"Clinical trials are space travel": Factors of psychological response to recurrence among oncologists enrolling patients in treatment optimization trials.

BACKGROUND: Cancer recurrence after treatment is a concern for patients and oncologists alike. The movement towards treatment optimization, with trials testing less than the current standard of care (SoC), complicates this experience. Our objective was to assess oncologists' psychological response to patient recurrence on optimization-focused trials and identify factors that influence those experiences. METHODS: Clinical oncologists participated in a semi-structured interview regarding patient enrollment in treatment optimization trials. We identified factors that influence the degree of psychological response that the oncologist may feel after patient recurrence. Residual agreement analysis was used to identify whether differences in reported psychological response was associated with alternative emphases on identified factors. RESULTS: Thirty-six oncologists identified 20 factors spanning five major themes that affected their psychological response to patient recurrence. All oncologists expressed willingness to enroll patients in treatment optimization clinical trials; however, half indicated that they were more likely to experience a negative psychological response after a treatment optimization trial than after a traditional intensification trial, and a quarter reported that patient recurrence on an optimization trial would impact their recommendations for future trial enrollment. Oncologists who reported more negative psychological responses to patient recurrence after participation in an optimization trial were more likely to emphasize introspective factors, while those who reported no difference in response emphasized patient- and process-focused factors. CONCLUSIONS: Although most oncologists recognize the importance of treatment optimization trials, a significant proportion indicated a greater potential for psychological distress following patient recurrence in such trials and offered insight into how trial design and the process of patient enrollment can be improved to minimize those negative psychological responses.

Correction: Andrews et al. Age at Arrival and Depression among Mexican Immigrant Women in Alabama: The Moderating Role of Culture. Int. J. Environ. Res. Public Health 2022, 19, 5342.

Several errors were introduced after proofreading, and the authors hence wish to make the following corrections to this paper [...].

Oncologist-Reported Barriers and Facilitators to Enrolling Patients in Optimization Trials That Test Less Intense Cancer Treatment.

PURPOSE: As outcomes improve in early-stage breast cancer, clinical trials are undergoing a paradigm shift from intensification trials (more therapy) to improve survival to optimization trials, which assess the potential for using less toxic therapy while preserving survival outcomes. However, little is known about physician perspectives in community and academic settings about possible barriers and facilitators that could affect accrual to optimization clinical trials and the generalizability of future findings. METHODS: We conducted a qualitative study with semistructured interviews of medical oncologists from different academic and community practices to assess their perspectives on optimization trials. Interviews were audio-recorded and transcribed. Three independent coders used a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. RESULTS: All 39 physicians reported that they would enroll patients in optimization clinical trials. Oncologists highlighted specific reasons to consider optimization trials. These included quality-of-life improvement by reducing toxicity, reduction in financial toxicity, fertility preservation, ability to avoid chemotherapy, minimization of overtreatment in patients with comorbid conditions, personalized treatment, opportunities to test novel therapies, and leveraging the availability of targeted therapies. Oncologists also identified accrual barriers, such as tumor-specific biology, individual (host) factors, prognostic markers of risk, access to therapies, provider experience, and system constraints. They voiced recommendations regarding preliminary data, trial design, and tools to support enrollment in optimization trials. CONCLUSION: Although oncologists are generally willing to enroll patients on optimization clinical trials, barriers affect their acceptance. A scientific focus on overcoming these barriers is needed to support future enrollment on trials tailoring therapy on the basis of risk and potential benefit to allow true personalization of treatment.

Vaccine Hesitancy versus Vaccine Behavior in Patients with Chronic Illness.

While vaccine hesitancy has been described for the general population, vaccine hesitancy among the chronically ill has not been well explored. This study assesses COVID­19 vaccine hesitancy and uptake among individuals with chronic illness using nationwide survey data. We analyzed vaccine hesitancy prior to and after approval of the vaccines using multinomial logistic regression and binomial logistic regression, respectively. In the first survey, 39% reported they were unlikely or unsure about receiving the vaccine. In adjusted analyses, female sex, Black race, anti­vaccination attitudes, media mistrust, and not following the media were associated with vaccine hesitancy. Despite this hesitance, in the follow­up survey, 89% reported vaccine receipt, with those more fearful of COVID­19, with more trust in the media, and closely following the development of the vaccine were most likely to move from hesitance to acceptance. Vaccine hesitancy is a mutable characteristic, underscoring the need for high-quality public health messaging.

Physician Perspectives on Reducing Curative Cancer Treatment Intensity for Populations Underrepresented in Clinical Trials.

