Institute Community Oncology Research Program Research Articles

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.)

Access to urologists for participation in research: An analysis of NCI's Community Oncology Research Program landscape survey

PurposeUrological cancer clinical trials face accrual challenges, which may stem from structural barriers within cancer programs. We sought to describe the extent to which urology cancer care providers are available within community cancer research programs and explore the role of oncology practice group ownership in their access to urology practices to participate in research. Materials and methodsWe conducted secondary analysis of organizational survey data collected in 2017 among National Cancer Institute Community Oncology Research Program practice groups. We used logistic regression to assess the association of self-reported access to urologists to participate in research and oncology practice group ownership type: independent, payor-provider, health-system, or public ownership. ResultsOf the 209 community oncology practice groups in the analysis sample, 133 (63.6%) had access to urologists for research participation. Ownership was not statistically significantly associated with access to urology practices after controlling for other covariates (p = 0.4). Instead, having a hospital outpatient clinic (p = 0.008) and identifying as a safety-net hospital (p = 0.035) were both positively significantly associated with access to urologists to participate in research. ConclusionsTwo-thirds of community cancer research groups have access to urology. Oncology ownership status was not associated with access to urologists for research. Research groups may need support to increase their capacity to engage non-oncology cancer care providers in research.

Rationale and design of Children’s Oncology Group (COG) study ACCL20N1CD: financial distress during treatment of acute lymphoblastic leukemia in the United States

BackgroundThe study purpose is to describe trajectories of financial distress for parents of children (ages 1–14.9 years) with newly diagnosed acute lymphoblastic leukemia (ALL). The secondary aim is to identify multilevel factors (child, parent, household, treating institution) that influence change in financial distress over time.MethodsThe study uses a prospective cohort design, repeated measurements, and mixed methods. The settings are Children’s Oncology Group (COG) institutions participating in the National Cancer Institute Community Oncology Research Program (NCORP). Eligible participants are English- and/or Spanish-speaking parents or legal guardians (hereafter “parents”) of index children. Parents are asked to complete a survey during their child’s induction (T1) and maintenance therapy (T2), and near treatment completion (T3). Study surveys include items about (a) the child’s cancer and clinical course, (b) parental socio-economic status, financial distress and financial coping behaviors, and (c) household material hardships. At least 15 parents will be invited to participate in an optional semi-structured interview. NCORP institutions that enroll at least one parent must complete an annual survey about institution resources that could influence parental financial distress.DiscussionThe results will inform future interventions to mitigate financial distress for parents of children diagnosed with ALL and could be instructive beyond this disease group.Trial registrationThis trial was initially registered with the NCI Clinical Trial Reporting Program ID: NCI-2021–03,567 on June 16, 2021. The study can be found on clinicaltrials.gov, Identifier NCT04928599.

Palliative specialty care availability for adults in community oncology practices.

e24110 Background: The American Society of Clinical Oncology recommends integration of palliative care in patients with advanced cancer. Studies have shown the availability of palliative care services, especially in outpatient settings, varies widely across practice sites; factors associated with outpatient palliative care clinic availability remain unknown. Our study describes the presence and characteristics of palliative care resources in community oncology practices. Methods: Analyses used data from the 2015 Cancer Care Delivery Research (CCDR) Landscape Assessment of National Cancer Institute Community Oncology Research Program (NCORP) practices (funding support provided by 2UG1CA189824). Oncology practices were surveyed regarding availability of specialty providers and supportive services, including palliative care, as reported by designated CCDR leads. Descriptive statistics describe availability of providers and services, and logistic regression models identify practice characteristics associated with supportive/palliative care specialist availability. Results: 216 non-pediatric exclusive NCORP practice groups were included in analyses. Characteristics are shown in Table. A majority of practices had palliative care specialists (76%), oncology certified nurses (95%), and advance practice providers (80%); 45% had nurse navigators for oncology. 76% of practices had inpatient palliative care consultation services, but only 36% had a dedicated outpatient palliative care clinic. Multivariable analyses demonstrated practices with Medicaid and/or uninsured patient volumes > 25% (Odds Ratio (OR) = 2.5, p = 0.020), more oncology providers (OR = 1.02, p = 0.025), survivorship clinic availability (OR = 2.5, p = 0.005), and who participated in the Quality Oncology Practice Initiative (QOPI) (OR = 2.0, p = 0.039) were significantly more likely to have an outpatient palliative care clinic. Conclusions: Most community oncology practices reported having palliative care specialists, although only a third had a dedicated outpatient palliative care clinic. Newly discovered factors associated with increased odds of having an outpatient palliative care clinic can inform future efforts to expand the availability of outpatient palliative care clinics within community oncology practices.[Table: see text]

