COVID-19-Related Outcomes Among Group Home Residents with Serious Mental Illness in Massachusetts in the First Year of the Pandemic.

This study examined COVID-19 infection and hospitalizations among people with serious mental illness who resided in residential care group homes in Massachusetts during the first year of the COVID-19 pandemic. The authors analyzed data on 2261 group home residents and COVID-19 data from the Massachusetts Department of Public Health. Outcomes included positive COVID-19 tests and COVID-19 hospitalizations March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2). Associations between hazard of outcomes and resident and group home characteristics were estimated using multi-level Cox frailty models including home- and city-level frailties. Between March 2020 and March 2021, 182 (8%) residents tested positive for COVID-19, and 51 (2%) had a COVID-19 hospitalization. Compared with the Massachusetts population, group home residents had age-adjusted rate ratios of 3.0 (4.86 vs. 1.60 per 100) for COVID infection and 13.5 (1.99 vs. 0.15 per 100) for COVID hospitalizations during wave 1; during wave 2, the rate ratios were 0.5 (4.55 vs. 8.48 per 100) and 1.7 (0.69 vs. 0.40 per 100). In Cox models, residents in homes with more beds, higher staff-to-resident ratios, recent infections among staff and other residents, and in cities with high community transmission risk had greater hazard of COVID-19 infection. Policies and interventions that target group home-specific risks are needed to mitigate adverse communicable disease outcomes in this population.Clinical Trial Registration Number This study provides baseline (i.e., pre-randomization) data from a clinical trial study NCT04726371.

Cancer care for people with significant mental health difficulties (SMHD) - patient perspectives.

OBJECTIVES: People with significant mental health difficulties (SMHD) experience inequities in cancer care. This study aims to deepen understanding of cancer care for individuals with SMHD. METHOD: We conducted semi-structured interviews with seven individuals with SMHD regarding their experiences accessing and engaging with cancer care from August 2021 to February 2022. Data were analyzed using thematic analysis where both inductive and deductive coding was adopted through the lens of the socio-ecological model (SEM) as a theoretical framework. RESULTS: The main themes included intrapersonal, interpersonal and organizational barriers and facilitators to care with a specific focus on modifiable factors related to cancer care delivery. CONCLUSION: This study provides further evidence for promoting collaborative mental health and cancer care delivery to prevent inequalities in cancer care for patients with SMHD. PRACTICE IMPLICATIONS: Adopting an interdisciplinary, team-based approach to cancer care and help with patient navigation across services are potential factors in improving cancer care for individuals with SMHD.

Challenges, rewards, and lessons learned from family and community caregivers of individuals with serious mental illness and cancer.

PURPOSE: The caregiving experience for individuals with serious mental illness (SMI) and cancer has not been explored in previous cancer caregiver research. This study assessed the challenges, rewards, and lessons learned from this unique population of caregivers. METHODS: We conducted qualitative interviews with 13 caregivers (9 family caregivers, 4 community caregivers) of patients recently diagnosed with head and neck, breast, lung, or gastrointestinal cancer and SMI who participated in a single-arm pilot of person-centered collaborative care. Interviews were transcribed and analyzed using inductive and deductive approaches. Investigators developed a coding scheme based on the interview guide. Interviews were double-coded and themes were identified via an iterative consensus process consistent with a content analysis framework. Comparisons between community and family caregiver experiences were explored. RESULTS: Caregiving challenges included the impact of mental health symptoms on timely diagnosis, treatment, and coordination of care and lack of resources specific to SMI and cancer caregiving. Family caregivers valued increased closeness and meaningfulness in their relationships. Family and community caregivers found it rewarding to be part of a person-centered care model that was effective for the patient. Lessons learned included tending to their own needs too, and the importance of advocacy and a team approach to decrease mental health stigma and coordinate care. CONCLUSIONS: This study highlights the complex challenges and rewards experienced by family and community caregivers for individuals with cancer and SMI. Tailored approaches to support caregivers as individuals are needed. Additional research on community caregiver-patient dyads and non-spousal family caregiver-patient dyads are needed to inform intervention development.

