Assessing safe chemotherapy needs and practices in Ile-Ife, Nigeria: a multi-disciplinary quality improvement project.

OBJECTIVE: To explore the gaps in the safe handling, administration, preparation and disposal of chemotherapy agents in low and middle-income countries. DESIGN: Two surveys comprising a needs assessment survey and an American Cancer Society (ACS) ChemoSafe Facility Assessment. SETTING: 2019 African Research Group for Oncology Symposium in South-West Nigeria (needs assessment) and the 2021 virtual engagement (ChemoSafe Assessment). PARTICIPANTS: Health professionals (n=50 of 98) from multiple institutions across Nigeria (needs assessment survey) and a designated task force of health professionals (n=10) from one teaching hospital in Southwest Nigeria(ChemoSafe Facility Assessment). RESULTS: In 2019, 75% of survey respondents (n=50) reported a lack of training resources for safe handling of chemotherapy. Additionally, 61% felt dissatisfaction with assessment practices for preparing and administering chemotherapy. ChemoSafe is a programme developed by the ACS to assess the ability of a facility to handle hazardous drugs. The 2021 ACS ChemoSafe survey administered at one teaching hospital indicated several areas for improvement to promote concordance with international standards for safe handling. Thirty-three (19.5%) items received a 'Yes' response (ie, met compliance with international standards). CONCLUSION: There is a need for the implementation of training resources for handling, administering and disposing of chemotherapy at sites across Nigeria. Strategies to identify and prioritise areas of need must be implemented in the context of available resources.

Translation and psychometric assessment of the mastectomy module of the BREAST-Q questionnaire for use in Nigeria.

BACKGROUND: The majority of non-metastatic breast cancer patients in sub-Saharan Africa are recommended to have mastectomy. The impact of mastectomy on a predominantly young African patient population requires evaluation. The BREAST-Q is a validated patient-reported outcome measure of quality-of-life following breast surgery that has been translated into 30 languages-none in Africa. This study aimed to translate and assess the psychometric properties of the mastectomy module of the BREAST-Q for use in Nigeria. METHODS: The BREAST-Q mastectomy module was translated from English to Yoruba and its psychometric properties assessed using best practice guidelines. Translation was performed in 4 steps: forward translation (x2), back translation, back translation review, and cognitive interviews with post-mastectomy patients. The translated BREAST-Q instrument was administered to post-mastectomy patients (n = 21) alongside the EORTC-QLQ BR23 to evaluate construct validity. Test-retest reliability was evaluated using intraclass correlation coefficients (ICC); surveys were re-administered 4 weeks apart. RESULTS: The translation process identified English phrases not amenable to direct translation, including "emotionally healthy" and descriptions of pain ("nagging," "throbbing," "sharp"). Translations were amended to reflect local context and question intent. During cognitive interviews, patients provided suggestions to simplify complex phrases, e.g. "discomfort in your breast area.". Internal consistency within scales was over 0.70 for psychosocial wellbeing (α = 0.84-0.87), sexual wellbeing (α = 0.98-0.99), physical wellbeing in chest (α = 0.84-0.86), and satisfaction with care (α = 0.89-0.93). ICC for test-retest reliability was moderate (0.46-0.63). CONCLUSIONS: The Yoruba version of the BREAST-Q mastectomy module presents a unique opportunity to adequately capture the experiences of Nigerian women post mastectomy. This instrument is being used in a pilot study of Nigerian patients to identify targets for intervention to improve the patient experience and compliance with breast cancer surgery.

Competencies of the UK nursing and midwifery workforce to mainstream genomics in the National Health Service: the ongoing gap between perceived importance and confidence in genomics.

