Adjuvant platinum versus capecitabine for residual, invasive, triple-negative breast cancer: Patient-reported outcomes in ECOG-ACRIN EA1131.

BACKGROUND: Patient-reported outcomes (PROs) are a better tool for evaluating the experiences of patients who have symptomatic, treatment-associated adverse events (AEs) compared with clinician-rated AEs. The authors present PROs assessing health-related quality of life (HRQoL) and treatment-related neurotoxicity for adjuvant capecitabine versus platinum on the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) EA1131 trial (ClinicalTrials.gov identifier NCT02445391). METHODS: Participants completed the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) and the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale (platinum arm only) at baseline, cycle 3 day 1 (C3D1), 6 months, and 15 months. Because of early termination, power was insufficient to test the hypothesis that HRQoL, as assessed by the NFBSI-16 treatment side-effect (TSE) subscale, would be better at 6 and 15 months in the capecitabine arm; all analyses were exploratory. Means were compared by using t-tests or the Wilcoxon rank-sum test, and proportions were compared by using the χ2 test. RESULTS: Two hundred ninety-six of 330 eligible patients provided PROs. The mean NFBSI-16 TSE subscale score was lower for the platinum arm at baseline (p = .02; absolute difference, 0.6 points) and for the capecitabine arm at C3D1 (p = .04; absolute difference, 0.5 points), but it did not differ at other times. The mean change in TSE subscale scores differed between the arms from baseline to C3D1 (platinum arm, 0.15; capecitabine arm, -0.72; p = .03), but not from baseline to later time points. The mean decline in Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale scores exceeded the minimal meaningful change (1.38 points) from baseline to each subsequent time point (all p < .05). CONCLUSIONS: Despite the similar frequency of clinician-rated AEs, PROs identified greater on-treatment symptom burden with capecitabine and complemented clinician-rated AEs by characterizing patients' experiences during chemotherapy.

Advancing survivorship at a comprehensive cancer center: integrating clinical care, education and research initiatives at Northwestern Medicine and the Robert H. Lurie Comprehensive Cancer Center.

The unprecedented and growing number of cancer survivors requires comprehensive quality care that includes cancer surveillance, symptom management, and health promotion to reduce morbidity and mortality and improve quality of life. However, coordinated and sustainable survivorship care has been challenged by barriers at multiple levels. We outline the survivorship programs at Northwestern Medicine and the Robert H. Lurie Comprehensive Cancer Center that have evolved over two decades. Our current survivorship clinics comprise STAR (Survivors Taking Action and Responsibility) for adult survivors of childhood cancers; Adult Specialty Survivorship for survivors of breast, colorectal and testicular cancers, lymphomas, and leukemias; and Gynecologic Oncology Survivorship. Care provision models align with general, disease/treatment-specific, and integrated survivorship models, respectively. Reimbursement for survivorship services has been bolstered by institutional budget allocations. We have standardized survivor education, counseling, and referrals through electronic health record (EHR)-integrated survivorship care plan (SCP) templates that incorporate partial auto-population. We developed EHR-integrated data collection tools (e.g., dashboards; SmartForm, and registry) to facilitate data analytics, personalized patient referrals, and reports to the Commission on Cancer (CoC). We report to the CoC on SCP delivery, dietitian encounters, and DEXA scans. For the last decade, our Cancer Survivorship Institute has aligned the efforts of clinicians, researchers, and educators. The institute promotes evidence-based care, high-impact research, and state-of-the-science educational programs for professionals, survivors, and the community. Future plans include expansion of clinical services and funding for applied research centered on the unique needs of post-treatment cancer survivors. IMPLICATIONS FOR CANCER SURVIVORS: The survivorship programs at Northwestern Medicine and the Robert H. Lurie Comprehensive Cancer Center underscore the imperative for comprehensive, coordinated, and sustainable survivorship care to address the needs of increasing numbers of cancer survivors, with a focus on evidence-based clinical practices, associated research, and educational initiatives.

Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol.

