Assessing the pre-implementation context for financial navigation in rural and non-rural oncology clinics.

Background: Financial navigation (FN) is an evidence-based intervention designed to address financial toxicity for cancer patients. FN's success depends on organizations' readiness to implement and other factors that may hinder or support implementation. Tailored implementation strategies can support practice change but must be matched to the implementation context. We assessed perceptions of readiness and perceived barriers and facilitators to successful implementation among staff at nine cancer care organizations (5 rural, 4 non-rural) recruited to participate in the scale-up of a FN intervention. To understand differences in the pre-implementation context and inform modifications to implementation strategies, we compared findings between rural and non-rural organizations. Methods: We conducted surveys (n = 78) and in-depth interviews (n = 73) with staff at each organization. We assessed perceptions of readiness using the Organizational Readiness for Implementing Change (ORIC) scale. In-depth interviews elicited perceived barriers and facilitators to implementing FN in each context. We used descriptive statistics to analyze ORIC results and deductive thematic analysis, employing a codebook guided by the Consolidated Framework for Implementation Research (CFIR), to synthesize themes in barriers and facilitators across sites, and by rurality. Results: Results from the ORIC scale indicated strong perceptions of organizational readiness across all sites. Staff from rural areas reported greater confidence in their ability to manage the politics of change (87% rural, 76% non-rural) and in their organization's ability to support staff adjusting to the change (96% rural, 75% non-rural). Staff at both rural and non-rural sites highlighted factors reflective of the Intervention Characteristics (relative advantage) and Implementation Climate (compatibility and tension for change) domains as facilitators. Although few barriers to implementation were reported, differences arose between rural and non-rural sites in these perceived barriers, with non-rural staff more often raising concerns about resistance to change and compatibility with existing work processes and rural staff more often raising concerns about competing time demands and limited resources. Conclusions: Staff across both rural and non-rural settings identified few, but different, barriers to implementing a novel FN intervention that they perceived as important and responsive to patients' needs. These findings can inform how strategies are tailored to support FN in diverse oncology practices.

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings.

PURPOSE: Patients with cancer are at heightened risk of experiencing financial hardship. Financial navigation (FN) is an evidence-based approach for identifying and addressing patient and caregiver financial needs. In preparation for the implementation of a multisite FN intervention, we describe existing processes (ie, events and actions) and mechanisms (ie, how events work together) connecting patients to financial assistance, comparing rural and nonrural practices. METHODS: We conducted in-depth, semistructured interviews with stakeholders (ie, administrators, providers, and staff) at each of the 10 oncology care sites across a single state (five rural and five nonrural practices). We developed process maps for each site and analyzed stakeholder perspectives using thematic analysis. After reporting findings back to stakeholders, we synthesized themes and process maps across rural and nonrural sites separately. RESULTS: Eighty-three stakeholders were interviewed. We identified six core elements of existing financial assistance processes across all sites: distress screening (including financial concerns), referrals, resource connection points, and pharmaceutical, insurance, and community/foundation resources. Processes differed by rurality; however, facilitators and barriers to identifying and addressing patient financial needs were consistent. Open communication between staff, providers, patients, and caregivers was a primary facilitator. Barriers included insufficient staff resources, challenges in routinely identifying needs, inadequate preparation of patients for anticipated medical costs, and limited tracking of resource availability and eligibility. CONCLUSION: This study identified a clear need for systematic implementation of oncology FN to equitably address patient and caregiver financial hardship. Results have informed our current efforts to implement a multisite FN intervention, which involves comprehensive financial toxicity screening and systematization of intake and referrals.

A Cluster Randomized Trial of a Community-Based Intervention Among African-American Adults: Effects on Dietary and Physical Activity Outcomes.

Evidence of the effectiveness of community-based lifestyle behavior change interventions among African-American adults is mixed. We implemented a behavioral lifestyle change intervention, Heart Matters, in two rural counties in North Carolina with African-American adults. Our aim was to evaluate the effect of Heart Matters on dietary and physical activity behaviors, self-efficacy, and social support. We used a cluster randomized controlled trial to compare Heart Matters to a delayed intervention control group after 6 months. A total of 143 African-American participants were recruited and 108 completed 6-month follow-up assessments (75.5%). We used mixed regression models to evaluate changes in outcomes from baseline to 6-month follow-up. The intervention had a significant positive effect on self-reported scores of encouragement of healthy eating, resulting in an increase in social support from family of 6.11 units (95% CI [1.99, 10.22]) (p < .01). However, intervention participants also had an increase in discouragement of healthy eating compared to controls of 5.59 units (95% CI [1.46, 9.73]) among family (p < .01). There were no significant differences in changes in dietary behaviors. Intervention participants had increased odds (OR = 2.86, 95% CI [1.18, 6.93]) of increased frequency of vigorous activity for at least 20 min per week compared to control participants (p < .05). Individual and group lifestyle behavior counseling can have a role in promoting physical activity levels among rural African-American adults, but more research is needed to identify the best strategies to bolster effectiveness and influence dietary change. Trial Registration: Clinical Trials, NCT02707432. Registered 13 March 2016.

Adaptation of an Evidence-Based Cardiovascular Health Intervention for Rural African Americans in the Southeast.

