Strategic use of resources to enhance colorectal cancer screening for patients with diabetes (SURE: CRC4D) in federally qualified health centers: a protocol for hybrid type ii effectiveness-implementation trial.

BACKGROUND: Persons with diabetes have 27% elevated risk of developing colorectal cancer (CRC) and are disproportionately from priority health disparities populations. Federally qualified health centers (FQHCs) struggle to implement CRC screening programs for average risk patients. Strategies to effectively prioritize and optimize CRC screening for patients with diabetes in the primary care safety-net are needed. METHODS: Guided by the Exploration, Preparation, Implementation and Sustainment Framework, we conducted a stakeholder-engaged process to identify multi-level change objectives for implementing optimized CRC screening for patients with diabetes in FQHCs. To identify change objectives, an implementation planning group of stakeholders from FQHCs, safety-net screening programs, and policy implementers were assembled and met over a 7-month period. Depth interviews (n = 18-20) with key implementation actors were conducted to identify and refine the materials, methods and strategies needed to support an implementation plan across different FQHC contexts. The planning group endorsed the following multi-component implementation strategies: identifying clinic champions, development/distribution of patient educational materials, developing and implementing quality monitoring systems, and convening clinical meetings. To support clinic champions during the initial implementation phase, two learning collaboratives and bi-weekly virtual facilitation will be provided. In single group, hybrid type 2 effectiveness-implementation trial, we will implement and evaluate these strategies in a in six safety net clinics (n = 30 patients with diabetes per site). The primary clinical outcomes are: (1) clinic-level colonoscopy uptake and (2) overall CRC screening rates for patients with diabetes assessed at baseline and 12-months post-implementation. Implementation outcomes include provider and staff fidelity to the implementation plan, patient acceptability, and feasibility will be assessed at baseline and 12-months post-implementation. DISCUSSION: Study findings are poised to inform development of evidence-based implementation strategies to be tested for scalability and sustainability in a future hybrid 2 effectiveness-implementation clinical trial. The research protocol can be adapted as a model to investigate the development of targeted cancer prevention strategies in additional chronically ill priority populations. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov (NCT05785780) on March 27, 2023 (last updated October 21, 2023).

The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators.

Background: Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm. Methods: Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods. Discussion: We will assess whether a decision coaching and patient navigation intervention can feasibly support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations. Trial Registration: This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022.

Identifying priority areas to support primary care engagement in breast cancer survivorship care: A Delphi study.

INTRODUCTION: Existing approaches in cancer survivorship care delivery have proven to be insufficient to engage primary care. This study aimed to identify stakeholder-informed priorities to improve primary care engagement in breast cancer survivorship care. METHODS: Experts in U.S. cancer survivorship care delivery were invited to participate in a 4-round online Delphi panel to identify and evaluate priorities for defining and fostering primary care's engagement in breast cancer survivorship. Panelists were asked to identify and then assess (ratings of 1-9) the importance and feasibility of priority items to support primary care engagement in survivorship. Panelists were asked to review the group results and reevaluate the importance and feasibility of each item, aiming to reach consensus. RESULTS: Respondent panelists (n = 23, response rate 57.5%) identified 31 priority items to support survivorship care. Panelists consistently rated three items most important (scored 9) but with uncertain feasibility (scored 5-6). These items emphasized the need to foster connections and improve communication between primary care and oncology. Panelists reached consensus on four items evaluated as important and feasible: (1) educating patients on survivorship, (2) enabling screening reminders and monitoring alerts in the electronic medical record, (3) identifying patient resources for clinicians to recommend, and (4) distributing accessible reference guides of common breast cancer drugs. CONCLUSION: Role clarity and communication between oncology and primary care were rated as most important; however, uncertainty about feasibility remains. These findings indicate that cross-disciplinary capacity building to address feasibility issues may be needed to make the most important priority items actionable in primary care.

Characteristics and Barriers of Emergency Department Patients Overdue for Cancer Screening.

