NCI Community Oncology Research Program Research Articles

The impact of non- and anthracycline-based chemotherapy on fatigue in breast cancer survivors: results from WF-97415

PurposeTo examine the differential effect of non- and anthracycline-based chemotherapy on fatigue over 12 months post-diagnosis among breast cancer survivors.MethodsThis study is based on a prospective Wake Forest NCI Community Oncology Research Program (NCORP) multicenter cohort study (WF-97415) of women with stage I to III breast cancer and non-cancer controls. Analyses compared those: 1) receiving, or 2) not receiving anthracycline chemotherapy, 3) receiving aromatase inhibitors (AIs) without chemotherapy, with 4) a comparator group without a history of cancer. In-person clinic assessments were conducted at: baseline (prior to chemotherapy or start of AI therapy), and 3 and 12 months after baseline. The Functional Assessment of Chronic Illness Therapy-Fatigue scale was the primary outcome. Estimated least squares means by group using mixed models with a random subject effect, fixed effects of time and group, and the interaction between time and group was used to compare groups across time, controlling for age, comorbidities, and treatment variables.ResultsAmong 284 women (mean age = 53.4 years, sd 11.9 years), there was a significant (p < 0.0001) group by time interaction, with a sharp increase in fatigue at 3 months in the two chemotherapy groups in comparison to the non-chemotherapy and non-cancer controls. The two chemotherapy groups did not significantly differ in fatigue at any time point.ConclusionWomen with breast cancer who receive non- or anthracycline-based chemotherapy experience similar trends in and levels of fatigue within the first year of treatment and greater fatigue than women receiving AIs alone or women without breast cancer.

If you build it, they will come: Success of the EROS (Engendering Reproductive Health Within Oncologic Survivorship)—ECOG-ACRIN E1Q11 in recruitment of minority patients.

11124 Background: The average recruitment of minority subjects in oncology trials is 4%. The ECOG-ACRIN EROS trial was designed to be inclusive of minority subjects by inviting Minority/Underserved NCI Community Oncology Research Program (MU-NCORP) sites first, with remaining sites fulfilled by inviting NCORP sites. Our objective is to examine if the EROS study recruited more than 4% minority patients, and if MU-NCORP sites provided higher rates of minority recruitment than NCORP sites. Methods: The EROS trial is a clustered randomized trial performed at 17 NCI Community Oncology Research Program (NCORP) sites (including 8 NCORP sites and 9 Minority/Underserved NCORP sites) from 2016-2023. Eligible subjects included reproductively capable women aged 15-55 with new cancer diagnosis. Intervention included RH didactics and decision aids. With respect to self-reported minority status, patients were classified into one of two categories, White and non-Hispanic/Latino or minority (non-White or Hispanic/Latino). Chi-square tests were used to evaluate distribution difference between groups and binomial tests were used for testing proportions against reference points. Results: Of the 434 patients enrolled to the trial, MU-NCORP sites recruited 266/434 (61.3%) and NCORP sites 168/434 (38.7%) patients. Among all enrolled patients, 422 patients’ race/ethnicity status could be classified. 202/422 (47.9%) self-reported as Hispanic/Latino or non-White (p&lt;.0001 0.48 against 0.04). In MU-NCORP (174/258) 67.4% and NCORP sites (28/164) 17.1% were of minority status. (p &lt; .0001). Conclusions: The EROS trial was designed with minority inclusion for generalizability of results. Prioritization to include MU-NCORP sites in the EROS trial did result in substantially increased minority recruitment, with the overall minority recruitment rate above usual cancer trials. Such strategy may be followed to increase minority recruitment to oncology trials.

EROS: Engendering reproductive health within oncologic survivorship—ECOG-ACRIN E1Q11 paradoxical provision of reproductive health.

