Oncologic drug repository programs in the United States: a review and comparison.

As cancer affects 40% of all Americans during their lifetime, the financial burden of cancer care represents a significant contribution towards the overall cost of health care in the United States. Cancer drug repository programs offer a unique solution for patients who have limited financial ability to access medications while reducing medical waste. We reviewed all state legislation in the United States regarding cancer drug repository programs. Five states have oral anticancer drug (OACD)-specific drug repository programs, while 28 states have generalized drug repository programs. Iowa's statewide, mail-order OACD repository program is the preeminent example of an effective and efficient program, which should be replicated across the country. Many states have passed legislation allowing for drug repository programs but have struggled to translate such legislation into active programs due to lack of funding and management. We offer recommendations across policy, manufacturing, institutional, health care professional, and patient domains in order provide optimal patient care.

Obstacles to Biosimilar Acceptance and Uptake in Oncology: A Review.

Importance: Biosimilar drugs provide cost-effective yet clinically indistinguishable replications of target drugs. During initial development, this class of biologic medicines was expected to revolutionize pharmaceutical markets; however, following US Food and Drug Administration approval of the first biosimilar drug in 2015, the commercialization of biosimilars has been limited. The lack of biosimilar use may be especially salient in oncology, given that biosimilar distribution in this particularly high-cost area of medicine would bring savings on the order of many billions of dollars. Observations: While researchers have focused on salient economic barriers to biosimilar uptake in the US, the present review provides insight regarding noneconomic barriers. This review discusses psychological, attitudinal, and educational factors among both health care professionals and payers in the US that may play a role in slowing biosimilar uptake. More specifically, these factors include a lack of health care professional education, concerns of safety and efficacy, and overly complex product naming systems. Conclusions and Relevance: The pathway to biosimilar use has been obstructed by economic elements as well as attitudinal and psychological factors. For biosimilar drugs to achieve their potential in decreasing treatment costs and thus increasing patient access, it will be essential for both economic and noneconomic factors to be identified and systematically addressed.

Prevention of allergic reactions during oxaliplatin desensitization through inhibition of Bruton tyrosine kinase.

BACKGROUND: Acute infusion reactions to oxaliplatin, a chemotherapeutic used to treat gastrointestinal cancers, are observed in about 20% of patients. Rapid drug desensitization (RDD) protocols often allow the continuation of oxaliplatin in patients with no alternative options. Breakthrough symptoms, including anaphylaxis, can still occur during RDD. OBJECTIVE: Our aim was to evaluate whether pretreatment with acalabrutinib, a Bruton tyrosine kinase inhibitor, can prevent anaphylaxis during RDD in a patient sensitized to oxaliplatin. METHODS: A 52-year-old male with locally advanced gastric carcinoma developed anaphylaxis during his fifth cycle of oxaliplatin. As he required 6 additional cycles to complete his curative-intent treatment regimen, he underwent RDD to oxaliplatin but still developed severe acute reactions. The risks and benefits of adding acalabrutinib before and during RDD were reviewed, and the patient elected to proceed. RESULTS: With acalabrutinib taken before and during the RDD, the patient was able to tolerate oxaliplatin RDD without complication. Consistent with its mechanism of action, acalabrutinib completely blocked the patient's positive skin prick response to oxaliplatin. Acalabrutinib did not alter the percentage of circulating basophils (1.24% vs 0.98%) before the RDD but did protect against basopenia (0.74% vs 0.09%) after the RDD. Acalabrutinib was associated with a drastic reduction in the ability of basophils to upregulate CD63 in vitro following incubation with oxaliplatin (0.11% vs 2.38%) or polyclonal anti-human IgE antibody (0.08% vs 44.2%). CONCLUSIONS: Five doses of acalabrutinib, 100 mg, orally twice daily starting during the evening 2 days before and continuing through RDD allowed a sensitized patient to receive oxaliplatin successfully and safely.

