Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study.

BACKGROUND: Most smokers are ambivalent about quitting-they want to quit someday, but not now. Interventions are needed that can engage ambivalent smokers, build their motivation for quitting, and support future quit attempts. Mobile health (mHealth) apps offer a cost-effective platform for such interventions, but research is needed to inform their optimal design and assess their acceptability, feasibility, and potential effectiveness. OBJECTIVE: This study aims to assess the feasibility, acceptability, and potential impact of a novel mHealth app for smokers who want to quit smoking someday but are ambivalent about quitting in the near term. METHODS: We enrolled adults across the United States who smoked more than 10 cigarettes a day and were ambivalent about quitting (n=60). Participants were randomly assigned to 1 of 2 versions of the GEMS app: standard care (SC) versus enhanced care (EC). Both had a similar design and identical evidence-based, best-practice smoking cessation advice and resources, including the ability to earn free nicotine patches. EC also included a series of exercises called experiments designed to help ambivalent smokers clarify their goals, strengthen their motivation, and learn important behavioral skills for changing smoking behavior without making a commitment to quit. Outcomes were analyzed using automated app data and self-reported surveys at 1 and 3 months post enrollment. RESULTS: Participants who installed the app (57/60, 95%) were largely female, White, socioeconomically disadvantaged, and highly nicotine dependent. As expected, key outcomes trended in favor of the EC group. Compared to SC users, EC participants had greater engagement (mean sessions 19.9 for EC vs 7.3 for SC). An intentional quit attempt was reported by 39.3% (11/28) of EC users and 37.9% (11/29) of SC users. Seven-day point prevalence smoking abstinence at the 3-month follow-up was reported by 14.7% (4/28) of EC users and 6.9% (2/29) of SC users. Among participants who earned a free trial of nicotine replacement therapy based on their app usage, 36.4% (8/22) of EC participants and 11.1% (2/18) of SC participants requested the treatment. A total of 17.9% (5/28) of EC and 3.4% (1/29) of SC participants used an in-app feature to access a free tobacco quitline. Other metrics were also promising. EC participants completed an average of 6.9 (SD 3.1) out of 9 experiments. Median helpfulness ratings for completed experiments ranged from 3 to 4 on a 5-point scale. Finally, satisfaction with both app versions was very good (mean 4.1 on a 5-point Likert scale) and 95.3% (41/43) of all respondents would recommend their app version to others. CONCLUSIONS: Ambivalent smokers were receptive to the app-based intervention, but the EC version, which combined best-practice cessation advice with self-paced, experiential exercises, was associated with greater use and evidence of behavior change. Further development and evaluation of the EC program is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04560868; https://clinicaltrials.gov/ct2/show/NCT04560868.

Parent Priorities in End-of-Life Care for Children With Cancer.

Importance: Robust quality measures to benchmark end-of-life care for children with cancer do not currently exist; 28 candidate patient-centered quality measures were previously developed. Objective: To prioritize quality measures among parents who lost a child to cancer. Design, Setting, and Participants: This survey study was conducted using an electronic, cross-sectional discrete choice experiment (DCE) with maximum difference scaling from January to June 2021 in the US. In each of 21 questions in the DCE, participants were presented with a set of 4 quality measures and were asked to select the most and least important measures within each set. All 28 quality measures were presented an equal number of times in different permutations. In the volunteer sample, 69 eligible bereaved parents enrolled in the study; 61 parents completed the DCE (participation rate, 88.4%). Main Outcomes and Measures: Using choices participants made, a hierarchical bayesian multinomial logistic regression was fit to derive mean importance scores with 95% credible intervals (95% Crs) for each quality measure, representing the overall probability of a quality measure being selected as most important. Importance scores were rescaled proportionally from 0 to 100, with the sum of scores for all quality measures adding up to 100. This enabled interpretation of scores as the relative importance of quality measures. Results: Participants included 61 bereaved parents (median [range] age, 48 [24-74] years; 55 individuals self-identified as women [90.2%]; 1 American Indian or Alaska Native [1.6%], 1 Asian [1.6%], 2 Black or African American [3.3%], 1 Native Hawaiian or Pacific Islander, and 58 White [91.8%]; 58 not Hispanic or Latinx [95.1%]). Highest-priority quality measures by mean importance score included having a child's symptoms treated well (9.25 [95% Cr, 9.06-9.45]), feeling that a child's needs were heard by the health care team (8.39 [95% Cr, 8.05-8.73]), and having a goal-concordant end-of-life experience (7.45 [95% Cr, 6.84-8.05]). Lowest-priority quality measures included avoiding chemotherapy (0.33 [95% Cr, 0.21-0.45]), provision of psychosocial support for parents (1.01 [95% Cr, 0.57-1.45]), and avoiding the intensive care unit (1.09 [95% Cr, 0.74-1.43]). Rank-ordering measures by mean importance revealed that symptom management was 9 times more important to parents than psychosocial support for themselves. Conclusions and Relevance: This study found that bereaved parents prioritized end-of-life quality measures focused on symptom management and goal-concordant care while characterizing quality measures assessing their own psychosocial support and their child's hospital resource use as substantially less important. These findings suggest that future research should explore innovative strategies to measure care attributes that matter most to families of children with advanced cancer.

