Association Between Medicare Site-Based Payment Policy, Physician Practice Characteristics, and Vertical Integration Among Oncologists.

PURPOSE: Medicare's differential payments for services delivered in physician offices versus hospital outpatient settings incentivize hospital-physician integration (ie, vertical integration) across many specialties, but evidence for oncologists is mixed. We examined the association of Medicare site-based payment policy and physician practice characteristics, including service volume and diversity, with vertical integration among oncologists in 2013-2019. METHODS: Using the Medicare Provider Utilization and Payment Data and Medicare Data on Provider Practice and Specialty in 2013-2019, we extracted nonintegrated medical/hematologic oncologists (hereafter oncologists) in 2013 and followed them through 2019. We quantified the incentives from Medicare site-based payment policy using the hospital-office ratio-total Medicare payments if all services were delivered in the hospital outpatient department (HOPD) versus physician office. Vertical integration was defined as billing >10% of services to HOPD in a year. Multivariable linear probability regressions estimated the association between hospital-office ratio and vertical integration in 2014-2019 with and without accounting for provider characteristics. RESULTS: In 2013, the average hospital-office ratio was 1.63, which increased to 1.99 in 2018. A 25th-to-75th percentile increase in the hospital-office ratio was negatively associated with integration (-1.01 percentage points [ppts], 95% CI = -1.45 to -0.57, p < .001) not accounting for physician practice characteristics; this association was attenuated (-0.30 ppts, 95% CI = -0.67 to 0.07, p = .11) after adjusting for these characteristics. Higher baseline (ie, 2013) service volume (Quartile4 v Quartile1 = -3.00 ppts, 95% CI = -4.42 to -1.59, p < .001), more diverse services (Quartile4 v Quartile1 = -3.55 ppts, 95% CI = -4.97 to -2.13, p < .001), and urban location (-5.23 ppts, 95% CI = -6.89 to -3.57, p < .001) were more strongly associated with vertical integration. CONCLUSION: Compared to Medicare site-based payment policy, oncologists' practice characteristics emerged as more potent factors for integration and should be considered to ensure the intended impacts of site-based payment reform. Our finding raises questions about the effectiveness of ongoing movements toward site-neutral payment for drug administration services to deter vertical integration in oncology.

Primary Care Telemedicine and Care Continuity: Implications for Timeliness and Short-term Follow-up Healthcare.

BACKGROUND: The effectiveness of telemedicine by a patient's own primary care provider (PCP) versus another available PCP is understudied. OBJECTIVE: Examine the association between primary care visit modality with timeliness and follow-up in-person healthcare, including variation by visits with the patient's own PCP versus another PCP. DESIGN AND PARTICIPANTS: Cohort study including primary care visits in a large, integrated delivery system in 2022. MEASURES: Outcomes included timeliness (visit completed within 7 days of scheduling) and in-person follow-up (PCP visits, emergency department (ED) visits, hospitalizations) within 7 days of the index PCP visit. Logistic regression measured the association between visit modality (in-person, video, and audio-only telemedicine) with the patient's own PCP or another PCP and outcomes, adjusting for characteristics. KEY RESULTS: Among 4,817,317 primary care visits, 59% were in-person, 27% audio-only, and 14% video telemedicine. Most (71.3%) were with the patient's own PCP. Telemedicine visits were timelier, with modality having a larger association for visits with patient's own PCP versus another PCP (P < 0.001). For visits with patient's own PCPs, return office visit rates were 1.2% for in-person, 5.3% for video, and 6.1% for audio-only. For another PCP, rates were 2.2% for in-person, 7.3% for video, and 8.1% for audio. Follow-up ED visits ranged from 1.4% (in-person) to 1.6% (audio-only) with own PCP, compared to 1.9% (in-person) to 2.3% (audio-only) with another PCP. Differences in return office and ED visits between in-person and telemedicine were larger for visits with another PCP compared to their own PCP (P < 0.001). Follow-up hospitalizations were rare, ranging from 0.19% (in-person with own PCP) to 0.32% (video with another PCP). CONCLUSION: Differences in return office and ED visits between in-person and telemedicine were larger when patients saw a less familiar PCP compared to their own PCP, reinforcing the importance of care continuity.

Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial.

Importance: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence. Objective: To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET. Design, Setting, and Participants: This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year. Interventions: Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team. Main Outcomes and Measures: The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms. Results: Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants. Conclusions and Relevance: This RCT found that a remote monitoring app with alerts to the patient's care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life. Trial Registration: ClinicalTrials.gov Identifier: NCT03592771.

Analysis of travel burden and travel support among patients treated at a comprehensive cancer center in the Southeastern United States.

INTRODUCTION: Travel burden leads to worse cancer outcomes. Understanding travel burden and the level and types of travel support provided at large cancer centers is critical for developing systematic programs to alleviate travel burden. This study analyzed patients who received travel assistance, including their travel burden, types and amount of travel support received, and factors that influenced these outcomes. METHODS: We analyzed 1063 patients who received travel support from 1/1/2021 to 5/1/2023 at Winship Cancer Institute, in which ~18,000 patients received cancer care annually. Travel burden was measured using distance and time to Winship sites from patients' residential address. Travel support was evaluated using the monetary value of total travel support and type of support received. Patients' sociodemographic and clinical factors were extracted from electronic medical records. Area-level socioeconomic disadvantage was coded by the Area Deprivation Index using patient ZIP codes. RESULTS: On average, patients traveled 57.2 miles and 67.3 min for care and received $74.1 in total for travel support. Most patients (88.3%) received travel-related funds (e.g., gas cards), 5% received direct rides (e.g., Uber), 3.8% received vouchers for taxi or public transportation, and 3% received combined travel support. Male and White had longer travel distance and higher travel time than female and other races, respectively. Patients residing in more disadvantaged neighborhoods had an increased travel distance and travel time. Other races and Hispanics received more travel support ($) than Black and White patients or non-Hispanics. Patients with higher travel distance and travel time were more like to receive travel-related financial support. CONCLUSION: Among patients who received travel support, those from socioeconomically disadvantaged neighborhoods had greater travel burden. Patients with greater travel burden were more likely to receive travel funds versus other types of support. Further understanding of the impact of travel burden and travel support on cancer outcomes is needed.

Leveraging Mobile Health to Improve Capecitabine Adherence Among Women With Breast Cancer: A Pilot Randomized Controlled Trial.

PURPOSE: Oral capecitabine improves convenience compared to intravenous therapies but presents monitoring challenges. We conducted a randomized pilot trial to evaluate a mobile health intervention to remotely monitor capecitabine adherence and patient-reported outcomes (PROs) among women with breast cancer. METHODS: Patients with breast cancer prescribed capecitabine, an oral chemotherapy with a complex, cyclical regimen, were randomly assigned to enhanced usual care (EUC) or PRO arm. Participants were asked to use a smart pill bottle to measure adherence (timing and dose) and complete baseline and 90-day follow-up surveys. PRO participants received text messages for missed or incorrect doses and weekly text-based symptom assessments, and their oncologists received alerts for severe symptoms or missed doses. We compared nonadherence (<80%) and changes from enrollment to follow-up on reported physical and mental health quality-of-life scores and number of severe symptoms by study arm. RESULTS: Overall, 32 women were randomly assigned (17 EUC and 15 PRO): 28 (87.5%) received the intervention and 24 (78.1%) completed the follow-up survey. Among participants who received the intervention, PRO participants responded to 83.3% of symptom questions; 7.7% of PRO participants were nonadherent compared with 40.0% of EUC participants (P = .049). Among those who completed the follow-up survey, 12.5% of PRO participants had reductions in their mental health composite scores compared with 69.2% of EUC participants (P = .011); 10% of PRO participants had more severe symptoms at follow-up compared with 57.1% of EUC participants (P = .019). CONCLUSION: A mobile health intervention using text message reminders and symptom assessments improved medication adherence and mental health quality-of-life scores and lowered symptom burden of patients with breast cancer prescribed capecitabine. Future work should evaluate the longer-term impacts of this intervention.

Silent suffering: the impact of sexual health challenges on patient-clinician communication and adherence to adjuvant endocrine therapy among Black women with early-stage breast cancer.