Challenges and Solutions to Support Oncology Professionals Serving Underserved Populations With Cancer in the United States: Results From the ASCO Serving the Underserved Task Force.

PURPOSE: Little data exist regarding approaches to support oncology professionals who deliver cancer care for underserved populations. In response, ASCO developed the Serving the Underserved Task Force to learn from and support oncology professionals serving underserved populations. METHODS: The Task Force developed a 28-question survey to assess oncology professionals' experiences and strategies to support their work caring for underserved populations. The survey was deployed via an online link to 600 oncology professionals and assessed respondent and patient demographic characteristics, clinic-based processes to coordinate health-related social services, and strategies for professional society support and engagement. We used chi-square tests to evaluate whether there were associations between percent full-time equivalent (FTE) effort serving underserved populations (<50% FTE v ≥50% FTE) with responses. RESULTS: Of 462 respondents who completed the survey (77% response rate), 79 (17.1%) were Asian; 30 (6.5%) Black; 43 (9.3%) Hispanic or Latino/Latina; and 277 (60%) White. The majority (n = 366, 79.2%) had a medical doctor degree (MD). A total of 174 (37.7%) had <25% FTE, 151 (32.7%) had 25%-50% FTE, and 121 (26.2%) had ≥50% FTE effort serving underserved populations. Most best guessed patients' sociodemographic characteristics (n = 388; 84%), while 42 (9.2%) used data collected by the clinic. Social workers coordinated most health-related social services. However, in clinical settings with high proportions of underserved patients, there was greater reliance on nonclinical personnel, such as navigators (odds ratio [OR], 2.15 [95% CI, 1.07 to 4.33]) or no individual (OR, 2.55 [95% CI, 1.14 to 5.72]) for addressing mental health needs and greater reliance on physicians or advance practice practitioners (OR, 2.54 [95% CI, 1.11 to 5.81]) or no individual (OR, 1.91 [95% CI, 1.09 to 3.35]) for addressing childcare or eldercare needs compared with social workers. Prioritization of solutions, which did not differ by FTE effort serving underserved populations, included a return-on-investment model to support personnel, integrated health-related social needs screening, and collaboration with the professional society on advocacy and policy. CONCLUSION: The findings highlight crucial strategies that professional societies can implement to support oncology clinicians serving underserved populations with cancer.

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.

Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer.

Importance: The longitudinal experience of patients is critical to the development of interventions to identify and reduce financial hardship. Objective: To evaluate financial hardship over 12 months in patients with newly diagnosed colorectal cancer (CRC) undergoing curative-intent therapy. Design, Setting, and Participants: This prospective, longitudinal cohort study was conducted between May 2018 and July 2020, with time points over 12 months. Participants included patients at National Cance Institute Community Oncology Research Program sites. Eligibility criteria included age at least 18 years, newly diagnosed stage I to III CRC, not started chemotherapy and/or radiation, treated with curative intent, and able to speak English. Data were analyzed from December 2022 through April 2023. Main Outcomes and Measures: The primary end point was financial hardship, measured using the Comprehensive Score for Financial Toxicity (COST), which assesses the psychological domain of financial hardship (range, 0-44; higher score indicates better financial well-being). Participants completed 30-minute surveys (online or paper) at baseline and 3, 6, and 12 months. Results: A total of 450 participants (mean [SD] age, 61.0 [12.0] years; 240 [53.3%] male) completed the baseline survey; 33 participants (7.3%) were Black and 379 participants (84.2%) were White, and 14 participants (3.1%) identified as Hispanic or Latino and 424 participants (94.2%) identified as neither Hispanic nor Latino. There were 192 participants (42.7%) with an annual household income of $60 000 or greater. There was an improvement in financial hardship from diagnosis to 12 months of 0.3 (95% CI, 0.2 to 0.3) points per month (P < .001). Patients with better quality of life and greater self-efficacy had less financial toxicity. Each 1-unit increase in Functional Assessment of Cancer Therapy-General (rapid version) score was associated with an increase of 0.7 (95% CI, 0.5 to 0.9) points in COST score (P < .001); each 1-unit increase in self-efficacy associated with an increase of 0.6 (95% CI, 0.2 to 1.0) points in COST score (P = .006). Patients who lived in areas with lower neighborhood socioeconomic status had greater financial toxicity. Neighborhood deprivation index was associated with a decrease of 0.3 (95% CI, -0.5 to -0.1) points in COST score (P = .009). Conclusions and Relevance: These findings suggest that interventions for financial toxicity in cancer care should focus on counseling to improve self-efficacy and mitigate financial worry and screening for these interventions should include patients at higher risk of financial burden.