Perceived Appropriateness of Assessing for Health-related Socioeconomic Risks Among Adult Patients with Cancer.

Cancer treatment can trigger or exacerbate health-related socioeconomic risks (HRSR; food/housing insecurity, transportation/utilities difficulties, and interpersonal violence). The American Cancer Society and National Cancer Institute recommend HRSR screening and referral, but little research has examined the perceptions of patients with cancer on the appropriateness of HRSR screening in healthcare settings. We examined whether HRSR status, desire for assistance with HRSRs, and sociodemographic and health care-related factors were associated with perceived appropriateness of HRSR screening in health care settings and comfort with HRSR documentation in electronic health records (EHR). A convenience sample of adult patients with cancer at two outpatient clinics completed self-administered surveys. We used χ 2 and Fisher exact tests to test for significant associations. The sample included 154 patients (72% female, 90% ages 45 years or older). Thirty-six percent reported ≥1 HRSRs and 27% desired assistance with HRSRs. Overall, 80% thought it was appropriate to assess for HRSRs in health care settings. The distributions of HRSR status and sociodemographic characteristics were similar among people who perceived screening to be appropriate and those who did not. Participants who perceived screening as appropriate were three times as likely to report prior experience with HRSR screening (31% vs. 10%, P = 0.01). Moreover, 60% felt comfortable having HRSRs documented in the EHR. Comfort with EHR documentation of HRSRs was significantly higher among patients desiring assistance with HRSRs (78%) compared with those who did not (53%, P < 0.01). While initiatives for HRSR screening are likely to be seen by patients with cancer as appropriate, concerns may remain over electronic documentation of HRSRs. Significance: National organizations recommend addressing HRSRs such as food/housing insecurity, transportation/utilities difficulties, and interpersonal violence among patients with cancer. In our study, most patients with cancer perceived screening for HRSRs in clinical settings as appropriate. Meanwhile, concerns may remain over the documentation of HRSRs in EHRs.

Incarceration status and cancer mortality: A population-based study.

BACKGROUND: The complex relationship between incarceration and cancer survival has not been thoroughly evaluated. We assessed whether cancer diagnosis during incarceration or the immediate post-release period is associated with higher rates of mortality compared with those never incarcerated. METHODS: We conducted a population-based study using a statewide linkage of tumor registry and correctional system movement data for Connecticut adult residents diagnosed with invasive cancer from 2005 through 2016. The independent variable was place of cancer diagnosis: during incarceration, within 12 months post-release, and never incarcerated. The dependent variables were five-year cancer-related and overall survival rates. RESULTS: Of the 216,540 adults diagnosed with invasive cancer during the study period, 239 (0.11%) people were diagnosed during incarceration, 479 (0.22%) within 12 months following release, and the remaining were never incarcerated. After accounting for demographics and cancer characteristics, including stage of diagnosis, the risk for cancer-related death at five years was significantly higher among those diagnosed while incarcerated (AHR = 1.39, 95% CI = 1.12-1.73) and those recently released (AHR = 1.82, 95% CI = 1.57-2.10) compared to the never-incarcerated group. The risk for all-cause mortality was also higher for those diagnosed with cancer while incarcerated (AHR = 1.92, 95% CI = 1.63-2.26) and those recently released (AHR = 2.18, 95% CI = 1.94-2.45). CONCLUSIONS AND RELEVANCE: There is a higher risk of cancer mortality among individuals diagnosed with cancer during incarceration and in the first-year post-release, which is not fully explained by stage of diagnosis. Cancer prevention and treatment efforts should target people who experience incarceration and identify why incarceration is associated with worse outcomes.