PURPOSE: Adjuvant endocrine therapy (AET) increases sexual health challenges for women with early-stage breast cancer. Black women are more likely than women of other racial/ethnic groups to report adverse symptoms and least likely to initiate and maintain AET. Little is known about how sexual health challenges influence patient-clinician communication and treatment adherence. This study explores facilitators of and barriers to patient-clinician communication about sexual health and how those factors might affect AET adherence among Black women with early-stage breast cancer. METHODS: We conducted 32 semi-structured, in-depth interviews among Black women with early-stage breast cancer in the U.S. Mid-South region. Participants completed an online questionnaire prior to interviews. Data were analyzed using thematic analysis. RESULTS: Participants' median age was 59 (range 40-78 years, SD = 9.0). Adverse sexual symptoms hindered participants' AET adherence. Facilitators of patient-clinician communication about sexual health included female clinicians and peer support. Barriers included perceptions of male oncologists' disinterest in Black women's sexual health, perceptions of male oncologists' biased beliefs about sexual activity among older Black women, cultural norms of sexual silence among Southern Black women, and medical mistrust. CONCLUSIONS: Adverse sexual symptoms and poor patient-clinician communication about sexual health contribute to lower AET adherence among Black women with early-stage breast cancer. New interventions using peer support models and female clinicians trained to discuss sexual health could ameliorate communication barriers and improve treatment adherence. IMPLICATIONS FOR CANCER SURVIVORS: Black women with early-stage breast cancer in the U.S. Mid-South may require additional resources to address sociocultural and psychosocial implications of cancer survivorship to enable candid discussions with oncologists.

Therapists' perspectives on access to telemental health among Medicaid-enrolled youth.

OBJECTIVE: The COVID-19 pandemic exacerbated risk for poor mental health (MH) outcomes among youth from low-income families and propelled a shift to telemental health. Yet, little is known about barriers to and facilitators of MH care access when services are delivered via synchronous telehealth to Medicaid-enrolled youth. STUDY DESIGN: Between December 2020 and March 2021, we conducted in-depth interviews with 19 therapists from a large safety-net organization who served Medicaid-enrolled youth (< 18 years of age) to elucidate their perspectives on barriers to and facilitators of access to telemental health services among this population. METHODS: We conducted a thematic content analysis, guided by the 5 dimensions of health care access identified by Fortney and colleagues: geographical, temporal, digital, cultural (including acceptability of services), and financial access. RESULTS: Therapists noted that when components of digital access are met (ie, access to hardware and software, connectivity, and technological literacy), then telehealth could facilitate temporal access and eliminate geographic barriers; elimination of these barriers was particularly beneficial for youth in rural and hard-to-reach communities. Notably, many families depended on smartphones for telemental health access, and many youth depended on their caregiver's smartphone. When considering acceptability of services, some youth preferred in-person services, whereas other youth (especially some teenagers with high technological literacy) had a preference for telemental health. CONCLUSIONS: Our results highlight the need for flexibility in reimbursement policies that allows providers to optimize MH care access by offering telehealth delivered via telephone and video as well as in-person services, depending on the needs and preferences of youth and families.

Telemedicine Versus In-Person Primary Care: Treatment and Follow-up Visits.