BACKGROUND: People with cancer experience symptoms that adversely affect quality of life. Despite existing interventions and clinical guidelines, timely symptom management remains uneven in oncology care. We describe a study to implement and evaluate an electronic health record (EHR)-integrated symptom monitoring and management program in adult outpatient cancer care. METHODS: Our cancer patient-reported outcomes (cPRO) symptom monitoring and management program is a customized EHR-integrated installation. We will implement cPRO across all Northwestern Memorial HealthCare (NMHC) hematology/oncology clinics. We will conduct a cluster randomized modified stepped-wedge trial to evaluate patient and clinician engagement with cPRO. Further, we will embed a patient-level randomized clinical trial to evaluate the impact of an additional enhanced care (EC; cPRO plus web-based symptom self-management intervention) relative to usual care (UC; cPRO alone). The project uses a Type 2 hybrid effectiveness-implementation approach. The intervention will be implemented across seven regional clusters within the healthcare system comprising 32 clinic sites. A 6-month prospective pre-implementation enrollment period will be followed by a post-implementation enrollment period, during which newly enrolled, consenting patients will be randomly assigned (1:1) to EC or UC. We will follow patients for 12 months post-enrollment. Patients randomized to EC will receive evidence-based symptom-management content on cancer-related concerns and approaches to enhance quality of life, using a web-based tool ("MyNM Care Corner"). This design allows for within- and between-site evaluation of implementation plus a group-based comparison to demonstrate effectiveness on patient-level outcomes. DISCUSSION: The project has potential to guide implementation of future healthcare system-level cancer symptom management programs. http://ClinicalTrials.gov # NCT03988543.

The increasing value of eHealth in the delivery of patient-centred cancer care.

The increasing use of eHealth has ushered in a new era of patient-centred cancer care that moves beyond the traditional in-person care model to real-time, dynamic, and technology-assisted assessments and interventions. eHealth has the potential to better the delivery of cancer care through improved patient-provider communication, enhanced symptom and toxicity assessment and management, and optimised patient engagement across the cancer care continuum. In this Review, we provide a brief, narrative appraisal of the peer reviewed literature over the past 10 years related to the uses of patient-centred eHealth to improve cancer care delivery. These uses include the addressal of symptom management, health-related quality of life, and other patient-reported outcomes across cancer care. In addition, we discuss the challenges of, and opportunities for, accessibility, scalability, and implementation of these technologies, important areas for further development, and future research directions.

Selenium and mercury in dolphinfish (Coryphaena hippurus) from the Gulf of California: inter-annual variations and selenium health benefit value.

With the aim of determining the benefit from consumption of dolphinfish Coryphaena hippurus from La Paz and Cabo San Lucas in the southern area of the Gulf of California, mercury (Hg) and selenium (Se) were measured in liver and muscle of specimens (n = 362) collected between 2006 and 2013. Mean levels of Hg in muscle (0.61 µg g-1) and liver (0.42 µg g-1) of all individuals from La Paz were significantly higher (p < 0.05) than in fish from Cabo San Lucas; in the case of Se, mean concentrations in liver (1.54 µg g-1) of all individuals from La Paz were significantly higher (p < 0.05) than in fish from Cabo San Lucas. Hg levels in muscle were positively and significantly (p < 0.05) correlated with fork length and weight of fish; in liver, Hg and Se were significantly (p < 0.05) correlated with fork length and weight of specimens. Levels of Hg and Se in muscle and liver among years varied significantly (p < 0.05); although there was not a defined pattern of temporal fluctuations for both elements, the lowest Hg levels occurred in 2009 when surface water temperatures were the highest for the sampled years. With respect to the Se health benefit value (HBVSe), results were positive and above the unit in all cases; it implies that consumption of dolphinfish in the southern Gulf of California is beneficial.

Implementing electronic health record-integrated screening of patient-reported symptoms and supportive care needs in a comprehensive cancer center.

BACKGROUND: Oncology practice can be enhanced by the integration of the assessment of patient-reported symptoms and concerns into the electronic health record (EHR) and clinical workflows. METHODS: Adult oncology outpatients (n = 6825) received 38,422 invitations to complete assessments through the EHR patient portal. Patient-Reported Outcomes Measurement Information System computer adaptive tests were administered to assess fatigue, pain interference, physical function, depression, and anxiety. Checklists identified psychosocial, nutritional, and informational needs. In real time, assessment results were populated in the EHR, and clinicians were notified of elevated symptoms and needs. RESULTS: In all, 3521 patients (51.6%) completed 8162 assessments; approximately 55% of the responding patients completed 2 or more within 32 months. Fatigue, pain, anxiety, and depression scores were comparable to those of the general population (approximately 5% of assessments triggered clinical alerts across those domains); mean scores indicated a lower level of physical function (with severe scores prompting alerts in nearly 5% of assessments). More than half of assessments triggered an alert based on patient endorsement of supportive care needs, with the majority of those being nutritional (41.82% of assessments). Patient endorsement of supportive care needs was associated with significantly higher anxiety, depression, fatigue, and pain interference scores and lower physical function scores. Patients who triggered clinical alerts tended to be younger and more recently diagnosed, to have greater comorbidities, and to be a racial/ethnic minority. Patients who triggered clinical alerts had more health care service encounters in the ensuing month. CONCLUSIONS: EHR integration facilitated the assessment and reporting of patient-reported symptoms and needs within routine oncology outpatient care.

