The National Cancer Institute's Cancer Disparities Research Partnership Program: a unique funding model 20 years later.

The burden of cancer and access to effective treatment are not experienced equally by all in the United States. For underserved populations that often access the health-care system when their cancers are in advanced disease stages, radiation oncology services are essential. In 2001, the National Cancer Institute's (NCI's) Radiation Research Program created and implemented the Cancer Disparities Research Partnership Program (CDRP). CDRP was a pioneering funding model whose goal was to increase participation of medically underserved populations in NCI clinical trials. CDRP's Cooperative Agreement funding supported for awardees the planning, development, and conduct of radiation oncology clinical research in institutions not traditionally involved in NCI-sponsored research and cared for a disproportionate number of medically underserved, health-disparities populations. The awardee secured and provided support for mentorship from 1 of 2 NCI comprehensive cancer centers named in its application. Six CDRP awards were made over two 5-year funding periods ending in 2013, with the end-of-program accomplishments previously reported. With the current focus on addressing equity, diversity, and inclusion, the 6 principal investigators were surveyed, 5 of whom responded about the impact of CDRP on their institutions, communities, and personal career paths. The survey that was emailed included 10 questions on a 5-point Likert scale. It was not possible to collect patient data this long after completion of the program. This article provides a 20-year retrospective of the experiences and observations from those principal investigators that can inform those now planning, building, and implementing equity, diversity, and inclusion programs.

Analysis of accumulated SARS-CoV-2 seroconversion in North Carolina: The COVID-19 Community Research Partnership.

INTRODUCTION: The COVID-19 Community Research Partnership is a population-based longitudinal syndromic and sero-surveillance study. The study includes over 17,000 participants from six healthcare systems in North Carolina who submitted over 49,000 serology results. The purpose of this study is to use these serology data to estimate the cumulative proportion of the North Carolina population that has either been infected with SARS-CoV-2 or developed a measurable humoral response to vaccination. METHODS: Adult community residents were invited to participate in the study between April 2020 and February 2021. Demographic information was collected and daily symptom screen was completed using a secure, HIPAA-compliant, online portal. A portion of participants were mailed kits containing a lateral flow assay to be used in-home to test for presence of anti-SARS-CoV-2 IgM or IgG antibodies. The cumulative proportion of participants who tested positive at least once during the study was estimated. A standard Cox proportional hazards model was constructed to illustrate the probability of seroconversion over time up to December 20, 2020 (before vaccines available). A separate analysis was performed to describe the influence of vaccines through February 15, 2021. RESULTS: 17,688 participants contributed at least one serology result. 68.7% of the population were female, and 72.2% were between 18 and 59 years of age. The average number of serology results submitted per participant was 3.0 (±1.9). By December 20, 2020, the overall probability of seropositivity in the CCRP population was 32.6%. By February 15, 2021 the probability among healthcare workers and non-healthcare workers was 83% and 49%, respectively. An inflection upward in the probability of seropositivity was demonstrated around the end of December, suggesting an influence of vaccinations, especially for healthcare workers. Among healthcare workers, those in the oldest age category (60+ years) were 38% less likely to have seroconverted by February 15, 2021. CONCLUSIONS: Results of this study suggest more North Carolina residents may have been infected with SARS-CoV-2 than the number of documented cases as determined by positive RNA or antigen tests. The influence of vaccinations on seropositivity among North Carolina residents is also demonstrated. Additional research is needed to fully characterize the impact of seropositivity on immunity and the ultimate course of the pandemic.

Survey of Adherence with COVID-19 Prevention Behaviors During the 2020 Thanksgiving and Winter Holidays Among Members of the COVID-19 Community Research Partnership.

