Guidelines for Designing and Evaluating Feasibility Pilot Studies.

BACKGROUND: Pilot studies test the feasibility of methods and procedures to be used in larger-scale studies. Although numerous articles describe guidelines for the conduct of pilot studies, few have included specific feasibility indicators or strategies for evaluating multiple aspects of feasibility. In addition, using pilot studies to estimate effect sizes to plan sample sizes for subsequent randomized controlled trials has been challenged; however, there has been little consensus on alternative strategies. METHODS: In Section 1, specific indicators (recruitment, retention, intervention fidelity, acceptability, adherence, and engagement) are presented for feasibility assessment of data collection methods and intervention implementation. Section 1 also highlights the importance of examining feasibility when adapting an intervention tested in mainstream populations to a new more diverse group. In Section 2, statistical and design issues are presented, including sample sizes for pilot studies, estimates of minimally important differences, design effects, confidence intervals (CI) and nonparametric statistics. An in-depth treatment of the limits of effect size estimation as well as process variables is presented. Tables showing CI around parameters are provided. With small samples, effect size, completion and adherence rate estimates will have large CI. CONCLUSION: This commentary offers examples of indicators for evaluating feasibility, and of the limits of effect size estimation in pilot studies. As demonstrated, most pilot studies should not be used to estimate effect sizes, provide power calculations for statistical tests or perform exploratory analyses of efficacy. It is hoped that these guidelines will be useful to those planning pilot/feasibility studies before a larger-scale study.

COVID-19-Related Discrimination Among Racial/Ethnic Minorities and Other Marginalized Communities in the United States.

Objectives. To determine the prevalence of COVID-19-related discrimination among major US racial/ethnic groups and estimate associations between discrimination, race/ethnicity, and other sociodemographic characteristics. Methods. We conducted a nationally representative online survey of 5500 American Indian/Alaska Native, Asian, Black/African American, Hawaiian/Pacific Islander, Latino (English and Spanish speaking), White, and multiracial adults from December 2020 to February 2021. Associations between sociodemographic characteristics and COVID-19-related discrimination were estimated via multinomial logistic regression. Results. A total of 22.1% of the participants reported experiencing discriminatory behaviors, and 42.7% reported that people acted afraid of them. All racial/ethnic minorities were more likely than White adults to experience COVID-19-related discrimination, with Asian and American Indian/Alaska Native adults being most likely to experience such discrimination (discriminatory behaviors: adjusted odd ratio [AOR] = 2.59; 95% confidence interval [CI] = 1.73, 3.89; and AOR = 2.67; 95% CI = 1.76, 4.04; people acting afraid: AOR = 1.54; 95% CI = 1.15, 2.07; and AOR = 1.84; 95% CI = 1.34, 2.51). Limited English proficiency, lower education, lower income, and residing in a big city or the East South Central census division also increased the prevalence of discrimination. Conclusions. COVID-19-related discrimination is common, and it appears that the pandemic has exacerbated preexisting resentment against racial/ethnic minorities and marginalized communities. Efforts are needed to minimize and discredit racially driven language and discrimination around COVID-19 and future epidemics. (Am J Public Health. 2022;112(3):453-466. https://doi.org/10.2105/AJPH.2021.306594).

The importance of patient engagement to quality of breast cancer care and health-related quality of life: a cross-sectional study among Latina breast cancer survivors in rural and urban communities.