Do Tobacco Treatment Trials Address Disparities in Smoking Outcomes Among Black and Hispanic Cancer Patients? A Systematic Review of Smoking Cessation Interventions for Black and Hispanic Patients Diagnosed with Cancer.

OBJECTIVE: To characterize the representation of Black and Hispanic cancer patients in tobacco treatment trials, and to offer recommendations for future research. METHODS: We conducted two systematic searches of the literature (2018, 2021) using 5 databases (MEDLINE via EBSCO, Pubmed, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE)) to examine the prevalence of tobacco trials that included Black or Hispanic cancer patients. Two coders independently screened all articles at title, abstract, and full-text to identify eligible trials. Information about the proportion of Black and Hispanic patients included, trial design features, and whether the authors analyzed outcomes for Black and Hispanic patients were documented. RESULTS: Of 4682 identified studies, only 10 published trials included and reported on the rates of Black or Hispanic cancer patients enrolled in their tobacco trial. The proportion of enrolled Black cancer patients ranged from 2 to 55.6%. Only our studies documented enrollment rates for Hispanics, and rates were less than 6%. None of the studies offered strategies to promote or the accrual of Black or Hispanic patients. DISCUSSION: There remains a large gap in the literature regarding the reach and efficacy of tobacco treatment for Black and Hispanic cancer patients. Black and Hispanic cancer patients remain largely under-represented in tobacco cessation trials, limiting the applicability of existing, evidence-based treatments. To optimize intervention generalizability, future studies should emphasize the targeted recruitment and engagement of these patients in tobacco trials.

Disease state associated with chronic toe lesions in hellbenders may alter anti-chytrid skin defenses.

Hellbenders (Cryptobranchus alleganiensis) are large, aquatic salamanders from the eastern United States. Both subspecies, eastern and Ozark hellbenders, have experienced declines resulting in federal listing of Ozark hellbenders. The globally distributed chytrid fungus, Batrachochytrium dendrobatidis (Bd) has been detected in both subspecies, and Batrachochytrium salamandrivorans (Bsal) poses a new threat if introduced into North America. Ozark hellbenders also suffer a high prevalence of toe lesions of unknown etiology, with changes in host immunocompetence hypothesized to contribute. Antimicrobial peptides (AMPs) secreted from dermal granular glands may play a role in hellbender health. We collected skin secretions from free-ranging hellbenders and enriched them for small cationic peptides used for growth inhibition assays against Bd and Bsal. Generalized linear mixed models revealed the presence of active toe lesions as the strongest and only significant predictor of decreased Bd inhibition by skin peptides. We also found skin secretions were more inhibitory of Bsal than Bd. MALDI-TOF mass spectrometry revealed candidate peptides responsible for anti-chytrid activity. Results support the hypothesis that hellbender skin secretions are important for innate immunity against chytrid pathogens, and decreased production or release of skin peptides may be linked to other sub-lethal effects of disease associated with toe lesions.

Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial.

BACKGROUND: People with serious mental illness (SMI) and intellectual disabilities and/or developmental disabilities (ID/DD) living in group homes (GHs) and residential staff are at higher risk for COVID-19 infection, hospitalization, and death compared with the general population. METHODS: We describe a hybrid type 1 effectiveness-implementation cluster randomized trial to assess evidence-based infection prevention practices to prevent COVID-19 for residents with SMI or ID/DD and the staff in GHs. The trial will use a cluster randomized design in 400 state-funded GHs in Massachusetts for adults with SMI or ID/DD to compare effectiveness and implementation of "Tailored Best Practices" (TBP) consisting of evidence-based COVID-19 infection prevention practices adapted for residents with SMI and ID/DD and GH staff; to "General Best Practices" (GBP), consisting of required standard of care reflecting state and federal standard general guidelines for COVID-19 prevention in GHs. External (i.e., community-based research staff) and internal (i.e., GH staff leadership) personnel will facilitate implementation of TBP. The primary effectiveness outcome is incident SARS-CoV-2 infection and secondary effectiveness outcomes include COVID-19-related hospitalizations and mortality in GHs. The primary implementation outcomes are fidelity to TBP and rates of COVID-19 vaccination. Secondary implementation outcomes are adoption, adaptation, reach, and maintenance. Outcomes will be assessed at baseline, 3-, 6-, 9-, 12-, and 15-months post-randomization. CONCLUSIONS: This study will advance knowledge on comparative effectiveness and implementation of two different strategies to prevent COVID-19-related infection, morbidity, and mortality and promote fidelity and adoption of these interventions in high-risk GHs for residents with SMI or ID/DD and staff. CLINICAL TRIAL REGISTRATION NUMBER: NCT04726371.

