Red Flag Signs and Symptoms for Patients With Early-Onset Colorectal Cancer: A Systematic Review and Meta-Analysis.

Importance: Early-onset colorectal cancer (EOCRC), defined as a diagnosis at younger than age 50 years, is increasing, and so-called red flag signs and symptoms among these individuals are often missed, leading to diagnostic delays. Improved recognition of presenting signs and symptoms associated with EOCRC could facilitate more timely diagnosis and impact clinical outcomes. Objective: To report the frequency of presenting red flag signs and symptoms among individuals with EOCRC, to examine their association with EOCRC risk, and to measure variation in time to diagnosis from sign or symptom presentation. Data Sources: PubMed/MEDLINE, Embase, CINAHL, and Web of Science were searched from database inception through May 2023. Study Selection: Studies that reported on sign and symptom presentation or time from sign and symptom presentation to diagnosis for patients younger than age 50 years diagnosed with nonhereditary CRC were included. Data Extraction and Synthesis: Data extraction and quality assessment were performed independently in duplicate for all included studies using Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guidelines. Joanna Briggs Institute Critical Appraisal tools were used to measure risk of bias. Data on frequency of signs and symptoms were pooled using a random-effects model. Main Outcomes and Measures: Outcomes of interest were pooled proportions of signs and symptoms in patients with EOCRC, estimates for association of signs and symptoms with EOCRC risk, and time from sign or symptom presentation to EOCRC diagnosis. Results: Of the 12 859 unique articles initially retrieved, 81 studies with 24 908 126 patients younger than 50 years were included. The most common presenting signs and symptoms, reported by 78 included studies, were hematochezia (pooled prevalence, 45% [95% CI, 40%-50%]), abdominal pain (pooled prevalence, 40% [95% CI, 35%-45%]), and altered bowel habits (pooled prevalence, 27% [95% CI, 22%-33%]). Hematochezia (estimate range, 5.2-54.0), abdominal pain (estimate range, 1.3-6.0), and anemia (estimate range, 2.1-10.8) were associated with higher EOCRC likelihood. Time from signs and symptoms presentation to EOCRC diagnosis was a mean (range) of 6.4 (1.8-13.7) months (23 studies) and a median (range) of 4 (2.0-8.7) months (16 studies). Conclusions and Relevance: In this systematic review and meta-analysis of patients with EOCRC, nearly half of individuals presented with hematochezia and abdominal pain and one-quarter with altered bowel habits. Hematochezia was associated with at least 5-fold increased EOCRC risk. Delays in diagnosis of 4 to 6 months were common. These findings highlight the need to identify concerning EOCRC signs and symptoms and complete timely diagnostic workup, particularly for individuals without an alternative diagnosis or sign or symptom resolution.

A practical method for integrating community priorities in planning and implementing cancer control programs.

PURPOSE: Community engagement is essential in effective public health programs. This paper illustrates the methods used to engage community in the development of a multi-level implementation intervention to address cancer disparities related to hereditary cancer syndromes. METHODS: Implementation Mapping (IM), was used to guide the co-creation of an intervention. Key partners were recruited to a 13-member statewide community advisory board (CAB) representing healthcare and community-based organizations. As part of a needs assessment, a 3-round modified Delphi method with the CAB was used to identify implementation outcomes to use in later steps of IM. An anonymous online survey of a validated community engagement measure assessed CAB members' satisfaction with the process. RESULTS: Using a modified Delphi method as part of the needs assessment of IM, the CAB identified three broad categories of strategies: Changing infrastructure using patient navigation; training and educating patients, navigators and providers; and supporting clinicians in case identification and management. Self-reported satisfaction with the IM and Delphi process was high. CONCLUSIONS: Implementation Mapping facilitated the use of available evidence, new data, and community engagement to identify strategies to improve the delivery of programs to reduce hereditary cancer disparities. The modified Delphi method was easy to administer in a virtual environment and may be a useful for others in community-engaged research.