The United Kingdom is recognised worldwide as a leader in genomics. The use of genomic technologies in the National Health Service (NHS) is expected to deliver faster and more accurate diagnoses, supporting personalized treatments to improve patient outcomes. The ambition of embedding genomic medicine in the diagnostic pathway requires involvement of the front-line clinical workforce, known as 'mainstreaming'. Nurses and midwives are the largest professionally qualified workforce in the National Health Service thus, it is anticipated that they will play key roles in mainstreaming. This study investigated the level of competence/confidence of practicing nurses and midwives to support mainstreaming and their perception of the importance of genomics in delivery of patient care. A literature review of genetics/genomics competency frameworks, semi structured interviews of lead nurses and stakeholders were conducted to identify relevant competencies needed for mainstreaming. These were then used to survey four cohorts of nurses (n = 153) across England in four consecutive years (2019-22). The confidence level of these professionals in all aspects of genomics was 2.07 ± 0.47 measured on a 5-point Likert scale (1"Low confidence"; 5 "High confidence"). Intriguingly, these professionals all appreciated the importance of genomics for their patient care (4.01 ± 0.06). Whilst the importance scores increased, the confidence scores declined at the time when major genomic transformation took place in the NHS (e.g.: launch of the Genomic Medicine Service, the National Genomic Test Directory). To bridge this gap, relevant genomic education can play key roles. However, nurses and midwives were found to be grossly underrepresented in formal genomic education courses offered by Health Education England Genomics Education Programme since 2014. This may result from the lack of direct applicability of the currently offered courses for their practice and role. Thematic analysis revealed that nurses and midwives wish to support their patients by providing more information on their condition, inheritance, and treatment options in combination with the use of relevant genetic counselling skills. This study identified easy to follow competencies for embedding genomics into routine clinical care. We propose a training programme that addresses the gap that nurses and midwives currently have, to enable them to harness genomic opportunities for patients and services.

Critical Dynamics in Black and Latino Parents' Perceptions of Childhood COVID-19 Vaccination: How the "Middle" Moves.

National and state data show low adoption of childhood COVID-19 vaccinations, despite emergency use authorizations and availability. We conducted 24 in-depth, semi-structured interviews with Black and Latino parents in New York City (15 in English, 9 in Spanish), who were undecided or somewhat likely to vaccinate their 5 to 11-year-old children in early 2022. The interviews explored the evolution of parental perceptions on childhood COVID-19 vaccines, and were analyzed using a matrix-driven rapid approach to thematic analysis. We present our findings as themes oriented around trust at three levels of the social ecological model. In summary, we found that structural positionality and historical traumas of participants seeded mistrust in institutions and government. This led to parental reliance on personal observations, conversations, and norms within social groups for vaccine decision-making. Our findings also describe key features of trust-building, supportive conversations that shaped the thinking of undecided parents. This study demonstrates how relational trust becomes a key factor in parental vaccine decision-making, and suggests the potential power of community ambassador models of vaccination promotion for increasing success and rebuilding trust with members of the "movable middle."

Impact of Disasters on Older Adult Cancer Outcomes: A Scoping Review.

PURPOSE: There is an urgent need to address the growing global cancer burden in the context of complex disaster events, which both disrupt access to oncology care and facilitate carcinogenic exposures. Older adults (65 years and older) are a growing population with multifaceted care needs, making them especially vulnerable to disasters. The objective of this scoping review is to characterize the state of the literature concerning older adult cancer-related outcomes and oncologic care after a disaster event. METHODS: A search was conducted in PubMed and Web of Science. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for scoping reviews, articles were extracted and screened for inclusion. Eligible articles were summarized using descriptive and thematic analyses. RESULTS: Thirty-five studies met all criteria for full-text review. The majority focused on technological disasters (60%, n = 21), followed by climate-amplified disasters (28.6%, n = 10) and geophysical disasters (11.4%, n = 4). Thematic analysis classified the current evidence into three major categories: (1) studies concerned with carcinogenic exposure and cancer incidence related to the disaster event, (2) studies examining changes in access to cancer care and cancer treatment disruptions as a result of the disaster event, and (3) studies exploring the psychosocial experiences of patients with cancer affected by a disaster event. Few studies focused on older adults specifically, and most of the current evidence focuses on disasters in the United States or Japan. CONCLUSION: Older adult cancer outcomes after a disaster event are understudied. Current evidence suggests that disasters worsen cancer-related outcomes among older adults by disrupting continuity of care and access to timely treatment. There is a need for prospective longitudinal studies following older adult populations postdisaster and studies focused on disasters in low- and middle-income country contexts.