Implementing a Patient-Reported Outcome Dashboard in Oncology Telemedicine Encounters: Clinician and Patient Adoption and Acceptability.

PURPOSE: Telemedicine provides numerous benefits to patients, yet effective communication and symptom assessment remain a concern. The recent uptake of telemedicine provided an opportunity to use a newly developed dashboard with patient-reported outcome (PRO) information to enhance communication and shared decision making (SDM) during telemedicine appointments. The objective of this study was to identify barriers to using the dashboard during telemedicine, develop implementation strategies to address barriers, and pilot test use of this dashboard during telemedicine appointments in two practice settings to evaluate acceptability, adoption, fidelity, and effectiveness. METHODS: Patients and clinicians were interviewed to identify determinants to dashboard use in telemedicine. Implementation strategies were designed and refined through iterative feedback from stakeholders. A pilot study of dashboard use was conducted from March to September 2022. Acceptability, adoption, and fidelity were evaluated using mixed methods. SDM was evaluated using the collaboRATE measure. RESULTS: One hundred two patient encounters were evaluated. Most patients (62; 60%) had completed some PRO data at the time of their telemedicine encounter. Most (82; 80%) encounters had clinician confirmation that PRO data had been reviewed; however, collaborative review of the dashboard was documented in only 27%. Degree of SDM was high (mean collaboRATE score 3.40; SD, 0.11 [95% CI, 3.17 to 3.63] out of a maximum score of 4). Implementation strategies focused on patient engagement, education, and remote PRO completion. Clinician-facing strategies included education, practice facilitation, and small tests of change. CONCLUSION: This study demonstrated that implementation of a PRO-based dashboard into telemedicine appointments was feasible and had acceptable adoption and acceptability by patients and clinicians when several strategies were used to engage end users. Strategies targeting both patients and clinicians are needed to support routine and effective PRO integration in telemedicine.

The effect of neighborhood socioeconomic disadvantage on smoking status, quit attempts, and receipt of cessation support among adults with cancer: Results from nine ECOG-ACRIN Cancer Research Group trials.

BACKGROUND: Tobacco use is associated with adverse outcomes among patients diagnosed with cancer. Socioeconomic determinants influence access and utilization of tobacco treatment; little is known about the relationship between neighborhood socioeconomic disadvantage (NSD) and tobacco assessment, assistance, and cessation among patients diagnosed with cancer. METHODS: A modified Cancer Patient Tobacco Use Questionnaire (C-TUQ) was administered to patients enrolled in nine ECOG-ACRIN clinical trials. We examined associations of NSD with (1) smoking status, (2) receiving tobacco cessation assessment and support, and (3) cessation behaviors. NSD was classified by tertiles of the Area Deprivation Index. Associations between NSD and tobacco variables were evaluated using logistic regression. RESULTS: A total of 740 patients completing the C-TUQ were 70% male, 94% White, 3% Hispanic, mean age 58.8 years. Cancer diagnoses included leukemia 263 (36%), lymphoma 141 (19%), prostate 131 (18%), breast 79 (11%), melanoma 69 (9%), myeloma 53 (7%), and head and neck 4 (0.5%). A total of 402 (54%) never smoked, 257 (35%) had formerly smoked, and 81 (11%) were currently smoking. Patients in high disadvantaged neighborhoods were approximately four times more likely to report current smoking (odds ratio [OR], 3.57; 95% CI, 1.69-7.54; p = .0009), and more likely to report being asked about smoking (OR, 4.24; 95% CI, 1.64-10.98; p = .0029), but less likely to report receiving counseling (OR, 0.11; 95% CI, 0.02-0.58; p = .0086) versus those in the least disadvantaged neighborhoods. CONCLUSIONS: Greater neighborhood socioeconomic disadvantage was associated with smoking but less cessation support. Increased cessation support in cancer care is needed, particularly for patients from disadvantaged neighborhoods.