11123 Background: For the 10% of women diagnosed with cancer in the reproductive age, reproductive health (RH) is a critical component of oncologic survivorship. RH includes oncocontraception (OC), oncofertility (OF) and sexuality. Guidelines segregate these components resulting in fragmented reproductive health care management. Methods: The EROS trial is a clustered randomized trial performed at 17 NCI Community Oncology Research Program (NCORP) sites (including 8 NCORP sites and 9 Minority/Underserved NCORP sites) from 2016-2023. Eligible subjects included reproductively capable women aged 15-55 with new cancer diagnosis. Intervention included RH didactics and decision aids. Childbearing interest was dichotomous, not completed childbearing (including either pregnant or future childbearing interest) or completed childbearing. The objective of this study is to determine provision of OC and OF referral by providers at the baseline visit based on patient’s self-reported childbearing interest at study entry. Chi-square tests were used to compare distribution differences in the referral status (receipt: yes vs. no) between treatment arms. Results: The EROS study enrolled 420 subjects. Of the 63.6% (267/420) completed childbearing, 62.4% (58/93) in the intervention arm and 40.2% (70/174) in the non-intervention arm received an OC referral (p=0.0006), whereas 98.9% (92/93) in the intervention arm and 93.7% (163/174) in the non-intervention arm received an OF referral (p=0.0487). Of the 36.4% (153/420) not completed childbearing, 48.3% (28/58) in the intervention arm and 33.72% (32/95) in the non-intervention arm received an OC referral (p=0.0729), while 77.6% (45/58) in the intervention arm and 70.5% (67/95) in the non-intervention arm received an OF referral (p=0.3388). Conclusions: While the intervention increased the rates of provision of oncocontraception and oncofertility for patients with completed childbearing, our study shows provision of oncofertility referrals at a markedly higher rate than oncontraception. Referral patterns were inconsistent with patient need particularly in completed (receiving OF referral) or delayed childbearing (not receiving OC referral) interest of the patient. The bias favoring oncofertility referral may reflect oncology guidelines emphasizing this aspect of reproductive health despite comprehensive needs of patient.

Beyond the “teachable moment”: Smoking cessation during cancer treatment remains challenging despite high motivation to quit.

e24141 Background: Continued smoking throughout cancer treatment, including surgery, is associated with treatment-related complications and a higher total symptom burden during treatment. This can lead to interruptions and delays in therapy that can compromise treatment efficacy and survival. Approximately 1 in 3 patients smoke at or around time of cancer diagnosis. Despite this “teachable moment” for smoking cessation, at least half of patients with cancer are unsuccessful in their attempts, and relapse rates for post-surgical cancer patients are high. Better understanding of quit motivation among these patients can help guide tobacco treatment interventions in the post-operative and adjuvant treatment time periods. Methods: This is an analysis of a longitudinal nationwide multicenter study of 1003 patients through the University of Rochester Cancer Center NCI Community Oncology Research Program (URCC NCORP) that assessed treatment type, treatment-related symptoms, smoking status, and motivation to quit smoking for patients with a new diagnosis of cancer. Patients supplied demographic and clinical information at enrollment with assessments at two weeks pre- adjuvant treatment, post adjuvant treatment, and 6 months. Chi-square, multinomial logistic regression, and ANOVA were used to analyze the difference between smokers and nonsmokers, and those with previous surgical treatment. Results: The majority of patients had surgery as part of their cancer treatment (n = 718, 71.6%). Of these (n = 222, 30.9%) had a diagnosis of a tobacco-associated cancer, which was associated with smoking status at pre-treatment (p &lt; 0.05). For those with previous surgery, n = 90 (68.7%, p &lt; 0.001) were current smokers before starting adjuvant treatment. Post-surgical patients who smoke had both higher total symptom burden ( M= 23.7 vs M= 17.0; p &lt; 0.05) and higher symptom severity ( M =1.97 vs M= 1.42; p &lt; 0.001) pre-adjuvant treatment and at 6 month follow up [( M =31.3 vs M= 22.2; p &lt; 0.05);( M= 2.6 vs M= 1.8; p &lt; 0.05)] compared to post-surgical patients who were not smokers. Motivation to quit was sustained among current smokers between the pre- and post- adjuvant treatment periods (p &lt; 0.001), as well as for those that had previous surgery (p &lt; 0.05). Despite motivation to quit among 64.4% of current smokers with previous surgery, 15.4% reported being able to quit by post-adjuvant treatment with 50% relapsing to smoking at 6-month follow up. Conclusions: For patients that continue to smoke after surgical treatment, cessation rates are much lower than motivation to quit with high rates of relapse. Early intervention around the time of surgery presents an ideal opportunity to optimize the “teachable moment” by providing longitudinal tobacco treatment as part of cancer care to improve treatment-related symptoms, as well as overall survival.