Introduction: People without reliable access to healthcare are more likely to be diagnosed with late-stage cancer that could have been treated more effectively if diagnosed earlier. Emergency departments (ED) may be a novel place for cancer screening education for underserved patients. In this study we sought to determine patient characteristics and barriers to cancer screening for those patients who presented to a large, academic safety-net ED and were overdue for breast, cervical, and colorectal cancer screening since the coronavirus 2019 (COVID-19) pandemic. Methods: Adult ED patients eligible for at least one cancer screening based on US Preventive Serivces Task Force guidelines completed a web-based survey. We examined the association of demographic characteristics and having a personal physician with being overdue on screening using chi-square or the Fisher exact test for categorical variables and t-tests for continuous variables. Results: Of 221 participants, 144 were eligible for colorectal, 96 for cervical, and 55 for breast cancer screening. Of eligible patients, 46% (25/55) were overdue for breast cancer screening, 43% (62/144) for colorectal, and 40% (38/96) for cervical cancer screening. There were no significant characteristics associated with breast cancer screening. Being overdue for cervical cancer screening was significantly more likely for patients who were of Asian race (P = 0.02), had less than a high school diploma (P = 0.01), and were without a routine checkup within the prior five years (P = 0.01). Overdue for colorectal cancer screening was associated with patients not having insurance (P = 0.04), being in their 40s (P = 0.03), being Hispanic (P = 0.01), and not having a primary care physician (P=0.01). Of 97 patients overdue for at least one screening, the most common barriers were cost (37%), lack of time (37%), and lack of knowledge of screening recommendations (34%). Only 8.3% reported that the COVID-19 pandemic delayed their screening. Conclusion: The ED may be a novel setting to target patients for cancer screening education. Future work that refers patients to free screening programs and primary care physicians may help improve disparities in cancer screening and cancer mortality rates for underserved populations.

Connect: Cultivating Academic-Community Partnerships to Address Our Communities' Complex Needs During Public Health Crises.

BACKGROUND: Black and Latino communities have been disproportionately impacted by coronavirus disease 2019 and we sought to understand perceptions and attitudes in four heavily impacted New Jersey counties to develop and evaluate engagement strategies to enhance access to testing. OBJECTIVE: To establish a successful academic/community partnership team during a public health emergency by building upon longstanding relationships and using principles from community engaged research. METHODS: We present a case study illustrating multiple levels of engagement, showing how we successfully aligned expectations, developed a commitment of cooperation, and implemented a research study, with community-based and health care organizations at the center of community engagement and recruitment. LESSONS LEARNED: This paper describes successful approaches to relationship building including information sharing and feedback to foster reciprocity, diverse dissemination strategies to enhance engagement, and intergenerational interaction to ensure sustainability. CONCLUSIONS: This model demonstrates how academic/community partnerships can work together during public health emergencies to develop sustainable relationships.

Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study.

BACKGROUND: Advances in detection and treatment for breast cancer have led to an increase in the number of individuals managing significant late and long-term treatment effects. Primary care has a role in caring for patients with a history of cancer, yet there is little guidance on how to effectively implement survivorship care evidence into primary care delivery. METHODS: This protocol describes a multi-phase, mixed methods, stakeholder-driven research process that prioritizes actionable, evidence-based primary care improvements to enhance breast cancer survivorship care by integrating implementation and primary care transformation frameworks: the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework and the Practice Change Model (PCM). Informed by depth interviews and a four round Delphi panel with diverse stakeholders from primary care and oncology, we will implement and evaluate an iterative clinical intervention in a hybrid type 1 effectiveness-implementation cluster randomized design in twenty-six primary care practices. Multi-component implementation strategies will include facilitation, audit and feedback, and learning collaboratives. Ongoing data collection and analysis will be performed to optimize adoption of the intervention. The primary clinical outcome to test effectiveness is comprehensive breast cancer follow-up care. Implementation will be assessed using mixed methods to explore how organizational and contextual variables affect adoption, implementation, and early sustainability for provision of follow-up care, symptom, and risk management activities at six- and 12-months post implementation. DISCUSSION: Study findings are poised to inform development of scalable, high impact intervention processes to enhance long-term follow-up care for patients with a history of breast cancer in primary care. If successful, next steps would include working with a national primary care practice-based research network to implement a national dissemination study. Actionable activities and processes identified could also be applied to development of organizational and care delivery interventions for follow-up care for other cancer sites. TRIAL REGISTRATION: Registered with ClinicalTrials.gov on June 2, 2022: NCT05400941.