Clinical Implications and Treatment Strategies for ESR1 Fusions in Hormone Receptor-Positive Metastatic Breast Cancer: A Case Series.

In hormone receptor-positive metastatic breast cancer (HR+ MBC), endocrine resistance is commonly due to genetic alterations of ESR1, the gene encoding estrogen receptor alpha (ERα). While ESR1 point mutations (ESR1-MUT) cause acquired resistance to aromatase inhibition (AI) through constitutive activation, far less is known about the molecular functions and clinical consequences of ESR1 fusions (ESR1-FUS). This case series discusses 4 patients with HR+ MBC with ESR1-FUS in the context of the existing ESR1-FUS literature. We consider therapeutic strategies and raise the hypothesis that CDK4/6 inhibition (CDK4/6i) may be effective against ESR1-FUS with functional ligand-binding domain swaps. These cases highlight the importance of screening for ESR1-FUS in patients with HR+ MBC while continuing investigation of precision treatments for these genomic rearrangements.

Patients With Serious Mental Illness Can Engage in Tobacco Treatment Trials and Tobacco Cessation Interventions During Cancer Treatment.

PURPOSE: More than half of individuals with serious mental illness (SMI) smoke, contributing to premature cancer mortality. A cancer diagnosis provides an opportunity to assist with smoking cessation; however, supportive oncology trials frequently exclude patients with SMI. To fill this gap, we examined differences in engagement and tobacco cessation in a pragmatic clinical trial. METHODS: We recruited 303 participants from two National Cancer Institute-designated Comprehensive Cancer Centers, of which 10% had prior diagnoses of SMI (major depressive disorder, bipolar disorder, and schizophrenia spectrum disorders). We compared self-reported smoking behaviors, patient attitudes and beliefs about cessation, and rates of trial completion, engagement, and smoking abstinence among recently diagnosed patients with cancer with and without SMI. Six months after trial completion, we completed qualitative interviews on barriers and facilitators to tobacco cessation in a random sample of participants with SMI. RESULTS: Trial participants with SMI had similar motivation to quit smoking as those without SMI. Additionally, participants with SMI had a similar ability to engage in a tobacco treatment trial (6.5 counseling sessions completed v 7.3 sessions) and benefit from tobacco treatment as those without SMI (32.3% v 27.8% 6-month quit rates). CONCLUSION: Patients with cancer and SMI were able to engage in and benefit from a tobacco cessation trial integrated into cancer care. A cancer diagnosis provides an opportunity to assist patients with SMI with smoking cessation referrals and treatment. Pragmatic supportive oncology trials that include a diverse population of adults with SMI are needed to inform care delivery and improve cancer outcomes for patients with SMI and cancer.

Study protocol for a randomized trial of bridge: Person-centered collaborative care for serious mental illness and cancer.

