HPV Status and Oral Health Symptom Patterning During Treatment and Survivorship in Patients With Head and Neck Cancer: A Longitudinal Analysis.

OBJECTIVES: To describe longitudinal oral health symptom patterns of patients receiving concurrent chemotherapy and radiation therapy for head and neck cancer (HNC) and examine associations between phenotypic characteristics, including human papillomavirus (HPV) status and oral health symptoms. SAMPLE & SETTING: A pilot retrospective longitudinal chart review (N = 270) of patients with HNC at a northeastern U.S. regional cancer institute. METHODS & VARIABLES: HPV status and oral health symptoms (pain, mucositis, taste alteration, xerostomia, dysphagia, and candidiasis) were examined during treatment (six weeks) and survivorship (three months). Latent transition analysis was conducted across each time point. RESULTS: The latent transition analysis revealed classes with moderate to high symptom expression persisted into survivorship. The HPV-negative phenotype had higher symptom expression across treatment and survivorship. IMPLICATIONS FOR NURSING: Patients with HPV-negative HNC may require early intervention, while considering social determinants of health to attenuate symptom expression and improve outcomes.

Baseline sLAG-3 levels in Caucasian and African-American breast cancer patients.

BACKGROUND: Worse survival persists for African-Americans (AA) with breast cancer compared to other race/ethnic groups despite recent improvements for all. Unstudied in outcomes disparities to date is soluble LAG-3 (sLAG-3), cleaved from the LAG-3 immune checkpoint receptor which is a proposed target for deactivation in emerging immunotherapies due to its prominent immunosuppressive function in the tumoral microenvironment. A prior study has found that lower sLAG-3 baseline level was associated with poor outcomes. METHODS: In a cross-sectional study of 95 patients with primary breast cancer (n = 58 Caucasian, n = 37 AA), we measured sLAG-3 (ELISA pg/ml) in pre-treatment blood samples using the non-parametric Mann-Whitney u-Test for independent samples, and, calculated Pearson r correlation coefficients of sLAG-3 with circulating cytokines by race. RESULTS: Mean sLAG-3 level was lower in AA compared to Caucasian patients (1377.6 vs 3690.3, P = .002), and in patients with triple-negative breast cancer (TNBC) compared to those with non-TNBC malignancies (P = .02). When patients with TNBC tumors were excluded from analyses, the difference in sLAG-3 level between AA (n = 21) and Caucasian patients (n = 40) substantially remained (1937.4 vs 4182.4, P = .06). Among Caucasian patients, sLAG-3 was correlated with IL-6, IL-8 and IL-10 (r = .69, P < .001; r = .70, P < .001; and, r = .46, P = .01; respectively). For AA patients, sLAG-3 was correlated only with IL-6 (r = .37, P = .03). CONCLUSIONS: We present the first report that African-American breast cancer patients might have comparatively low pre-treatment sLAG-3 levels, independent of TNBC status, along with reduced co-expression with circulating cytokines. The mechanistic and prognostic role of cleaved LAG-3, particularly in disparate outcomes, remains to be elucidated.

Dietary consumption patterns in breast cancer survivors: Pilot evaluation of diet, supplements and clinical factors.