EROS: Engendering reproductive health within oncologic survivorship—ECOG-ACRIN E1Q11 assessing discrepancy in clinician-patient importance of sexuality over 2 years post-cancer diagnosis.

e23197 Background: Cancer diagnosis and therapeutic interventions are associated with altered reproductive health including sexuality. Despite pertinence to quality of life, cancer management frequently precludes periodic assessments of sexual health. Methods: The EROS trial is a clustered randomized trial performed at 17 NCI Community Oncology Research Program (NCORP) sites (including 8 NCORP sites and 9 Minority/Underserved NCORP sites) from 2016-2023. Eligible subjects included reproductively capable women aged 15-55 with new cancer diagnosis. We report on an embedded observational study pertaining to oncosexuality. Perceived importance of patient’s sexuality maintenance was assessed for clinicians and patients on a 10-point Likert scale (1 = Not important; 10 = Extremely important). Mean and standard deviation were computed for value discrepancy (pairwise clinician-patient differential) by arm assignment and timepoint (baseline, 3-, 6-, 12- and 24-months). One-sample t-test was conducted with Bonferroni’s adjustment to evaluate cell mean of the value discrepancy against zero (α = 0.02). A mixed effect model analyzed intervention effect on value discrepancy over time, adjusting for baseline covariates (α = 0.05). Results: Mean patient importance rating within the intervention arm ranged from 8.39 (SD = 2.39) at baseline to 7.84 (SD = 2.86) at 24-month assessment; paired clinician value varied from 8.17 (SD = 2.57) to 7.77 (SD = 2.92), respectively. Within non-intervention arm, mean patient importance rating varied from 8.23 (SD = 1.95) at baseline to 8.68 (SD = 1.67) at 24-month assessment; paired clinician value ranged from 7.93 (SD = 1.86) to 8.15 (SD = 1.70). Mean clinician-patient value differentials with respect to arm assignment and timepoint were not significantly different from zero. A significant arm-by-timepoint interaction effect was noted (p = 0.0417). Post-hoc simple main effect analysis exhibited no intervention effect at any assessment timepoint. Conclusions: Data indicate high concordance of sexuality importance within oncologic clinicians and patients over the 2 years. Findings necessitate investigation to ensure management of sexual health matches level of importance to the cancer survivor. Clinical trial information: NCT01806129 .

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.

Sexual Orientation and Gender Identity Data Collection in Cancer Care: A Nationwide Landscape Assessment Update.

Routine collection of sexual orientation (SO) and gender identity (GI; collectively SOGI) in cancer clinics advances cancer care equity. In 2022, NCI Community Oncology Research Program (NCORP) practice groups were asked about routine collection of SOGI data in the electronic health record. The proportions of practice groups reporting collection of SO and/or GI data were calculated, and practice group characteristics were assessed for associations. Of 271 practice groups nationwide, 42% (n = 112) collect SO data, 58% (n = 157) collect GI data, and 35% (n = 96) collect both. In multivariate analyses, SO data collection was associated with practice groups having minority outreach staff (odds ratio [OR], 2.07 [95% CI, 1.12 to 3.81]; P = .02); GI data collection was associated with practice groups located in the Northeastern United States (OR, 2.08 [95% CI, 0.73 to 5.91]; P = .045), and those with a higher proportion of new patients who were White (OR, 1.02 [95% CI, 1.01 to 1.04]; P < .001). Practice groups in the South were least likely to collect SOGI data (OR, 0.49 [95% CI, 0.26 to 0.94]; P = .004). There were no statistically significant differences in SO and/or GI collection on the basis of the practice group's proportion of Medicaid/Medicare patients, number of new patients with cancer per year, or practice ownership. Slightly over one third of NCORP practice groups report routinely collecting SOGI data. There are regional differences in data collection, underscoring the need to craft targeted, region-specific interventions focused on boosting the capture and recording of SOGI data in an affirming manner.

Phase III Randomized, Placebo-Controlled Clinical Trial of Donepezil for Treatment of Cognitive Impairment in Breast Cancer Survivors After Adjuvant Chemotherapy (WF-97116).