Human Papillomavirus (HPV)-Associated Cancers Among Hispanic Males in the United States: Late-Stage Diagnosis by Country of Origin.

INTRODUCTION: The epidemiology of human papillomavirus (HPV)-associated cancers has changed since the development of the multivalent vaccine. This is evidenced by the decline in incidence of cervical cancers in the post-vaccine era. By contrast, studies have reported the rise in incidence of these cancers in males. Though little is known regarding HPV-associated cancers in males, Hispanic males have been largely excluded from research on these cancers. OBJECTIVE: The purpose of this study was to examine the differences in late-stage diagnosis of HPV-associated cancers (oropharyngeal, anorectal, or penile) among subgroups of Hispanic males in the U.S. METHODS: We performed a population-based retrospective cohort study using the 2005-2016 North American Association of Central Cancer Registries Cancer in North America Deluxe data file (n = 9242). Multivariable logistic regression modeling was used in studying late-stage diagnosis. RESULTS: There were no differences in late-stage diagnosis of oropharyngeal cancer between Hispanic subgroups. Higher odds of late-stage penile cancers were observed among Mexican and Puerto Rican males relative to European Spanish males. Lower odds of late-stage anorectal cancers were observed among Central or South American and Puerto Rican males. Having Medicaid or no insurance were associated with late-stage diagnosis for all cancers. CONCLUSION: Certain subgroups of Hispanic males have higher odds of late-stage HPV-associated cancer diagnosis based on country of origin and insurance status. These findings call for improved efforts to increase HPV vaccination, particularly among these subgroups of Hispanic males. Efforts to improve health care access and early detection from health care providers are also needed.

Promoting informed approaches in precision oncology and clinical trial participation for Black patients with cancer: Community-engaged development and pilot testing of a digital intervention.

BACKGROUND: Black patients with cancer are less likely to receive precision cancer treatments than White patients and are underrepresented in clinical trials. To address these disparities, the study aimed to develop and pilot-test a digital intervention to improve Black patients' knowledge about precision oncology and clinical trials, empower patients to increase relevant discussion, and promote informed decision-making. METHODS: A community-engaged approach, including a Community Advisory Board and two rounds of key informant interviews with Black patients with cancer, their relatives, and providers (n = 48) was used to develop and refine the multimedia digital intervention. Thematic analysis was conducted for qualitative data. The intervention was then pilot-tested with 30 Black patients with cancer to assess feasibility, acceptability, appropriateness, knowledge, decision self-efficacy, and patient empowerment; Wilcoxon matched pairs signed-rank test was used to analyze quantitative data. RESULTS: The digital tool was found to be feasible, acceptable, and culturally appropriate. Key informants shared their preferences and recommendations for the digital intervention and helped improve cultural appropriateness through user and usability testing. In the pilot test, appreciable improvement was found in participants' knowledge about precision oncology (z = -2.04, p = .052), knowledge about clinical trials (z = -3.14, p = .001), and decisional self-efficacy for targeted/immune therapy (z = -1.96, p = .0495). CONCLUSIONS: The digital intervention could be a promising interactive decision-support tool for increasing Black patients' participation in clinical trials and receipt of precision treatments, including immunotherapy. Its use in clinical practice may reduce disparities in oncology care and research. PLAIN LANGUAGE SUMMARY: We developed a digital interactive decision support tool for Black patients with cancer by convening a Community Advisory Board and conducting interviews with Black patients with cancer, their relatives, and providers. We then pilot-tested the intervention with newly diagnosed Black patients with cancer and found appreciable improvement in participants' knowledge about precision oncology, knowledge about clinical trials, and confidence in making decisions for targeted/immune therapy. Our digital tool has great potential to be an affordable and scalable solution for empowering and educating Black patients with cancer to help them make informed decisions about precision oncology and clinical trials and ultimately reducing racial disparities.