PURPOSE: Adherence to dietary intake guidelines is recommended for optimal nutrition and outcomes in breast cancer survivors. The purpose of this study was to examine dietary quality in a cohort of breast cancer survivors related to current guidelines, guiding further education-based research. METHODS: This exploratory evaluation examined compliance with current dietary guidelines. Data collected included demographics, medical histories and repeated, three-day 24-h dietary recalls. Women with early-stage breast cancer (n = 97) who completed breast cancer treatment between 6 and 24 months were recruited. Descriptive statistics and frequencies were calculated for demographic and lifestyle characteristics, reported fish consumption, body mass index categories, supplement consumption, and adequacy of macronutrient and micronutrient consumption (classified as below, meeting, or exceeding needs). RESULTS: In this cohort, 28.9% were classified as overweight and 35% were obese. The mean dietary macronutrient consumption was 44.3% (±8.9%) carbohydrates, 36.6% (±7.3%) fat, and 17.3% (±4.7%) protein. Additionally, 32.3% participants consumed >45 g sugar/d. The mean n-6 to n-3 ratio was 8.0 (±3.3):1. Further, 38% of survivors reported consuming less than 1 serving of fish per week. Participants consumed between 0 and 1.03 servings of fish per day, with an average consumption of 0.16 (±0.26) servings per day and 61.5% (n = 59) consuming 0 servings per day. The mean daily combined dietary and supplement consumption of multiple micronutrients was below the Recommended Daily Allowance for Vitamin D (30%), Calcium (52.6%), Magnesium (42.1%), and Vitamin E (80%). CONCLUSION: Breast cancer survivors 0.5-2 years post-treatment are not meeting recommended nutrition consumption guidelines for a number of nutrients. Findings suggested that nutrition therapy targeting weight loss through reduced sugar, total and saturated fat, while increasing foods rich in omega-3, and ensuring adequate micronutrient consumption would promote better nutritional consumption patterns and improve overall health during survivorship.

Acceptability, Effectiveness, and Roles of mHealth Applications in Supporting Cancer Pain Self-Management: Integrative Review.

BACKGROUND:  Cancer pain remains highly prevalent and persistent throughout survivorship, and it is crucial to investigate the potential of leveraging the advanced features of mobile health (mHealth) apps to empower individuals to self-manage their pain. OBJECTIVE:  This review aims to comprehensively understand the acceptability, users' experiences, and effectiveness of mHealth apps in supporting cancer pain self-management. METHODS:  We conducted an integrative review following Souza and Whittemore and Knafl's 6 review processes. Literature was searched in PubMed, Scopus, CINAHL Plus with Full Text, PsycINFO, and Embase, from 2013 to 2023. Keywords including "cancer patients," "pain," "self-management," "mHealth applications," and relevant synonyms were used in the search. The Johns Hopkins research evidence appraisal tool was used to evaluate the quality of eligible studies. A narrative synthesis was conducted to analyze the extracted data. RESULTS:  A total of 20 studies were included, with the overall quality rated as high (n=15) to good (n=5). Using mHealth apps to monitor and manage pain was acceptable for most patients with cancer. The internal consistency of the mHealth in measuring pain was 0.96. The reported daily assessment or engagement rate ranged from 61.9% to 76.8%. All mHealth apps were designed for multimodal interventions. Participants generally had positive experiences using pain apps, rating them as enjoyable and user-friendly. In addition, 6 studies reported significant improvements in health outcomes, including enhancement in pain remission (severity and intensity), medication adherence, and a reduced frequency of breakthrough pain. The most frequently highlighted roles of mHealth apps included pain monitoring, tracking, reminders, education facilitation, and support coordination. CONCLUSIONS:  mHealth apps are effective and acceptable in supporting pain self-management. They offer a promising multi-model approach for patients to monitor, track, and manage their pain. These findings provide evidence-based insights for leveraging mHealth apps to support cancer pain self-management. More high-quality studies are needed to examine the effectiveness of digital technology-based interventions for cancer pain self-management and to identify the facilitators and barriers to their implementation in real-world practice.

Implementation Strategies to Promote Short-Course Radiation for Bone Metastases.