Construct validity and responsiveness of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions (HSIL): AMC-A01/-A03.

PURPOSE: To determine whether treatment of anal high-grade squamous intraepithelial lesions (HSIL), vs active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV, the US National Cancer Institute funded the Phase III ANal Cancer/HSIL Outcomes Research (ANCHOR) clinical trial. As no established patient-reported outcomes (PRO) tool exists for persons with anal HSIL, we sought to estimate the construct validity and responsiveness of the ANCHOR Health-Related Symptom Index (A-HRSI). METHODS: The construct validity phase enrolled ANCHOR participants who were within two weeks of randomization to complete A-HRSI and legacy PRO questionnaires at a single time point. The responsiveness phase enrolled a separate cohort of ANCHOR participants who were not yet randomized to complete A-HRSI at three time points: prior to randomization (T1), 14-70 (T2), and 71-112 (T3) days following randomization. RESULTS: Confirmatory factor analysis techniques established a three-factor model (i.e., physical symptoms, impact on physical functioning, impact on psychological functioning), with moderate evidence of convergent validity and strong evidence of discriminant validity in the construct validity phase (n = 303). We observed a significant moderate effect for changes in A-HRSI impact on physical functioning (standardized response mean = 0.52) and psychological symptoms (standardized response mean = 0.60) from T2 (n = 86) to T3 (n = 92), providing evidence of responsiveness. CONCLUSION: A-HRSI is a brief PRO index that captures health-related symptoms and impacts related to anal HSIL. This instrument may have broad applicability in other contexts assessing individuals with anal HSIL, which may ultimately help improve clinical care and assist providers and patients with medical decision-making.

An investigation of Head Start preschool children's executive function, early literacy, and numeracy learning in the midst of the COVID-19 pandemic.

The COVID-19 pandemic's impact on preschool children's school readiness skills remains understudied. This research investigates Head Start preschool children's early numeracy, literacy, and executive function outcomes during a pandemic-affected school year. Study children (N = 336 assessed at fall baseline; N = 237-250 assessed in spring depending on outcome; fall baseline sample: mean age = 51 months; 46% Hispanic; 36% Black Non-Hispanic; 52% female) in a network of Head Start centers in four states (Nevada, New Jersey, Pennsylvania, and Wisconsin) experienced low in-person preschool exposure compared to national pre-pandemic norms. Children experienced fall to spring score gains during the pandemic-affected year of 0.05 SD in executive function, 0.27 SD in print knowledge, and 0.45-0.71 SD in early numeracy skills. Descriptively, for two of the three early numeracy domains measured, spring test score outcomes were stronger among children who attended more in-person preschool. We discuss implications for future research and policy.

Suggestions for modifications to the Female Sexual Function Index based on cognitive interviews with sexual and gender minority individuals and cisgender, heterosexual persons.