Association of Oncologist-Patient Communication With Functional Status and Physical Performance in Older Adults

The functional status and physical performance of older adults with cancer are underassessed and undertreated despite the high prevalence of impaired functional status and physical performance in this population and their associations with chemotherapy-induced toxic effects and mortality. To examine the association between providing oncologists with a geriatric assessment (GA) summary with recommendations and having oncologist-patient conversations about functional and physical performance. Data for this secondary analysis were collected from October 29, 2014, to April 28, 2017, for a national cluster randomized clinical trial conducted by the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program evaluating the effect of a GA intervention on patient satisfaction with communication about aging-related concerns. There were 17 practice clusters in the intervention group and 14 in the usual care group. All 541 participants underwent a GA including standardized functional and physical performance measures and had 1 clinical encounter audio-recorded, transcribed, and blindly coded to categorize conversations by GA domain. Participants were aged 70 years or older, with a stage III or IV solid tumor or lymphoma with palliative treatment intent, and impairment in 1 or more GA domain. Statistical analysis was performed from August 18, 2020, to January 10, 2022. Oncologist practices randomized to the intervention received a GA summary and validated recommendations for each patient prior to the audio-recorded clinical encounter. The primary analysis of this clinical trial assessed the effect of the intervention on patient satisfaction with oncologist communication about aging-related concerns. This secondary analysis assessed the post hoc hypothesis that the intervention would be associated with an increase in the proportion of patients having conversations with their oncologists and receiving oncologist recommendations specific to functional and physical performance concerns. A total of 541 patients (276 men [51%]; mean [SD] age, 77.5 [5.2] years [range, 70-96 years]) were analyzed at baseline. Excluding 13 patients without audio recordings, 86% of patients (95% CI, 78%-91%) in the intervention group vs 59% of patients (95% CI, 47%-69%; P < .001) receiving usual care had conversations about functional or physical performance. Conversations were more frequently initiated by oncologists in the intervention group (84%; 95% CI, 77%-90%) than oncologists in the usual care group (58%; 95% CI, 45%-70%; P < .001). Oncologists in the intervention group were more likely to address patients' concerns (43%; 95% CI, 33%-53%) than oncologists in the usual care group (17%; 95% CI, 10%-26%; P < .001). In this secondary analysis of a cluster randomized clinical trial, providing oncologists with a GA summary was associated with an increase in the number of oncologist-patient conversations about functional and physical performance-related concerns with recommendations to address these concerns. These findings support the use of the GA summary and recommendations as important tools in caring for older adults with advanced cancer and functional or physical impairments. ClinicalTrials.gov Identifier: NCT02107443.

Clinical Research Professional Providing Care Coordination Support: A Study of Hawaii Minority/Underserved NCORP Community Site Trial Participants.

Although effective care coordination (CC) is recognized as a vital component of a patient-centered, high-quality cancer care delivery system, CC experiences of patients who enroll and receive treatment through clinical trials (CTs) are relatively unknown. Using mixed methods, we examined perceptions of CC among patients enrolled onto therapeutic CTs through the Hawaii Minority/Underserved National Cancer Institute Community Oncology Research Program. The Care Coordination Instrument, a validated instrument, was used to measure patients' perceptions of CC among CT participants (n = 45) and matched controls (n = 45). Paired t-tests were used to compare overall and three CC domain scores (Communication, Navigation, and Operational) between the groups. Semistructured focus group interviews were conducted virtually with 14 CT participants in 2020/2021. CT participants reported significantly higher total CC scores than non-CT participants (P = .0008). Similar trends were found for Navigation and Operational domain scores (P = .007 and .001, respectively). Twenty-nine percent of CT participants reported receiving high-intensity CC assistance from their clinical research professionals (CRPs). Content analysis of focus group discussions revealed that nearly half of the focus group discussions centered on CRPs (47%), including CC support provided by CRPs (26%). Other key themes included general CT experiences (22%) and CRP involvement as an additional benefit to CT participation (15%). Our results show that patients on CTs in this study had a more positive CC experience. This may be attributable in part to CC support provided by CRPs. These findings highlight both the improved experience of treatment for patients participating in a trial and the generally unrecognized yet integral role of CRPs as part of a cancer CT care team.