Enhancement and Implementation of a Health Information Technology Module to Improve the Discrete Capture of Cancer Staging in a Diverse Regional Health System.

PURPOSE: Cancer staging is the foundation for all cancer management decisions. For real-time use, stage must be embedded in the electronic health record as a discrete data element. The objectives of this quality improvement (QI) initiative were to (1) identify barriers to utilization of an existing discrete cancer staging module, (2) identify health information technology (HIT) solutions to support discrete capture of cancer staging data, and (3) increase capture across the oncology enterprise in our diverse health system. METHODS: Six sigma QI methodologies were used to define barriers and solutions to improve discrete cancer staging. Design thinking principles informed solution development to test prototypes. Two multidisciplinary teams of disease-specific clinicians within GI and genitourinary conducted phased testing pilots to determine health system solutions. Solutions were expanded to all oncology specialties across our health system. RESULTS: Baseline average discrete staging capture across our health system was 31%. Poor workflow efficiency, limited accountability, and technical design gaps were key barriers to timely, complete staging. Implementation of more than 25 design enhancements to a HIT solution and passive user alerts led to a postimplementation capture rate of 58% across 55 outpatient clinics involving more than 400 clinicians. CONCLUSION: We identified key barriers to discrete data capture and designed solutions through iterative use of QI methodologies and disease-specific pilots. After implementation, discrete capture of cancer staging nearly doubled across our diverse health system. This approach is scalable and transferable to other initiatives to develop and implement clinically relevant HIT solutions across a diverse health system.

Assessing the Needs of Those Who Serve the Underserved: A Qualitative Study among US Oncology Clinicians.

BACKGROUND: The American Society of Clinical Oncology established the 'Supporting Providers Serving the Underserved' (SUS) Task Force with a goal to develop recommendations to support cancer clinicians who deliver care for populations at risk for cancer disparities. As a first step, the Task Force explored barriers and facilitators to equitable cancer care delivery. METHODS: Clinicians across the United States who deliver care predominantly for low-income and racially and ethnically minoritized populations were identified based on lists generated by the Task Force and the Health Equity Committee. Through purposive sampling based on geographical location, clinicians were invited to participate in 30-60 min semi-structured interviews to explore experiences, barriers, and facilitators in their delivery of cancer care. Interviews were recorded, transcribed, imported into qualitative data management software, and analyzed using thematic analysis. RESULTS: Thematic analysis revealed three major themes regarding barriers (lack of executive leadership recognition of resources; patient-related socio-economic needs; clinician burnout) and two major themes regarding facilitators (provider commitment, experiential training). CONCLUSIONS: Findings reveal modifiable barriers and potential solutions to facilitate equitable cancer care delivery for populations at risk for cancer disparities.

Adverse COVID-19 experiences and health-related quality of life in cancer survivors: indirect effects of COVID-19-related depression and financial burden.