Prevention behaviors represent important public health tools to limit spread of SARS-CoV-2. Adherence with recommended public health prevention behaviors among 20000 + members of a COVID-19 syndromic surveillance cohort from the mid-Atlantic and southeastern United States was assessed via electronic survey following the 2020 Thanksgiving and winter holiday (WH) seasons. Respondents were predominantly non-Hispanic Whites (90%), female (60%), and ≥ 50 years old (59%). Non-household members (NHM) were present at 47.1% of Thanksgiving gatherings and 69.3% of WH gatherings. Women were more likely than men to gather with NHM (p < 0.0001). Attending gatherings with NHM decreased with older age (Thanksgiving: 60.0% of participants aged < 30 years to 36.3% aged ≥ 70 years [p-trend < 0.0001]; WH: 81.6% of those < 30 years to 61.0% of those ≥ 70 years [p-trend < 0.0001]). Non-Hispanic Whites were more likely to gather with NHM than were Hispanics or non-Hispanic Blacks (p < 0.0001). Mask wearing, reported by 37.3% at Thanksgiving and 41.9% during the WH, was more common among older participants, non-Hispanic Blacks, and Hispanics when gatherings included NHM. In this survey, most people did not fully adhere to recommended public health safety behaviors when attending holiday gatherings. It remains unknown to what extent failure to observe these recommendations may have contributed to the COVID-19 surges observed following Thanksgiving and the winter holidays in the United States.

Changing Attitudes toward the COVID-19 Vaccine among North Carolina Participants in the COVID-19 Community Research Partnership.

Coronavirus Disease-2019 (COVID-19) vaccine acceptance is variable. We surveyed participants in the COVID-19 Community Research Partnership from 17 December 2020 to 13 January 2021 to assess vaccine receptiveness. Vaccine uptake was then monitored until 15 May 2021; 20,232 participants responded to the receptiveness survey with vaccination status accessed in 18,874 participants via daily follow-up surveys (participants not completing daily surveys ≥30 days to 15 May 2021, were excluded). In the initial survey, 4802 (23.8%) were vaccine hesitant. Hesitancy was most apparent in women (Adjusted RR 0.93, p < 0.001), Black Americans (Adjusted RR 1.39, 1.41, 1.31 to non-Hispanic Whites, Other, and Hispanic or Latino, respectively p < 0.001), healthcare workers (Adjusted RR 0.93, p < 0.001), suburbanites (ref. Urban Adjusted RR 0.85, 0.90 to urban and rural dwellers, respectively, p < 0.01), and those previously diagnosed with COVID-19 (RR 1.20, p < 0.01). Those <50 years were also less accepting of vaccination. Subsequent vaccine uptake was 99% in non-hesitant participants. For those who were unsure, preferred not to answer, or answered "no", vaccination rates were 80% (Adjusted RR 0.86, p < 0.0001), 78% (Adjusted RR 0.83, p < 0.0001), and 52.7% (Adjusted RR 0.65, p < 0.0001), respectively. These findings suggest that initial intent did not correlate with vaccine uptake in our cohort.

Single-Arm Phase 2 Trial of Elective Nodal Dose Reduction for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck.

PURPOSE: To evaluate a novel chemoradiation therapy (CRT) regimen for patients with squamous cell carcinoma of the head and neck (SCCHN) incorporating a lower intensity modulated radiation therapy dose to electively treated neck lymph nodes than is currently standard. METHODS AND MATERIALS: Eligible patients had locally advanced SCCHN of the oral cavity, oropharynx, larynx, or hypopharynx. The 7-week CRT course consisted of weekly cisplatin at 35 mg/m2 concurrently with sequential-boost intensity modulated radiation therapy: 36 Gy to high- and low-risk planning target volumes followed by a sequential boost to the high-risk planning target volume to 70 Gy. The primary endpoint was elective nodal failure. Secondary endpoints were survival, toxicity, feeding tube duration, and quality of life evaluated by the FACT-HN and QOL-RTI surveys. RESULTS: Between 2011 and 2014, 54 patients were enrolled, 31 (57%) of whom had human papillomavirus (HPV)-positive disease. Of the patients, 35 (65%) had stage IVa disease. The median follow-up period for survivors was 36 months (range, 12-66 months). Elective nodal failure did not develop in any patient. The actuarial 3-year survival rate for the entire cohort was 91% (95% confidence interval [CI] 0.79-0.96); for the HPV-negative group, 85% (95% CI 0.61-0.95); and for the HPV-positive group, 96% (95% CI 0.77-0.99). Common grade 3 toxicities were dysphagia (79%), mucositis and/or stomatitis (41%), nausea (20%), xerostomia (13%), vomiting (11%), and neutropenia (10%). The median feeding tube duration was 142 days. Patient FACT-HN scores were higher at 3, 6, and 12 months versus at the end of treatment (P < .0001). Total FACT-HN scores returned to pretreatment baseline by 6 months. Overall QOL-RTI scores were lower from pretreatment to the end of treatment through 12 months (P = .0001). CONCLUSIONS: This CRT regimen for patients with advanced SCCHN demonstrated the potential feasibility of reducing the elective dose to the neck, a topic that requires additional study in future clinical trials.