Protocol paper: Multi-site, cluster-randomized clinical trial for optimizing functional outcomes of older cancer survivors after chemotherapy

BackgroundCancer survivors over the age of 65 have unique needs due to the higher prevalence of functional and cognitive impairment, comorbidities, geriatric syndromes, and greater need for social support after chemotherapy. In this study, we will evaluate whether a Geriatric Evaluation and Management-Survivorship (GEMS) intervention improves functional outcomes important to older cancer survivors following chemotherapy. MethodsA cluster-randomized trial will be conducted in approximately 30 community oncology practices affiliated with the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Participating sites will be randomized to the GEMS intervention, which includes Advanced Practice Practitioner (APP)-directed geriatric evaluation and management (GEM), and Survivorship Health Education (SHE) that is combined with Exercise for Cancer Patients (EXCAP©®), or usual care. Cancer survivors will be recruited from community oncology practices (of participating oncology physicians and APPs) after the enrolled clinicians have consented and completed a baseline survey. We will enroll 780 cancer survivors aged 65 years and older who have completed curative-intent chemotherapy for a solid tumor malignancy within four weeks of study enrollment. Cancer survivors will be asked to choose one caregiver to also participate for a total up to 780 caregivers. The primary aim is to compare the effectiveness of GEMS for improving patient-reported physical function at six months. The secondary aim is to compare effectiveness of GEMS for improving patient-reported cognitive function at six months. Tertiary aims include comparing the effectiveness of GEMS for improving: 1) Patient-reported physical function at twelve months; 2) objectively assessed physical function at six and twelve months; and 3) patient-reported cognitive function at twelve months and objectively assessed cognitive function at six and twelve months. Exploratory health care aims include: 1) Survivor satisfaction with care, 2) APP communication with primary care physicians (PCPs), 3) completion of referral appointments, and 4) hospitalizations at six and twelve months. Exploratory caregiver aims include: 1) Caregiver distress; 2) caregiver quality of life; 3) caregiver burden; and 4) satisfaction with patient care at six and twelve months. DiscussionIf successful, GEMS would be an option for a standardized APP-led survivorship care intervention. Trial RegistrationClinicalTrials.govNCT05006482, registered on August 9, 2021.

Comparing Barriers and Facilitators to Adolescent and Young Adult Clinical Trial Enrollment Across High- and Low-Enrolling Community-Based Clinics.

Adolescent and young adult (AYA) patients with cancer are underrepresented on cancer clinical trials (CCTs), and most AYAs are treated in the community setting. Past research has focused on individual academic institutions, but factors impacting enrollment vary across institutions. Therefore, we examined the patterns of barriers and facilitators between high- and low-AYA enrolling community-based clinics to identify targets for intervention. We conducted 34 semi-structured interviews with stakeholders employed used at National Cancer Institute Community Oncology Research Program (NCORP) affiliate sites ("clinics"). Stakeholders (eg, clinical research associates, patient advocates) were recruited from high- and low-AYA enrolling clinics. We conducted a content analysis and calculated the percentage of stakeholders from each clinic type that reported the barrier or facilitator. A 10% gap between high- and low-enrollers was considered the threshold for differences. Both high- and low-enrollers highlighted insufficient resources as a barrier and the presence of a patient eligibility screening process as a facilitator to AYA enrollment. High-enrolling clinics reported physician gatekeeping as a barrier and the improvement of departmental collaboration as a facilitator. Low-enrollers reported AYAs' uncertainty regarding the CCT process as a barrier and the need for increased physician endorsement of CCTs as a facilitator. High-enrolling clinics reported more barriers downstream in the enrollment process, such as physician gatekeeping. In contrast, low-enrolling clinics struggled with the earlier steps in the CCT enrollment process, such as identifying eligible trials. These findings highlight the need for multi-level, tailored interventions rather than a "one-size-fits-all" approach to improve AYA enrollment in the community setting.