BACKGROUND: Historically, clinical trials involved adding novel agents to standard of care to improve survival. There has been a shift to an individualized approach with testing less intense treatment, particularly in breast cancer where risk of recurrence is low. Little is known about physician perspectives on delivering less intense treatment for patients who are not well represented in clinical trials. METHODS: Open-ended, individual qualitative interviews with medical oncologists explored their perspectives on trials that test less intense treatment for patients with cancer, with a focus on breast cancer. Interviews were audio-recorded and transcribed. Four independent coders utilized a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. RESULTS: Of the 39 participating physicians, 61.5% felt comfortable extrapolating, 30.8% were hesitant, and 7.7% would not feel comfortable extrapolating trial outcomes to underrepresented populations. Facilitators of comfort included the sentiment that "biology is biology" (such that the cancer characteristics were what mattered), the strength of the evidence, inclusion of subset analysis on underrepresented populations, and prior experience making decisions with limited data. Barriers to extrapolation included potential harm over the patient's lifetime, concerns about groups that had minimal participants, application to younger patients, and extending findings to diverse populations. Universally, broader inclusion in trials testing lowering chemotherapy was desired. CONCLUSIONS: The majority (92%) of physicians reported that they would de-implement treatment for patients poorly represented in clinical trials testing less treatment, while expressing concerns about applicability to specific subpopulations. Further work is needed to increase clinical trial representation of diverse populations to safely and effectively optimize treatment for patients with cancer. TRIAL REGISTRATION: NCT03248258.

Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings.

PURPOSE: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. METHODS: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman's Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (phase I) and workflow (phase II and III) using electronic health data; qualitative evaluation with semistructured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. RESULTS: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. CONCLUSION: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

Time in the United States and diabetes among Mexican immigrant women: The moderating role of culture.

Mexican immigrants in the U.S. show high incidence of type 2 diabetes, and increased risk is associated with longer duration of residency. This study considers the impact of culture over time for Mexican immigrant women in a southern U.S. city. Using cultural consensus analysis to empirically derive the substance and structure of a cultural model for la buena vida (the good life) among Mexican immigrant women in Birmingham, Alabama, we assess the extent to which respondents are aligned with the model in their everyday lives. This measure of 'cultural consonance' is explored as a moderating variable between length of time living in the U.S. and level of Hemoglobin A1c. Results demonstrate that for those with more time in the U.S., those with lower consonance are more likely to have diabetes, while those who are more aligned with la buena vida are at lower risk.

Age at Arrival and Depression among Mexican Immigrant Women in Alabama: The Moderating Role of Culture.

Mexican-born women in the U.S. are at high risk of depression. While acculturation is the primary analytical framework used to study immigrant mental health, this research suffers from (1) a lack of specificity regarding how cultural models of living and being take shape among migrants converging in new destinations in the U.S., and (2) methods to empirically capture the impact of cultural positioning on individual health outcomes. Instead of relying on proxy measures of age at arrival and time in the U.S. to indicate where an individual is located on the acculturation spectrum, this study uses cultural consensus analysis to derive the substance and structure of a cultural model for la buena vida (the good life) among Mexican immigrant women in Birmingham, Alabama, and then assesses the extent to which respondents are aligned with the model in their everyday lives. This measure of 'cultural consonance' is explored as a moderating variable between age at arrival in the U.S. and number of depressive symptoms. Results demonstrate that for those who arrived at an older age, those with lower consonance are at the highest risk for depression, while those who are more aligned with la buena vida are at lower risk.

"It's Not Good to Be Sick and Have the Child": Perspectives on Pregnancy After HIV-Positive Diagnosis Among Women in Western Jamaica.

Purpose: To identify factors associated with reproductive decision-making for women living with HIV in Western Jamaica, to assess their confidence in anti-retroviral therapy to reduce the chances of mother to child transmission of HIV, and to better understand the experience of stigmatization surrounding becoming pregnant after HIV diagnosis. Participants and Methods: Two focus groups were conducted among women living with HIV in the four parishes of Western Jamaica in 2011. A trained moderator conducted the focus groups along with two student notetakers. Qualitative coding and content analysis were used to identify common themes and exemplary quotations characterizing those themes. Results: Participants agree that adherence to antiretroviral therapy as prescribed by a physician facilitates better health and longevity; however, they were conflicted on the efficacy of the therapy to prevent mother to child transmission of the virus. Participants report that becoming pregnant after HIV diagnosis continues to be highly stigmatized. Among participants, fear of MTCT and concern that their children will be mistreated are the primary drivers of reproductive decision-making. Conclusion: Despite advances in HIV treatment and assisted technologies to prevent MTCT, participants show skepticism that ARV medication is effective at preventing MTCT. Stigma and discriminatory behavior by community members and health-care professionals continue to shape reproductive decision-making for the women who participated in this study. More informed counseling that includes education on recent advancements in HIV treatment and its efficacy at preventing MTCT should be more widely available to pregnant women. To reduce stigma and discriminatory behavior, this education should extend to the larger community.