BACKGROUND: Beyond initial COVID-19 pandemic emergency expansions of telemedicine use, it is unclear how well primary care telemedicine addresses patients' needs. OBJECTIVE: To compare treatment and follow-up visits (office, emergency department, hospitalization) between primary care video or telephone telemedicine and in-person office visits. DESIGN: Retrospective design based on administrative and electronic health record (EHR) data. SETTING: Large, integrated health care delivery system with more than 1300 primary care providers, between April 2021 and December 2021 (including the COVID-19 pandemic Delta wave). PATIENTS: 1 589 014 adult patients; 26.5% were aged 65 years or older, 54.9% were female, 22.2% were Asian, 7.4% were Black, 22.3% were Hispanic, 46.5% were White, 21.5% lived in neighborhoods with lower socioeconomic status, and 31.8% had a chronic health condition. MEASUREMENTS: Treatment outcomes included medication or antibiotic prescribing and laboratory or imaging ordering. Follow-up visits included in-person visits to the primary care office or emergency department or hospitalization within 7 days. Outcomes were adjusted for sociodemographic and clinical characteristics overall and stratified by clinical area (abdominal pain, gastrointestinal concerns, back pain, dermatologic concerns, musculoskeletal pain, routine care, hypertension or diabetes, and mental health). RESULTS: Of 2 357 598 primary care visits, 50.8% used telemedicine (19.5% video and 31.3% telephone). After adjustment, medications were prescribed in 46.8% of office visits, 38.4% of video visits, and 34.6% of telephone visits. After the visit, 1.3% of in-person visits, 6.2% of video visits, and 7.6% of telephone visits had a 7-day return in-person primary care visit; 1.6% of in-person visits, 1.8% of video visits, and 2.1% of telephone visits were followed by an emergency department visit. Differences in follow-up office visits were largest after index office versus telephone visits for acute pain conditions and smallest for mental health. LIMITATIONS: In the study setting, telemedicine is fully integrated with ongoing EHRs and with clinicians, and the study examines an insured population during the late COVID-19 pandemic period. Observational comparison lacks detailed severity or symptom measures. Follow-up was limited to 7 days. Clinical area categorization uses diagnosis code rather than symptom. CONCLUSION: In-person return visits were somewhat higher after telemedicine compared with in-person primary care visits but varied by specific clinical condition. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Patient-reported Primary Care Video and Telephone Telemedicine Preference Shifts During the COVID-19 Pandemic.

BACKGROUND: Patient perceptions of primary care telephone and video telemedicine and whether COVID-19 pandemic-related telemedicine exposure shifted patients' visit preference is unknown. OBJECTIVES: We examined patient surveys to understand the health care experience of patients seeking primary care through telemedicine and how patients expected their preferences to shift as a result of the COVID-19 pandemic. RESEARCH DESIGN/SUBJECTS: In an integrated delivery system that shifted to a "telemedicine-first" health care model during the COVID-19 pandemic, we sampled monthly and collected 1000 surveys from adults with primary care telemedicine visits scheduled through the online patient portal between 3/16/2020 and 10/31/2020. MEASURES: Participants reported their preferred primary care visit modality (telephone, video, or in-person visits) across 3 time points: before, during and (hypothetically) after the COVID-19 pandemic, and reported their general assessment of primary care visits during the pandemic. RESULTS: The majority of participants preferred in-person visits before (69%) and after the COVID-19 pandemic (57%). However, most participants reported a preference for telemedicine visits during the pandemic and continue to prefer telemedicine visits at a 12% higher rate post-pandemic. Many participants (63%) expressed interest in using telemedicine at least some of the time. Among participants reporting a recent telemedicine visit, 85% agreed that the visit addressed their health needs. CONCLUSION: As primary care visit modality preferences continue to evolve, patients anticipate that they will continue to prefer telemedicine visits, both video and telephone, at an increased rate than before the COVID-19 pandemic.

"I don't just say, Hi! I'm gay": Sexual Orientation Disclosures in Oncology Clinic Settings Among Sexual Minority Women Treated for Breast Cancer in the U.S. South.

OBJECTIVES: Few studies examine sexual orientation disclosures (SODs) among women with breast cancer; fewer examine the impact of culture and geography on disclosure processes. This study explores how sexual minority women (SMW) in the Southern United States engage in SODs with oncology clinicians. DATA SOURCES: We conducted in-depth interviews with SMW (eg, lesbian, bisexual) treated for early-stage (stages I-III), hormone receptor-positive breast cancer (N = 12), using a semistructured interview guide. Participants completed an online survey prior to the 60-minute interview. Data was analyzed using an adapted pile sorting approach and thematic analysis conventions. CONCLUSION: Average age of participants was 49.5 years (range: 30-69), all self-identified as cisgender; 83.3% as lesbian, 58.3% were married, 91.7% had completed a 4-year college degree or higher, 66.7% identified as non-Hispanic White, 16.7% as Black, and 16.7% as Hispanic/Latina. Half of the sample had not engaged in SODs with an oncology clinician. Key themes were: (1) religious and political conservatism in the South create SOD barriers; (2) oncologist-specific barriers to SODs; (3) "straight passing" as a discrimination mitigation strategy; and (4) SOD facilitators in oncology settings (ie, strategic disclosures, medical privilege, and lesbian, gay, bisexual, and transgender-friendly branding of oncology centers). IMPLICATIONS FOR NURSING PRACTICE: SMW with breast cancer living in the U.S. South navigate unique interpersonal barriers to SODs in oncology settings. Clinicians could encourage SODs by fostering inclusive environments via nonheteronormative language, inclusive intake forms, and respect for SMW's SOD navigation processes. Oncology clinicians require culturally relevant, geographic-specific communication training to facilitate SODs among SMW.