BACKGROUND: Cancer survivors are at greater risk for poor health outcomes due to COVID-19. However, the pandemic's impact on patients' health-related quality of life (HRQoL) is not well known. This study hypothesized that cancer survivors' adverse COVID-19 experiences would be associated with worse HRQoL. Further, this association would be moderated by psychosocial resiliency factors (perceived social support, benefits, and ability to manage stress) and mediated by psychosocial risk factors (anxiety, depression; health, financial and social concerns). METHODS: 1,043 cancer survivors receiving care at Northwestern Medicine completed a cross-sectional survey on COVID-19 practical and psychosocial concerns from 6/2021 to 3/2022. Participants reported on 21 adverse COVID-19 experiences (e.g., COVID-19 hospitalization, death of family/friends, loss of income, medical delays). The survey assessed 9 psychosocial factors related to COVID-19: anxiety, depression; health care, financial, and social disruptions; health care satisfaction; social support, perceived benefits, and stress management skills. The FACT-G7 assessed HRQoL. Hypotheses were tested in a structural equation model. The number of reported adverse COVID-19 experiences was the primary (observed) independent variable. The dependent variable of HRQoL, and the proposed mediating and moderating factors, were entered as latent variables indicated by their respective survey items. Latent interaction terms between the independent variable and each resiliency factor tested moderation effects. Analyses were adjusted for demographic and COVID-specific variables. RESULTS: Participants were, on average, aged 58 years and diagnosed with cancer 4.9 years prior. They were majority female (73.3%), White (89.6%), non-Hispanic/Latino (94.5%), college-educated (81.7%), and vaccinated for COVID-19 (95.5%). An average of 3.8 adverse COVID-19 experiences were reported. Results of structural equation modeling demonstrated that the association between adverse COVID-19 experiences and HRQoL was explained by indirect effects through COVID-19-related depression (ß = - 0.10, percentile bootstrap 95% CI - 0.15 to - 0.07) and financial concerns (ß = - 0.04, percentile bootstrap 95% CI - 0.07 to - 0.01). Hypotheses testing moderation by resiliency factors were not significant. CONCLUSIONS: Adverse COVID-19 experiences were associated with higher depression symptoms and financial concerns about COVID-19, and in turn, worse HRQoL. Oncology clinics should be cognizant of the experience of adverse COVID-19 events when allocating depression and financial support resources.

We conducted an online survey of cancer survivors receiving treatment at Northwestern Medicine in Chicago, Illinois. Participants responded to a list of 21 adverse experiences related to the pandemic, such as COVID-19 hospitalization, death of family/friends, loss of income, and medical delays. They also responded to questionnaires measuring their degree of anxiety, depression, daily disruptions, health disruptions, financial disruptions, social support, perceived benefits, and ability to manage stress during the pandemic. Lastly, they responded to a questionnaire on health-related quality of life, capturing their physical symptoms, emotional symptoms, and satisfaction with life. Our survey found that people who had a greater number of adverse COVID-19 experiences had higher levels of depression and financial burden, which in turn was associated with worse health-related quality of life.

Combination of pembrolizumab and pelareorep promotes anti-tumour immunity in advanced pancreatic adenocarcinoma (PDAC).

BACKGROUND: We previously reported activity of pelareorep, pembrolizumab and chemotherapy. Patients developed new T-cell clones and increased peripheral T-cell clonality, leading to an inflamed tumour. To evaluate a chemotherapy-free regimen, this study assesses if pelareorep and pembrolizumab has efficacy by inducing anti-tumour immunological changes (NCT03723915). METHODS: PDAC patients who progressed after first-line therapy, received iv pelareorep induction with pembrolizumab every 21-days. Primary objective is overall response rate. Secondary objectives included evaluation of immunological changes within tumour and blood. RESULTS: Clinical benefit rate (CBR) was 42% amongst 12 patients. One patient achieved partial response (PR) and four stable disease (SD). Seven progressed, deemed non-responders (NR). VDAC1 expression in peripheral CD8+ T cells was higher at baseline in CBR than NR but decreased in CBR upon treatment. On-treatment peripheral CD4+ Treg levels decreased in CBR but not in NR. Analysis of tumour demonstrated PD-L1+ cells touching CD8+ T cells, and NK cells were more abundant post-treatment vs. baseline. A higher intensity of PD-L1 in tumour infiltrates at baseline, particularly in CBR vs. NR. Finally, higher levels of soluble (s)IDO, sLag3, sPD-1 observed at baseline among NR vs. CBR. CONCLUSION: Pelareorep and pembrolizumab showed modest efficacy in unselected patients, although potential immune and metabolic biomarkers were identified to warrant further evaluation.