Association of Prognostic Understanding With Health Care Use Among Older Adults With Advanced Cancer

A poor prognostic understanding regarding curability is associated with lower odds of hospice use among patients with cancer. However, the association between poor prognostic understanding or prognostic discordance and health care use among older adults with advanced incurable cancers is not well characterized. To evaluate the association of poor prognostic understanding and patient-oncologist prognostic discordance with hospitalization and hospice use among older adults with advanced cancers. This was a post hoc secondary analysis of a cluster randomized clinical trial that recruited patients from October 29, 2014, to April 28, 2017. Data were collected from community oncology practices affiliated with the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program. The parent trial enrolled 541 patients who were aged 70 years or older and were receiving or considering any line of cancer treatment for incurable solid tumors or lymphomas; the patients' oncologists and caregivers (if available) were also enrolled. Patients were followed up for at least 1 year. Data were analyzed from January 3 to 16, 2021. At enrollment, patients and oncologists were asked about their beliefs regarding cancer curability (100%, >50%, 50%, <50%, and 0%; answers other than 0% reflected poor prognostic understanding) and life expectancy (≤6 months, 7-12 months, 1-2 years, 2-5 years, and >5 years; answers of >5 years reflected poor prognostic understanding). Any difference between oncologist and patient in response options was considered discordant. Outcomes were any hospitalization and hospice use at 6 months captured by the clinical research associates. Among the 541 patients, the mean (SD) age was 76.6 (5.2) years, 264 of 540 (49%) were female, and 486 of 540 (90%) were White. Poor prognostic understanding regarding curability was reported for 59% (206 of 348) of patients, and poor prognostic understanding regarding life expectancy estimates was reported for 41% (205 of 496) of patients. Approximately 60% (202 of 336) of patient-oncologist dyads were discordant regarding curability, and 72% (356 of 492) of patient-oncologist dyads were discordant regarding life expectancy estimates. Poor prognostic understanding regarding life expectancy estimates was associated with lower odds of hospice use (adjusted odds ratio, 0.30; 95% CI, 0.16-0.59). Discordance regarding life expectancy estimates was associated with greater odds of hospitalization (adjusted odds ratio, 1.64; 95% CI, 1.01-2.66). This study highlights different constructs of prognostic understanding and the need to better understand the association between prognostic understanding and health care use among older adult patients with advanced cancer. ClinicalTrials.gov Identifier: NCT02107443.

Qualitative and dosimetric assessment of radiation-induced xerostomia in patients with oral cancers treated with 3DCRT versus IMRT: A prospective observational study

Background: Xerostomia is an important complication in patients with head-and-neck cancer treated with radiotherapy. It is caused by the radiation dose to the salivary glands situated in the lateral facial and submandibular regions, which are commonly included in or are close to the target volume.Objectives: Our primary objective was to evaluate xerostomia in patients treated with three-dimensional conformal radiotherapy (3DCRT) and intensity-modulated radiation therapy (IMRT). We also aimed to identify the risk factors for the development of xerostomia and the treatment-related and dosimetric parameters associated with xerostomia in patients with oral cancers receiving radiotherapy.Materials and Methods: We enrolled 100 patients with oral cancers between Sept 2015 and Apr 2018 who were planned for adjuvant radiotherapy. Patients were treated with unilateral portals in 3DCRT or IMRT. Xerostomia was assessed using the Wake Forest National Cancer Institute Community Oncology Research Program Research Base (WF NCORP RB) # 97115 Questionnaire at baseline, treatment completion, and at 1, 4, and 7 months following the completion of radiotherapy. Detailed salivary gland dosimetric parameters including the minimum (Dmin), maximum (Dmax), and mean dose (Dmean) and other dose and volume parameters (e.g., D25, D50, D75, and V10–V60) were assessed through cumulative dose volume histograms (DVH). Multivariate analysis was performed to determine the factors associated with the development of xerostomia and assess the correlation with dosimetric parameters.Results: At a median follow-up of 20 (95% confidence interval [CI], 8–32) months, the V20, V25, V30, V40, V45, V50, V60, Dmin, and Dmean received by the ipsilateral parotid gland were significantly lower in patients treated with IMRT compared to those treated with 3DCRT (P < 0.001). After the completion of radiotherapy, the mean xerostomia scores at each follow-up were significantly lower in the patients who had received IMRT, compared to 3DCRT. At 7 months of completion of treatment, the mean score of xerostomia in the 3DCRT arm was 44.4, compared to 33.8 in the IMRT arm (P = 0.023). On multivariate analysis, Dmin, V30, V40, V45, V60, history of substance abuse, advanced age, and lower body weight were found to be associated with higher chances of xerostomia.Conclusion: Compared to 3DCRT, IMRT results in lower rates of xerostomia based on dosimetric as well as subjective analysis.