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study.

OBJECTIVE: To pilot test a mobile health intervention using a CONnected CUstomized Treatment Platform that integrates a connected electronic adherence monitoring smartbox and an early warning system of non-adherence with bidirectional automated texting feature and provider alerts. METHODS: In total, 29 adult women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer and a prescription for palbociclib were asked to complete a survey and participate in a CONnected CUstomized Treatment Platform intervention, including use of a smartbox for real-time adherence monitoring, which triggered text message reminders for any missed or extra dose, and referrals to (a) participant's oncology provider after three missed doses or an episode of over-adherence, or (b) a financial navigation program for any cost-related missed dose. Use of smartbox, number of referrals, palbociclib adherence, CONnected CUstomized Treatment Platform usability measured by System Usability Scale, and changes in symptom burden and quality of life were assessed. RESULTS: Mean age was 57.6 and 69% were white. The smartbox was used by 72.4% of participants, with palbociclib adherence rate of 95.8%±7.6%. One participant was referred to oncology provider due to missed doses and one was referred to financial navigation. At baseline, 33.3% reported at least one adherence barrier including inconvenience to get prescription filled, forgetfulness, cost, and side effects. There were no changes in self-reported adherence, symptom burden or quality of life over 3 months. CONnected CUstomized Treatment Platform usability score was 61.9 ± 14.2. CONCLUSION: The CONnected CUstomized Treatment Platform interventions is feasible, resulting in a high palbociclib adherence rate without any decline in overtime. Future efforts should focus on improving usability.

The effect of cancer exemption in mandatory-access prescription drug monitoring programs among oncologists.

To address the opioid epidemic, some states mandate that prescribers review a state-run prescription drug monitoring program (PDMP) database before prescribing opioids. We used Medicare Part D prescriber data from 2013 (baseline) to 2019 to examine the association between state mandatory-access PDMPs, with and without a cancer exemption, and changes in the percent of oncologists' patients with any opioid fill per year, stratified by oncologists' baseline prescribing volume. Among 9746 medical or hematologic oncologists, the proportion of patients prescribed opioids declined after states implemented mandatory-access PDMPs without a cancer exemption overall (-0.49 percentage point, 95% confidence interval = -0.78 to -0.20 percentage point) and among those with above-median baseline prescribing, but not in states with a cancer exemption (-0.16 percentage point, 95% confidence interval = -0.50 to 0.18 percentage point) or with below-median baseline prescribing. Carefully designed mandatory-access PDMPs with cancer exemptions minimize unnecessary reductions in prescription opioid treatments among oncology patients in need of pain management.

Primary care video and telephone telemedicine during the COVID-19 pandemic: treatment and follow-up health care utilization.