BACKGROUND: African Americans (AA) living in the southeast United States have the highest prevalence of cardiovascular diseases (CVD) and rural minorities bear a significant burden of co-occurring CVD risk factors. Few evidence-based interventions (EBI) address social and physical environmental barriers in rural minority communities. We used intervention mapping together with community-based participatory research (CBPR) principles to adapt objectives of a multi-component CVD lifestyle EBI to fit the needs of a rural AA community. We sought to describe the process of using CPBR to adapt an EBI using intervention mapping to an AA rural setting and to identify and document the adaptations mapped onto the EBI and how they enhance the intervention to meet community needs. METHODS: Focus groups, dyadic interviews, and organizational web-based surveys were used to assess content interest, retention strategies, and incorporation of auxiliary components to the EBI. Using CBPR principles, community and academic stakeholders met weekly to collaboratively integrate formative research findings into the intervention mapping process. We used a framework developed by Wilstey Stirman et al. to document changes. RESULTS: Key changes were made to the content, context, and training and evaluation components of the existing EBI. A matrix including behavioral objectives from the original EBI and new objectives was developed. Categories of objectives included physical activity, nutrition, alcohol, and tobacco divided into three levels, namely, individual, interpersonal, and environmental. CONCLUSIONS: Intervention mapping integrated with principles of CBPR is an efficient and flexible process for adapting a comprehensive and culturally appropriate lifestyle EBI for a rural AA community context.

Proteasome inhibitor bortezomib is a novel therapeutic agent for focal radiation-induced osteoporosis.

Bone atrophy and its related fragility fractures are frequent, late side effects of radiotherapy in cancer survivors and have a detrimental impact on their quality of life. In another study, we showed that parathyroid hormone 1-34 and anti-sclerostin antibody attenuates radiation-induced bone damage by accelerating DNA repair in osteoblasts. DNA damage responses are partially regulated by the ubiquitin proteasome pathway. In the current study, we examined whether proteasome inhibitors have similar bone-protective effects against radiation damage. MG132 treatment greatly reduced radiation-induced apoptosis in cultured osteoblastic cells. This survival effect was owing to accelerated DNA repair as revealed by γH2AX foci and comet assays and to the up-regulation of Ku70 and DNA-dependent protein kinase, catalytic subunit, essential DNA repair proteins in the nonhomologous end-joining pathway. Administration of bortezomib (Bzb) reversed the loss of trabecular bone structure and strength in mice at 4 wk after focal radiation. Histomorphometry revealed that Bzb significantly increased the number of osteoblasts and activity in the irradiated area and suppressed the number and activity of osteoclasts, regardless of irradiation. Two weeks of Bzb treatment accelerated DNA repair in bone-lining osteoblasts and thus promoted their survival. Meanwhile, it also inhibited bone marrow adiposity. Taken together, we demonstrate a novel role of proteasome inhibitors in treating radiation-induced osteoporosis.-Chandra, A., Wang, L., Young, T., Zhong, L., Tseng, W.-J., Levine, M. A., Cengel, K., Liu, X. S., Zhang, Y., Pignolo, R. J., Qin, L. Proteasome inhibitor bortezomib is a novel therapeutic agent for focal radiation-induced osteoporosis.

Suppression of Sclerostin Alleviates Radiation-Induced Bone Loss by Protecting Bone-Forming Cells and Their Progenitors Through Distinct Mechanisms.

Focal radiotherapy is frequently associated with skeletal damage within the radiation field. Our previous in vitro study showed that activation of Wnt/ß-catenin pathway can overcome radiation-induced DNA damage and apoptosis of osteoblastic cells. Neutralization of circulating sclerostin with a monoclonal antibody (Scl-Ab) is an innovative approach for treating osteoporosis by enhancing Wnt/ß-catenin signaling in bone. Together with the fact that focal radiation increases sclerostin amount in bone, we sought to determine whether weekly treatment with Scl-Ab would prevent focal radiotherapy-induced osteoporosis in mice. Micro-CT and histomorphometric analyses demonstrated that Scl-Ab blocked trabecular bone structural deterioration after radiation by partially preserving osteoblast number and activity. Consistently, trabecular bone in sclerostin null mice was resistant to radiation via the same mechanism. Scl-Ab accelerated DNA repair in osteoblasts after radiation by reducing the number of γ-H2AX foci, a DNA double-strand break marker, and increasing the amount of Ku70, a DNA repair protein, thus protecting osteoblasts from radiation-induced apoptosis. In osteocytes, apart from using similar DNA repair mechanism to rescue osteocyte apoptosis, Scl-Ab restored the osteocyte canaliculi structure that was otherwise damaged by radiation. Using a lineage tracing approach that labels all mesenchymal lineage cells in the endosteal bone marrow, we demonstrated that radiation damage to mesenchymal progenitors mainly involves shifting their fate to adipocytes and arresting their proliferation ability but not inducing apoptosis, which are different mechanisms from radiation damage to mature bone forming cells. Scl-Ab treatment partially blocked the lineage shift but had no effect on the loss of proliferation potential. Taken together, our studies provide proof-of-principle evidence for a novel use of Scl-Ab as a therapeutic treatment for radiation-induced osteoporosis and establish molecular and cellular mechanisms that support such treatment. © 2016 American Society for Bone and Mineral Research.