The Clinical Sustainability Assessment Tool (CSAT) is designed to capture determinants of sustainable clinical practices over time. Although the full 49-item CSAT instrument has demonstrated strong psychometric properties, the 21-item short form has had limited evaluation. This study aimed to assess the CSAT short form (CSAT Short) across different respondent characteristics and care delivery settings. We evaluated the CSAT Short in a sample of healthcare personnel (N = 256 respondents) drawn from across three hybrid effectiveness-implementation studies in a research consortium, all of which tested routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings in the US. Confirmatory factor analyses (CFA) and mIRT were conducted to assess the CSAT Short's fit to the hypothesized factor structure. Multiple-group CFA was used to test for measurement invariance across groups of respondents with different professional roles, years in current role, and different work settings. The hypothesized seven factor structure of the CSAT Short exhibited good fit to the data and strong internal consistency in our sample of healthcare personnel drawn from across three large pragmatic trials (CFI = .99,TLI = .98,X2(182) = 658.99,p < .001;SRMR = .031,RMSEA = .10). Tests of measurement invariance indicated the respondent’s role in the clinical setting (i.e., clinician vs. non-clinician) and years in current role (< 10 years vs. ≥10 years) were invariant. However, significant variance was found between respondents from three different Research Centers within the IMPACT consortium. The second-order mIRT model demonstrated acceptable fit based on most indices (M2(56) = 148.69, p < .001; RMSEA = 0.059, 90

BackgroundEmbedded pragmatic clinical trials (ePCTs) are conducted as part of routine care, which provides researchers and health systems multiple opportunities to study implementation processes and outcomes.MethodsWe conducted a cross-sectional survey of 32 ePCTs associated with the NIH Pragmatic Trials Collaboratory to assess the implementation-related outcomes that were measured or were planned to be measured, including reach (number and percent of eligible patients who participate in an intervention and the representativeness of those patients), patient engagement in or adherence to the intervention, adoption (number and percent of eligible organizations or clinicians that decide to take up or use an intervention), fidelity (clinician's delivery of an intervention as intended), adaptations (changes or modifications to an intervention), sustainability (potential for an intervention to be maintained or institutionalized after a trial concludes), sustainment (actual maintenance or institutionalization of an intervention after a trial concludes), and costs. The trials represented different phases of progress (planned, ongoing, or completed).Results91% of study teams completed the survey, and most (86%) reported measuring reach. The total number of teams measuring other outcomes was 76% for adherence, 45% for clinician adoption, 93% for fidelity, 69% for adaptations, 24% for sustainability, 38% for sustainment, and 31% for costs.ConclusionThere is an opportunity for growth in measuring clinician adoption of the intervention, sustainability, sustainment, and associated costs. Measurement of these constructs in future ePCTs could result in development of improved implementation strategies to increase the likelihood of effective implementation leading to equitable, sustainable, and scalable improvement in practice.

Methods of integrating qualitative data across diverse studies and within multi-site research consortia are less developed than those for integrating quantitative data. The development ofsuchmethods is essential to support the data exchange needed for cross-study qualitative inquiry and given the increasing emphasis on data sharing and open science. We describe methods for qualitative data integration within the National Cancer Institute’s Improving the Management of symPtoms During And following Cancer Treatment (IMPACT) Consortium funded by the Cancer MoonshotSM. Data collection and analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Our case study highlights potential solutions for unique challenges faced when integrating qualitative data across multiple settings in a research consortium. The IMPACT consortium is comprised of three research centers (RCs) each conducting pragmatic trials examining the effectiveness of routine symptom management on patient-centered outcomes. After reaching consensus on use of CFIR as the common implementation determinant framework, RCs developed a semi-structured interview guide and tailored it to features of their healthcare setting and symptom management interventions. RCs conducted interviews/focus groups with healthcare system partners to examine contextual factors impacting implementation. RCs exchanged 1–2 transcripts (n = 5 total) for purposes of pilot testing the methodology. Given the heterogeneity of study settings and contexts, it was challenging to simultaneously assign codes at both domain and construct levels and the process was resource intensive. Recommendations include employing a common framework for data collection and analyses from the outset, coding at domain level first and then incorporating construct codes, and centralizing processes via a coordinating center (or similar entity) and combining coded transcripts using qualitative software. We also generated an iteratively refined codebook that employed the CFIR schema and incorporated CFIR 2.0 to provide detailed guidance for coders conducting cross-study qualitative inquiry. Limited guidance exists on how to support qualitative data integration, data exchange, and sharing across multiple studies. This paper describes a systematic method for employing an implementation determinant framework-guided approach to foster data integration. This methodology can be adopted by other research consortia to support qualitative data integration, cross-site qualitative inquiry, and generate improved understanding of evidence-based intervention implementation.