Piloting a Financial Counseling Intervention for Patients With Cancer Receiving Chemotherapy.

PURPOSE: National organizations encourage communication about costs of cancer care; however, few data are available on health system models for identifying and assisting patients with financial distress (FD). We report the feasibility and acceptability of a financial counseling (FC) intervention for patients who receive chemotherapy at a comprehensive cancer center. MATERIALS AND METHODS: Patients were randomly assigned 1:1 to FC or standard care. The FC arm received education, financial assistance screening, and an estimation tool with total billed charges and out-of-pocket (OOP) cost of one cycle of chemotherapy from a financial counselor through phone call and in-person visit. Participants completed measures of FD, health-related quality of life, and acceptability. RESULTS: Ninety-five participants enrolled (mean age, 61 years; 72% white; 50% commercially insured), with a 32% attrition rate between assessments. Rates of completion for the phone call, in-person, and entire intervention were 98%, 47%, and 30%, respectively. The OOP estimation tool was considered understandable and acceptable to the majority of participants. No significant changes in FD were found between arms. Emotional functioning was negatively associated with having high FD (95% CI, -0.13379 to -0.013; P = .0189). Being married was associated with a decrease in log-odds of having high FD (ß = -1.916; 95% CI, -3.358 to -0.475; P = .0092). CONCLUSION: Implementation of an FC program that provides transparent cost data is feasible and acceptable. Incorporation of FC into clinical workflow, including phone counseling, is important to improve feasibility. Additional work is needed to develop tailored educational materials that are patient specific.

Cancer experiences and health-related quality of life among racial and ethnic minority survivors of young adult cancer: a mixed methods study.

PURPOSE: Young adult (YA) racial and ethnic minority survivors of cancer (diagnosed ages 18-39) experience significant disparities in health outcomes and survivorship compared to non-minorities of the same age. However, little is known about the survivorship experiences of this population. The purpose of this study is to explore the cancer experiences and health-related quality of life (HRQOL) among YA racial/ethnic minorities in an urban US city. METHODS: Racial and ethnic minority YA cancer survivors (0 to 5 years posttreatment) were recruited from a comprehensive cancer center using a purposive sampling approach. Participants (n = 31) completed semi-structured interviews, the FACT-G (physical, emotional, social well-being) and the FACIT-Sp (spiritual well-being). Mixed methods data were evaluated using thematic analysis and analysis of covariance (ANCOVA). RESULTS: The majority of survivors were women (65 %), single (52 %), and Hispanic (42 %). Across interviews, the most common themes were the following: "changes in perspective," "emotional impacts," "received support," and "no psychosocial changes." Other themes varied by racial/ethnic subgroups, including "treatment effects" (Hispanics), "behavior changes" (Blacks), and "appreciation for life" (Asians). ANCOVAs (controlling for gender and ECOG performance status scores) revealed that race/ethnicity had a significant main effect on emotional (P = 0.05), but not physical, social, or spiritual HRQOL (P > 0.05). CONCLUSIONS: Our findings suggest that minority YA cancer survivors report complex positive and negative experiences. In spite of poor health outcomes, survivors report experiencing growth and positive change due to cancer. Variations in experiences and HRQOL highlight the importance of assessing cultural background to tailor survivorship care among YA racial and ethnic minorities.

Survivorship care planning in a comprehensive cancer center using an implementation framework.