BACKGROUND: Patient-reported outcome measures for sexual health were often designed for research studies that included only heterosexual, partnered, and cisgender participants; as such, they may have limited applicability for clinical use among sexual and gender minority (SGM) individuals or those without a partner. AIM: We aimed to conduct cognitive interviews with SGM persons and heterosexual women to determine the readability, comprehension, and applicability of questionnaire items to assess sexual function among diverse sexual and gender identities. METHODS: We conducted 4 rounds of cognitive interviews with 52 participants (28 SGM; 24 cisgender, heterosexual) who provided feedback on the comprehension and wording of questionnaire items and response scales. We used items from the Female Sexual Function Index (FSFI) and focused on establishing content validity of a modified measure. Participants made recommendations for changes to the questionnaire, which was iteratively revised between interview rounds. Two independent coders analyzed the transcripts using structural coding based on 5 predefined codes: satisfaction with item, specificity/language change needed, missing/suggested item, patient definitions of concepts, and confusion with item. OUTCOMES: Content validity. RESULTS: After 3 rounds of cognitive interviews and revisions to the questionnaire, participants found the final version acceptable and understandable, thereby reaching thematic saturation and establishing content validity of the modified FSFI. Modifications included the following: replacing all instances of "sexual stimulation" and "intercourse" with "sexual activity (alone or with a partner)," broadening the definition of "vaginal penetration" beyond penile-vaginal penetration, and adding skip logic to include the option "no sexual activity." Participants identified missing concepts important to their sexual health, such as use of an external lubricant. CLINICAL IMPLICATIONS: The FSFI and similar questionnaires need to be adapted to broader clinical practice populations such that all persons' experiences are accurately reflected and assessed, ensuring that sexual health needs can be met more inclusively. STRENGTH AND LIMITATIONS: A strength of the study was using cognitive interviews engaging patient perspectives, which is considered the gold standard for establishing content validity. One limitation is that participants included predominantly White and highly educated women. CONCLUSION: Feedback from interviews supports modifying FSFI items and further psychometric testing, and future studies should evaluate the measure among racially and educationally diverse groups.

Patient Perceptions of a Decision Support Tool for Men with Localized Prostate Cancer.

Purpose. To evaluate patient perceptions of a Web-based decision aid for the treatment of localized prostate cancer. Methods. We assessed patient perceptions of a multicomponent, Web-based decision aid with a preference elicitation/values clarification exercise using adaptive conjoint analysis, the generation of a summary report, and provision of information about localized prostate cancer treatment options. Using a think-aloud approach, we conducted 21 cognitive interviews with prostate cancer patients presented with the decision aid prior to seeing their urologist. Thematic content analysis was used to examine patient perceptions of the tool's components and content prior to engaging in shared decision making with their clinician. Results. Five themes were identified: 1) patients had some negative emotional reactions to the tool, pointing out what they perceived to be unnecessarily negative framing and language used; 2) patients were forced to stop and think about preferences while going through the tool and found this deliberation to be useful; 3) patients were confused by the tool; 4) patients tried to discern the intent of the conjoint analysis questions; and 5) there was a disconnect between patients' negative reactions while using the tool and a contrasting general satisfaction with the final "values profile" created by the tool. Conclusions. Studies are needed to explore the disconnect between patients' expressing negative reactions while going through some components of decision aids but satisfaction with the final output. In particular, we hypothesize that this effect might be explained by cognitive biases such as choice-supportive bias, hindsight bias, and the "IKEA effect." This is one of the first projects to elicit patient reactions while they were completing a decision aid, and we recommend further similar, qualitative postprocess evaluation studies. Highlights: We explored perceptions of a decision aid with education about localized prostate cancer treatment and preference elicitation using adaptive conjoint analysis.Patients found the tool useful but were also confused by it, tried to discern the intent of the questions, and expressed negative emotional reactions.In particular, there was a disconnect between patients' negative reactions while using the tool and general satisfaction with the final values profile generated by the tool, which is an area for future research.

"It Took Away and Stripped a Part of Myself": Clinician Distress and Recommendations for Future Telepalliative Care Delivery in the Cancer Context.