BACKGROUND:Patient navigation services can substantially boost participation in colorectal cancer screening and follow-up. As part of the Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS) consortium, this study describes facilitators, barriers, and context-specific adaptations to sustainably deliver navigation in diverse settings. METHODS:Qualitative interviews were conducted with patient navigators and ACCSIS research project team members between February and August 2024; interviews were recorded, transcribed, and analyzed via rapid methods. RESULTS:Seventeen patient navigators and eight research project team members (from six research projects) were interviewed. The navigation programs varied in scope: supporting initial screenings, follow-ups for abnormal stool tests, or both. Common facilitators were training navigators via multiple teaching methods and integrating navigators directly into clinic teams. Common barriers were high staff turnover, lack of sustainable funding for navigator positions, limited clinic resources and inadequate electronic health record tools, difficulty in contacting patients, and problems in accessing endoscopy services. Common adaptations made to improve programs included providing gift bags or drop boxes to make stool testing more appealing to patients, adjusting how often and how navigators were trained, evaluating clinic and specialist capacity before implementation, allowing navigators to schedule colonoscopies directly, and establishing partnerships that reduced colonoscopy costs and shortened wait times. CONCLUSIONS:Identified barriers to patient navigation program implementation might be addressed by providing ongoing navigator training via multiple delivery modes; applying best practices for engaging clinic teams, gastroenterology practices, and community partners; building centralized repositories of navigation training and patient-facing materials; and securing consistent funding via billing and institutional support.

The continued use of low-value cancer screening practices not only represents healthcare waste but also a potential cascade of invasive diagnostic procedures and patient anxiety and distress. While prior research has shown it takes an average of 15 years to implement evidence-based practices in cancer control, little is known about how long it takes to de-implement low-value cancer screening practices. We reviewed evidence on six United States Preventive Services Task Force 'Grade D' cancer screening practices: (1) cervical cancer screening in women<21 years and >65 years, (2) prostate cancer screening in men≥70 years and (3) ovarian, (4) thyroid, (5) testicular and (6) pancreatic cancer screening in asymptomatic adults. We measured the time from a landmark publication supporting the guideline publication and subsequent de-implementation, defined as a 50% reduction in the use of the practice in routine care. The pace of de-implementation was assessed using nationally representative surveillance systems and peer-reviewed literature from the USA. We found the time to de-implementation of cervical cancer screening was 4 years for women<21 and 16 years for women>65. Prostate screening in men ≥70 has not reached a 50% reduction in use since the 2012 guideline release. We did not identify sufficient evidence to measure the time to de-implementation for ovarian, thyroid, testicular and pancreatic cancer screening in asymptomatic adults. Surveillance of low-value cancer screening is sparse, posing a clear barrier to tracking the de-implementation of these screening practices. Improving the systematic measurement of low-value cancer control practices is imperative for assessing the impact of de-implementation on patient outcomes, healthcare delivery and healthcare costs.

As dissemination and implementation (D I) research increases, we must continue to expand training capacity and research networks. Documenting, understanding, and enhancing advice networks identifies key connectors and areas where networks are less established. In 2012 Norton et al. mapped D I science advice and collaboration networks. The current study builds on this work and aims to map current D I research advice networks. D I researchers in the United States (US) and Canada were identified through a combination of publication metrics, and key persons identified networks and were invited to participate (n = 1,576). In this social network analysis study, participants completed an online survey identifying up to 10 people from whom they sought and/or gave advice on D I research. Participants identified four types of advice received: research methods, grant, career, or another type (e.g., work/life balance). We used descriptive statistics to characterize the sample and network metrics and visualizations to describe the composition of advice networks. A total of 482 individuals completed the survey. Eighty-six (18

Data sharing, the act of making scientific research data available to others, can accelerate innovation and discoveries, and ultimately enhance public health. The National Cancer Institute Implementation Science Centers in Cancer Control convened a diverse group of research scientists, practitioners, and community partners in three interactive workshops (May-June 2022) to identify and discuss factors that must be considered when designing research for equitable data sharing with a specific emphasis on implementation science and social, behavioral, and population health research. This group identified and operationalized a set of seven key considerations for equitable data sharing-conceptualized as an inclusive process that fairly includes the perspectives and priorities of all partners involved in and impacted by data sharing, with consideration of ethics, history, and benefits-that were integrated into a framework. Key data-sharing components particularly important for health equity included: elevating data sharing into a core research activity, incorporating diverse perspectives, and meaningfully engaging partners in data-sharing decisions throughout the project lifecycle. As the process of data sharing grows in research, it is critical to continue considering the potential positive and adverse impact of data sharing on diverse beneficiaries of health data and research.