End-of-life care quality for children with cancer who receive palliative care.

BACKGROUND: We previously developed stakeholder-informed quality measures to assess end-of-life care quality for children with cancer. We sought to implement a subset of these quality measures in the multi-center pediatric palliative care (PPC) database. PROCEDURES: We utilized the Shared Data and Research database to evaluate the proportion of childhood cancer decedents from 2017-2021 who, in the last 30 days of life, avoided chemotherapy, mechanical ventilation, intensive care unit admissions, and > 1 hospital admission; were enrolled in hospice services, and reported ≤ 2 highly distressing symptoms. We then explored patient factors associated with the attainment of quality benchmarks. RESULTS: Across 79 decedents, 82% met ≥ 4 quality benchmarks. Most (76%) reported > 2 highly distressing symptoms; 17% were enrolled in hospice. In univariable analyses, patients with an annual household income ≤$50,000 had lower odds of hospice enrollment and avoidance of mechanical ventilation or intensive care unit admissions near end of life (odds ratio [OR] 0.10 [95% confidence interval (C.I.) 0.01, 0.86], p = 0.04; OR 0.13 [0.02, 0.64], p = 0.01; OR 0.36 [0.13, 0.98], p = 0.04, respectively). In multivariable analyses, patients with an income ≤$50,000 remained less likely to enroll in hospice, after adjusting for cancer type (OR 0.10 [0.01, 0.87]; p = 0.04). CONCLUSIONS: Childhood cancer decedents who received PPC met a large proportion of quality measures near the end of their life. Yet, many reported highly distressing symptoms. Moreover, patients with lower household incomes appeared less likely to enroll in hospice and more likely to receive intensive hospital services near the end of life. This study identifies opportunities for palliative oncology quality improvement.

Impact of a Dedicated Cancer Urgent Care Center on Acute Care Utilization.

PURPOSE: Acute care imposes a significant burden on patients and cancer care costs. We examined whether an advanced practice provider-driven, cancer-specific urgent care center embedded within a large tertiary academic center decreased acute care use among oncology patients on active therapy. MATERIALS AND METHODS: We conducted a quasi-experimental study anchored around the Oncology Extended Care Clinic (OECC) opening date. We evaluated two parallel 4-month periods: a post-OECC period that followed a 5-month run-in phase, and the identical calendar period 1 year earlier. Our primary outcomes included all emergency department (ED) presentations and hospital admissions during the 3-month window following the index provider visit. We used Poisson models to calculate absolute pre-OECC v post-OECC rate differences. RESULTS: Our cohort included 2,095 patients in the pre-OECC period and 2,188 in the post-OECC period. We identified 32.6 ED visits/100 patients and 41.2 hospitalizations/100 patients in the pre-OECC period, versus 28.2 ED visits/100 patients and 26.1 hospitalizations/100 patients post-OECC. After adjusting for age, sex, race and ethnicity, and practice location, we observed a significant decrease of 4.6 ED visits/100 patients during the post-OECC period (95% CI, -8.92/100 to -0.28/100; P = .04) compared with the pre-OECC period. There was no significant association between the OECC opening and hospitalization rate (rate difference: -3.29 admissions/100 patients; 95% CI, -8.24/100 to 1.67/100; P = .19). CONCLUSION: Establishing a cancer-specific urgent care center was significantly associated with a modest decrease in emergency room utilization but not with hospitalization rate. Barriers included clinic capacity, patient awareness, and physician comfort with advanced practice provider autonomy. Optimizing workflow and standardizing clinical pathways can create benchmarks useful for value-based payments.

Refining Patient-Centered Measures of End-of-Life Care Quality for Children With Cancer.