Capacity for cancer care delivery research in gynecologic oncology within the National Cancer Institute Community Oncology Research Program (NCORP)

<h3>Objectives:</h3> The National Cancer Institute (NCI) Community Oncology Research Program (NCORP) was developed as a platform to study cancer care delivery at 23 community sites and 14 minority/underserved sites, encompassing 943 care delivery locations nationwide. We describe the capacity of the NCORP network to conduct cancer care delivery research for gynecologic cancers. We also characterize community practices where patients are treated for gynecologic cancers without an affiliated gynecologic oncologist, as these patients may be at higher risk for outcomes disparities. <h3>Methods:</h3> The 2017 Landscape Capacity Assessment (LCA) was designed by the NCI Division of Cancer Prevention and administered to 943 NCORP locations. This survey included elements related to clinical setting (e.g., size, location, characteristics of patients), staffing (e.g., number/types of care providers), and cancer care practices (e.g., genetic testing, patient navigation). Primary populations of interest were practices identified as providing gynecologic cancer services, and the subgroup of practices providing gynecologic cancer services without an affiliated gynecologic oncologist. χ² tests were used to test for differences in categorical variables. <h3>Results:</h3> A total of 504/943 locations (54%), representing 227 practices completed the LCA; 17 practices solely providing pediatric care were excluded. A total of 46% of responding practices serve >1000 patients per year, 23% report at least 30% of new patients represent minority populations. 41% and 11% of practices report >10% of patients are insured through Medicaid, or are uninsured, respectively. 36% of practices are independently owned while 54% are owned by a larger health system. 22% of practices are embedded in Critical Access hospitals. 29% participate in the Oncology Care Model through the Centers for Medicare and Medicaid Services. 84% record patient data in an EHR. 30% of sites utilize telemedicine for cancer care and 51% of these practices can adapt telemedicine for research purposes. 93% of practices provide survivorship care. 129 groups (56%) reported GYN cancer services; 48% of all practices have an affiliated gynecologic oncologist (median 0; range 1-48). Practices evaluating >1000 patients annually were significantly more likely to offer GYN cancer services. No association was seen between availability of GYN cancer services and insurance mix, proportion of minority patients, use of telemedicine, or availability of community outreach staff. Of practices providing GYN cancer services, practices without an affiliated gynecologic oncologist were less likely to evaluate >1000 new patients annually (35% vs 76%; p<0.001), to have a genetic counselor on site (83% vs 49%, p<0.001), and to have support services available (e.g., social workers, pharmacists, dieticians, psychologists). No significant difference was seen in insurance mix, proportion of minority patients, use of EHR or telemedicine, or availability of community outreach staff between practices with and without an affiliated gynecologic oncologist (Table 1). <h3>Conclusions:</h3> NCORP offers a unique opportunity to study cancer care delivery in community settings, including in underserved minority populations. This platform should be considered for the study of interventional trials aimed at ensuring that patients receive high-quality gynecologic cancer care, especially in the high-risk population of patients who are treated in practices without an affiliated gynecologic oncologist.

Addressing cancer survivors’ cardiovascular health using the automated heart health assessment (AH-HA) EHR tool: Initial protocol and modifications to address COVID-19 challenges