BACKGROUND: Individuals with serious mental illness (SMI) experience inequities in cancer care that contribute to increased cancer mortality. Involving mental health at the time of cancer diagnosis may improve cancer care delivery for patients with SMI yet access to care remains challenging. Collaborative care is a promising approach to integrate mental health and cancer care that has not yet been studied in this marginalized population. METHODS/DESIGN: We describe a 24-week, two-arm, single-site randomized trial of person-centered collaborative care (Bridge) for patients with SMI (schizophrenia, bipolar disorder, or major depression with psychiatric hospitalization) and their caregivers. 120 patients are randomized 1:1 to Bridge or Enhanced Usual Care (EUC) along with their caregivers. Researchers proactively identify individuals with SMI and a new breast, lung, gastrointestinal, or head and neck cancer that can be treated with curative intent. EUC includes informing oncologists about the patient's psychiatric diagnosis, notifying patients about available psychosocial services, and tracking patient and caregiver outcomes. Bridge includes a proactive assessment by psychiatry and social work, a person-centered, team approach including collaboration between mental health and oncology, and increased access to evidence-based psycho-oncology care. The primary outcome is cancer care disruptions evaluated by a blinded panel of oncologists. Secondary outcomes include patient and caregiver-reported outcomes and healthcare utilization. Barriers to Bridge implementation and dissemination are assessed using mixed methods. DISCUSSION: This trial will inform efforts to systematically identify individuals with SMI and cancer and generate the first experimental evidence for the impact of person-centered collaborative care on cancer care for this underserved population.

Developing a Virtual Equity Hub: Adapting the Tumor Board Model for Equity in Cancer Care.

We define cancer equity as all people having as the same opportunity for cancer prevention, treatment, and survivorship care. However, marginalized populations continue to experience avoidable and unjust disparities in cancer care, access to clinical trials, and cancer survival. Racial and ethnic minorities, and individuals with low socioeconomic status, Medicaid insurance, limited health literacy, disabilities, and mental health disorders are more likely to experience delays to cancer diagnosis and less likely to receive guideline-concordant cancer care. These disparities are impacted by the social determinants of health including structural discrimination, racism, poverty, and inequities in access to healthcare and clinical trials. There is an urgent need to develop and adapt evidence-based interventions in collaboration with community partners that have potential to address the social determinants of health and build capacity for cancer care for underserved populations. We established the Virtual Equity Hub by developing a collaborative network connecting a comprehensive cancer center, academic safety net hospital, and community health centers and affiliates. The Virtual Equity Hub utilizes a virtual tumor board, an evidence-based approach that increases access to multi-specialty cancer care and oncology subspecialty expertise. We adapted the tumor board model by engaging person-centered teams of multi-disciplinary specialists across health systems, addressing the social determinants of health, and applying community-based research principles with a focus on populations with poor cancer survival. The virtual tumor board included monthly videoconferences, case discussion, sharing of expertise, and a focus on addressing barriers to care and trial participation. Specifically, we piloted virtual tumor boards for breast oncology, neuro-oncology, and individuals with cancer and serious mental illness. The Virtual Equity Hub demonstrated promise at building capacity for clinicians to care for patients with complex needs and addressing barriers to care. Research is needed to measure the impact, reach, and sustainability of virtual equity models for patients with cancer.

The Strategies for Quantitative and Qualitative Remote Data Collection: Lessons From the COVID-19 Pandemic.

The COVID-19 pandemic has necessitated a rapid shift to web-based or blended design models for both ongoing and future clinical research activities. Research conducted virtually not only has the potential to increase the patient-centeredness of clinical research but may also further widen existing disparities in research participation among underrepresented individuals. In this viewpoint, we discuss practical strategies for quantitative and qualitative remote research data collection based on previous literature and our own ongoing clinical research to overcome challenges presented by the shift to remote data collection. We aim to contribute to and catalyze the dissemination of best practices related to remote data collection methodologies to address the opportunities presented by this shift and develop strategies for inclusive research.

Barriers and facilitators to accessing cancer care for people with significant mental health difficulties: A qualitative review and narrative synthesis.