Prioritizing rural populations in state comprehensive cancer control plans: a qualitative assessment.

PURPOSE: The Centers for Disease Control and Prevention's National Comprehensive Cancer Control Program (NCCCP) requires that states develop comprehensive cancer control (CCC) plans and recommends that disparities related to rural residence are addressed in these plans. The objective of this study was to explore rural partner engagement and describe effective strategies for incorporating a rural focus in CCC plans. METHODS: States were selected for inclusion using stratified sampling based on state rurality and region. State cancer control leaders were interviewed about facilitators and barriers to engaging rural partners and strategies for prioritizing rural populations. Content analysis was conducted to identify themes across states. RESULTS: Interviews (n = 30) revealed themes in three domains related to rural inclusion in CCC plans. The first domain (barriers) included (1) designing CCC plans to be broad, (2) defining "rural populations," and (3) geographic distance. The second domain (successful strategies) included (1) collaborating with rural healthcare systems, (2) recruiting rural constituents, (3) leveraging rural community-academic partnerships, and (4) working jointly with Native nations. The third domain (strategies for future plan development) included (1) building relationships with rural communities, (2) engaging rural constituents in planning, (3) developing a better understanding of rural needs, and (4) considering resources for addressing rural disparities. CONCLUSION: Significant relationship building with rural communities, resource provision, and successful strategies used by others may improve inclusion of rural needs in state comprehensive cancer control plans and ultimately help plan developers directly address rural cancer health disparities.

Flexibility, adaptation, and roles of patient navigators in oncology during COVID-19.

BACKGROUND: The impact of COVID-19 on cancer care during the first 6 months of the pandemic has been significant. The National Navigation Roundtable Workforce Development Task Group conducted a national survey to highlight the role of patient navigators (PNs). METHODS: An anonymous online survey captured how cancer care navigation changed during 2 phases: 1) March 13 to May 31, 2020; and 2) June 1 to September 4, 2020. Differences between the 2 time periods for categorical variables were assessed using χ2 tests, and 1-way analyses of variance were used for ordinal variables. RESULTS: Almost one-half of PNs expected changes in duties (49%) during phase 1. By phase 2, PNs showed greater confidence in retaining PN work (P < .001) and reduced changes to duties (P < .01). PNs reported new training on COVID-19 and telehealth during phase 1 (64% and 27%, respectively) and phase 2 (54% and 19%, respectively). Significant decreases in service delays were identified by phase 2 for cancer screening (P < .001), preventive care (P < .001), medical treatment (P < .01), cancer treatment (P < .001), and cancer survivorship services (P < .01). PNs reported that the top patient issues were COVID-19 concerns, medical care disruptions, and finances, and there were decreases in medical care disruptions (P < .01) during phase 2. PNs addressed myths related to mask use, COVID-19 spread, disbelief, risk, clinical changes, transmission prevention, and finances/politics. CONCLUSIONS: The PN role demonstrated resiliency and adaptability. Both clinical and nonclinical oncology PNs identified key patient needs and can provide connections with patient populations that have been economically and socially marginalized, which is necessary to build trust throughout the pandemic.

Evaluating the sustainability of patient navigation programs in oncology by length of existence, funding, and payment model participation.

BACKGROUND: For this study, the authors examined whether specific programmatic factors were associated with the sustainability of patient navigation programs. METHODS: This cross-sectional survey explored navigation programmatic factors associated with 3 measures of sustainability: 1) length of program existence, 2) reliance on sustainable funding, and 3) participation in alternative payment models. In total, 750 patient navigators or program administrators affiliated with oncology navigation programs in clinical-based and community-based settings completed the survey between April and July 2019. RESULTS: Associations were observed between both accreditation and work setting and measures of program sustainability. Accredited programs and larger, more resourced clinical institutions were particularly likely to exhibit multiple measures of sustainability. The results also identified significant gaps at the programmatic level in data collection and reporting among navigation programs, but no association was observed between programmatic data collection/reporting and sustainability. CONCLUSIONS: Navigation is not currently a reimbursable service and has historically been viewed as value-added in oncology settings. Therefore, factors associated with sustainability are critical to understand how to build a framework for successful navigation programs within the current system and also to develop the case for potential reimbursement in the future.