BackgroundThe purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach to cancer care delivery research. This study aims to assess the effect of a clinical decision support tool for cancer survivors on cardiovascular health (CVH) discussions, referrals, completed visits with primary care providers and cardiologists, and control of modifiable CVH factors and behaviors. The COVID-19 pandemic has caused widespread disruption to clinical trial accrual and operations. Studies conducted with potentially vulnerable populations, including cancer survivors, must shift towards virtual consent, data collection, and study visits to reduce risk for participants and study staff. Studies examining cancer care delivery innovations may also need to accommodate the increased use of virtual visits. Methods/designThis group-randomized, mixed methods study will recruit 600 cancer survivors from 12 National Cancer Institute Community Oncology Research Program (NCORP) practices. Survivors at intervention sites will use the AH-HA tool with their oncology provider; survivors at usual care sites will complete routine survivorship visits. Outcomes will be measured immediately after the study visit, with follow-up at 6 and 12 months. The study was amended during the COVID-19 pandemic to allow for virtual consent, data collection, and intervention options, with the goal of minimizing participant-staff in-person contact and accommodating virtual survivorship visits. ConclusionsChanges to the study protocol and procedures allow important cancer care delivery research to continue safely during the COVID-19 pandemic and give sites and survivors flexibility to conduct study activities in-person or remotely.

Targeted eHealth Intervention to Reduce Breast Cancer Survivors' Fear of Recurrence: Results From the FoRtitude Randomized Trial.

BackgroundFear of recurrence (FoR) is a prevalent concern among breast cancer survivors (BCS), yet few accessible interventions exist. This study evaluated a targeted eHealth intervention, “FoRtitude,” to reduce FoR using cognitive behavioral skills training and telecoaching. MethodsBCS (N  = 196) were recruited from an academic medical center and 3 National Cancer Institute Community Oncology Research Program community sites, had stage 0-III breast cancer, were 1-10 years postprimary treatment, with moderate to high FoR and familiarity with the internet. Using the Multiphase Optimization Strategy, participants were independently randomly assigned to 3 cognitive behavioral skills (relaxation, cognitive restructuring, worry practice) vs an attention control condition (health management content [HMC]) and to telecoaching (motivational interviewing) vs no telecoaching. Website content was released across 4 weeks and included didactic lessons, interactive tools, and a text-messaging feature. BCS completed the Fear of Cancer Recurrence Inventory at baseline and at 4 and 8 weeks. Fear of Cancer Recurrence Inventory scores over time were compared using mixed-effects models. All statistical tests were 2-sided.ResultsFCRI scores [SD] decreased statistically significantly from baseline to postintervention (T0 = 53.1 [17.4], T2 = 41.9 [16.2], P < .001). The magnitude of reduction in FCRI scores was comparable across cognitive behavior therapy (CBT) and attention control HMC conditions and was predicted by increased self-efficacy. Telecoaching was associated with lower attrition and greater website use (mean adherence score [SD] = 26.6 [7.2] vs 21.0 [10.5], P < .001).ConclusionsBCS experienced statistically significant reductions in FoR postintervention, but improvements were comparable between CBT and attention controls. Telecoaching improved adherence and retention. Future research is needed on optimal integration of CBT and HMC, dose, and features of eHealth delivery that contributed to reducing FoR. In the COVID-19 era, remote delivery has become even more essential for reaching survivors struggling with FoR.

Immune cell counts and perceived cognitive impairment before and after chemotherapy among 544 women with breast cancer.

12114 Background: In a nationwide prospective study, we found that patients with breast cancer had greater perceived cognitive impairment (PCI) before and after chemotherapy compared to controls without cancer. To gain further insight into the role that inflammation plays in cognitive function, we evaluated relationships between immune cell counts and lymphocyte:monocyte ratio with PCI at pre- and post- chemotherapy. Methods: Data were collected as part of longitudinal cohort study conducted through the National Cancer Institute Community Oncology Research Program network (NCT01382082). Self-reported PCI was scored at pre-chemotherapy (0-7 days before first chemotherapy) and post-chemotherapy (0-30 days after last chemotherapy) from the PCI sub-scale of the Functional Assessment of Cancer Therapy: Cognitive Function (possible score range 0-72). Immune cell counts were measured by complete blood count with differential at pre- and post- chemotherapy. Lymphocyte:monocyte ratio (LMR) was calculated. Separate linear regression models evaluated the association of immune cell counts and LMR with 1) pre-chemotherapy PCI and 2) post-chemotherapy PCI. Models were adjusted for age, cognitive reserve (reading score), anxiety, and depression. Results: PCI and immune cell data were available for 544 patients at pre-chemotherapy and 532 at post-chemotherapy. Subjects had a mean age of 53.1 (SD=10.8). At pre-chemotherapy, higher basophil count and higher LMR were significantly associated with worse PCI (β=5.73, SE=2.37, p&lt;0.05; β=0.047, SE=0.02, p&lt;0.05, respectively). Higher basophil count and higher LMR were also significantly associated with worse PCI at post-chemotherapy (β=5.84, SE=2.92, p&lt;0.05; β=1.01, SE=0.48, p&lt;0.05). Conclusions: These data support the hypothesis that inflammation is associated with perceived cognitive function before and after chemotherapy in adults with breast cancer. Targeting inflammatory processes may be beneficial for reducing cancer-related cognitive impairment. Funding: NCI UG1CA289961, T32CA102618, R01CA231014, DP2CA195765.