OBJECTIVES: Inequities in cancer care contribute to higher rates of cancer mortality for individuals with significant mental health difficulties (SMHD) compared to the general population. The aim of the current systematic review was to identify, appraise and synthesise qualitative evidence of patient and clinician/system barriers and facilitators to cancer screening and treatment for individuals with SMHD. METHODS: We conducted a systematic search across three electronic databases in May 2020 and we carried out a second search across five electronic databases in January 2021. A narrative synthesis was conducted across eligible studies. RESULTS: We identified the same six studies from both searches, with 133 individuals with SMHD and experiences of cancer care and 102 healthcare professionals. Key barriers to cancer care were related to patients' uncontrolled psychiatric symptoms and the adverse impact of their symptoms on engaging with cancer care; clinician barrier-attitudes included stigmatising attitudes from clinicians and other staff towards individuals with SMHD and systems barrier-fragmentation included the fragmentation of mental health and cancer care delivery. Key patient facilitators to accessing cancer care and completing cancer treatment included being connected with mental health services and controlled psychiatric symptoms. Stronger collaboration among healthcare professionals working across different sectors in addition to the development of a patient navigator role were identified as key facilitators to enhance patient care. CONCLUSIONS: Innovative approaches are needed to decrease mental health stigma, foster collaboration across disciplines, and facilitate the integration of timely mental health and cancer care for individuals with SMHD to address the mortality gap.

Feasibility and Acceptability of a Collaborative Lung Cancer Screening Educational Intervention Tailored for Individuals With Serious Mental Illness.

PURPOSE: Individuals with serious mental illness (SMI) experience disparities in lung cancer mortality. Using a two-phase, mixed-methods approach, we developed a person-centered lung cancer screening (LCS) educational intervention (phase 1) for individuals with SMI (schizophrenia and bipolar disorder) and evaluated acceptability, feasibility, and changes in attitudes toward LCS (phase 2). METHODS: Phase 1: We conducted three focus groups with mental health, primary care, and radiology clinicians and utilized rapid qualitative analysis to adapt the LCS intervention (LCS walk-through video and smoking cessation handouts) tailored for individuals with SMI. Phase 2: We enrolled LCS-eligible patients with SMI (n = 15) and assessed the feasibility (>50% enrollment; >75% completion) and acceptability (>75% overall satisfaction) of an LCS educational intervention delivered by a radiologist and a mental health clinician at a community mental health clinic. We explored changes in participant attitudes about lung cancer, LCS, and smoking before and after the intervention. RESULTS: Phase 1: Focus groups with primary care (n = 5), radiologists (n = 9), and mental health clinicians (n = 6) recommended person-centered language and adapting a video demonstrating the process of LCS to address concerns specific to SMI, including paranoia and concrete thinking. Phase 2: Fifty percent (15 of 30) of eligible patients enrolled in the LCS intervention, 100% (15 of 15) completed the intervention, and 93% (14 of 15) were satisfied with the intervention. Participants reported a significantly greater worry about developing lung cancer postintervention, but there were no other significant differences. CONCLUSIONS: Radiologists can partner with primary care and community mental health clinics to lead equity efforts in LCS among individuals with SMI.

Cervical Cancer-Associated Suffering: Estimating the Palliative Care Needs of a Highly Vulnerable Population.

PURPOSE: To enable design of optimum palliative care for women with cervical cancer, we studied the most common types of suffering and their severity, prevalence, and duration. METHODS: We first reviewed the literature on the major types, severity, prevalence, and duration of suffering associated with cervical cancer. We then conducted a modified Delphi process with experts in cervical cancer care to supplement the literature. For each type of suffering, we distinguished between decedents (those who die from cervical cancer in a given year) and nondecedents (those who have cervical cancer in a given year but do not die). By applying the suffering prevalence and duration estimates to the number of decedents, nondecedents, and family caregivers in 2017, we were able to estimate their palliative care needs and the intensity of palliative care needed to respond adequately to this suffering. RESULTS: There is a high prevalence among decedents of moderate or severe pain (84%), vaginal discharge (66%), vaginal bleeding (61%), and loss of faith (31%). Among both decedents and nondecedents, there is a high prevalence of clinically significant anxiety (63% and 50%, respectively), depressed mood (52% and 38%, respectively), and sexual dysfunction (87% and 83%, respectively). Moderate or severe financial distress is prevalent among decedents, nondecedents, and family caregivers (84%, 74%, and 66%, respectively). More than 40% of decedents and nondecedents are abandoned by their intimate partners. Most patients experience some combination of moderate or severe physical, psychological, social, and spiritual suffering. In total, 258,649 decedents and 2,558,857 nondecedents needed palliative care in 2017, approximately 85% of whom were in low- and middle-income countries where palliative care is rarely accessible. CONCLUSION: Among women with advanced cervical cancer, suffering is highly prevalent and often severe and multifaceted.