Barriers and opportunities to measuring oncology patient navigation impact: Results from the National Navigation Roundtable survey.

BACKGROUND: Patient navigation improves cancer care delivery for those most at risk for poor outcomes. Lack of sustainable funding threatens the full integration of navigation services into health care delivery systems. Standardized navigation metrics that document impact and identify best practices are necessary to support sustainability. METHODS: The National Navigation Roundtable administered a web-based, cross-sectional survey to oncology patient navigation programs to identify barriers and facilitators to the use of navigation metrics. The 38-item survey asked about data-collection practices and specific navigation metrics used by the program. Exploratory and descriptive statistics were used to identify factors associated with data collection and reporting. RESULTS: Seven hundred fifty respondents from across the country represented navigation programs across the continuum of care. Although 538 respondents (72%) reported participating in routine data collection, only one-half of them used data for reporting purposes. For the 374 programs that used electronic health records, only 40% had discrete, reportable navigation fields, and 25% had an identifier for navigated patients. Program funding was identified as the only characteristic associated with data collection, whereas the type of data collected was associated with work setting, participation in alternative payment models, and where on the continuum navigation services are provided. Respondents participating in an oncology accreditation program were more likely to collect specific outcome metrics across the continuum and to use those data for reporting purposes. The most common barriers to data collection were time (55%) and lack of support for complex data systems and/or platforms (50%). CONCLUSIONS: Inconsistent data collection and reporting of oncology navigation programs remain a threat to sustainability. Aligning data collection with oncology accreditation, funding, and reimbursement is a viable path forward.

Change agents in the oncology workforce: Let's be clear about community health workers and patient navigators.

Despite efforts of professional organizations and government agencies to solidify the professional identities of community health workers and patient navigators in the oncology workforce, the scientific literature perpetuates wide variation in the nomenclature used to define these natural change agents, who have proven efficacy in improving access to quality cancer care for historically marginalized populations. To disseminate, sustain, and scale-up these life-saving roles in cancer care, the oncology field must come together now to adopt clear and consistent job titles and occupational identities.

Collective pursuit for equity in cancer care: The National Navigation Roundtable.

BACKGROUND: The evidence continues to build in support of implementing patient navigation to reduce barriers and increase access to care. However, health disparities remain in cancer outcomes. The goal of the National Navigation Roundtable (NNRT) is to serve as a convener to help support the field of navigation to address equity. METHODS: To examine the progress and opportunities for navigation, the NNRT submitted a collection of articles based on the results from 2 dedicated surveys and contributions from member organizations. The intent was to help inform what we know about patient navigation since the last dedicated examination in this journal 10 years ago. RESULTS: The online survey of >700 people described navigators and examined sustainability and policy issues and the longevity, specific role and function, and impact of clinical and nonclinical navigators in addition to the role of training and supervision. In addition, a full examination of coronavirus disease 2019 and contributions from member organizations helped further define progress and future opportunities to meet the needs of patients through patient navigation. CONCLUSIONS: To achieve equity in cancer care will demand the sustained action of virtually every component of the cancer care system. It is the hope and intent of the NNRT that the information presented in this supplement will be a catalyst for action in this collective action approach.

Comparing clinical and nonclinical cancer patient navigators: A national study in the United States.