The Head and Neck Survivorship Tool (HN-STAR) Trial (WF-1805CD): A protocol for a cluster-randomized, hybrid effectiveness-implementation, pragmatic trial to improve the follow-up care of head and neck cancer survivors

Survivors of head and neck cancer (HNC) can have multiple health concerns. To facilitate their care, we developed and pilot-tested a clinical informatics intervention, HN-STAR. HN-STAR elicits concerns online from HNC survivors prior to a routine oncology clinic visit. HN-STAR then presents tailored evidence-based clinical recommendations as a clinical decision support tool to be used during the visit where the oncology clinician and survivor select symptom management strategies and other actions. This generates a survivorship care plan (SCP). Online elicitation of health concerns occurs 3, 6, and 9 months after the clinic visit, generating an updated SCP each time. HN-STAR encompasses important methods of improving survivorship care (e.g., needs assessment, tailored interventions, dissemination of guidelines) and will be evaluated in a pragmatic trial to maximize external validity. This hybrid type 1 implementation-effectiveness trial tests HN-STAR effectiveness while studying barriers and facilitators to implementation in community oncology practices within the National Cancer Institute Community Oncology Research Program. Effectiveness will be measured as differences in key survivorship outcomes between HNC participants who do and do not use HN-STAR over one year after the clinic visit. The primary endpoint is HNC-specific quality of life; other outcomes include patient-centered measures and receipt of guideline-concordant care. Implementation outcomes will be assessed of survivors, providers, and clinic stakeholders. The hybrid design will provide insight into a dose-response relationship between the extent of implementation fidelity and effectiveness outcomes, as well as how to incorporate HN-STAR into standard practice outside the research setting.

Barriers and Facilitators to Adolescent and Young Adult Cancer Trial Enrollment: NCORP Site Perspectives.

BackgroundAlthough it is well documented that adolescents and young adults (AYAs) with cancer have low participation in cancer clinical trials (CCTs), the underlying reasons are not well understood. We used the National Cancer Institute Community Oncology Research Program (NCORP) network to identify barriers and facilitators to AYA CCT enrollment, and strategies to improve enrollment at community-based and minority and/or underserved sites.MethodsWe performed one-on-one semistructured qualitative interviews with stakeholders (NCORP site principle investigators, NCORP administrators, physicians involved in enrollment, lead clinical research associates or clinical research nurses, nurse navigators, regulatory research associates, patient advocates) in the AYA CCT enrollment process. NCORP sites that included high and low AYA–enrolling affiliate sites and were diverse in geography and department representation (eg, pediatrics, medical oncology) were invited to participate. All interviews were recorded and transcribed. Themes related to barriers and facilitators and strategies to improve enrollment were identified.ResultsWe conducted 43 interviews across 10 NCORP sites. Eleven barriers and 13 facilitators to AYA enrollment were identified. Main barriers included perceived limited trial availability and eligibility, physician gatekeeping, lack of provider and research staff time, and financial constraints. Main facilitators and strategies to improve AYA enrollment included having a patient screening process, physician endorsement of trials, an “AYA champion” on site, and strong communication between medical and pediatric oncology.ConclusionsStakeholders identified several opportunities to address barriers contributing to low AYA CCT enrollment at community-based and minority and/or underserved sites. Results of this study will inform development and implementation of targeted interventions to increase AYA CCT enrollment.

A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

BackgroundVirtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers.MethodsUsing Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms.DiscussionThis study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices.Trial registrationClinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

DeImplementing Ineffective and Low-Value Clinical Practices: Research and Practice Opportunities in Community Oncology Settings.