OBJECTIVES: Telemedicine use expanded greatly during the COVID-19 pandemic, and broad use of telemedicine is expected to persist beyond the pandemic. More evidence on the efficiency and safety of different telemedicine modalities is needed to inform clinical and policy decisions around telemedicine use. To evaluate the efficiency and safety of telemedicine, we compared treatment and follow-up care between video and telephone visits during the COVID-19 pandemic. STUDY DESIGN: Observational study of patient-scheduled telemedicine visits for primary care. METHODS: We used multivariate logistic regression to compare treatment (medication prescribing, laboratory/imaging orders) and 7-day follow-up care (in-person office visits, emergency department visits, and hospitalizations) between video and telephone visits, adjusted for patient characteristics. RESULTS: Among 734,442 telemedicine visits, 58.4% were telephone visits. Adjusted rates of medication prescribing and laboratory/imaging orders were higher in video visits than telephone visits, with differences of 3.5% (95% CI, 3.3%-3.8%) and 3.9% (95% CI, 3.6%-4.1%), respectively. Adjusted rates of 7-day follow-up in-person office visits, emergency department visits, and hospitalizations were lower after video than telephone visits, with differences of 0.7% (95% CI, 0.5%-0.9%), 0.3% (95% CI, 0.2%-0.3%), and 0.04% (95% CI, 0.02%-0.06%), respectively. CONCLUSIONS: Among telemedicine visits with primary care clinicians, return visits were not common and downstream emergency events were rare. Adjusted rates of treatment measures were higher and adjusted rates of follow-up care were lower for video visits than telephone visits. Although video visits were marginally more efficient than telephone visits, telephone visits may offer an accessible option to address patient primary care needs without raising safety concerns.

Implementing a COVID-19 Virtual Observation Unit in Emergency Medicine: Frontline Clinician and Staff Experiences.

The COVID-19 pandemic pushed hospitals to deliver care outside of their four walls. To successfully scale virtual care delivery, it is important to understand how its implementation affects frontline workers, including their teamwork and patient-provider interactions. We conducted in-depth interviews of 17 clinicians and staff involved with the COVID-19 Virtual Observation Unit (CVOU) in the emergency department (ED) of an academic hospital. The program leveraged remote patient monitoring and mobile integrated health care. In the CVOU (vs. the ED), participants observed increases in interactions among clinicians and staff, patient participation in care delivery, attention to nonmedical factors, and involvement of coordinators and paramedics in patient care. These changes were associated with unintended, positive consequences for staff, namely, feeling heard, experience of meaningfulness, and positive attitudes toward virtual care. This study advances research on reconfiguration of roles following implementation of new practices using digital tools, virtual work interactions, and at-home care delivery.

Mobile application to support oncology patients during treatment on patient outcomes: Evidence from a randomized controlled trial.

BACKGROUND: Cancer treatment requires substantial demands on patients and their caregivers. Mobile apps can provide support for self-management during oncology treatment, but few have been rigorously evaluated. METHODS: A 3-month randomized controlled trial was conducted at a large cancer center to evaluate the efficacy of an app (LivingWith®) that provides self-management support during cancer treatment on quality of life and health care utilization. Patients in chemotherapy treatment were randomized into the intervention (n = 113) and control group (n = 111). Intervention group participants agreed to use the app weekly for 3 months, and all participants completed a survey at enrollment and after 3 months to evaluate changes in quality of life and health care utilization. RESULTS: Retention rate was 75.4% with 169 participants completing the follow-up survey. The intervention group reported 0.74 fewer medical office visits (p = 0.043) and 0.24 fewer visits with a mental health professional (p = 0.061) during the 3 and month intervention compared with controls. There were no significant changes by study group in quality of life, or emergency room and urgent care visits. Among intervention participants, 75.3% reported using the app and on average, used it 11.7 times during the 3-month intervention. Reasons for not using the app among intervention participants included lack of time, lack of interest in apps, and usability challenges. CONCLUSIONS AND RELEVANCE: Apps are inexpensive and scalable tools that can provide additional support for individuals coping with complex cancer treatments. This trial provides evidence that a well-designed oncology support app used during chemotherapy resulted in fewer clinic visits. Still, nearly a quarter of participants randomized to the intervention arm reported never using the app due to personal preference and usability challenges, which points to future opportunities for calibrating target user population and improving user-centered design. CLINICALTRIALS: gov identifier: NCT04331678.

Vertical integration of oncologists and cancer outcomes and costs in metastatic castration-resistant prostate cancer.