BACKGROUND: A nationwide survey was conducted to examine differences between clinical and nonclinical oncology navigators in their service provision, engagement in the cancer care continuum, personal characteristics, and program characteristics. METHODS: Using convenience sampling, 527 oncology navigators participated and completed an online survey. Descriptive statistics, χ2 statistics, and t tests were used to compare nonclinical (eg, community health worker) and clinical (eg, nurse navigators) navigators on the provision of various navigation services, personal characteristics, engagement in the cancer care continuum, and program characteristics. RESULTS: Most participants were clinical navigators (76.1%). Compared to nonclinical navigators, clinical navigators were more likely to have a bachelor's degree or higher (88.6% vs 69.6%, P < .001), be funded by operational budgets (84.4% vs 35.7%, P < .001), and less likely to work at a community-based organization or nonprofit (2.0% vs 36.5%, P < .001). Clinical navigators were more likely to perform basic navigation (P < .001), care coordination (P < .001), treatment support (P < .001), and clinical trial/peer support (P = .005). Clinical navigators were more likely to engage in treatment (P < .001), end-of-life (P < .001), and palliative care (P = .001) navigation. CONCLUSIONS: There is growing indication that clinical and nonclinical oncology navigators perform different functions and work in different settings. Nonclinical navigators may be more likely to face job insecurity because they work in nonprofit organizations and are primarily funded by grants.

What makes for successful patient navigation implementation in cancer prevention and screening programs using an evaluation and sustainability framework.

BACKGROUND: Integrating patient navigation into cancer prevention and early detection efforts has been effective in increasing cancer screening rates for the medically underserved. Few publications have focused on how cancer screening interventions in the primary care setting using patient navigation as a primary strategy are implemented, adapted, and sustained. In 2006, the University of Colorado Cancer Center established a statewide colorectal cancer screening program to reduce disparities and improve colorectal cancer (CRC) screening for the medically underserved in partnership with the safety net system. The program, known as the Colorado Cancer Screening Program (CCSP), has provided navigation into preventive screening for more than 35,000 patients. METHODS: To evaluate sustainability and implementation, the Practical, Robust Implementation and Sustainability Model was used to examine the implementation and impact. To complement this model, the CCSP adapted the Program Sustainability Framework and Clinical Sustainability Framework and Assessment Tools to measure the capacity of participating clinics to sustain the program beyond grant funding. RESULTS: The domains most frequently targeted for improvement in the sustainability plans were Workflow Integration (8 clinics), Communication, Planning, and Implementation (8 clinics), and Funding Stability (5 clinics). Activities in the implementation plans included revising workflows for efficiencies, incorporating quality improvement strategies, and building a business case for patient navigation. CONCLUSIONS: Findings from this sustainability planning process provide insight about program outcomes, satisfaction, and illustrate that although funding remains one of the key sustainability questions, many clinic systems have prioritized other specific domains to continue sustainability beyond grant funding.

The Current Landscape of Research Advocacy and Education for Patients with Colorectal Cancer.

OPINION STATEMENT: Research advocacy is an evolving concept and should be tailored for the colorectal cancer research community. Research advocacy training and evaluation must be designed for the patient community with their insight included at each step of engagement, training, and implementation. Patient advocates bring a great deal of expertise to the research review process, but it is important to ensure that their insight is appropriately placed, and they bring an appropriate orientation to the research process as the most informed patient. This can be accomplished in part by providing advocates with the proper training, employing universal core competencies, and applying principles of adult learning. Additionally, the research community, advocacy organizations, and industry partners must understand the need to diversify the voices that are being leveraged to guide research, recognizing the importance of adequate mental health tools and compensation commensurate with their experience. As a community, it is necessary that we create and implement training programs, as well as evaluate and measure their impact to continually improve and tailor the delivery of this specific education. Research advocacy has become a necessity to the field, and when implemented effectively, research advocates can have a significant impact on the delivery of health care research, improving health outcomes for all those affected by colorectal cancer.

Aligning implementation science with improvement practice: a call to action.