Patients, practitioners, and policy makers are increasingly concerned about the delivery of ineffective or low-value clinical practices in cancer care settings. Research is needed on how to effectively deimplement these types of practices from cancer care. In this commentary, we spotlight the National Cancer Institute Community Oncology Research Program (NCORP), a national network of community oncology practices, and elaborate on how it is an ideal infrastructure for conducting rigorous, real-world research on deimplementation. We describe key multilevel issues that affect deimplementation and also serve as a guidepost for developing strategies to drive deimplementation. We describe optimal study designs for testing deimplementation strategies and elaborate on how and why the NCORP network is uniquely positioned to conduct rigorous and impactful deimplementation trials. The number and diversity of affiliated community oncology care sites, coupled with the overall objective of improving cancer care delivery, make the NCORP an opportune infrastructure for advancing deimplementation research while simultaneously improving the care of millions of cancer patients nationwide.

Caregiver engagement practices in National Cancer Institute Clinical Oncology Research Program settings: Implications for research to advance the field.

Supportive care interventions have demonstrated benefits for both informal and/or family cancer caregivers and their patients, but uptake generally is poor. To the authors' knowledge, little is known regarding the availability of supportive care services in community oncology practices, as well as engagement practices to connect caregivers with these services. Questions from the National Cancer Institute Community Oncology Research Program (NCORP)'s 2017 Landscape Survey examined caregiver engagement practices (ie, caregiver identification, needs assessment, and supportive care service availability). Logistic regression was used to assess the relationship between the caregiver engagement outcomes and practice group characteristics. A total of 204 practice groups responded to each of the primary outcome questions. Only 40.2% of practice groups endorsed having a process with which to systematically identify and document caregivers, although approximately 76% were routinely using assessment tools to identify caregiver needs and approximately 63.7% had supportive care services available to caregivers. Caregiver identification was more common in sites affiliated with a critical access hospital (odds ratio [OR], 2.44; P = .013), and assessments were less common in safety-net practices (OR, 0.41; P = .013). Supportive care services were more commonly available in the Western region of the United States, in practices with inpatient services (OR, 2.96; P = .012), and in practices affiliated with a critical access hospital (OR, 3.31; P = .010). Although many practice groups provide supportive care services, fewer than one-half systematically identify and document informal cancer caregivers. Expanding fundamental engagement practices such as caregiver identification, assessment, and service provision will be critical to support recent calls to improve caregivers' well-being and skills to perform caregiving tasks.

Capacity to Provide Geriatric Specialty Care for Older Adults in Community Oncology Practices

American Society of Clinical Oncology guidelines recommend that patients ≥65 years of age starting chemotherapy undergo a geriatric assessment (GA) to inform and guide management; however, little is known about resources available in community oncology practices to implement these guidelines and to facilitate geriatric oncology research. Oncology practices within the National Cancer Institute Community Oncology Research Program (NCORP) were electronically surveyed in 2017 regarding the availability of specialty providers, supportive services, and practice characteristics, as part of a larger survey of cancer care delivery research capacity. Of the 943 NCORP practices, 504 (54%) responded to the survey, representing 210 practice groups. The median new cancer cases per year ≥65 years of age was 457 (interquartile range 227-939). Of respondents, only 2.0% of practices had a fellowship-trained geriatric oncologist on staff. Geriatricians were available for consultation or comanagement at 37% of sites, and of those, only 13% had availability within the oncology clinic (5% of overall). Practice size of ≥1,000 new adult cancer cases (ages ≥18) per year was associated with higher odds (1.81, confidence interval 1.02-3.23) of geriatrician availability. Other multidisciplinary care professionals that could support GA were variably available onsite: social worker (84%), nurse navigator (81%), pharmacist (77%), dietician (71%), rehabilitative medicine (57%), psychologist (42%), and psychiatrist (37%). Only a third of community oncology practices have access to a geriatrician within their group and only 5% of community sites have access within the oncology clinic. Use of primarily self-administered GA tools that direct referrals to available services may be an effective implementation strategy for guideline-based care. Only a minority of community oncology practices in the U.S. have access to geriatric specialty care. Developing models of care that use patient-reported measures and/or other geriatric screening tools to assess and guide interventions in older adults, rather than geriatric consultations, are likely the most practical methods to improve the care of this vulnerable population.