Importance: For patients with nonspine bone metastases, short-course radiotherapy (RT) can reduce patient burden without sacrificing clinical benefit. However, there is great variation in uptake of short-course RT across practice settings. Objective: To evaluate whether a set of 3 implementation strategies facilitates increased adoption of a consensus recommendation to treat nonspine bone metastases with short-course RT (ie, ≤5 fractions). Design, Setting, and Participants: This prospective, stepped-wedge, cluster randomized quality improvement study was conducted at 3 community-based cancer centers within an existing academic-community partnership. Rollout was initiated in 3-month increments between October 2021 and May 2022. Participants included treating physicians and patients receiving RT for nonspine bone metastases. Data analysis was performed from October 2022 to May 2023. Exposures: Three implementation strategies-(1) dissemination of published consensus guidelines, (2) personalized audit-and-feedback reports, and (3) an email-based electronic consultation platform (eConsult)-were rolled out to physicians. Main Outcomes and Measures: The primary outcome was adherence to the consensus recommendation of short-course RT for nonspine bone metastases. Mixed-effects logistic regression at the bone metastasis level was used to model associations between the exposure of physicians to the set of strategies (preimplementation vs postimplementation) and short-course RT, while accounting for patient and physician characteristics and calendar time, with a random effect for physician. Physician surveys were administered before implementation and after implementation to assess feasibility, acceptability, and appropriateness of each strategy. Results: Forty-five physicians treated 714 patients (median [IQR] age at treatment start, 67 [59-75] years; 343 women [48%]) with 838 unique nonspine bone metastases during the study period. Implementing the set of strategies was not associated with use of short-course RT (odds ratio, 0.78; 95% CI, 0.45-1.34; P = .40), with unadjusted adherence rates of 53% (444 lesions) preimplementation vs 56% (469 lesions) postimplementation; however, the adjusted odds of adherence increased with calendar time (odds ratio, 1.68; 95% CI, 1.20-2.36; P = .003). All 3 implementation strategies were perceived as being feasible, acceptable, and appropriate; only the perception of audit-and-feedback appropriateness changed before vs after implementation (19 of 29 physicians [66%] vs 27 of 30 physicians [90%]; P = .03, Fisher exact test), with 20 physicians (67%) preferring reports quarterly. Conclusions and Relevance: In this quality improvement study, a multicomponent set of implementation strategies was not associated with increased use of short-course RT within an academic-community partnership. However, practice improved with time, perhaps owing to secular trends or physician awareness of the study. Audit-and-feedback was more appropriate than anticipated. Findings support the need to investigate optimal approaches for promoting evidence-based radiation practice across settings.

Pain management for post-treatment survivors of complex cancers: a qualitative study of opioids and cannabis.

Aim: We aimed to understand experiences with opioids and cannabis for post-treatment cancer survivors. Patients & methods: We conducted seven focus groups among head and neck and lung cancer survivors, using standard qualitative methodology to explore themes around 1) post-treatment pain and 2) utilization, perceived benefits and perceived harms of cannabis and opioids. Results & conclusion: Survivors (N = 25) experienced addiction fears, stigma and access challenges for both products. Opioids were often perceived as critical for severe pain. Cannabis reduced pain and anxiety for many survivors, suggesting that anxiety screening, as recommended in guidelines, would improve traditional pain assessment. Opioids and cannabis present complex harms and benefits for post-treatment survivors who must balance pain management and minimizing side effects.

Physician knowledge, practice patterns, and barriers encountered regarding guideline-concordant use of bone modifying agents for prostate cancer.

BACKGROUND: Guidelines recommend bone-modifying agents (BMAs) for patients with castrate-resistant prostate cancer (CRPC) and bone metastasis, but not for castrate-sensitive prostate cancer (CSPC). Physicians beliefs and practices regarding BMA therapy are poorly understood. METHODS: This was a qualitative interview study with embedded Likert-scale elements. Study participants were physicians who treat prostate cancer, located within an academic cancer center or an affiliated community-based network. Participants were asked about their experiences and practice patterns regarding BMA therapy. Participants used Likert-scale items to identify the most common barriers to guideline-concordant BMA use and the most effective potential interventions. Participants were subsequently asked to rank the three most common barriers and the three most effective interventions to reduce underuse (for CRPC) and overuse (for CSPC). RESULTS: Nineteen physicians were invited and 15 participated; one physician did not answer some questions as outside of their practice scope. All were aware of the recommendation for BMAs in CRPC. 14% (2/14) were unaware of the recommendation against BMA use for CSPC; an additional 29% (4/14) believed that BMA use could be appropriate for CSPC depending on the metastatic disease burden. 36% (5/14) were unaware of recommendations for screening and treatment of low bone mineral density. The most common barriers (occurring "often" or "sometimes") were obtaining dental clearance (11/15) and insufficient clinic time (6/15). The interventions identified as most effective to reduce underuse were dental navigation (11/15) and electronic medical record (EMR)-based guidance (9/15). The interventions identified as most effective to reduce overuse were peer-to-peer education (14/15) and EMR-based guidance (13/15). CONCLUSIONS: Awareness of guideline recommendations for screening and treatment of low bone mineral density and against BMA use for CSPC was good, but not complete. Dental navigation, peer-to-peer education, and EMR-based guidance were preferred intervention strategies to improve guideline-concordant use.