BACKGROUND: In several recent articles, authors have called for aligning the fields of implementation and improvement science. In this paper, we call for implementation science to also align with improvement practice. Multiple implementation scholars have highlighted the importance of designing implementation strategies to fit the existing culture, infrastructure, and practice of a healthcare system. Worldwide, healthcare systems are adopting improvement models as their primary approach to improving healthcare delivery and outcomes. The prevalence of improvement models raises the question of how implementation scientists might best align their efforts with healthcare systems' existing improvement infrastructure and practice. MAIN BODY: We describe three challenges and five benefits to aligning implementation science and improvement practice. Challenges include (1) use of different models, terminology, and methods, (2) a focus on generalizable versus local knowledge, and (3) limited evidence in support of the effectiveness of improvement tools and methods. We contend that implementation science needs to move beyond these challenges and work toward greater alignment with improvement practice. Aligning with improvement practice would benefit implementation science by (1) strengthening research/practice partnerships, (2) fostering local ownership of implementation, (3) generating practice-based evidence, (4) developing context-specific implementation strategies, and (5) building practice-level capacity to implement interventions and improve care. Each of these potential benefits is illustrated in a case study from the Centers for Disease Control and Prevention's Cancer Prevention and Control Research Network. CONCLUSION: To effectively integrate evidence-based interventions into routine practice, implementation scientists need to align their efforts with the improvement culture and practice that is driving change within healthcare systems worldwide. This paper provides concrete examples of how researchers have aligned implementation science with improvement practice across five implementation projects.

Community health workers and non-clinical patient navigators: A critical COVID-19 pandemic workforce.

The COVID-19 pandemic has resulted in substantial morbidity and mortality and challenged public health agencies and healthcare systems worldwide. In the U.S., physical distancing orders and other restrictions have had severe economic and societal consequences. Populations already vulnerable in the United States have experienced worse COVID-19 health outcomes. The World Health Organization has made recommendations to engage at risk populations and communicate accurate information about risk and prevention; to conduct contract tracing; and to support those affected by COVID-19. This Commentary highlights the ways in which an existing and cost-effective, but underutilized workforce, community health workers and non-clinical patient navigators, should be deployed to address the COVID-19 pandemic. Community health workers and non-clinical patient navigators have skills in community engagement and health communication and are able to gain the trust of vulnerable communities. Furthermore, many community health workers and non-clinical patient navigators have skills in assisting community members with meeting basic needs and with navigating public health and healthcare systems. Members of this workforce are more than prepared to conduct contact tracing. State, local, tribal, and territorial public health agencies and healthcare systems should be collaborating with national, state, and local organizations that represent and employ CHWs/non-clinical patient navigators to determine how to better mobilize this workforce to address the COVID-19 pandemic. Furthermore, Congress, the Centers for Medicare & Medicaid Services (CMS), and individual states need to adopt policies to sustainably fund their critically needed services in the long term.

Priorities of Unmet Needs for Those Affected by Colorectal Cancer: Considerations From a Series of Nominal Group Technique Sessions.

BACKGROUND: Colorectal cancer (CRC) is the third most common cancer among men and women in the United States. Patients and survivors experience a range of challenges, including anxiety, financial issues, long-term adverse effects, and more. The intent of this project was to assess the needs of the CRC community directly from survivors and their caregivers and to lay a foundation for ongoing support. METHODS: Twelve nominal group technique sessions were facilitated. Participants were randomized and presented with the following questions: "What information do you wish you had at the time of diagnosis?" and "What information do you need now as a survivor?" After the nominal group technique process, each statement's score was divided by the number of people in the session, providing the average to identify the top-ranked statements. Themes and subthemes were applied to statements. Results were compared between coders. RESULTS: There was a total of 79 participants, 49 of whom self-identified as a patient with or survivor of cancer. Patient/survivor demographics were as follows: stage IV disease (n=20), stage III disease (n=22), stage II disease (n=5), stage I disease (n=2), caregiver/family member (n=30), male (n=16), female (n=63), White (n=50), Native Hawaiian/Pacific Islander (n=1), Hispanic/Latino (n=13), Black/African American (n=11), Asian (n=1), and more than one race/ethnicity (n=3). The most frequent themes among responses to the first question were communication and coordination with care team and access to CRC resources. The most frequent themes among responses to the second question were psychosocial support and family/caregiver support. Frequent themes among responses across both questions were understanding treatment options and adverse effects. CONCLUSIONS: These findings highlight gaps in support for individuals affected by CRC, and lay a foundation for ongoing assistance. Future studies exploring differences based on disease stage, race/ethnicity, age, gender identity, geographic location, and tumor location are needed to further tailor support for those experiencing CRC. Themes identified in this project require a multidisciplinary approach to ensure that the unmet needs of survivors are addressed.