BACKGROUND: The share of oncology practices owned by hospitals (ie, vertically integrated) nearly doubled from 2007 to 2017. We examined how integration between hospitals and oncologists affected care quality, outcomes, and spending among metastatic castration-resistant prostate cancer (mCRPC) patients. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare linked data and the Medicare Data on Provider Practice and Specialty, we identified Medicare beneficiaries who initiated systemic therapy for mCRPC between 2008 and 2017 (n = 9172). Primary outcomes included 1) bone-modifying agents (BMA) use, 2) time on systemic therapy, 3) survival, and 4) Medicare spending for the first 3 months following therapy initiation. We used a differences-in-differences approach to estimate the impact of vertical integration on outcomes, adjusting for patient and provider characteristics. RESULTS: The proportion of patients treated by integrated oncologists increased from 28% to 55% from 2008 to 2017. Vertical integration was associated with an 11.7 percentage point (95% confidence interval [CI] = 4.2 to 19.1) increased likelihood of BMA use. There were no satistically significant changes in time on systemic therapy, survival, or total per-patient Medicare spending. Further decomposition showed an increase in outpatient payment ($5190, 95% CI = $1451 to $8930) and decrease in professional service payment (-$4757, 95% CI = -$7644 to -$1870) but no statistically significant changes for other service types (eg, inpatient and prescription drugs). CONCLUSIONS: Vertical integration was associated with statistically significant increased BMA use but not with other cancer outcomes among mCRPC patients. For oncologists who switched service billing from physician offices to outpatient departments, there was no statistically significant change in overall Medicare spending in the first 3 months of therapy initiation. Future studies should extend the investigation to other cancer types and patient outcomes.

Race Differences in Patient-Reported Symptoms during Chemotherapy among Women with Early-Stage Hormone Receptor-Positive Breast Cancer.

BACKGROUND: Symptom burden differences may contribute to racial disparities in breast cancer survival. We compared symptom changes from before to during chemotherapy among women with breast cancer. METHODS: This observational study followed a cohort of Black and White women diagnosed with Stage I-III, hormone receptor-positive breast cancer from a large cancer center in 2007 to 2015, and reported symptoms before and during chemotherapy. We identified patients who experienced a one-standard deviation (SD) increase in symptom burden after starting chemotherapy using four validated composite scores (General Physical Symptoms, Treatment Side Effects, Acute Distress, and Despair). Kitagawa-Blinder-Oaxaca decomposition was used to quantify race differences in symptom changes explained by baseline characteristics (sociodemographic, baseline scores, cancer stage) and first-line chemotherapy regimens. RESULTS: Among 1,273 patients, Black women (n = 405, 31.8%) were more likely to report one-SD increase in General Physical Symptoms (55.6% vs. 48.2%, P = 0.015), Treatment Side Effects (74.0% vs. 63.4%, P < 0.001), and Acute Distress (27.4% vs. 20.0%, P = 0.010) than White women. Baseline characteristics and first-line chemotherapy regimens explained a large and significant proportion of the difference in Acute Distress changes (93.7%, P = 0.001), but not General Physical Symptoms (25.7%, P = 0.25) or Treatment Side Effects (16.4%, P = 0.28). CONCLUSIONS: Black women with early-stage breast cancer were more likely to experience significant increases in physical and psychological symptom burden during chemotherapy. Most of the difference in physical symptom changes remained unexplained by baseline characteristics, which suggests inadequate symptom management among Black women. IMPACT: Future studies should identify strategies to improve symptom management among Black women and reduce differences in symptom burden. See related commentary by Rosenzweig and Mazanec, p. 157.

An examination of health care utilization during the COVID-19 pandemic among women with early-stage hormone receptor-positive breast cancer.