BACKGROUND: Compared to their white counterparts, Latina breast cancer survivors experience poorer quality of care and worse health-related quality of life. Limited English proficiency (LEP) and patient engagement in cancer care could help explain these disparities. We assessed associations between LEP status and difficulty engaging with physicians, with self-reported quality of breast cancer care and health-related quality of life (physical and emotional well-being) among rural and urban Latina breast cancer survivors. METHODS: Analyses used cross-sectional baseline survey data from two studies that tested a stress management program among rural and urban Latina breast cancer survivors in California. Medical information was collected through medical records review. Linear regression models examined bivariate and multivariable associations of LEP status (yes or no), difficulty engaging with doctors (asking questions and participating in treatment decisions) (1-4; higher score = greater difficulty), and rural versus urban site, with three outcomes: (1) quality of breast cancer care and information; (2) physical well-being; and (3) and emotional well-being, controlling for demographic and medical factors. RESULTS: The total sample included 304 women (151 from urban and 153 from rural sites). Mean age was 52.7 years (SD 10.9). Most were limited English proficient (84.5%) and had less than a high school education (67.8%). Difficulty engaging with doctors was inversely associated with patient ratings of quality of breast cancer care and information (B = - 0.190, p = 0.014), emotional well-being (B = - 1.866, p < 0.001), and physical well-being (B = - 1.272, p = 0.002), controlling for demographic and treatment factors. LEP (vs. not; B = 1.987, p = 0.040) was independently associated with physical well-being only. Rural/urban status was not related independently to any outcome. CONCLUSIONS: Rural and urban Latina breast cancer survivors who report greater difficulty engaging with physicians experienced worse quality of breast cancer care and health-related quality of life. Promoting greater engagement of Latina breast cancer survivors in cancer care and providing medical interpreters when needed could improve patient outcomes among this vulnerable group. TRIAL REGISTRATION: http://www.ClinicalTrials.gov identifier NCT02931552 and NCT01383174.

Nuevo Amanecer-II: Results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors.

OBJECTIVE: We report results of a community-based multisite, randomized controlled trial of Nuevo Amanecer (NA-II), a 10-week stress management program for rural, low literacy Latina breast cancer survivors. METHODS: Trained peers delivered NA-II to Spanish-speaking Latinas with non-metastatic breast cancer in three rural communities. Women were randomized to receive the program immediately or wait 6 months. Assessments were conducted at baseline, 3 months, and 6 months. Primary outcomes were breast cancer-specific quality of life domains; secondary outcomes included general distress symptoms and stress management skills. Intention-to-treat analyses using repeated-measures linear regression models estimated changes in slope between groups. RESULTS: Of 153 participants (76 randomized to intervention, 77 to control group), 92% were retained at 6 months. Mean age was 54.8 years (SD = 10.5); 80% had less than high school education. There were no statistically significant treatment × time effects on quality of life. Compared to women in the control group, intervention group women reported greater improvements in anxiety at 6 months (-0.20 vs -0.02, P = .049; range 0-4) as well as three stress management skills: relaxation at 3 months (+0.98 vs -0.07, P < .0001; range 0-4) and 6 months (+0.82 vs +0.04, P < .001), awareness of tension at 3 months (+0.31 vs -0.19, P < .01; range 0-4) and 6 months (+0.29 vs -0.11, P < .05), and coping confidence at 3 months (+0.12 vs -0.23, P < .01; range 0-4). CONCLUSIONS: Stress management programs delivered by trained peers in rural community settings can reduce anxiety and improve stress management skills among Latina breast cancer survivors.

Development and Preliminary Validation of the Lung Transplant Quality of Life (LT-QOL) Survey.

RATIONALE: Although lung transplantation aims to improve health-related quality of life (HRQL), existing instruments fail to include health domains considered important in this population. OBJECTIVES: We aimed to develop a comprehensive lung transplant-specific instrument to address this shortcoming. METHODS: We developed a pool of 126 candidate items addressing domains previously identified as important by lung transplant recipients. Through cognitive interviews conducted in 43 transplant recipients, items deemed irrelevant or redundant were dropped. The 84 remaining items were field tested in lung transplant recipients. Exploratory and confirmatory factor analyses were used to evaluate the factor structure, and scales were evaluated for internal consistency and construct validity. MEASUREMENTS AND MAIN RESULTS: The 84-item preliminary survey was administered to 201 lung transplant recipients with a mean age of 57.9 (±12.7) years; 46% were female. After factor analyses and internal consistency evaluation, we retained 60 items comprising the Lung Transplant Quality of Life (LT-QOL) Survey. The LT-QOL contains 10 scales that measure symptoms, health perceptions, functioning, and well-being. The confirmatory factor analysis model had good approximate fit (comparative fit index = 0.990; standardized root-mean-square residual = 0.062). Cronbach αs for the 10 scales ranged from 0.75 to 0.95. Interscale correlations were consistent with hypothesized relationships. Subjects with severe chronic lung allograft dysfunction (n = 13) reported significantly worse HRQL than subjects without chronic lung allograft dysfunction (n = 168) on 6 of the 10 LT-QOL scales. CONCLUSIONS: The LT-QOL is a new, multidimensional instrument that characterizes and quantifies HRQL in lung transplant recipients.