Evaluating the usability and safety of the semaglutide single-dose pen-injectors through summative (human factors) usability testing.

AIMS/INTRODUCTION: A single-dose, shield-activated pen-injector for each of the three approved dose variants (0.25, 0.5 and 1 mg) of once-weekly subcutaneous semaglutide has been developed to improve usability. This analysis presents findings from the summative usability testing process for the single-dose semaglutide pen-injectors, including the pen-injector four-pack cartons and instructions for use. MATERIALS AND METHODS: A total of 60 adults representing four user groups were included: patients with/without pen-injector experience, non-pharmacist healthcare professionals and pharmacists (each n = 15). Participants carried out four tasks: (i) pen-injector carton retrieval; (ii) first simulated injection; (iii) pen-injector retrieval; and (iv) second simulated injection. All participants carried out task 1, and patients and non-pharmacist healthcare professionals took part in tasks 2-4 (n = 45). The number and types of use errors, close calls and operational difficulties were evaluated, and participants subjectively rated the ease of each task on a scale of 1 (difficult) to 7 (easy). RESULTS: No potentially serious use errors and only one non-serious use error were reported. Eight participants committed use errors with no potential for harm, one participant committed an unclassified use error, one participant encountered a close call with no potential for harm and one participant experienced an operational difficulty. Mean ease-of-use ratings were 6.7 (task 1), 5.9 (task 2), 6.6 (task 3) and 6.9 (task 4). CONCLUSIONS: All three dose variants of the semaglutide single-dose pen-injector were considered easy to use (subjective feedback scores near 7) and not associated with any serious use errors, even when participants received no training before study participation.

ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper.

An increasing number of studies are describing potential uses of circulating tumour DNA (ctDNA) in the care of patients with colorectal cancer. Owing to this rapidly developing area of research, the Colon and Rectal-Anal Task Forces of the United States National Cancer Institute convened a panel of multidisciplinary experts to summarize current data on the utility of ctDNA in the management of colorectal cancer and to provide guidance in promoting the efficient development and integration of this technology into clinical care. The panel focused on four key areas in which ctDNA has the potential to change clinical practice, including the detection of minimal residual disease, the management of patients with rectal cancer, monitoring responses to therapy, and tracking clonal dynamics in response to targeted therapies and other systemic treatments. The panel also provides general guidelines with relevance for ctDNA-related research efforts, irrespective of indication.

A path to improve colorectal cancer screening outcomes: faculty roundtable evaluation of cost-effectiveness and utility.

The American Journal of Managed Care® and Exact Sciences Corporation hosted a roundtable meeting to discuss the impact of colorectal cancer (CRC) screening modalities on improving patient outcomes. The roundtable participants were a diverse panel of experts, including primary care, gastroenterology, and oncology providers; experts in health outcomes research and health policy; and managed care executives with commercial and public payer experience. Participants discussed CRC prevention and treatment strategies, screening modalities and adherence, molecular diagnostics, patient navigation, evaluation of large data sets, managed care, outcomes research, quality improvement, and reimbursement policies. They focused on developing better value-based medical policies and payment procedures, identifying knowledge, practice, and access deficits related to CRC screening. Participants also provided suggestions on how to improve care quality and patient outcomes through effective evidence-based approaches. They also discussed costeffectiveness modeling for CRC screening, specifically the advantages and the real-world limitations of these models.