Cigarette and Alternative Tobacco Product Use among Adult Cancer Survivors Enrolled in 9 ECOG-ACRIN Clinical Trials.

BACKGROUND: While cigarette smoking has declined among the U.S. general population, sale and use of non-cigarette alternative tobacco products (ATP; e.g., e-cigarettes, cigars) and dual use of cigarettes/ATPs are rising. Little is known about ATP use patterns in cancer survivors enrolled in clinical trials. We investigated prevalence of tobacco product use, and factors associated with past 30-day use, among patients with cancer in national trials. METHODS: Cancer survivors (N = 756) enrolled in 9 ECOG-ACRIN clinical trials (2017-2021) completed a modified Cancer Patient Tobacco Use Questionnaire (C-TUQ) which assessed baseline cigarette and ATP use since cancer diagnosis and in the past 30 days. RESULTS: Patients were on average 59 years old, 70% male, and the mean time since cancer diagnosis was 26 months. Since diagnosis, cigarettes (21%) were the most common tobacco product used, followed by smokeless tobacco use (5%), cigars (4%), and e-cigarettes (2%). In the past 30 days, 12% of patients reported smoking cigarettes, 4% cigars, 4% using smokeless tobacco, and 2% e-cigarettes. Since cancer diagnosis, 5.5% of the sample reported multiple tobacco product use, and 3.0% reported multiple product use in the past 30 days. Males (vs. females; OR 4.33; P = 0 < 0.01) and individuals not living with another person who smokes (vs. living with; OR, 8.07; P = 0 < 0.01) were more likely to use ATPs only versus cigarettes only in the past 30 days. CONCLUSIONS: Among patients with cancer, cigarettes were the most prevalent tobacco product reported. IMPACT: Regardless, ATPs and multiple tobacco product use should be routinely assessed in cancer care settings.

Current communication practices for biomarker testing in non-small cell lung cancer: Exploring patient and clinician perspectives.

OBJECTIVES: We qualitatively explored patient and clinician experiences with biomarker testing in one academic health system to identify current communication practices and unmet testing information needs. METHODS: We conducted 1:1 in-depth interviews with 15 clinicians (i.e., nurses, oncologists, pathologists) and 12 patients diagnosed with non-small cell lung cancer between January and May 2022. Participants described experiences with biomarker testing as well as associated communication practices and needs. Interviews were audio-recorded and transcribed. Analysis was informed by the Framework Method. RESULTS: Patients described challenges retaining information early in their patient journey. While patients were generally aware of biomarkers and their effect on treatment options, they expressed limited knowledge of expected time delays between testing and receiving results. Additionally, many did not know their testing results. Clinicians and patients both noted no standard education material on biomarker testing is currently available. They suggested such materials could support patient knowledge and decision-making. CONCLUSIONS: Communication between patients and clinicians about biomarker testing is largely delivered through verbal counseling at a time when patients may be cognitively compromised. All participants supported the idea of delivering standard, tangible education materials on biomarker testing to patients. PRACTICE IMPLICATIONS: Education materials may enhance counseling efforts and patient knowledge.

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.

Effectiveness and implementation of an electronic health record-integrated digital health intervention for managing depressive symptoms in ambulatory oncology: The My Well-Being Guide study rationale and protocol.