Work-health balance of cancer survivors returning to work: A meta-ethnography.

PURPOSE: This meta-ethnography investigates the multifaceted health-related experiences of cancer survivors returning to work (RTW), recognizing the pivotal role of employment in overall well-being, particularly in the context of increasing cancer cases among working-age adults. METHOD: Following the methodology of Noblit and Hare, a comprehensive literature search was conducted from 2013 to 2023 in databases including PubMed, Scopus, CINAHL, PsycINFO, and Embase. Qualitative studies assessing cancer survivors' experiences, motivation, concern, resilience, and need in the process of RTW were identified. Eligible studies were assessed for quality using the Critical Appraisal Skills Program Checklist, and their findings were subsequently synthesized. RESULTS: Seventeen studies were included for analysis. The finding revealed five key themes: motivations (voluntary and involuntary), cancer-related concerns, resilience, needs for cancer healthcare support, and workplace accommodation. Voluntarily RTW was primarily linked to desires of normalcy, while involuntary RTW was often financially driven. Cancer survivors often face physical, psychological, and social challenges in the RTW process. Resilience played a crucial role in their readaptation to the workplace. Participants expressed the need for additional guidance from healthcare providers and tailored support from the workplace to facilitate a smoother RTW experience. CONCLUSION: Cancer survivors aspire to be actively engaged, have their specific needs addressed, and achieve success in their return-to-work endeavors. Occupational guidance and accommodation from healthcare providers and employers play a pivotal role in empowering survivors to balance cancer and work, facilitating the return-to-work process, and enhancing the quality of survivorship.

Virtual Tumor Board to Foster Interinstitutional Head and Neck Cancer Subspecialty Care.

This cross-sectional study evaluates the concordance on treatment and diagnostic recommendations between clinicians at 2 collaborating health systems.

Spatiotemporally organized immunomodulatory response to SARS-CoV-2 virus in primary human broncho-alveolar epithelia.

The COVID-19 pandemic continues to be a health crisis with major unmet medical needs. The early responses from airway epithelial cells, the first target of the virus regulating the progression toward severe disease, are not fully understood. Primary human air-liquid interface cultures representing the broncho-alveolar epithelia were used to study the kinetics and dynamics of SARS-CoV-2 variants infection. The infection measured by nucleoprotein expression, was a late event appearing between day 4-6 post infection for Wuhan-like virus. Other variants demonstrated increasingly accelerated timelines of infection. All variants triggered similar transcriptional signatures, an "early" inflammatory/immune signature preceding a "late" type I/III IFN, but differences in the quality and kinetics were found, consistent with the timing of nucleoprotein expression. Response to virus was spatially organized: CSF3 expression in basal cells and CCL20 in apical cells. Thus, SARS-CoV-2 virus triggers specific responses modulated over time to engage different arms of immune response.

Spatiotemporally organized immunomodulatory response to SARS-CoV-2 virus in primary human broncho-alveolar epithelia.

The COVID-19 pandemic continues to be a health crisis with major unmet medical needs. The early responses from airway epithelial cells, the first target of the virus regulating the progression towards severe disease, are not fully understood. Primary human air-liquid interface cultures representing the broncho-alveolar epithelia were used to study the kinetics and dynamics of SARS-CoV-2 variants infection. The infection measured by nucleoprotein expression, was a late event appearing between day 4-6 post infection for Wuhan-like virus. Other variants demonstrated increasingly accelerated timelines of infection. All variants triggered similar transcriptional signatures, an "early" inflammatory/immune signature preceding a "late" type I/III IFN, but differences in the quality and kinetics were found, consistent with the timing of nucleoprotein expression. Response to virus was spatially organized: CSF3 expression in basal cells and CCL20 in apical cells. Thus, SARS-CoV-2 virus triggers specific responses modulated over time to engage different arms of immune response.