BACKGROUND: The COVID-19 pandemic has led to the rapid expansion of telehealth service delivery. We explored the experiences of a multidisciplinary palliative care team delivering telepalliative care for oncology inpatients during a 10-weeks COVID-19 surge in New York City. METHODS/PARTICIPANTS: We conducted semi-structured qualitative interviews with a targeted sample, employing a phenomenological approach with applied thematic text analysis. An interdisciplinary coding team iteratively coded data using a mix of a priori and inductive codes. Team members first independently reviewed each category, then met to reach consensus on recurring themes. The sample (n = 11) included a chaplain (n = 1), social worker (n = 1), pharmacist (n = 1), physicians (n = 3), physician assistant (n = 1), and nurse practitioners (n = 4). RESULTS: Participants described multidimensional clinician distress as a primary experience in delivering telepalliative care during the COVD-19 surge, characterized by competing loyalties (e.g., institutional obligations, ethical obligations to patients, resentment and distrust of leadership) and feelings of disempowerment (e.g., guilt in providing subpar support, decisional regret, loss of identity as a provider). Participants provided explicit recommendations to improve telepalliative care delivery for acute oncology inpatients in the future. CONCLUSION: Palliative care clinicians experienced personal and professional distress providing inpatient telepalliative care during this COVID-19 surge. Clinician strain providing telehealth services must be explored further as the pandemic and utilization of telehealth evolves. Telepalliative care planning must include attention to clinician wellbeing to sustain the workforce and promote team cohesion, and a focus on infrastructure needed to deliver high-quality, holistic care for oncology patients and their families when in-person consultation is impossible.

Assessing the Prevalence of Trachoma: Lessons from Community Screening with Laboratory Testing in Australia's Torres Strait Islands.

PURPOSE: We undertook a screening program between 2016 and 2019 to determine if trachoma was endemic in the Torres Strait Islands of Queensland, Australia. METHODS: Eleven screening surveys assessing trachoma prevalence were undertaken in seven communities using the World Health Organization (WHO) simplified grading tool. Additionally, an ophthalmologist performed a detailed clinical assessment including examination for Herbert's pits and corneal pannus and, where clinically indicated, collection of conjunctival specimens to investigate the presence of Chlamydia trachomatis nucleic acid. RESULTS: Prevalence of trachomatous inflammation-follicular (TF) in children aged 5-9 years for the aggregated first survey across all communities was 6% (17/284). No child had trachomatous inflammation-intense, trachomatous scarring, corneal pannus, or Herbert's pits. Of the 66 times any child was tested for C. trachomatis by polymerase chain reaction (PCR), the result was negative. No cicatricial trachoma was identified amongst the adults (n = 186) who were opportunistically offered examination. CONCLUSION: Whilst TF was present, the lack of intense inflammatory thickening in any child examined, the lack of end-stage trachomatous disease, and the lack of ocular C. trachomatis detection by PCR indicate trachoma is not endemic in the Torres Strait Islands, and no ongoing public health intervention is required. These findings add to a growing body of evidence suggesting that use of the WHO simplified grading tool alone in the peri-elimination setting may overestimate the community burden of trachoma.

Linguistic validation of the Spanish version of the Anal Cancer High-Grade squamous intraepithelial lesions outcomes Research Health-Related Symptom Index (A-HRSI): AMC-A04.

OBJECTIVES: The Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI. METHODS: Following independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable. RESULTS: Seventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). CONCLUSION: The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL. Language is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care.

Challenges and positive impact of rare cancer caregiving: A mixed-methods study of caregivers of patients with Erdheim-Chester disease and other histiocytic neoplasms.