To test efficacy of donepezil, a cognitive enhancer, to improve memory in breast cancer survivors who report cancer-related cognitive impairment 1-5 years postchemotherapy. Adult female BCS exposed to ≥4 cycles of adjuvant chemotherapy 1-5 years before enrollment who reported cancer-related cognitive impairment were eligible. Participants, enrolled at sites affiliated with the Wake Forest NCI Community Oncology Research Program (NCORP) Research Base, were randomly assigned to receive 5 mg of donepezil once daily for 6 weeks titrated to 10 mg once daily for 18 weeks or placebo. Cognition and self-report cognitive functioning was assessed at baseline, 12, 24 (end of intervention), and 36 (washout) weeks postrandomization. Mixed-effects repeated measures analysis of covariance models were used to assess treatment differences in immediate recall (primary outcome) on the Hopkins Verbal Learning Test-Revised (HVLT-R) and other cognitive domains (secondary outcomes) with covariates of treatment, time, time by treatment interaction, baseline outcome level, age stratification, and an unstructured covariance matrix to account for within participant correlation over time. Two hundred seventy-six BCS from 87 NCORP practices (mean age, 57.1, standard deviation [SD], 10.5) who were at a mean of 29.6 months (SD, 14.2) postchemotherapy were randomly assigned to donepezil (n = 140) or placebo (n = 136). At 24 weeks, treatment groups did not differ on HVLT-R scores (donepezil mean = 25.98, placebo = 26.50, P = .32). There were no statistically significant differences between treatments at 12, 24, or 36 weeks for attention, executive function, verbal fluency, processing speed, or self-reported cognitive functioning. Endocrine therapy and menopausal status did not affect results. BCS 1-5 years after completing chemotherapy with documented memory problems, randomly assigned to 24 weeks of 5-10 mg of donepezil once daily, did not perform differently at the end of treatment on tests of memory, other cognitive functions, or subjective functioning than those randomly assigned to placebo.

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.

Increasing diversity in clinical trials: demographic trends at the National Cancer Institute, 2005-2020.

We described participant demographics for National Cancer Institute (NCI) clinical trials at the clinical center (NCI-CC participants) of the National Institutes of Health to identify enrollment disparities. We analyzed NCI-CC data from 2005 to 2020, calculated enrollment fractions, compared with the US cancer population represented by the Surveillance, Epidemiology, and End Results cancer incidence data (2018) and the Cancer in North America database (2018), and compared further with clinical trial disparities data from the NCI Community Oncology Research Program and National Clinical Trials Network (2005-2019), and from ClinicalTrials.gov (2003-2016). NCI-CC (38 531 participants) had higher enrollment fractions for older adults (8.5%), male (5.6%), non-Hispanic (5.1%), and Black or African American (5.3%) participants; lower women proportion across race and ethnicity; and fewer female sex-specific cancer (6.8%) than male sex-specific cancer (11.7%) participants. NCI-CC had lower median age than Surveillance, Epidemiology, and End Results (54.0 vs 65.4); more Black or African American participants (12.0% vs 11.1%); and fewer women (41.7% vs 49.5%), White (76.1% vs 80.5%), Asian or Pacific Islander (4.6% vs 6.0%), American Indian or Alaska Native (0.3% vs 0.5%), and Hispanic participants (7.1% vs 13%). NCI-CC had more Black or African American and Asian or Pacific Islander participants; fewer Hispanic participants than the NCI Community Oncology Research Program and National Clinical Trials Network; more Black or African American and Hispanic participants; fewer Asian or Pacific Islander participants than ClinicalTrials.gov data. Improvement was noted for NCI-CC (older adults, Black or African American, Asian or Pacific Islander, Hispanic participants). We found lower representation of older adults, women, Asian or Pacific Islander, American Indian or Alaska Native, and Hispanic participants vs the US cancer population and higher representation of Black or African American vs US cancer population and oncology clinical trials. Multifaceted efforts are underway to reduce disparities in cancer clinical trials at the NCI-CC.

Cardiovascular health assessment in routine cancer follow-up in community settings: survivor risk awareness and perspectives

BackgroundGuidelines recommend cardiovascular risk assessment and counseling for cancer survivors. For effective implementation, it is critical to understand survivor cardiovascular health (CVH) profiles and perspectives in community settings. We aimed to (1) Assess survivor CVH profiles, (2) compare self-reported and EHR-based categorization of CVH factors, and (3) describe perceptions regarding addressing CVH during oncology encounters.MethodsThis cross-sectional analysis utilized data from an ongoing NCI Community Oncology Research Program trial of an EHR heart health tool for cancer survivors (WF-1804CD). Survivors presenting for routine care after potentially curative treatment recruited from 8 oncology practices completed a pre-visit survey, including American Heart Association Simple 7 CVH factors (classified as ideal, intermediate, or poor). Medical record abstraction ascertained CVD risk factors and cancer characteristics. Likert-type questions assessed desired discussion during oncology care.ResultsOf 502 enrolled survivors (95.6% female; mean time since diagnosis = 4.2 years), most had breast cancer (79.7%). Many survivors had common cardiovascular comorbidities, including high cholesterol (48.3%), hypertension or high BP (47.8%) obesity (33.1%), and diabetes (20.5%); 30.5% of survivors received high cardiotoxicity potential cancer treatment. Less than half had ideal/non-missing levels for physical activity (48.0%), BMI (18.9%), cholesterol (17.9%), blood pressure (14.1%), healthy diet (11.0%), and glucose/ HbA1c (6.0%). While > 50% of survivors had concordant EHR-self-report categorization for smoking, BMI, and blood pressure; cholesterol, glucose, and A1C were unknown by survivors and/or missing in the EHR for most. Most survivors agreed oncology providers should talk about heart health (78.9%).ConclusionsTools to promote CVH discussion can fill gaps in CVH knowledge and are likely to be well-received by survivors in community settings.Trial registrationNCT03935282, Registered 10/01/2020

