely discussion and offering of FP options before cancer treatment initiation, as adjudicated centrally by a panel. Results: A total of 129 patients from 25 sites were included. Among these, 48% (62/129) received CPG-inconsistent care. Most CPG-inconsistent care was due to lack of FP discussion documentation (93.5%, 58/62). Small site size, treatment at a pediatric (vs mixed adult/pediatric) site, and female sex were associated with higher odds of CPG-inconsistent care delivery. Conclusions: Newly diagnosed pediatric cancer patients often received CPG-inconsistent care for FP, with disproportionate gaps noted for females, and those treated at smaller or pediatric NCORP sites. The primary reason for CPG-inconsistent care is lack of FP discussion from clinicians. Opportunities to improve FP CPG implementation are highlighted.

Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer

Patients with head and neck cancer who undergo radiotherapy can develop chronic radiation-induced xerostomia. Prior acupuncture studies were single center and rated as having high risk of bias, making it difficult to know the benefits of acupuncture for treating radiation-induced xerostomia. To compare true acupuncture (TA), sham acupuncture (SA), and standard oral hygiene (SOH) for treating radiation-induced xerostomia. A randomized, blinded, 3-arm, placebo-controlled trial was conducted between July 29, 2013, and June 9, 2021. Data analysis was performed from March 9, 2022, through May 17, 2023. Patients reporting grade 2 or 3 radiation-induced xerostomia 12 months or more postradiotherapy for head and neck cancer were recruited from community-based cancer centers across the US that were part of the Wake Forest National Cancer Institute Community Oncology Research Program Research Base. Participants had received bilateral radiotherapy with no history of xerostomia. Participants received SOH and were randomized to TA, SA, or SOH only. Participants in the TA and SA cohorts were treated 2 times per week for 4 weeks. Those experiencing a minor response received another 4 weeks of treatment. Patient-reported outcomes for xerostomia (Xerostomia Questionnaire, primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General) were collected at baseline, 4 (primary time point), 8, 12, and 26 weeks. All analyses were intention to treat. A total of 258 patients (201 men [77.9%]; mean [SD] age, 65.0 [9.16] years), participated from 33 sites across 13 states. Overall, 86 patients were assigned to each study arm. Mean (SD) years from diagnosis was 4.21 (3.74) years, 67.1% (n = 173) had stage IV disease. At week 4, Xerostomia Questionnaire scores revealed significant between-group differences, with lower Xerostomia Questionnaire scores with TA vs SOH (TA: 50.6; SOH: 57.3; difference, -6.67; 95% CI, -11.08 to -2.27; P = .003), and differences between TA and SA (TA: 50.6; SA: 55.0; difference, -4.41; 95% CI, -8.62 to -0.19; P = .04) yet did not reach statistical significance after adjustment for multiple comparisons. There was no significant difference between SA and SOH. Group differences in Functional Assessment of Cancer Therapy-General scores revealed statistically significant group differences at week 4, with higher scores with TA vs SOH (TA: 101.6; SOH: 97.7; difference, 3.91; 95% CI, 1.43-6.38; P = .002) and at week 12, with higher scores with TA vs SA (TA: 102.1; SA: 98.4; difference, 3.64; 95% CI, 1.10-6.18; P = .005) and TA vs SOH (TA: 102.1; SOH: 97.4; difference, 4.61; 95% CI, 1.99-7.23; P = .001). The findings of this trial suggest that TA was more effective in treating chronic radiation-induced xerostomia 1 or more years after the end of radiotherapy than SA or SOH. ClinicalTrials.gov Identifier: NCT02589938.

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]