Symptom Patterning Across the Cancer Care Trajectory for Patients Receiving Chemoradiation for Head and Neck Cancer: A Retrospective Longitudinal Study Using Latent Transition Analysis.

BACKGROUND: Patients with head and neck cancer (HNC) experience a multitude of symptoms because of the tumor and its treatment. OBJECTIVE: To identify the symptom patterns present in cancer treatment and survivorship periods for patients with HNC using latent class analysis. METHODS: A retrospective longitudinal chart review was conducted to examine symptoms reported by patients who received concurrent chemoradiation for HNC in a regional Northeastern United States cancer institute. Latent class analysis was performed to identify the latent classes present across multiple timepoints during treatment and survivorship for the most commonly reported symptoms. RESULTS: In 275 patients with HNC, the latent transition analysis revealed 3 latent classes for both treatment and survivorship periods: (1) mild, (2) moderate, and (3) severe symptoms. Patients were more likely to report a greater number of symptoms in a more severe latent class. During treatment, moderate and severe classes had representation of all most common symptoms: pain, mucositis, taste alterations, xerostomia, dysphagia, and fatigue. Different symptom patterns emerged for survivorship, with prominence of taste alterations and xerostomia across all classes, and all symptoms present in the severe class. The probability of symptom expression varied more in the survivorship period compared with the treatment period. CONCLUSIONS: Patients reported numerous symptoms during active treatment persisting into survivorship. Patients tended to transition to more severe symptomatology as treatment progressed and to more moderate symptomatology as survivorship evolved. IMPLICATIONS FOR PRACTICE: Examining the trend of persistent moderate symptomatology into survivorship is useful to optimize symptom management.

Feasibility of Investigational Procedures and Efficacy of a Personalized Omega-3 Dietary Intervention in Alleviating Pain and Psychoneurological Symptoms in Breast Cancer Survivors.

BACKGROUND: Breast cancer survivors (BCS) are at risk for psychoneurological symptoms (PNS) and inflammation for years following cancer treatment. Fish, particularly salmon, provides a rich source of omega-3 long chain fatty acids (omega-3LC), which has an anti-inflammatory effect. However, the benefit of omega-3LC on PNS is not well-known. AIMS: This study evaluated the feasibility and the initial efficacy of a personalized meal plan with dietary omega-3LC in reducing PNS. METHODS: A prospective, randomized controlled trial design (n = 46) was used to evaluate the feasibility of a personalized meal plan using two omega-3LC dose levels (high and low omega-3LC) in reducing PNS including pain, depression, fatigue, sleep, and stress. RESULTS: The recruitment rate was 4.9% with overall retention rate of 74% and 67.1% adherence to personalized meal plan and dietary procedures. Of participants who completed the investigation, 94% completed fish adherence logs and consumed ≥70% of the assigned quantity of fish. Saliva collection was 97.8% at baseline and 100% at follow-up. BCS in the high omega-3LC group had a significant decrease in pain (p < .01), perceived stress (p < .05), sleep (p < .001), depression (p < .001), and fatigue (p < .01) over the course of intervention. There were trends of PNS improvement in the low omega-3LC group but the differences did not reach statistical significance. CONCLUSION: Our results support the feasibility of our investigational design, procedures, and intervention. The outcomes provide preliminary support for an expanded research effort using fish as a source of omega-3LC and personalized dietary planning as a vehicle for symptom self-management in BCS.

Implementation Strategies to Increase Clinical Trial Enrollment in a Community-Academic Partnership and Impact on Hispanic Representation: An Interrupted Time Series Analysis.