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.

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.

Availability of cancer survivorship support services across the National Cancer Institute Community Oncology Research Program network.

National cancer organizations recommend provision of nutrition, physical activity, and mental health supportive services to cancer survivors. However, the availability of these services across diverse community oncology settings remains unclear. The National Cancer Institute Community Oncology Research Program (NCORP) is a national network of community oncology practices engaged in cancer research. The 2022 NCORP Landscape Assessment (5UG1CA189824) assessed individual practices' establishment of survivorship clinics and nutrition, physical activity, and mental health services, resources, and/or referrals. Descriptive statistics summarized and logistic regression quantified the association between services, practice, and patient characteristics. Of 46 NCORP community sites, 45 (98%) responded to the survey, representing 259 adult practice groups. A total of 41% had a survivorship clinic; 96% offered mental health, 94% nutrition, and 53% physical activity services, resources, and/or referrals. All 3 services were offered in various formats (eg, in-house, referrals, education) by 51% and in-house only by 25% of practices. Practices with advanced practice providers were more likely to have a survivorship clinic (odds ratio [OR] = 3.19, 95% confidence interval [CI] = 1.04 to 9.76). Practices with at least 30% Medicare patients (OR = 2.54, 95% CI = 1.39 to 4.66) and more oncology providers (OR = 1.02, 95% CI = 1.01 to 1.04) were more likely to have all 3 services in any format. Practices with at least 30% Medicare patients (OR = 3.41, 95% CI = 1.50 to 7.77) and a survivorship clinic (OR = 2.84, 95% CI = 1.57 to 5.14) were more likely to have all 3 services in-house. Larger oncology practices and those caring for more survivors on Medicare provided more supportive services, resources, and/or referrals. Smaller practices and those without survivorship clinics may need strategies to address potential gaps in supportive services.

Barriers and facilitators to the implementation of family cancer history collection tools in oncology clinical practices.

This study aimed to identify barriers and facilitators to the implementation of family cancer history (FCH) collection tools in clinical practices and community settings by assessing clinicians' perceptions of implementing a chatbot interface to collect FCH information and provide personalized results to patients and providers. By identifying design and implementation features that facilitate tool adoption and integration into clinical workflows, this study can inform future FCH tool development and adoption in healthcare settings. Quantitative data were collected using survey to evaluate the implementation outcomes of acceptability, adoption, appropriateness, feasibility, and sustainability of the chatbot tool for collecting FCH. Semistructured interviews were conducted to gather qualitative data on respondents' experiences using the tool and recommendations for enhancements. We completed data collection with 19 providers (n = 9, 47%), clinical staff (n = 5, 26%), administrators (n = 4, 21%), and other staff (n = 1, 5%) affiliated with the NCI Community Oncology Research Program. FCH was systematically collected using a wide range of tools at sites, with information being inserted into the patient's medical record. Participants found the chatbot tool to be highly acceptable, with the tool aligning with existing workflows, and were open to adopting the tool into their practice. We further the evidence base about the appropriateness of scripted chatbots to support FCH collection. Although the tool had strong support, the varying clinical workflows across clinic sites necessitate that future FCH tool development accommodates customizable implementation strategies. Implementation support is necessary to overcome technical and logistical barriers to enhance the uptake of FCH tools in clinical practices and community settings.

Clinical research in the community.