PURPOSE: There are no existing quality measures (QMs) to optimize end-of-life care for children with cancer. Previously, we developed a set of 26 candidate QMs. Our primary objective in this study was to achieve stakeholder consensus on priority measures. METHODS: We conducted an iterative, cross-sectional electronic survey, using a modified Delphi method to build consensus among clinician and family stakeholders. In each of the two rounds of surveys, stakeholders were asked to rate QMs on a 9-point Likert scale, on the basis of perceived importance. Health care professionals were additionally asked to rate measures on perceived feasibility. After each round, we computed median scores on importance and feasibility of measurement, retaining QMs with median importance scores ≥ 8. RESULTS: Twenty-five participants completed both rounds of the survey. In round 1, participants were asked to rate 26 QMs; nine QMs, including QMs pertaining to health care use, were removed because of median importance scores < 8. Two new measures were proposed for consideration in round 2, on the basis of participant feedback. Following round 2, 17 QMs were ultimately retained. QMs related to symptom screening and palliative care consultation were rated highly in importance and feasibility. QMs related to communication were rated highly important, yet less feasible. Measuring whether a patient's needs were heard by their health care team was rated among the least feasible. CONCLUSION: Childhood cancer stakeholders prioritized QMs pertaining to patient-reported outcomes, deeming measures of health care resource use less important. Future research should seek to develop novel tools for quality assessment to enhance feasibility of implementing priority measures.

Sociodemographic and hospital-based predictors of intense end-of-life care among children, adolescents, and young adults with hematologic malignancies.

BACKGROUND: Children, adolescents, and young adults with hematologic malignancies tend to receive high-intensity end-of-life care (HI-EOLC), but sociodemographic and hospital-based predictors of HI-EOLC remain unclear. METHODS: The authors conducted a population-based, retrospective cohort study with the Premier Healthcare Database. They identified individuals with hematologic malignancies who were 0 to 39 years old at death and died between 2010 and 2017. HI-EOLC was defined as experiencing 2 or more of the following: cardiopulmonary resuscitation, intravenous chemotherapy, hemodialysis, mechanical ventilation, tracheostomy placement, or an emergency department visit within the last 30 days of life and death in the intensive care unit. Multivariable logistic regression models were constructed to identify patient sociodemographic and hospital characteristics associated with HI-EOLC. RESULTS: Among 1454 decedents, more than half (55%) experienced HI-EOLC. In multivariable models, patients treated in medium (adjusted odds ratio [aOR], 1.63; 95% confidence interval [CI], 1.07-2.50) or large hospitals (aOR, 2.21; 95% CI, 1.45-3.39), insured by Medicaid (aOR, 1.40 ; 95% CI, 1.09-2.06), or receiving cancer-directed treatment in the Northeast (aOR, 1.50; 95% CI, 1.05-2.15) were more likely to receive HI-EOLC. CONCLUSIONS: A majority of children, adolescents, and young adults with hematologic malignancies experienced HI-EOLC, and the likelihood of HI-EOLC was influenced by the hospital size, type of insurance, and geographic region. Further research is needed to determine how to mitigate these risks.

Incarceration and Cancer-Related Outcomes (ICRO) study protocol: using a mixed-methods approach to investigate the role of incarceration on cancer incidence, mortality and quality of care.

INTRODUCTION: Incarceration is associated with decreased cancer screening rates and a higher risk for hospitalisation and death from cancer after release from prison. However, there is a paucity of data on the relationship between incarceration and cancer outcomes and quality of care. In the Incarceration and Cancer-Related Outcomes Study, we aim to develop a nuanced understanding of how incarceration affects cancer incidence, mortality and treatment, and moderates the relationship between socioeconomic status, structural racism and cancer disparities. METHODS AND ANALYSIS: We will use a sequential explanatory mixed-methods study design. We will create the first comprehensive linkage of data from the Connecticut Department of Correction and the statewide Connecticut Tumour Registry. Using the linked dataset, we will examine differences in cancer incidence and stage at diagnosis between individuals currently incarcerated, formerly incarcerated and never incarcerated in Connecticut from 2005 to 2016. Among individuals with invasive cancer, we will assess relationships among incarceration, quality of cancer care and mortality, and will assess the degree to which incarceration status moderates relationships among race, socioeconomic status, quality of cancer care and cancer mortality. We will use multivariable logistic regression and Cox survival models with interaction terms as appropriate. These results will inform our conduct of in-depth interviews with individuals diagnosed with cancer during or shortly after incarceration regarding their experiences with cancer care in the correctional system and the immediate postrelease period. The results of this qualitative work will help contextualise the results of the data linkage. ETHICS AND DISSEMINATION: The Yale University Institutional Review Board (#2000022899) and the Connecticut Department of Public Health Human Investigations Committee approved this study. We will disseminate study findings through peer-reviewed publications and academic and community presentations. Access to the deidentified quantitative and qualitative datasets will be made available on review of the request.