PURPOSE: Community-academic partnerships have the potential to improve access to clinical trials for under-represented minority patients who more often receive cancer treatment in community settings. In 2017, the Memorial Sloan Kettering (MSK) Cancer Center began opening investigator-initiated clinical trials in radiation oncology in targeted community-based partner sites with a high potential to improve diverse population accrual. This study evaluates the effectiveness of a set of implementation strategies for increasing overall community-based enrollment and the resulting proportional enrollment of Hispanic patients on trials on the basis of availability in community-based partner sites. METHODS: An interrupted time series analysis evaluating implementation strategies was conducted from April 2018 to September 2021. Descriptive analysis ofHispanic enrollment on investigator-initiated randomized therapeutic radiation trials open at community-based sites was compared with those open only at themain academic center. RESULTS: Overall, 84 patients were enrolled in clinical trials in the MSK Alliance, of which 48 (56%) identified as Hispanic. The quarterly patient enrollment pre- vs postimplementation increased from 1.39 (95% CI, -3.67 to 6.46) to 9.42 (95% CI, 2.05 to 16.78; P5 .017). In the investigator-initiated randomized therapeutic radiation trials open in the MSK Alliance, Hispanic representation was 11.5% and 35.9% in twometastatic trials and 14.2% in a proton versus photon trial. Inmatched trials open only at the main academic center, Hispanic representation was 5.6%, 6.0%, and 4.0%, respectively. CONCLUSION: A combination of practice-level and physician-level strategies implemented at community-based partner sites was associated with increased clinical trial enrollment, which translated to improved Hispanic representation. This supports the role Q:2 of strategic community-academic partnerships in addressing disparities in clinical trial enrollment.

Multidisciplinary Treatment of Non-Spine Bone Metastases: Results of a Modified Delphi Consensus Process.

Purpose: Local treatment for bone metastases is becoming increasingly complex. National guidelines traditionally focus only on radiation therapy (RT), leaving a gap in clinical decision support resources available to clinicians. The objective of this study was to reach expert consensus regarding multidisciplinary management of non-spine bone metastases, which would facilitate standardizing treatment within an academic-community partnership. Methods and Materials: A multidisciplinary panel of physicians treating metastatic disease across the Memorial Sloan Kettering (MSK) Cancer Alliance, including community-based partner sites, was convened. Clinical questions rated of high importance in the management of non-spine bone metastases were identified via survey. A literature review was conducted, and panel physicians drafted initial recommendation statements. Consensus was gathered on recommendation statements through a modified Delphi process from a full panel of 17 physicians from radiation oncology, orthopaedic surgery, medical oncology, interventional radiology, and anesthesia pain. Consensus was defined a priori as 75% of respondents indicating "agree" or "strongly agree" with the consensus statement. Strength of Recommendation Taxonomy was employed to assign evidence strength for each statement. Results: Seventeen clinical questions were identified, of which 11 (65%) were selected for the consensus process. Consensus was reached for 16 of 17 answer statements (94%), of which 12 were approved after Round 1 and additional 4 approved after Round 2 of the modified Delphi voting process. Topics included indications for referral to surgery or interventional radiology, radiation fractionation and appropriate use of stereotactic approaches, and the handling of systemic therapies during radiation. Evidence strength was most commonly C (n = 7), followed by B (n = 5) and A (n = 3). Conclusions: Consensus among a multidisciplinary panel of community and academic physicians treating non-spine bone metastases was feasible. Recommendations will assist clinicians and potentially provide measures to reduce variation across diverse practice settings. Findings highlight areas for further research such as pathologic fracture risk estimation, pre-operative radiation, and percutaneous ablation.

Validation of a Population-Based Data Source to Examine National Cancer Clinical Trial Participation.