Facilitators and barriers to reducing chemotherapy for early-stage breast cancer: a qualitative analysis of interviews with patients and patient advocates.

BACKGROUND: As the combination of systemic and targeted chemotherapies is associated with severe adverse side effects and long-term health complications, there is interest in reducing treatment intensity for patients with early-stage breast cancer (EBC). Clinical trials are needed to determine the feasibility of reducing treatment intensity while maintaining 3-year recurrence-free survival of greater than 92%. To recruit participants for these trials, it is important to understand patient perspectives on reducing chemotherapy. METHODS: We collected qualitative interview data from twenty-four patients with Stage II-III breast cancer and sixteen patient advocates. Interviews explored potential barriers and facilitators to participation in trials testing reduced amounts of chemotherapy. As the COVID-19 pandemic struck during data collection, seventeen participants were asked about the potential impact of COVID-19 on their interest in these trials. Interviews were audio-recorded and transcribed, and researchers used qualitative content analysis to code for dominant themes. RESULTS: Seventeen participants (42.5%) expressed interest in participating in a trial of reduced chemotherapy. Barriers to reducing chemotherapy included (1) fear of recurrence and inefficacy, (2) preference for aggressive treatment, (3) disinterest in clinical trials, (4) lack of information about expected outcomes, (5) fear of regret, and (6) having young children. Facilitators included (1) avoiding physical toxicity, (2) understanding the scientific rationale of reducing chemotherapy, (3) confidence in providers, (4) consistent monitoring and the option to increase dosage, (5) fewer financial and logistical challenges, and (6) contributing to scientific knowledge. Of those asked, nearly all participants said they would be more motivated to reduce treatment intensity in the context of COVID-19, primarily to avoid exposure to the virus while receiving treatment. CONCLUSIONS: Among individuals with EBC, there is significant interest in alleviating treatment-related toxicity by reducing chemotherapeutic intensity. Patients will be more apt to participate in trials testing reduced amounts of chemotherapy if these are framed in terms of customizing treatment to the individual patient and added benefit-reduced toxicities, higher quality of life during treatment and lower risk of long-term complications-rather than in terms of taking treatments away or doing less than the standard of care. Doctor-patient rapport and provider support will be crucial in this process.

Patient perspectives on chemotherapy de-escalation in breast cancer.

BACKGROUND: Given excellent survival outcomes in breast cancer, there is interest in de-escalating the amount of chemotherapy delivered to patients. This approach may be of even greater importance in the setting of the COVID-19 pandemic. METHODS: This concurrent mixed methods study included (1) interviews with patients and patient advocates and (2) a cross-sectional survey of women with breast cancer served by a charitable nonprofit organization. Questions evaluated interest in de-escalation trial participation, perceived barriers/facilitators to participation, and language describing de-escalation. RESULTS: Sixteen patient advocates and 24 patients were interviewed. Key barriers to de-escalation included fear of recurrence, worry about decision regret, lack of clinical trial interest, and dislike for focus on less treatment. Facilitators included trust in physician recommendation, toxicity avoidance, monitoring for progression, perception of good prognosis, and impact on daily life. Participants reported that the COVID-19 pandemic made them more likely to avoid chemotherapy if possible. Of 91 survey respondents, many (43%) patients would have been unwilling to participation in a de-escalation clinical trial. The most commonly reported barrier to participation was fear of recurrence (85%). Few patients (19%) considered clinical trials themselves as a barrier to de-escalation trial participation. The most popular terminology describing chemotherapy de-escalation was "lowest effective chemotherapy dose" (53%); no patients preferred the term "de-escalation." CONCLUSIONS: Fear of recurrence is a common concern among breast cancer survivors and patient advocates, contributing to resistance to de-escalation clinical trial participation. Additional research is needed to understand how to engage patients in de-escalation trials.

Intimate Partner Violence, Human Rights Violations, and HIV among Women in Nairobi, Kenya.