Cancer survivorship care plans (SCPs) have been recommended to improve clinical care and patient outcomes. Research is needed to establish their efficacy and identify best practices. Starting in 2015, centers accredited by the American College of Surgeons Commission on Cancer must deliver SCPs to patients completing primary cancer treatment with curative intent. We describe how we established routine SCP delivery at the Robert H Lurie Comprehensive Cancer Center in Chicago, Illinois, using the Quality Implementation Framework. We evaluated local practices, gathered clinician and patient stakeholder input, developed customized SCP templates within the electronic health record (EHR), and implemented 2 complementary delivery models. Clinician interviews (n = 41) and survey responses (n = 12), along with input from patients (n = 68) and a patient advisory board (n = 15), indicated support for SCPs and survivorship services. To promote feasible implementation and leverage existing workflows, we harmonized 2 SCP delivery models: integrated care within clinics where patients received treatment, and referral to a centralized survivorship clinic. We are implementing SCP delivery with prominent disease sites and will extend services to survivors of other cancers in the future. We developed four electronic disease-specific SCP templates for breast, colorectal, lung, and prostate cancers and a fifth, generic template that can be used for other malignancies. The templates reduced free-text clinician entry by auto-populating 20% of the fields from existing EHR data, and using drop-down menus for another 65%. Mean SCP completion time is 12 minutes (range, 10-15; n = 64). We designed our framework to facilitate ongoing evaluation of implementation and quality improvement. Funding/sponsorship Robert H Lurie Comprehensive Cancer Center, the Coleman Foundation, and the Lynn Sage Cancer Research Foundation.

Implementation of distress screening in an oncology setting.

The recommendations of numerous groups, such as the Institute of Medicine and the National Comprehensive Cancer Network, have resulted in the first regulatory standard on distress screening in oncology implemented in 2015 by the American College of Surgeons Commission on Cancer. This practice-changing standard promises to result in better quality cancer care, but presents unique challenges to many centers struggling to provide high-quality practical assessment and management of distress. The current paper reviews the history behind the CoC standard, identifies the most prevalent symptoms underlying distress, and discusses the importance of distress screening. We also review some commonly used instruments for assessing distress, and address barriers to implementation of screening and management.

Priority symptoms in advanced breast cancer: development and initial validation of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16).

OBJECTIVES: By using methods consistent with recent regulatory guidance on patient-reported outcomes as endpoints in clinical trials, we created a new version of the Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (FBSI), with emphasis on patient input during the development process. METHODS: We obtained input on the most important symptoms to monitor during treatment for stage III or IV breast cancer from 52 patients recruited from National Comprehensive Cancer Network institutions as well as support service organizations. Participating patients shared their top-priority symptoms/concerns through open-ended interviews and symptom checklists. To ensure adequate content coverage, we evaluated results alongside the original version of the FBSI, which was created on the basis of a survey of oncology clinicians at National Comprehensive Cancer Network institutions and items in the Functional Assessment of Chronic Illness Therapy measurement system. We also obtained input from 10 National Comprehensive Cancer Network oncologists regarding whether symptoms were primarily related to disease or treatment. RESULTS: We selected breast cancer-related symptoms and concerns endorsed as high priority by both oncology patients and clinicians for inclusion in the new National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index-16 (NFBSI-16), which includes all eight items from the original FBSI and eight additional items from Functional Assessment of Chronic Illness Therapy measures. The NFBSI-16 is formatted by subscale: Disease-Related Symptom, Treatment Side-Effect, and General Function and Well-Being. Results provide preliminary support for NFBSI-16's internal consistency reliability (α = 0.87) and validity as evidenced by moderate-to-strong relationships with expected criteria. CONCLUSIONS: Reflecting the priority symptoms of breast cancer patients and clinicians, the NFBSI-16 can be used to help evaluate the effectiveness of treatments for advanced breast cancer in clinical practice and research.

Have a little faith: measuring the impact of illness on positive and negative aspects of faith.

BACKGROUND: The importance of faith and its associations with health are well documented. As part of the Patient Reported Outcomes Measurement Information System, items tapping positive and negative impact of illness (PII and NII) were developed across four content domains: Coping/Stress Response, Self-Concept, Social Connection/Isolation, and Meaning and Spirituality. Faith items were included within the concept of meaning and spirituality. METHODS: This measurement model was tested on a heterogeneous group of 509 cancer survivors. To evaluate dimensionality, we applied two bi-factor models, specifying a general factor (PII or NII) and four local factors: Coping/Stress Response, Self-Concept, Social Connection/Isolation, and Meaning and Spirituality. RESULTS: Bi-factor analysis supported sufficient unidimensionality within PII and NII item sets. The unidimensionality of both PII and NII item sets was enhanced by extraction of the faith items from the rest of the questions. Of the 10 faith items, nine demonstrated higher local than general factor loadings (range for local factor loadings = 0.402 to 0.876), suggesting utility as a separate but related 'faith' factor. The same was true for only two of the remaining 63 items across the PII and NII item sets. CONCLUSIONS: Although conceptually and to a degree empirically related to Meaning and Spirituality, Faith appears to be a distinct subdomain of PII and NII, better handled by distinct assessment. A 10-item measure of the impact of illness upon faith (II-Faith) was therefore assembled.