Importance: The Centers for Medicare & Medicaid Services requires health care organizations to report the National Clinical Trial (NCT) identifier on claims for items and services related to clinical trials that qualify for coverage. This same NCT identifier is used to identify clinical trials in the ClinicalTrials.gov registry. If linked, this information could facilitate population-based analyses of clinical trial participation and outcomes. Objective: To evaluate the validity of a linkage between fee-for-service (FFS) Medicare claims and ClinicalTrials.gov through the NCT identifier for patients with cancer enrolled in clinical trials. Design, Setting, and Participants: This cohort study included 2 complementary retrospective analyses for a validation assessment. First, billing data from 3 health care institutions were used to estimate the missingness of the NCT identifier in claims by calculating the proportion of known participants in cancer clinical trials with no NCT identifier on any submitted Medicare claims. Second, the Surveillance Epidemiology and End Results-Medicare data set, which includes a subset of all FFS Medicare beneficiaries for whom health insurance claims are linked with cancer registry data, was used to identify adult patients diagnosed with cancer between 2006 and 2015 with an NCT identifier in claims corresponding to an interventional cancer clinical trial. To estimate the accuracy of the NCT identifier when present, the proportion of NCT identifiers that corresponded to trials that were aligned with the patients' known primary or secondary diagnoses was calculated. Data were analyzed from March 2020 to March 2021. Exposures: An NCT identifier present in Medicare claims. Main Outcomes and Measures: The main outcome was participating in a clinical trial relevant to patient's cancer diagnosis. Results: A total of 1 171 816 patients were included in analyses. Across the 3 participating institutions, there were 5061 Medicare patients enrolled in a clinical trial, including 3797 patients (75.0%) with an NCT identifier on at least 1 billing claim that matched the clinical trial on which the patient was participating. Among 1 171 816 SEER-Medicare patients, 29 138 patients (2.5%) had at least 1 claim with a value entered in the NCT identifier field corresponding to 32 950 unique patient-NCT identifier pairs. There were 26 694 pairs (81.0%) with an NCT identifier corresponding to a clinical trial registered in ClinicalTrials.gov, of which 10 170 pairs (38.1%) were interventional cancer clinical trials. Among these, 9805 pairs (96.4%) were considered appropriate. Conclusions and Relevance: In this cohort study, this data linkage provided a novel data source to study clinical trial enrollment patterns among Medicare patients with cancer on a population level. The presence of the NCT identifiers in claims for Medicare patients participating in clinical trials is likely to improve over time with increasing adherence with the Centers for Medicare & Medicaid Services mandate.

A Descriptive Survey Study of Patient Needs and Preferences for Cancer Pain Self-Management Support.

OBJECTIVES: To characterize the needs and preferences for pain self-management support (SMS) among patients with cancer during the transition of cancer care from the hospital to the home setting. SAMPLE & SETTING: 38 participants with cancer pain at a research-intensive cancer center in New England. METHODS & VARIABLES: A descriptive, cross-sectional survey study was conducted to investigate relationships among preferred and received support, extent and management of transitional change, and pain outcomes. Pain intensity and interference were measured using the Brief Pain Inventory-Short Form, transitional change was measured using the Measurement of Transitions in Cancer Scale, and SMS was measured using dichotomous questions. RESULTS: About half of participants reported concordance between preferred and received cancer pain SMS in the hospital and at home. The extent of transitional change in cancer care was found to be a significant predictor of average pain intensity in the hospital and pain interference at home. Satisfaction with cancer pain SMS was a significant predictor of pain intensity at home. IMPLICATIONS FOR NURSING: The extent of change during care transitions should be considered when fulfilling patient needs and preferences for cancer pain SMS to optimize outcomes.

The Head and Neck Survivorship Tool (HN-STAR) Trial (WF-1805CD): A protocol for a cluster-randomized, hybrid effectiveness-implementation, pragmatic trial to improve the follow-up care of head and neck cancer survivors.

Survivors of head and neck cancer (HNC) can have multiple health concerns. To facilitate their care, we developed and pilot-tested a clinical informatics intervention, HN-STAR. HN-STAR elicits concerns online from HNC survivors prior to a routine oncology clinic visit. HN-STAR then presents tailored evidence-based clinical recommendations as a clinical decision support tool to be used during the visit where the oncology clinician and survivor select symptom management strategies and other actions. This generates a survivorship care plan (SCP). Online elicitation of health concerns occurs 3, 6, and 9 months after the clinic visit, generating an updated SCP each time. HN-STAR encompasses important methods of improving survivorship care (e.g., needs assessment, tailored interventions, dissemination of guidelines) and will be evaluated in a pragmatic trial to maximize external validity. This hybrid type 1 implementation-effectiveness trial tests HN-STAR effectiveness while studying barriers and facilitators to implementation in community oncology practices within the National Cancer Institute Community Oncology Research Program. Effectiveness will be measured as differences in key survivorship outcomes between HNC participants who do and do not use HN-STAR over one year after the clinic visit. The primary endpoint is HNC-specific quality of life; other outcomes include patient-centered measures and receipt of guideline-concordant care. Implementation outcomes will be assessed of survivors, providers, and clinic stakeholders. The hybrid design will provide insight into a dose-response relationship between the extent of implementation fidelity and effectiveness outcomes, as well as how to incorporate HN-STAR into standard practice outside the research setting.