Community- Versus Health Care Organization-Based Approaches to Expanding At-Home COVID-19 Testing in Black and Latino Communities, New Jersey, 2021.

At-home COVID-19 testing offers convenience and safety advantages. We evaluated at-home testing in Black and Latino communities through an intervention comparing community-based organization (CBO) and health care organization (HCO) outreach. From May through December 2021, 1100 participants were recruited, 94% through CBOs. The odds of COVID-19 test requests and completions were significantly higher in the HCO arm. The results showed disparities in test requests and completions related to age, race, language, insurance, comorbidities, and pandemic-related challenges. Despite the popularity of at-home testing, barriers exist in underresourced communities. (Am J Public Health. 2022;112(S9):S918-S922. https://doi.org/10.2105/AJPH.2022.306989).

Experiences of Black and Latinx health care workers in support roles during the COVID-19 pandemic: A qualitative study.

Black and Latinx individuals, and in particular women, comprise an essential health care workforce often serving in support roles such as nursing assistants and dietary service staff. Compared to physicians and nurses, they are underpaid and potentially undervalued, yet play a critical role in health systems. This study examined the impact of the coronavirus disease 2019 (COVID-19) pandemic from the perspective of Black and Latinx health care workers in support roles (referred to here as HCWs). From December 2020 to February 2021, we conducted 2 group interviews (n = 9, 1 group in English and 1 group in Spanish language) and 8 individual interviews (1 in Spanish and 7 in English) with HCWs. Participants were members of a high-risk workforce as well as of communities that suffered disproportionately during the pandemic. Overall, they described disruptive changes in responsibilities and roles at work. These disruptions were intensified by the constant fear of contracting COVID-19 themselves and infecting their family members. HCWs with direct patient care responsibilities reported reduced opportunities for personal connection with patients. Perspectives on vaccines reportedly changed over time, and were influenced by peers' vaccination and information from trusted sources. The pandemic has exposed the stress endured by an essential workforce that plays a critical role in healthcare. As such, healthcare systems need to dedicate resources to improve the work conditions for this marginalized workforce including offering resources that support resilience. Overall working conditions and, wages must be largely improved to ensure their wellbeing and retain them in their roles to manage the next public health emergency. The role of HCWs serving as ambassadors to provide accurate information on COVID-19 and vaccination among their coworkers and communities also warrants further study.

More than cervical cancer: Understanding racial/ethnic disparities in oropharyngeal cancer outcomes among males by HPV status.