Background: The importance of deriving benefit and meaning has been identified among cancer caregivers, but this has yet to be examined in the context of rare cancers. We sought to characterize unmet needs and experiences of caregivers of patients with Erdheim-Chester disease (ECD) and other histiocytic neoplasms (HN) and to identify factors associated with finding benefit and meaning-making in providing care for patients with rare cancers. Methods: Caregivers of patients with ECD and other HN completed quantitative surveys. Linear univariable regression modeling examined associations between unmet needs, social and family support, and intolerance of uncertainty with benefit finding and meaning-making. A subset participated in qualitative interviews assessing experiences of rare cancer caregiving that were analyzed with applied thematic analysis (NCT039900428). Findings: Of caregivers (N = 92, M = 54 years old, 68% female) of patients with ECD (75%) and other HN (25%), 78% reported moderately or severely unmet support needs, most frequently informational (58%) and psychological/emotional (66%) needs. Caregivers with unmet informational, psychological/emotional, and social support needs, difficulty tolerating uncertainty, a longer duration of the patient's illness, lower social support, more family conflict, and higher anxiety and depression symptoms demonstrated less benefit finding and meaning-making (ps <.05). Qualitative interviews (N = 19) underscored information and support needs and the capacity to derive meaning from caregiving. Interpretation: Rare cancer caregivers report numerous unmet information and support needs, needs that arise from disease rarity itself and which are associated with diminished capacity for deriving benefit and meaning from caregiving. Findings highlight targets for interventions to improve support for caregivers with HN and other rare cancers. Funding: NIH P30 CA008748 (PI: Craig Thompson, MD), NIH T32 CA009461 (H.M.; PI: Jamie Ostroff, PhD), Frame Family Fund (E.L.D.), Applebaum Foundation (E.L.D.).

Clinical signs of trachoma and laboratory evidence of ocular Chlamydia trachomatis infection in a remote Queensland community: a serial cross-sectional study.

OBJECTIVES: To compare the findings of standard clinical assessments and of complementary clinical and laboratory methods for determining whether community-wide treatment for trachoma is warranted in a remote Queensland community. DESIGN: Three cross-sectional screening surveys, 2019-2021, complemented by laboratory pathology testing. SETTING: Small community in northwest Queensland with geographic and cultural ties to Northern Territory communities where trachoma persists. PARTICIPANTS: Children aged 1-14 years; opportunistic screening of people aged 15 years or more. MAIN OUTCOME MEASURES: Prevalence of clinical signs of trachoma, Chlamydia trachomatis infection, ocular non-chlamydial infections, and seropositivity for antibodies to the C. trachomatis Pgp3 protein. RESULTS: During the three surveys, 73 examinations of 58 children aged 1-4 years, 309 of 171 aged 5-9 years, and 142 of 105 aged 10-14 years for trachoma were undertaken, as were 171 examinations of 164 people aged 15 years or more; 691 of 695 examinations were of Aboriginal or Torres Strait Islander people (99%), 337 were of girls or young women (48%). Clinical signs consistent with trachomatous inflammation-follicular were identified in 5-9-year-old children 23 times (7%), including in eleven with non-chlamydial infections and one with a C. trachomatis infection. One child (10-14 years) met the criteria for trachomatous scarring. Two of 272 conjunctival swab samples (all ages) were polymerase chain reaction-positive for C. trachomatis (0.7%). Two of 147 people aged 15 years or more examined in 2019 had trichiasis, both aged 40 years or more. Seven of 53 children aged 1-9 years in 2019 and seven of 103 in 2021 were seropositive for anti-Pgp3 antibodies. CONCLUSIONS: Despite the prevalence of clinical signs consistent with trachomatous inflammation-follicular among 5-9-year-old children exceeding the 5% threshold for community-wide treatment, laboratory testing indicated that childhood exposure to ocular C. trachomatis is rare in this community. Laboratory testing should be integrated into Australian trachoma guidelines.

Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings.