BACKGROUND: Rates of clinically elevated depressive symptoms among ambulatory oncology patients are higher than in the general population and are associated with poorer health-related quality of life. Furthermore, a reduction in depressive symptoms may be associated with improved cancer survival. Several interventions have demonstrated efficacy in reducing oncologic depressive symptoms, including cognitive-behavioral stress management (CBSM). However, more work is needed to understand how to best implement CBSM into practice, such as through stepped-care approaches and digital health interventions linked to electronic health records (EHR). This manuscript presents the protocol of the My Well-Being Guide study, a pragmatic type 1 effectiveness-implementation hybrid study. This trial will test the effectiveness of My Well-Being Guide, a seven-week structured, CBSM-based digital health intervention designed to reduce depressive symptoms. This trial will also evaluate My Well-Being Guide's implementation across two health systems. METHODS: The final sample (N = 4561) will be oncology patients at Northwestern Medicine or University of Miami Health System who are ≥18 years of age; have a cancer diagnosis; elevated depressive symptoms on the Patient-Reported Outcomes Measurement Information System Depression; and primary language is English or Spanish. Data collection will occur at baseline, and 2-, 6-, and 12-months post baseline. Outcome domains include depressive symptoms and implementation evaluation. DISCUSSION: This study may provide valuable data on the effectiveness of our depressive symptom management digital health intervention linked to the EHR and the scalability of digital health interventions in general.

Medical Oncologists' Knowledge and Perspectives on the Use of Biosimilars in the United States.

PURPOSE: Despite increasing availability of biosimilar cancer treatments, little is known about oncologists' knowledge and concerns regarding biosimilar use in the United States. We surveyed medical oncologists to examine their knowledge, attitudes, and experience with biosimilars. METHODS: Oncologists recruited via the ASCO Research Survey Pool completed a 29-question survey in 2020 designed with input from clinical and health care system experts and literature review. RESULTS: Of the 269 respondents, most treated patients with biosimilars (n = 236, 88%) and reported that biosimilars were required at their institution (n = 168, 63%). Approximately half (n = 140, 52%) of oncologists correctly responded that biosimilars were not the same as generic medicines. Commonly reported barriers to use of biosimilars included concerns regarding a perceived lack of relevant research (n = 85, 33% reporting quite a bit/very much), the potential for extrapolation (n = 83, 33%), and efficacy limitations (n = 77, 30%). More oncologists from university hospitals (n = 36, 22%) than from community/private hospitals (n = 28, 38%) or private practices (n = 13, 38%) were concerned about biosimilar efficacy. A high proportion of oncologists reported that information on safety (n = 259, 99%) and efficacy (n = 255, 99%) is important when considering whether to use biosimilars. Less than half reported that their institution provided education about biosimilars (n = 108, 40%). CONCLUSION: In this sample of medical oncologists, knowledge about basic features of biosimilars was limited and access to information about biosimilars was insufficient. The present study determined that educational programs on biosimilars for oncologists are needed and identified priorities for such efforts.

Resource and Reimbursement Barriers to Comprehensive Cancer Care Delivery: An Analysis of Association of Community Cancer Centers Survey Data.

PURPOSE: Comprehensive cancer care (CCC) delivery is recommended in guidelines and considered essential for high-quality cancer management. Barriers, such as insufficient reimbursement, prevent consistent access to and delivery of CCC. Association of Community Cancer Centers conducted a national survey to elucidate capacity and barriers to CCC delivery to inform policy and value-based payment reform. METHODS: Survey methodology included item generation with expert review, iterative piloting, and cognitive validity testing. In the final instrument, 27 supportive oncology services were assessed for availability, reasons not offered, and coverage/reimbursement. RESULTS: 204 of 704 member programs completed survey questions. Despite most services being reported as offered, a minority were funded through insurance reimbursement. The services least likely to obtain reimbursement were those that address practical and family/childcare needs (0.7%), caregiver support (1.5%), advanced care directives (1.7%), spiritual services (1.8%), and navigation (2.7%). These findings did not vary by region or practice type. CONCLUSION: There is a lack of sufficient reimbursement, staffing, and budget to provide CCC across the United States. Care models and reimbursement policies must include CCC services to optimize delivery of cancer care.