Expanded indications for the deep plane cervicofacial flap: aesthetic reconstruction of large combined temporofrontal and brow defects.

The deep plane cervicofacial (DPCF) rotation advancement flap has been well described for coverage of cheek and lower eyelid defects. The extension of this flap for coverage of complex combined temporofrontal and brow defects has not been previously described. The primary investigator (E.L.C.) performed a chart review of all 7 DPCF flaps performed for reconstructive purposes at the University of Texas Medical Branch, Galveston, Tex, from November 2011 through August 2012. Three patients with complex combined temporal and brow defects were identified. Three patients underwent coverage of complex combined temporofrontal and brow defects using the DPCF flap. Adequate coverage was provided with good skin color match. No flap loss or tip necrosis was seen, despite immediate excision of the resulting cheek standing cone deformity in 2 of the 3 patients at the time of reconstruction. All patients had suture fixation of the DPCF flap to cheek periosteum. All had none or mild lateral canthal distortion, with less than 1 mm of asymptomatic ectropion at a minimum follow-up of 4 months. The DPCF flap is a safe, effective, and reliable means to provide coverage for complex combined temporofrontal and brow defects. The deep plane elevation and musculocutaneous blood supply may improve flap mobility, viability, and resistance to tension. The standing cone deformity resulting from flap advancement can be primarily excised without risking flap necrosis. With further study, indications for the DPCF flap may include adjacent areas of the face currently being reconstructed using other means.

Oncoplastic surgery and radiation therapy for breast conservation: early outcomes.

PURPOSE: To analyze a multidisciplinary community experience with oncoplastic breast surgery (OBS) and postoperative radiation therapy (RT). METHODS: The records of 79 patients with localized breast cancer who underwent OBS+RT were reviewed. OBS included immediate reconstruction and contralateral mammoreduction. All patients had negative surgical margins. Whole-breast RT was delivered without boost. A subset of 44 patients agreed to complete a validated quality of life survey pre-RT, post-RT, 6 months after RT, and at final follow-up assessing cosmesis and treatment satisfaction. RESULTS: Sixty-seven patients (85%) were white. Median age was 62 years. Median interval between OBS and RT start was 9.6 weeks. Median RT dose was 46 Gy. Fourteen patients (18%) developed surgical toxicities before RT. Five patients (6%) developed RT toxicities. Physician rating of cosmesis post-RT was: 3% excellent, 94% good, and 4% fair. Cosmesis was rated as excellent or good by 87% of patients pre-RT, 82% post-RT, 75% at 6 months, and 88% at the final follow-up. Treatment satisfaction was rated as "total" or "somewhat" by 97% of patients pre-RT, 93% post-RT, 75% at 6 months, and 96% at final follow-up. No significant relation was found between patient or treatment-related factors and toxicity. Local control is 100% at median follow-up of 2.9 years. CONCLUSIONS: OBS followed by RT resulted in acceptable toxicity and favorable physician-rated cosmesis in this large community series. Patients' ratings of cosmesis and treatment satisfaction were initially high, decreasing at 6 months, returning near baseline at final follow-up.

National Cancer Institute's Cancer Disparities Research Partnership Program: Experience and Lessons Learned.