Context: Over the last two decades the incidence of male oropharyngeal cancers (OPCa) has increased rapidly in the United States, yet OPCa is mostly preventable. Differences in OPCa incidence and outcomes by race/ethnicity and human papillomavirus (HPV) status have not been previously studied. Objective: Examine racial/ethnic disparities in HPV-related and non-HPV related OPCa outcomes among males. Study Design: Nationwide population-based retrospective cohort study. Setting or Dataset: North American Association of Central Cancer Registries' Cancer in North America Deluxe dataset, covering 93% of the U.S. population. Population studied: Males diagnosed with OPCa in the U.S. between January 2005 and December 2016 (N=175,843). Outcome Measures: OPCa incidence rates by race/ethnicity [Non-Hispanic White, Non-Hispanic Black, Hispanic, Non-Hispanic Other] and HPV status (HPV-related or non-HPV-related); late-stage diagnosis; mean and cumulative survival; cancer-specific mortality. Results: Most male OPCa were HPV-related (92.2%) and in Whites (83.6%), with over 50% increase from 2005 to 2016 in age-adjusted incidence of late-stage HPV-related OPCa among Whites. There was no difference in late-stage diagnosis between Whites and Blacks (aOR, 0.99, 95% CI, 0.94-1.05) or Hispanics (aOR, 0.96, 95% CI, 0.89-1.03), while Other race had 15% lower odds of late-stage diagnosis (95% CI, 0.79-0.95). Independent predictors of late-stage disease included having Medicaid (aOR, 1.37, 95% CI, 1.28-1.46) or no insurance (aOR, 1.44, 95% CI, 1.32-1.57) and HPV-related OPCa (aOR, 3.53, 95% CI, 3.37-3.70). Lower mean survival in HPV-related OPCa compared with Whites (99.63 months, 95% CI, 99.18-100.07) was seen among Blacks (69.72 months, 95% CI, 68.14-71.31) and Hispanics (91.89 months, 95% CI, 89.87-93.91; p < 0.01). Blacks had lowest adjusted cumulative survival for HPV and non-HPV related OPCa (p<0.001). Blacks (aHR, 1.78, 95% CI, 1.70-1.87), Hispanics (aHR, 1.11, 95% CI, 1.03-1.19), and HPV-related OPCa (aHR, 1.25, 95% CI, 1.17-1.34) had higher cancer-specific mortality. Adjusting for treatment eliminated the higher mortality among Hispanics, but not in Blacks. Conclusions: To decrease incidence rates of late stage OPCa, HPV vaccination and possibly, HPV OPCa screening should be advocated, especially in White males. Further research to explicate possible biologic mechanisms and behaviors or comorbidities contributing to the higher OPCa mortality among Black males is needed.

Patterns of Fitbit Use and Activity Levels Among African American Breast Cancer Survivors During an eHealth Weight Loss Randomized Controlled Trial.

PURPOSE: This study examined adherence with a physical activity tracker and patterns of activity among different subgroups of African American/Black breast cancer survivors (AABCS). DESIGN: Secondary analysis of weight loss trial that used an activity tracker (FitBit) with or without a commercial eHealth program (SparkPeople) over 12 months. SETTING AND SUBJECTS: AABCS (N = 44) in New Jersey. MEASURES AND ANALYSIS: Adherence with tracker use, steps per day, and active minutes per week were compared by demographic and clinical characteristics using nonparametric statistics. RESULTS: Median adherence was over 6 days per week throughout the 12-months. Adherence was significantly correlated with steps and active minutes (p < 0.015). Groups with lower adherence included: those with 5 or more conditions (p = 0.039), had higher number of household members (p = 0.008), and younger than 60 years (p = 0.044). Median number of steps per day remained consistently around 7000 throughout 12 months. Factors associated with lower activity included: age > 60; retirement; higher number of household members, comorbidity, or baseline BMI; and those in the SparkPeople + Fitbit group. Self-monitoring, goal setting, and self-efficacy were significantly correlated with activity levels (p < 0.05). CONCLUSION: Use of a physical activity tracker may help increase activity levels in AABCS. Certain subgroups, e.g. those older than age 60 years, retired, with BMI over 40, higher number of comorbidities or more household members, may require additional interventions.

User-Centered Development and Patient Acceptability Testing of a Health-Coaching Intervention to Enhance Cancer Survivorship Follow-up in Primary Care.

We describe an iterative three-phase approach used to develop a cancer survivorship health-coaching intervention to guide self-management and follow-up care for post-treatment breast, colorectal, and prostate cancer survivors. Informed by theory (e.g., Cognitive-Social Health Information Processing Model (C-SHIP)), relevant literature, and clinical guidelines, we engaged in a user-centered design process. In phase I, we conducted depth interviews with survivors of breast (n = 34), prostate (n = 4), and colorectal (n = 6) cancers to develop a health coaching prototype. In phase II, we utilized user-testing interviews (n = 9) to test and refine the health coaching prototype. For both phases, we used a template analysis independently coding each interview. In phase I, majority (n = 34, 81%) of survivors were positive about the utility of health coaching. Among these survivors (n = 34), the top areas of identified need were emotional support (44%), general health information (35.3%), changes in diet and exercise (29.3%), accountability and motivation (23.5%), and information about treatment effects (17.7%). The prototype was developed and user-tested and refined in phase III to address the following concerns: (1) the amount of time for calls, (2) density of reading materials, (3) clarity about health coaches' role, (4) customization. Collectively, this resulted in the development of the Extended Cancer Educational for Long-Term Cancer Survivors health-coaching (EXCELSHC) program, which represents the first cancer survivorship follow-up program to support follow-up care designed-for-dissemination in primary care settings. EXCELSHC is being tested in a clinical efficacy trial. Future research will focus on program refinement and testing for effectiveness in primary care.