Essential Package of Palliative Care for Women With Cervical Cancer: Responding to the Suffering of a Highly Vulnerable Population.

Women with cervical cancer, especially those with advanced disease, appear to experience suffering that is more prevalent, complex, and severe than that caused by other cancers and serious illnesses, and approximately 85% live in low- and middle-income countries where palliative care is rarely accessible. To respond to the highly prevalent and extreme suffering in this vulnerable population, we convened a group of experienced experts in all aspects of care for women with cervical cancer, and from countries of all income levels, to create an essential package of palliative care for cervical cancer (EPPCCC). The EPPCCC consists of a set of interventions, medicines, simple equipment, social supports, and human resources, and is designed to be safe and effective for preventing and relieving all types of suffering associated with cervical cancer. It includes only inexpensive and readily available medicines and equipment, and its use requires only basic training. Thus, the EPPCCC can and should be made accessible everywhere, including for the rural poor. We provide guidance for integrating the EPPCCC into gynecologic and oncologic care at all levels of health care systems, and into primary care, in countries of all income levels.

Augmented Package of Palliative Care for Women With Cervical Cancer: Responding to Refractory Suffering.

The essential package of palliative care for cervical cancer (EPPCCC), described elsewhere, is designed to be safe and effective for preventing and relieving most suffering associated with cervical cancer and universally accessible. However, it appears that women with cervical cancer, more frequently than patients with other cancers, experience various types of suffering that are refractory to basic palliative care such as what can be provided with the EPPCCC. In particular, relief of refractory pain, vomiting because of bowel obstruction, bleeding, and psychosocial suffering may require additional expertise, medicines, or equipment. Therefore, we convened a group of experienced experts in all aspects of care for women with cervical cancer, and from countries of all income levels, to create an augmented package of palliative care for cervical cancer with which even suffering refractory to the EPPCCC often can be relieved. The package consists of medicines, radiotherapy, surgical procedures, and psycho-oncologic therapies that require advanced or specialized training. Each item in this package should be made accessible whenever the necessary resources and expertise are available.

Addressing distress management challenges: Recommendations from the consensus panel of the American Psychosocial Oncology Society and the Association of Oncology Social Work.

Distress management (DM) (screening and response) is an essential component of cancer care across the treatment trajectory. Effective DM has many benefits, including improving patients' quality of life; reducing distress, anxiety, and depression; contributing to medical cost offsets; and reducing emergency department visits and hospitalizations. Unfortunately, many distressed patients do not receive needed services. There are several multilevel barriers that represent key challenges to DM and affect its implementation. The Consolidated Framework for Implementation Research was used as an organizational structure to outline the barriers and facilitators to implementation of DM, including: 1) individual characteristics (individual patient characteristics with a focus on groups who may face unique barriers to distress screening and linkage to services), 2) intervention (unique aspects of DM intervention, including specific challenges in screening and psychosocial intervention, with recommendations for resolving these challenges), 3) processes for implementation of DM (modality and timing of screening, the challenge of triage for urgent needs, and incorporation of patient-reported outcomes and quality measures), 4) organization-inner setting (the context of the clinic, hospital, or health care system); and 5) organization-outer setting (including reimbursement strategies and health-care policy). Specific recommendations for evidence-based strategies and interventions for each of the domains of the Consolidated Framework for Implementation Research are also included to address barriers and challenges.