Identification of a five gene signature to predict time to biochemical recurrence after radical prostatectomy.

BACKGROUND: Identification of novel biomarkers associated with high-risk prostate cancer or biochemical recurrence can drive improvement in detection, prognosis, and treatment. However, studies can be limited by small sample sizes and sparse clinical follow-up data. We utilized a large sample of prostate specimens to identify a predictive model of biochemical recurrence following radical prostatectomy and we validated this model in two external data sets. METHODS: We analyzed prostate specimens from patients undergoing radical prostatectomy at Hartford Hospital between 2008 and 2011. RNA isolated from formalin-fixed paraffin-embedded prostates was hybridized to a custom Affymetrix microarray. Regularized (least absolute shrinkage and selection operator [Lasso]) Cox regression was performed with cross-validation to identify a model that incorporated gene expression and clinical factors to predict biochemical recurrence, defined as postoperative prostate-specific antigen (PSA) > 0.2 ng/ml or receipt of triggered salvage treatment. Model performance was assessed using time-dependent receiver operating curve (ROC) curves and survival plots. RESULTS: A total of 606 prostate specimens with gene expression and both pre- and postoperative PSA data were available for analysis. We identified a model that included Gleason grade and stage as well as five genes (CNRIP1, endoplasmic reticulum protein 44 [ERP44], metaxin-2 [MTX2], Ras homolog family member U [RHOU], and OXR1). Using the Lasso method, we determined that the five gene model independently predicted biochemical recurrence better than a model that included Gleason grade and tumor stage alone. The time-dependent ROCAUC for the five gene signature including Gleason grade and tumor stage was 0.868 compared to an AUC of 0.767 when Gleason grade and tumor stage were included alone. Low and high-risk groups displayed significant differences in their recurrence-free survival curves. The predictive model was subsequently validated on two independent data sets identified through the Gene Expression Omnibus. The model included genes (RHOU, MTX2, and ERP44) that have previously been implicated in prostate cancer biology. CONCLUSIONS: Expression of a small number of genes is associated with an increased risk of biochemical recurrence independent of classical pathological hallmarks.

An Integrative Review of the Role of the Oral and Gut Microbiome in Oral Health Symptomatology During Cancer Therapy.

PROBLEM IDENTIFICATION: Both chemotherapy and radiation therapy cause considerable symptom burden on patients' oral health, influencing nutritional status and quality of life. The role of the oral and gut microbiome in oral health alterations during cancer therapy is an emerging area of science in symptom management. LITERATURE SEARCH: PubMed®, CINAHL®, and Scopus® were searched for articles published from January 2000 through July 2020. DATA EVALUATION: Articles published in English that were focused on chemotherapy and/or radiation therapy were included in the review. SYNTHESIS: Of the 22 identified studies, 12 described oral health symptoms during chemotherapy and radiation therapy for head and neck cancer. Ten studies assessed symptoms during treatment for a variety of solid tumors and blood cancers, with four of these describing microbial interventions for the management of oral mucositis. Interventions varied, but the results supported the benefits of probiotics and synbiotics in reducing mucositis severity. Overall, less diverse oral and gut microbiome environments were associated with increased severity of oral health symptomatology. IMPLICATIONS FOR PRACTICE: Additional research is needed to determine how the oral and gut microbiome and microbial interventions may be used to improve oral health management during cancer treatment.