BACKGROUND: There is widespread agreement that the integration of cessation services in lung cancer screening (LCS) is essential for achieving the full benefits of LCS with low-dose computed tomography (LDCT). There is a formidable knowledge gap about how to best design feasible, effective, and scalable cessation services in LCS facilities. A collective of NCI-funded clinical trials addressing this gap is the Smoking Cessation at Lung Examination (SCALE) Collaboration. METHODS: The Cessation and Screening to Save Lives (CASTL) trial seeks to advance knowledge about the reach, effectiveness, and implementation of tobacco treatment in lung cancer screening. We describe the rationale, design, evaluation plan, and interventions tested in this multiphase optimization strategy trial (MOST). A total of 1152 screening-eligible current smokers are being recruited from 18 LCS sites (n = 64/site) in both academic and community settings across the USA. Participants receive enhanced standard care (cessation advice and referral to the national Quitline) and are randomized to receive additional tobacco treatment components (motivational counseling, nicotine replacement patches/lozenges, message framing). The primary outcome is biochemically validated, abstinence at 6 months follow-up. Secondary outcomes are self-reported smoking abstinence, quit attempts, and smoking reduction at 3 and 6 months. Guided by the Implementation Outcomes Framework (IOF), our evaluation includes measurement of implementation processes (reach, fidelity, acceptability, appropriateness, sustainability, and cost). CONCLUSION: We will identify effective treatment components for delivery by LCS sites. The findings will guide the assembly of an optimized smoking cessation package that achieves superior cessation outcomes. Future trials can examine the strategies for wider implementation of tobacco treatment in LDCT-LCS sites. TRIAL REGISTRATION: ClinicalTrials.gov NCT03315910.

Examining the Impact of COVID-19 on Upper Manhattan Community-Based Organizations: A Qualitative Analysis of Employee Focus Groups.

Community-based organizations (CBOs) play a key role in assisting local communities, especially those in under-resourced areas, through their deep knowledge of the community's needs and available resources. We examined perceptions of COVID-19's impact on health-related services in CBOs located in Upper Manhattan, New York City (serving East Harlem, Central Harlem, Morningside Heights and Hamilton Heights, and Washington Heights and Inwood). Three focus groups were conducted on Zoom in November 2020; focus groups were composed of participants employed at CBOs in this catchment area. Deidentified interview transcripts were evaluated using an iterative process of thematic content analysis. We identified five major themes related to the impact of COVID-19 on community needs: 1) increased mistrust and decreased service utilization, 2) breakdowns in communication, 3) shift in need, 4) increased risk factors for negative health outcomes among staff and community, and 5) decreased funding and an uncertain future. Because of the pandemic, CBOs have pivoted to cater to the immediate and changing needs of the community and, in doing so, revised their menu of services as well as their service delivery model. In trying to maintain connectivity with and the trust of community members, participants had to construct novel strategies and develop new outreach strategies; participants also recognized the role strain of trying to balance community needs with home responsibilities. Given these findings, concern arises around the long-term health and well-being of community members and participants. The government must provide the necessary resources to ensure the viability of CBOs and create a stronger infrastructure for future emergencies.

Meaning-Centered Psychotherapy for Cancer Caregivers: A pilot trial among caregivers of patients with glioblastoma multiforme.

Caregivers of patients with glioblastoma multiforme (GBM) are at significant risk for existential distress. Such distress negatively impacts caregivers' quality of life and capacity to serve in their role as healthcare proxies, and ultimately, contributes to poor bereavement outcomes. Our team developed Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C), the first targeted psychosocial intervention that directly addresses existential distress in caregivers. The purpose of this study was to evaluate the feasibility, acceptability, and preliminary effects of MCP-C among caregivers of patients with GBM via a mixed-method pilot trial. Caregivers were randomized to seven sessions of MCP-C or Enhanced Usual Care (EUC), which included distress screening and the provision of targeted referrals and completed quantitative assessments at baseline (T1), after completion of MCP-C (T2), and at 2-month follow-up (T3). A subset of participants engaged in semistructured interviews at T2. Of 60 caregivers randomized, 55 were evaluable for preliminary efficacy analysis. Constrained linear mixed models indicated the MCP-C arm had statistically significant improvement relative to the EUC arm in the primary outcome of personal meaning and multiple secondary outcomes, including benefit finding, depressive symptomatology, and spiritual wellbeing. MCP-C demonstrated preliminary efficacy in facilitating caregivers' capacity to experience a sense of meaning and purpose despite the challenges and suffering associated with providing care to patients with GBM. Future studies are needed among more diverse samples of caregivers and should include the opportunity for concurrent patient enrollment to allow for a reciprocal and augmented experience of meaning among patient-caregiver dyads.