Black and Latinx Community Perspectives on COVID-19 Mitigation Behaviors, Testing, and Vaccines.

Importance: Black and Latinx communities have been disproportionately affected by the COVID-19 pandemic, yet little work has sought to understand their perspectives. Objective: To explore the experiences of Black and Latinx communities during the pandemic to better understand their perspectives on COVID-19 mitigation behaviors (eg, mask wearing), testing, and vaccines. Design, Setting, and Participants: In this community-engaged qualitative study conducted with 18 community-based organizations and 4 health care organizations between November 19, 2020, and February 5, 2021, in New Jersey counties severely affected by the pandemic, group and individual interviews were used to purposively sample 111 Black and Latinx individuals. A total of 13 group interviews were organized by race/ethnicity and language: 4 English-speaking groups with Black participants (n = 34), 3 Spanish-speaking groups with Latinx participants (n = 24), and 4 English-speaking groups with Black and Latinx participants (n = 36). To understand the views of health care workers from these communities, 2 additional groups (n = 9) were convened and supplemented with individual interviews. Main Outcomes and Measures: Description of Black and Latinx participants' experiences during the COVID-19 pandemic and their perspectives on mitigation behaviors, testing, and vaccines. Results: The study included 111 participants (87 women [78.4%]; median age, 43 years [range, 18-93 years]). Participants described the devastating effects of the pandemic on themselves, loved ones, and their community. Their experiences were marked by fear, illness, loss, and separation. These experiences motivated intense information seeking, mitigation behaviors, and testing. Nevertheless, vaccine skepticism was high across all groups. Participants did not trust the vaccine development process and wanted clearer information. Black participants expressed that they did not want to be subjects of experiments. Conclusions and Relevance: The remaining unknowns about new vaccines need to be acknowledged and described for Black and Latinx communities to make informed decisions. Ultimately, scientists and public officials need to work transparently to address unanswered questions and work collaboratively with trusted community leaders and health professionals to foster partnered approaches, rather than focusing on marketing campaigns, to eliminate vaccine skepticism.

Cancer Survivorship Care Roles for Primary Care Physicians.

PURPOSE: Despite a burgeoning population of cancer survivors and pending shortages of oncology services, clear definitions and systematic approaches for engaging primary care in cancer survivorship are lacking. We sought to understand how primary care clinicians perceive their role in delivering care to cancer survivors. METHODS: We conducted digitally recorded interviews with 38 clinicians in 14 primary care practices that had national reputations as workforce innovators. Interviews took place during intense case study data collection and explored clinicians' perspectives regarding their role in cancer survivorship care. We analyzed verbatim transcripts using an inductive and iterative immersion-crystallization process. RESULTS: Divergent views exist regarding primary care's role in cancer survivor care with a lack of coherence about the concept of survivorship. A few clinicians believed any follow-up care after acute cancer treatment was oncology's responsibility; however, most felt cancer survivor care was within their purview. Some primary care clinicians considered cancer survivors as a distinct population; others felt cancer survivors were like any other patient with a chronic disease. In further interpretative analysis, we discovered a deeply ingrained philosophy of whole-person care that creates a professional identity dilemma for primary care clinicians when faced with rapidly changing specialized knowledge. CONCLUSIONS: This study exposes an emerging identity crisis for primary care that goes beyond cancer survivorship care. Facilitated national conversations might help specialists and primary care develop knowledge translation platforms to support the prioritizing, integrating, and personalizing functions of primary care for patients with highly complicated issues requiring specialized knowledge.