Generating actionable research findings quickly and efficiently is critical for improving the delivery of cancer-related care and outcomes. To address this issue, the National Cancer Institute convened subject matter experts, researchers, clinicians, and patients for a 2-day virtual meeting in February 2022. The purpose of this meeting was to identify how rapid cycle interventional research methods can be used to generate findings useful in improving routine clinical practice. The meeting yielded an initial conceptualization of rapid cycle interventional research as being comprised of 6 key elements: use of iterative study designs; reliance on proximal primary outcomes; early and continued engagement with community and clinical partners; use of existing data sources to measure primary outcomes; facilitative features of the study setting and context; and consideration of appropriate rigor relative to intended use of findings. The meeting also identified the types of study designs that can be leveraged to conduct rapid cycle interventional research and provided examples of these; considered this approach from the perspective of key partners; described the clinical and data infrastructure, research resources, and key collaborations needed to support this work; identified research topics best addressed using this approach; and considered needed methodological advances. The National Cancer Institute is committed to exploring opportunities to encourage further development and application of this research approach as a means for better promoting improvements in the delivery of cancer-related care.

BACKGROUND:Rapid cycle interventional research can accelerate improvements to cancer care delivery and patient health outcomes by answering multiple questions as part of a single research study. To complement ongoing efforts to increase awareness of and support for rapid cycle interventional research, we conducted a systematic portfolio analysis of research grants funded by the National Cancer Institute on the topic. METHODS:We used standard portfolio analytic methods for identifying, coding, and synthesizing rapid cycle interventional research funded by the National Cancer Institute between 2016 and 2022. A codebook was used to standardize assessment of the grants by common study characteristics, intervention topics, and cancer care delivery context. RESULTS:We identified 26 grants, mostly funded since 2019, as rapid cycle interventional research. Most studies included adult or older adult target populations, used electronic systems for intervention delivery, and focused primarily on testing different components of interventions. Studies also used a range of study designs, intervention content areas, cancer sites, and across the cancer control continuum. CONCLUSIONS:The current portfolio analysis of funded rapid cycle interventional research grants suggests a growing albeit relatively small number of studies in this area. Several efforts are needed to continue to grow this area of research, including training programs, funding opportunities, and strengthening research-practice partnerships. This analysis provides a snapshot of current studies and highlights the opportunity for growing this important area of research to optimize cancer care delivery and improve patient outcomes.

Background Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative. Methods We developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation. Results ACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs. Conclusions Our detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice.

Abstract Background Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time. Methods The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User’s Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study. Results Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies. Conclusions The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.

People experiencing financial burden are underrepresented in clinical trials. Describe the prevalence of cost-related considerations influential to trial participation and their associations with person-level characteristics. This cross-sectional study used and assessed how three cost-related considerations would influence the decision to participate in a hypothetical clinical trial. A total of 3682 US adult respondents to the Health Information National Trends Survey Survey-weighted multivariable logistic regression estimated associations between respondent characteristics and odds of reporting cost-related considerations as very influential to participation. Among 3682 respondents, median age was 48 (IQR 33–61). Most were non-Hispanic White (60%), living comfortably or getting by on their income (74%), with ≥ 1 medical condition (61%). Over half (55%) of respondents reported at least one cost-related consideration as very influential to trial participation, including if usual care was not covered by insurance (reported by 42%), payment for participation (24%), or support for participation (24%). Respondents who were younger (18–34 vs. ≥ 75, adjusted odds ratio [aOR] 4.3, 95% CI 2.3–8.1), more educated (high school vs. <high school, aOR 2.1, 95% CI 1.1–4.1), or with lower perceived income (having difficulty vs. living comfortably, aOR 2.1, 95% CI 1.1–3.8) had higher odds of reporting any cost-related consideration as very influential to trial participation. Non-Hispanic Black vs. non-Hispanic White respondents had 29% lower odds (95% CI 0.5–0.9) of reporting any cost-related consideration as very influential to trial participation. Cost-related considerations would influence many individuals’ decisions to participate in a clinical trial, though prevalence of these concerns differed by respondent characteristics. Reducing financial barriers to trial participation may promote equitable trial access and greater trial enrollment diversity.