BACKGROUND: Women undergoing treatment for breast cancer require frequent clinic visits for maintenance of therapy. With COVID-19 causing health care disruptions, it is important to learn about how this population's access to health care has changed. This study compares self-reported health care utilization and changes in factors related to health care access among women treated at a cancer center in the mid-South US before and during the pandemic. METHODS: Participants (N = 306) part of a longitudinal study to improve adjuvant endocrine therapy (AET) adherence completed pre-intervention baseline surveys about their health care utilization prior to AET initiation. Questions about the impact of COVID-19 were added after the pandemic started assessing financial loss and factors related to care. Participants were categorized into three time periods based on the survey completion date: (1) pre-COVID (December 2018 to March 2020), (2) early COVID (April 2020 - December 2020), and later COVID (January 2021 to June 2021). Negative binomial regression analyses used to compare health care utilization at different phases of the pandemic controlling for patient characteristics. RESULTS: Adjusted analyses indicated office visits declined from pre-COVID, with an adjusted average of 17.7 visits, to 12.1 visits during the early COVID period (p = 0.01) and 9.9 visits during the later COVID period (p < 0.01). Hospitalizations declined from an adjusted average 0.45 admissions during early COVID to 0.21 during later COVID, after vaccines became available (p = 0.05). Among COVID period participants, the proportion reporting changes/gaps in health insurance coverage increased from 9.5% participants during early-COVID to 14.8% in the later-COVID period (p = 0.05). The proportion reporting financial loss due to the pandemic was similar during both COVID periods (34.3% early- and 37.7% later-COVID, p = 0.72). The proportion of participants reporting delaying care or refilling prescriptions decreased from 15.2% in early-COVID to 4.9% in the later-COVID period (p = 0.04). CONCLUSION: COVID-19 caused disruptions to routine health care for women with breast cancer. Patients reported having fewer office visits at the start of the pandemic that continued to decrease even after vaccines were available. Fewer patients reported delaying in-person care as the pandemic progressed.

Changes in Opioid Prescriptions and Potential Misuse and Substance Use Disorders Among Childhood Cancer Survivors Following the 2016 Opioid Prescribing Guideline.

Importance: The Centers for Disease Control and Prevention (CDC) released an opioid-prescribing guideline in March 2016. Little is known about the guideline's potential effects on childhood cancer survivors, a population at high risk for pain. Objective: To examine changes in opioid prescriptions and potential misuse/substance use disorders (SUD) among childhood cancer survivors and peers without cancer following the guideline release. Design, Setting, and Participants: In this cohort study using the MarketScan Commercial Claims and Encounters Database, 8969 survivors who completed treatment for hematologic, central nervous system, bone, or gonadal cancers (aged ≤21 years at diagnosis) from 2009 to 2018 and 44 845 age-matched, sex-matched, and region-matched individuals without cancer were identified. With data aggregated based on the quarter-year of survivors' treatment completion, interrupted time series analyses were conducted in this cohort study to estimate the immediate (level) change and change in time trend (trend change) for each outcome after the guideline release, accounting for autocorrelation. Data were analyzed from September 2021 to April 2022. Exposures: Release of the CDC opioid-prescribing guideline. Main Outcomes and Measures: Outcomes included any opioid prescription and any indicator for potential misuse/SUD within 1 year following completion of treatment. Results: This study included 8969 childhood cancer survivors (mean [SD] age, 13.7 [6.2] years old; 3814 [42.5%] female patients) and 44 845 peers without cancer (mean [SD] age, 13.7 [6.2] years old; 19 070 [42.5%] female patients). Before the guideline release, the opioid prescription rate (21.1% vs 7.2%) and rate of potential misuse/SUD (5.6% vs 1.9%) were higher among survivors than peers without cancer. After the guideline release, the trend in opioid prescription rate declined among survivors (trend change, -1.1 percentage points [ppt]; P < .001; 95% CI, -1.5 to -0.7). Survivors also experienced an immediate level decrease (-2.1 ppt; P = .04; 95% CI, -4.2 to -0.1) and a decreasing trend (trend change, -0.4 ppt; P = .009; 95% CI, -0.6 to -0.1) in rate of potential misuse/SUD. Peers without cancer experienced decreasing trends in opioid prescription rate (trend change, -0.3 ppt; P < .001; 95% CI, -0.5 to -0.1) and rate of potential misuse/SUD (trend change, -0.1 ppt; P = .03; 95% CI, -0.1 to -0.01). By 2 years after the guideline release, relative reductions in opioid prescription rate and rate of potential misuse/SUD among survivors were 36.7% and 65.4%, respectively, with peers without cancer experiencing smaller reductions (15.9% and 29.9%). Conclusions and Relevance: In this cohort study, the opioid prescription rate and rate of potential misuse/SUD declined among both survivors and peers without cancer following the CDC guideline release, with survivors experiencing greater reductions. More research is needed to understand the guideline's potential effects on access to opioids required for pain control among childhood cancer survivors.