Most patients with high-risk hematologic malignancies are treated in community oncology practices near their residence. This is partly due to patients' ardent desire to be closer to home and trust in local caregivers. Treatments are increasingly complex, even as initial therapy, and more so upon relapse. Improved outcomes in the past decade are largely available through clinical trials primarily offered through academic medical centers. Limited availability of clinical trials at community oncology practices is a major contributor to outcome disparities among minorities, rural, and elderly patients, all of whom are underrepresented in clinical trials. Between 2003 and 2023, the National Cancer Institute (NCI) established programs to address these challenges: the Community Clinical Oncology Program, Minority- Based Community Clinical Oncology Program, NCI Community Cancer Centers Program, and NCI Community Oncology Research Program. However, disparities have persisted, particularly for pharmaceutical-directed clinical research. Lack of representation in clinical research results in data absenteeism, data chauvinism and hallucination, and a delay in treatment availability for high-risk hematologic malignancies in community practice. To address this, the US Congress enacted the Food and Drug Administration Omnibus Act in 2022 to help establish diversity plans that would broaden clinical trial patient enrollment in the United States. We recommend using these initiatives in community oncology practices, including the adoption of the DRIVE strategy in collaboration with pharmaceutical companies, as well as using the NCI-established programs to promote clinical trial availability for patients with high-risk malignancies treated in community oncology practices.

Abstract IA030: Ensuring diversity in clinical trials

Abstract It is well known that minorities, particularly Blacks, are underrepresented in cancer prevention, early detection, and treatment trials. However the mortality rates for Blacks are significantly higher than other race/ethnic groups. Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials-a gold standard. Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. Being able to identify and resolve social determinants of health is essential for clinical trial participation. It is increasingly necessary to be aware of defining characteristics, such as location and culture of the populations from which research participants are enrolled. Utilizing embedded community academic sites to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials is warranted. Considerable attention has focused on the need to increase underserved racial and ethnic populations in clinical research, especially in light of the cancer health disparities that disproportionately plague these groups. Clinical trial design and implementation are time-consuming and require a multistep process that is complicated by other factors, including eligibility criteria for clinical trials for underserved racial and ethnic populations, recruitment processes, and patients’ misconceptions or lack of information about clinical trials. Georgetown-Lombardi National Capital Area Minority/Underserved NCORP (NCI Community Oncology Research Program) coupled with the Ralph Lauren Center for Cancer Prevention will reveal strategies and approaches instrumental to our success. These efforts resulted in the development of a strong community capacity–building and clinical research cancer recruitment strategy, and improved engagement of the community in clinical research, thus ensuring diversity in clinical trials. Citation Format: Lucile Adams-Campbell. Ensuring diversity in clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr IA030.

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.

Comprehensive pediatric cancer care in the community oncology setting: 2022 Landscape survey results.

92 Background: A first step in providing guideline-endorsed, cancer-related psychosocial resources for children with cancer treated in community oncology settings is screening for need. We describe the current landscape of screening for distress and social determinants of health (SDoH) for children treated in NCI-Community Oncology Research Program (NCORP) practices. Methods: NCORP practice groups completed the Landscape Survey in 2022 to describe infrastructure, resources, and research capacity. Practice groups were assessed for capacity to provide oncology care for pediatric patients, presence of a Pediatric Oncology Program (POP), and the annual pediatric cancer cases seen. Among practice groups with a POP, we describe the proportion with routine screening for distress (psychosocial and financial) and SDoH. Results: Of 271 responding NCORP practice groups, 54 (20%) reported providing oncology care for children; 47 (87%) of these had a dedicated POP. Of these 47 practice groups, 33 reported the number of new pediatric cases seen per year (range 7-126). Of the seven practices that reported providing oncology care for children, but did not have a dedicated POP, the practice either did not report the number of pediatric cases (n=3) or fewer than 2% of annual cancer cases were children aged 0-14 years. Among the 47 practices with a dedicated POP, 12 were affiliated with a Minority- Underserved NCORP. Geographically, most of these NCORPs (n=18, 38%) were located within the South, followed by the Midwest (n=11, 23%), the Northeast and the West (both, n=9, 19%). Within the 47 NCORP practices with a POP, but not specifically within the POP, 41 (87%) conducted routine psychosocial distress screening, 39 (83%) routine financial screening (other than insurance/billing purposes), and 41 (87%) screened for SDoH with a variety of tools. Most of the practices (n=33, 70%) screened for all three indicators of need for cancer-related resources. Conclusions: This analysis describes the settings where children with cancer are treated in the community and the infrastructure across NCORP practices with a POP. These data are indicative of potential research capacity and will be used to develop future Cancer Care Delivery Research (CCDR) studies through the NCORP. Future research will seek to identify multi-level barriers and facilitators to linking families with identified needs to available resources and to resource uptake.

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.