Importance:Representative enrollment in clinical trials is critical to ensure equitable and effective translation of research to practice, yet disparities in clinical trial enrollment persist. Objective:To examine person-level factors associated with invitation to and participation in clinical trials. Design, Setting, and Participants:This cross-sectional study analyzed responses from 3689 US adults who participated in the nationally representative Health Information National Trends Survey, collected February through June 2020 via mailed questionnaires. Exposures:Demographic, clinical, and health behavior-related characteristics. Main Outcomes and Measures:History of invitation to and participation in a clinical trial, primary information sources, trust in information sources, and motives for participation in clinical trials were described. Respondent characteristics are presented as absolute numbers and weighted percentages. Associations between respondent demographic, clinical, and health behavior-related characteristics and clinical trial invitation and participation were estimated using survey-weighted logistic regression models. Results:The median (IQR) age of the 3689 respondents was 48 (33-61) years, and most were non-Hispanic White individuals (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]). Overall, 439 respondents (9%) had been invited to participate in any clinical trial. Respondents with increased odds of invitation were non-Hispanic Black compared with non-Hispanic White (adjusted odds ratio [aOR], 1.85; 95% CI, 1.13-3.02), had greater than a high school education compared with less than high school education (eg, ≥college degree: aOR, 4.84; 95% CI, 1.89-12.39), were single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and had at least 1 medical condition compared to none (eg, 1 medical condition: aOR, 2.25; 95% CI, 1.32-3.82). Respondents residing in rural vs urban areas had 77% decreased odds of invitation to a clinical trial (aOR 0.33; 95% CI 0.17-0.65). Of invited respondents, 199 (47%) participated. Compared with non-Hispanic White respondents, non-Hispanic Black respondents had 72% decreased odds of clinical trial participation (aOR, 0.28; 95% CI, 0.09-0.87). Respondents most frequently reported "health care providers" as the first and most trusted source of clinical trial information (first source: 2297 [59%]; most trusted source: 2597 [70%]). The most frequently reported motives for clinical trials participation were "wanting to get better" (2294 [66%]) and the standard of care not being covered by insurance (1448 [41%]). Conclusions and Relevance:The findings of this study suggest that invitation to and participation in clinical trials may differ by person-level demographic and clinical characteristics. Strategies toward increasing trial invitation and participation rates across diverse patient populations warrant further research to ensure equitable translation of clinical benefits from research to practice.

Despite considerable evidence that psychosocial care can effectively reduce distress in patients with cancer, many individuals who could benefit from these services do not receive them. This situation reflects, in part, the general lack of studies informed by implementation science that are designed specifically to promote the adoption of evidence-based models of psychosocial care as part of routine clinical practice. Thus, part of the solution involves expanding the scope of research in psychosocial oncology to include designing and conducting pragmatic clinical trials and using hybrid designs to simultaneously evaluate clinical effectiveness and barriers and facilitators of implementation. Use of these approaches holds considerable potential for promoting more widespread adoption of evidence-based models of care and providing stronger support for standards and policies related to the psychosocial care of people with cancer.

BACKGROUND:First articulated by Schwartz and Lellouch (1967), randomized controlled trials (RCTs) can be conceptualized along a continuum from more explanatory to more pragmatic. The purpose and intent of the former is to test interventions under ideal contexts, and the purpose and intent of the latter is to test interventions in real-world contexts. The PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) is a validated tool that helps researchers make decisions about the elements of the trial to match the overall purpose and intent of the trial along the continuum. The PRECIS-2 tool has guided the design of hundreds of RCTs. However, a few aspects of the tool would benefit from greater clarity, including its application to provider-focused implementation trials rather than patient-focused intervention trials.MAIN TEXT:We describe the newly developed PRECIS-2-Provider Strategies (PRECIS-2-PS) tool, an extension of the PRECIS-2 tool, which has been adapted for trials testing provider-focused strategies. We elaborate on nine domains that can make a provider-focused trial more explanatory or more pragmatic, including eligibility, recruitment, setting, implementation resources, flexibility of provider strategies, flexibility of intervention, data collection, primary outcome, and primary analysis. We detail the complementary roles that researchers and stakeholders play in the trial design phase, with implications for generalizability of trial results to the contexts in which they are intended to be applied.CONCLUSIONS:The PRECIS-2-PS tool is designed to help research and practice teams plan for provider-focused trials that reflect the overall intent and purpose of the trial. The tool has potential to help advance the science of provider-focused strategies across a range of trials, with the ultimate goal of facilitating the adoption, integration, and sustainability of provider-focused strategies outside the context of trials.