A Stakeholder-Driven Qualitative Study to Define High Quality End-of-Life Care for Children With Cancer.

CONTEXT: Among adults with cancer, measures for high quality end-of-life care (EOLC) include avoidance of hospitalizations near end of life. For children with cancer, no measures exist to evaluate or improve EOLC, and adult quality measures may not apply. OBJECTIVE: We engaged key stakeholders to explore EOLC priorities for children with cancer and their families, and to examine relevance of existing adult EOLC quality measures for children with cancer. METHODS: In a multicenter qualitative study, we conducted interviews and focus groups with: adolescents and young adults (AYAs) with advanced cancer, parents of children with advanced cancer, bereaved parents, and interdisciplinary healthcare professionals. We transcribed, coded, and employed thematic analysis to summarize findings. RESULTS: We enrolled 54 stakeholders (25 parents [including 12 bereaved parents], 10 AYAs, and 19 healthcare professionals). Participants uniformly prioritized direct communication with children about preferences and prognosis, interdisciplinary care, symptom management, and honoring family preference for location of death. Many participants valued access to the emergency department or hospital for symptom management or supportive care, which diverges from measures for high quality EOLC in adults. Most wished to avoid mechanical ventilation and cardiopulmonary resuscitation. Notably, participants generally valued hospice; however, few understood hospice care or had utilized its services. CONCLUSION: Childhood cancer stakeholders define high quality EOLC primarily through person-centered measures, characterizing half of existing adult-focused measures as limited in relevance to children. Future research should focus on developing techniques for person-centered quality measurement to capture attributes of greatest importance to children with cancer and their families.

Patterns of treatment with everolimus exemestane in hormone receptor-positive HER2-negative metastatic breast cancer in the era of targeted therapy.

BACKGROUND: There is currently no clinical trial data regarding the efficacy of everolimus exemestane (EE) following prior treatment with CDK4/6 inhibitors (CDK4/6i). This study assesses the use and efficacy of everolimus exemestane in patients with metastatic HR+ HER2- breast cancer previously treated with endocrine therapy (ET) or endocrine therapy + CDK4/6i. METHODS: Retrospective analysis of electronic health record-derived data for HR+ HER2- metastatic breast cancer from 2012 to 2018. The proportion of patients receiving EE first-line, second-line, or third-line, and the median duration of EE prior to next line of treatment (TTNT) by line of therapy was calculated. OS for patients receiving EE first-line, second-line, or third-line, indexed to the date of first-line therapy initiation and stratified by prior treatment received, was calculated with Kaplan-Meier method with multivariable Cox proportional hazards regression analysis. RESULTS: Six hundred twenty-two patients received EE first-line (n = 104, 16.7%), second-line (n = 273, 43.9%) or third-line (n = 245, 39.4%). Median TTNT was 8.3 months, 5.5 months, and 4.8 months respectively. Median TTNT of EE second-line was longer following prior ET alone compared to prior ET + CDK4/6i (6.2 months (95% CI 5.2, 7.3) vs 4.3 months (95% CI 3.2, 5.7) respectively, p = 0.03). Similarly, EE third-line following ET alone vs ET + CDK4/6i in first- or second-line resulted in median TTNT 5.6 months (95% CI 4.4, 6.9) vs 4.1 months (95% CI 3.6, 6.1) respectively, although this was not statistically significant (p = 0.08). Median OS was longer for patients who received EE following prior ET + CDK4/6i. EE second-line following ET + CDK 4/6i vs ET alone resulted in median OS 37.7 months vs. 32.7 months (p = 0.449). EE third-line following ET + CDK4/6i vs prior ET alone resulted in median OS 59.2 months vs. 40.8 months (p < 0.010). This difference in OS was not statistically significant when indexed to the start of EE therapy. CONCLUSION: This study suggests that EE remains an effective treatment option after prior ET or ET + CDK4/6i use. Median TTNT of EE was longer for patients who received prior ET, whereas median OS was longer for patients who received prior ET + CDK4/6i. However, this improvement in OS was not statistically significant when indexed to the start of EE therapy suggesting that OS benefit is primarily driven by prior CDK4/6i use. EE remains an effective treatment option regardless of prior treatment option.