This study presents qualitative results from a mixed-method investigation conducted between May and August 2012 into the prevalence and consequences of four forms of intimate partner violence among women living with HIV who attended the Comprehensive Care Clinic at the Kenyatta National Hospital in Nairobi. As a part of the research, a quantitative survey found that among 600 sexually active women living with HIV aged 18-69, all reported experiencing emotional abuse; 20%, 17%, and 15% experienced controlling behavior, physical violence, and sexual violence, respectively. Qualitative research using focus group discussions with 19 women from the quantitative survey sought to contextualize these experiences and place them within a larger social structure where institutionalized gender inequality sets the tone for intimate partner violence against women in households. Participants reported that intimate partner violence led to their exposure to the virus and made them leery of disclosing their positive status or seeking support from a male partner for fear of a violent reaction. This fear and the socio-structural conditions in Kenya limit their ability to actively pursue comprehensive care, the stress of which can exacerbate symptoms and make managing the disease more difficult.

Wives who outearn their husbands: a transitory or persistent phenomenon for couples?

In what percentage of married couples do wives outearn their husbands, and, moreover, how persistent are these patterns? This study systematically examined variation in point-in-time estimates across alternative measures of earnings, definitions of types of couples, and data sources and gauged the persistence of these patterns for a period of three calendar years using data from the 2000 Current Population Survey and the 1996-2000 Survey of Income and Program Participation. Among the findings are that in 19% to 30% of all married couples, wives have higher earnings than their husbands. In 60% of such couples, this arrangement persists over the three-year period; for the rest, this arrangement is transitory.

The Federal Employees Health Benefits Program: a model for competition in rural America?

CONTEXT: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) created the Medicare Advantage (MA) program, which promotes the entry of private Preferred Provider Organization (PPO) plans into regions that have not previously had Medicare managed care plans. The assumption that a competitive environment will develop is based on experiences in the Federal Employees Health Benefits Program (FEHBP). PURPOSE: The authors test the hypothesis that the FEHBP has fostered an environment of competing health plans, especially preferred provider organizations (PPOs), in rural areas. METHODS: Data from the US Office of Personnel Management are used to quantify the number of FEHBP-certified plans in each US county and the number of enrollees in each plan. Data from the Area Resource File are used to measure independent variables in multivariate analysis to account for the number of FEHBP-certified health plans competing in each US county. FINDINGS: While 98% of all counties have at least 3 plans with enrollment, in many sparsely populated rural areas, only 1 of the plans is an open-enrollment plan (excludes plans for letter carriers). There is a strong relationship between the number of FEHBP plans and areas with high population counts and high population density. In many counties with low population counts (under 3,000), most PPOs are not contracting with the nearest primary care provider. CONCLUSIONS: The FEHBP is not a perfect predictor of MA plan activity because the MA program does not use the FEHBP approach of certifying regional plans that must offer local access. However, the FEHBP experience indicates that plans are attracted to areas with high population counts and high population density.

Patterns of individual health insurance coverage, 1996-2000.

Information about patterns of individual health insurance coverage is limited. Knowledge gaps include the extent to which individual insurance provides transitional versus long-term coverage, and participants' insurance status before and after being covered by an individual plan. In this study we use data from the 1996-2000 Survey of Income and Program Participation (SIPP) to examine how long the individually insured maintain their coverage; sources of coverage before and after enrolling in an individual health plan; and characteristics of those who rely on individual insurance coverage. Understanding the dynamics of this market will better inform federal and state insurance reform efforts.

Enrollment in FEHBP plans in rural America: what are the implications for Medicare reform?

In places where the competing health plans are unlikely to ever emerge, any policy predicated on assumptions that competing plans will deliver health insurance benefits needs to have a "fallback" option that is guaranteed to work.

An analysis of availability of Medicare+Choice, commercial HMO, and FEHBP plans in rural areas: implications for Medicare reform.

This Policy Brief examines the viability of introducing private competition into the Medicare program by studying the availability of Medicare+Choice (M+C), commercial HMO, and Federal Employees Health Benefits Program (FEHBP) plans in rural (nonmetropolitan) counties. The Brief also presents evidence regarding the variables that influence plan availability and impact plan choice across counties in the U.S. The findings in this Brief will be useful to policymakers considering using a competitive model to design a Medicare prescription drug benefit or to redesign the entire Medicare program. As changes in the Medicare program are considered, the information in this Brief will provide background regarding rural participation in earlier Medicare program changes and in other programs said to be models for change.