Feasibility and potential efficacy of commercial mHealth/eHealth tools for weight loss in African American breast cancer survivors: pilot randomized controlled trial.

Weight management after breast cancer (BC) treatment in African American (AA) women is crucial to reduce comorbid conditions and health disparities. We examined feasibility and potential efficacy of commercial eHealth/mHealth tools for weight management in AA BC survivors in New Jersey. Participants (N = 35) were randomized to an intervention (SparkPeople) plus activity tracker, Fitbit Charge (n = 18), or wait-list active control group (Fitbit only, n = 17). Anthropometric, behavioral, and quality of life (QOL) outcomes were collected at baseline, 3, 6, and 12 months. Differences in outcomes were assessed using intent-to-treat analysis. Retention was 97.1%. Both groups lost weight, with no significant differences between groups. At month 6, mean weight change was: intervention: -1.71 kg (SD 2.33; p = .006), 33.3% lost ≥3% of baseline weight; control: -2.54 kg (SD 4.00, p = .002), 23.5% lost ≥3% weight. Intervention participants achieved significant improvements in waist circumference (-3.56 cm, SD 4.70, p = .005), QOL (p = .030), and use of strategies for healthy eating (p = .025) and decreasing calories (p < .001). Number of days logged food per week was associated with decreases in waist circumference at 6 months (ß -0.79, 95% CI, -1.49, -0.09, p = .030) and 12 months (ß -2.16, 95% CI, -4.17, -0.15, p = .038). Weight loss was maintained at 12 months. This is the first study to demonstrate potential efficacy of commercial eHealth/mHealth tools for weight loss in AA BC survivors, without additional counseling from the research team. If effective, they may be convenient weight loss tools that can be easily and widely disseminated. Clinical Trials registration: ClinicalTrials.gov NCT02699983.

Greater adherence to a Mediterranean-like diet is associated with later breast development and menarche in peripubertal girls.

OBJECTIVE: To examine adherence to a Mediterranean-like diet at age 9-10 years in relation to onset of breast development (thelarche) and first menstruation (menarche). DESIGN: We evaluated the associations of adherence to a Mediterranean-like diet (measured by an adapted Mediterranean-like Diet Score, range 0-9) with thelarche at baseline, age at thelarche and time to menarche. Data were collected at baseline during a clinic visit, complemented with a mailed questionnaire and three 24 hour telephone dietary recalls, followed by annual follow-up questionnaires. Multivariable Poisson regression, linear regression and Cox proportional hazards regression were used to evaluate timing of pubertal development in relation to diet adherence. SETTING: New Jersey, USA. PARTICIPANTS: Girls aged 9 or 10 years at baseline (2006-2014, n 202). RESULTS: High Mediterranean-like diet adherence (score 6-9) was associated with a lower prevalence of thelarche at baseline compared with low adherence (score 0-3; prevalence ratio = 0·65, 95 % CI 0·48, 0·90). This may have been driven by consumption of fish and non-fat/low-fat dairy. Our models also suggested a later age at thelarche with higher Mediterranean-like diet adherence. Girls with higher Mediterranean-like diet adherence had significantly longer time to menarche (hazard ratio = 0·45, 95 % CI 0·28, 0·71 for high v. low adherence). Further analysis suggested this may have been driven by vegetable and non-fat/low-fat dairy consumption. CONCLUSIONS: Consuming a Mediterranean-like diet may be associated with older age at thelarche and menarche. Further research is necessary to confirm our findings in other US paediatric populations and elucidate the mechanism through which Mediterranean-like diet may influence puberty timing.

Development and usability testing of the e-EXCELS tool to guide cancer survivorship follow-up care.