PURPOSE: To increase access of underserved/health disparities communities to National Cancer Institute (NCI) clinical trials, the Radiation Research Program piloted a unique model - the Cancer Disparities Research Partnership (CDRP) program. CDRP targeted community hospitals with a limited past NCI funding history and provided funding to establish the infrastructure for their clinical research program. METHODS: Initially, 5-year planning phase funding was awarded to six CDRP institutions through a cooperative agreement (U56). Five were subsequently eligible to compete for 5-year implementation phase (U54) funding and three received a second award. Additionally, the NCI Center to Reduce Cancer Health Disparities supported their U56 patient navigation programs. RESULTS: Community-based hospitals with little or no clinical trials experience required at least a year to develop the infrastructure and establish community outreach/education and patient navigation programs before accrual to clinical trials could begin. Once established, CDRP sites increased their yearly patient accrual mainly to NCI-sponsored cooperative group trials (~60%) and Principal Investigator/mentor-initiated trials (~30%). The total number of patients accrued on all types of trials was 2,371, while 5,147 patients received navigation services. CONCLUSION: Despite a historical gap in participation in clinical cancer research, underserved communities are willing/eager to participate. Since a limited number of cooperative group trials address locally advanced diseases seen in health disparities populations; this shortcoming needs to be rectified. Sustainability for these programs remains a challenge. Addressing these gaps through research and public health mechanisms may have an important impact on their health, scientific progress, and efforts to increase diversity in NCI clinical trials.

Phase II trial of hyperfractionated intensity-modulated radiation therapy and concurrent weekly cisplatin for Stage III and IVa head-and-neck cancer.

PURPOSE: To investigate a novel chemoradiation regimen designed to maximize locoregional control (LRC) and minimize toxicity for patients with advanced head-and-neck squamous cell carcinoma (HNSCC). METHODS AND MATERIALS: Patients received hyperfractionated intensity modulated radiation therapy (HIMRT) in 1.25-Gy fractions b.i.d. to 70 Gy to high-risk planning target volume (PTV). Intermediate and low-risk PTVs received 60 Gy and 50 Gy, at 1.07, and 0.89 Gy per fraction, respectively. Concurrent cisplatin 33 mg/m(2)/week was started Week 1. Patients completed the Quality of Life Radiation Therapy Instrument pretreatment (PRE), at end of treatment (EOT), and at 1, 3, 6, 9, and 12 months. Overall survival (OS), progression-free (PFS), LRC, and toxicities were assessed. RESULTS: Of 39 patients, 30 (77%) were alive without disease at median follow-up of 37.5 months. Actuarial 3-year OS, PFS, and LRC were 80%, 82%, and 87%, respectively. No failures occurred in the electively irradiated neck and there were no isolated neck failures. Head and neck QOL was significantly worse in 18 of 35 patients (51%): mean 7.8 PRE vs. 3.9 EOT. By month 1, H&N QOL returned near baseline (mean 6.2, SD = 1.7). The most common acute Grade 3+ toxicities were mucositis (38%), fatigue (28%), dysphagia (28%), and leukopenia (26%). CONCLUSIONS: Hyperfractionated IMRT with low-dose weekly cisplatin resulted in good LRC with acceptable toxicity and QOL. Lack of elective nodal failures despite very low dose per fraction has led to an attempt to further minimize toxicity by reducing elective nodal doses in our subsequent protocol.

A bridge between academic and community radiation oncology treatment planning.

PURPOSE: To evaluate Telesynergy (TS) as a method of interactive treatment planning between academic and community radiation oncology departments. METHODS: Through a grant from the National Cancer Institute to improve cancer outcomes for underserved populations, community radiation oncologists at New Hanover Regional Medical Center (NHRMC) in Wilmington, North Carolina, partnered with those at the University of North Carolina (UNC) in Chapel Hill, North Carolina. TS suites were installed at both sites to facilitate teleconferencing and review of treatment planning for intensity-modulated radiation therapy (IMRT). Patients with locally advanced head and neck cancer at NHRMC who were enrolled on a clinical trial of chemoirradiation underwent IMRT planning utilizing commercial software. NHRMC physicians contoured tumor targets and adjacent healthy organs. Physics staff at NHRMC generated an initial IMRT plan for each patient. Radiation oncologists at UNC then reviewed individual IMRT plans via TS conferences. RESULTS AND CONCLUSION: Between August 2004 and August 2005, seven IMRT plans were reviewed in eight TS conferences. Physician contours of tumor targets and healthy organs, dose volume histograms, IMRT beams, and isodose distributions were shared during each TS conference successfully. Median time for each session was 35 minutes (range, 30 to 75). Physician satisfaction with the interactive planning process was high at both NHRMC and UNC. A cycle would likely evolve of initial intensive use of TS conferences, to gradual use for ongoing quality control, then greater use as the treatment planning technology undergoes its next change. Complex IMRT treatment planning review was feasible between an academic and community hospital via TS with a high level of physician participant satisfaction.