National Cancer Institute Community Oncology Research Articles

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

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

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

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

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

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

Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment

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

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.

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

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

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]

Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD

BackgroundCancer Care Delivery (CCD) research studies often require practice-level interventions that pose challenges in the clinical trial setting. The SWOG Cancer Research Network (SWOG) conducted S1415CD, one of the first pragmatic cluster-randomized CCD trials to be implemented through the National Cancer Institute (NCI) Community Oncology Program (NCORP), to compare outcomes of primary prophylactic colony stimulating factor (PP-CSF) use for an intervention of automated PP-CSF standing orders to usual care. The introduction of new methods for study implementation created challenges and opportunities for learning that can inform the design and approach of future CCD interventions.MethodsThe order entry system intervention was administered at the site level; sites were affiliated NCORP practices that shared the same chemotherapy order system. 32 sites without existing guideline-based PP-CSF standing orders were randomized to the intervention (n = 24) or to usual care (n = 8). Sites assigned to the intervention participated in tailored training, phone calls and onboarding activities administered by research team staff and were provided with additional funding and external IT support to help them make protocol required changes to their order entry systems.ResultsThe average length of time for intervention sites to complete reconfiguration of their order sets following randomization was 7.2 months. 14 of 24 of intervention sites met their individual patient recruitment target of 99 patients enrolled per site.ConclusionsIn this paper we share seven recommendations based on lessons learned from implementation of the S1415CD intervention at NCORP community oncology practices representing diverse geographies and patient populations across the U. S. It is our hope these recommendations can be used to guide future implementation of CCD interventions in both research and community settings.Trial RegistrationNCT02728596, registered April 5, 2016.

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.

Facilitators and barriers to clinical practice guideline-consistent supportive care at pediatric oncology institutions: a Children\u2019s Oncology Group study

BackgroundClinical practice guideline (CPG)-consistent care improves patient outcomes, but CPG implementation is poor. Little is known about CPG implementation in pediatric oncology. This study aimed to understand supportive care CPG implementation facilitators and barriers at pediatric oncology National Cancer Institute (NCI) Community Oncology Research Program (NCORP) institutions.MethodsHealthcare professionals at 26 pediatric, Children's Oncology Group-member, NCORP institutions were invited to participate in face-to-face focus groups. Serial focus groups were held until saturation of ideas was reached. Supportive care CPG implementation facilitators and barriers were solicited using nominal group technique (NGT), and implementation of specific supportive care CPG recommendations was discussed. Notes from each focus group were analyzed using a directed content analysis. The top five themes arising from an analysis of NGT items were identified, first from each focus group and then across all focus groups.ResultsSaturation of ideas was reached after seven focus groups involving 35 participants from 18 institutions. The top five facilitators of CPG implementation identified across all focus groups were organizational factors including charging teams with CPG implementation, individual factors including willingness to standardize care, user needs and values including mentorship, system factors including implementation structure, and implementation strategies including a basis in science. The top five barriers of CPG implementation identified were organizational factors including tolerance for inconsistencies, individual factors including lack of trust, system factors including administrative hurdles, user needs and values including lack of inclusivity, and professional including knowledge gaps.ConclusionsHealthcare professionals at pediatric NCORP institutions believe that organizational factors are the most important determinants of supportive care CPG implementation. They believe that CPG-consistent supportive care is most likely to be delivered in organizations that prioritize evidence-based care, provide structure and resources to implement CPGs, and eliminate implementation barriers.Trial registrationClinicalTrials.gov Identifier: NCT02847130. Date of registration: July 28, 2016.

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.

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.