OBJECTIVE: The aim of this study is to describe a user-centered (e.g., cancer survivors and clinicians) development process of an eHealth tool designed to facilitate self-management of cancer survivorship follow-up care. METHODS: Guided by Cognitive-Social Health Information Processing (C-SHIP) model and informed by core self-management skills, we engaged in a user-centered design process. In phase I, we conducted in-depth interviews with survivors of breast (n = 33), prostate (n = 4), and colorectal (n = 6) cancers, and (n = 9) primary care providers to develop content and design of the web tool. Phase II utilized iterative user testing interviews (n = 9) to test the web-based tool prototype. Data from both phases were independently coded using a template/content analytic approach. RESULTS: The top 5 functions identified in phase I for the web-based platform included: (a) educational materials to learn and prepare for health encounters (80%); (b) questions for health providers (74%); (c) ability to track contact information of providers (67%); (d) provide general information (64%); and, (e) support information (62%). Users of the prototype reported patient burden, tool fatigue, introduction timing of the tool, relevance, and security/privacy as concerns in phase II. CONCLUSIONS: This study demonstrates the value of using a theoretically informed and user-centered design process to develop relevant and patient-centered eHealth resources to support cancer survivorship. A larger study is needed to establish the efficacy of this eHealth tool as an intervention to improve adherence to follow-up care guidelines.

Understanding primary care-oncology relationships within a changing healthcare environment.

BACKGROUND: Management of care transitions from primary care into and out of oncology is critical for optimal care of cancer patients and cancer survivors. There is limited understanding of existing primary care-oncology relationships within the context of the changing health care environment. METHODS: Through a comparative case study of 14 innovative primary care practices throughout the United States (U.S.), we examined relationships between primary care and oncology settings to identify attributes contributing to strengthened relationships in diverse settings. Field researchers observed practices for 10-12 days, recording fieldnotes and conducting interviews. We created a reduced dataset of all text related to primary care-oncology relationships, and collaboratively identified patterns to characterize these relationships through an inductive "immersion/crystallization" analysis process. RESULTS: Nine of the 14 practices discussed having either formal or informal primary care-oncology relationships. Nearly all formal primary care-oncology relationships were embedded within healthcare systems. The majority of private, independent practices had more informal relationships between individual primary care physicians and specific oncologists. Practices with formal relationships noted health system infrastructure that facilitates transfer of patient information and timely referrals. Practices with informal relationships described shared commitment, trust, and rapport with specific oncologists. Regardless of relationship type, challenges reported by primary care settings included lack of clarity about roles and responsibilities during cancer treatment and beyond. CONCLUSIONS: With the rapid transformation of U.S. healthcare towards system ownership of primary care practices, efforts are needed to integrate strengths of informal primary care-oncology relationships in addition to formal system driven relationships.

Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care.

BACKGROUND: Breast, colorectal, and prostate cancer survivors are at increased risk for late and long-term effects post-treatment. The post-treatment phase of care is often poorly coordinated and survivors navigate follow-up care with minimal information or guidance from their healthcare team. This manuscript describes the Extended Cancer Education for Longer-term Survivors (EXCELS) in Primary Care protocol. EXCELS is a randomized controlled trial to test the efficacy of patient-level self-management educational strategies on adherence to preventative health service use and cancer survivorship follow-up guidelines. METHODS: The EXCELS trial compares four conditions: (1) EXCELS-website (e.g., a mobile-optimized technology platform); (2) EXCELS-health coaching; (3) EXCELS-website and health coaching; and (4) a print booklet. Approximately 480 breast, colorectal, and prostate survivors will be recruited through the New Jersey Primary Care Research Network (NJPCRN) and New Jersey State Cancer Registry (NJSCR). Eligible survivors (diagnosed stages 1-3) must have completed active treatment, access to a phone and a computer, smartphone or tablet with internet access, and be able to speak and read English. Patient assessments occur at baseline, 6, 12, and 18 months. The primary outcomes are increased engagement in preventive health services and monitoring for cancer recurrence and treatment-related late effects. DISCUSSION: The EXCELS trial is the first to test cancer survivorship educational self-management interventions for cancer survivors in a primary care context. Findings from this trial will inform successful implementation and engagement strategies for longer-term, post-treatment cancer survivors managed in primary care settings. TRIAL REGISTRATION: Registered August 1, 2017 at ClinicalTrials.gov , trial # NCT03233555.