Multi-cultural perspectives on group singing among diverse older adults.

Group choir singing has been shown to have health benefits for older adults. However, because most studies have included predominantly white participants, it is unknown whether findings generalize to older adults from more diverse backgrounds. This multi-site qualitative study assessed perceived benefits of group singing for socioeconomically and racially/ethnically diverse older adults. We interviewed 31 choir participants, 6 music professionals and 6 administrators involved in a large, cluster-randomized trial. We used content analysis to identify themes. Psychosocial engagement was most commonly reported, with six components: emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation. A few reported cognitive and physical benefits. They also suggest that group singing among ethnically diverse older adults can have multiple psychosocial benefits and enhance a sense of cultural identity and appreciation of other cultures. These findings can help in selecting structured outcome measures for choir interventions.

Social support as a moderator in the relationship between intrusive thoughts and anxiety among Spanish-speaking Latinas with breast cancer.

OBJECTIVE: Intrusive thoughts, defined as unwanted and recurrent thoughts about a stressful experience, are associated with psychological distress in women with breast cancer. This study assessed moderating effects of various social support dimensions on associations between intrusive thoughts and psychological distress among Latina breast cancer survivors. METHODS: We used baseline data from a randomized controlled trial of a stress management intervention delivered to 151 Spanish-speaking Latinas with nonmetastatic breast cancer within 1 year of diagnosis. Intrusive thoughts, four dimensions of social support (emotional/informational, tangible, affectionate, and positive social interaction), and symptoms of anxiety and depression were assessed through in-person interviews. Information on age, time since diagnosis, breast cancer variables, history of depression, and marital status served as covariates. Generalized linear models were used to investigate bivariate and multivariate associations and to explore moderation effects of the four dimensions of social support. RESULTS: In bivariate models, intrusive thoughts were associated positively with depression (ß = .024, .001) and anxiety (ß = .047, P < .001) symptoms. Adjusting for other factors, intrusive thoughts remained associated with depression symptoms (ß = .022, .008), regardless of level of social support (for all support dimensions). For anxiety, there were significant interactions of tangible (ß = -.013, .034) and affectionate (ß = -.022, .005) support with intrusive thoughts. Intrusive thoughts were associated more strongly with anxiety symptoms among women reporting less tangible and affectionate support than those with higher levels of these types of support. CONCLUSIONS: Tangible and affectionate support have protective effects on anxiety symptoms among Spanish-speaking Latina breast cancer survivors experiencing intrusive thoughts, but not depression symptoms.

Understanding racial/ethnic differences in breast cancer-related physical well-being: the role of patient-provider interactions.

PURPOSE: Racial/ethnic differences in cancer symptom burden are well documented, but limited research has evaluated modifiable factors underlying these differences. Our objective was to examine the role of patient-provider interactions to help explain the relationship between race/ethnicity and cancer-specific physical well-being (PWB) among women with breast cancer. METHODS: The Pathways Study is a prospective cohort study of 4505 women diagnosed with breast cancer at Kaiser Permanente Northern California between 2006 and 2013. Our analysis included white, black, Hispanic, and Asian participants who completed baseline assessments of PWB, measured using the Functional Assessment of Cancer Therapy for Breast Cancer, and patient-provider interactions, measured by the Interpersonal Processes of Care Survey (IPC) (N = 4002). Using step-wise linear regression, we examined associations of race/ethnicity with PWB, and changes in associations when IPC domains were added. RESULTS: We observed racial/ethnic differences in PWB, with minorities reporting lower scores than whites (beta, black: - 1.79; beta, Hispanic: - 1.92; beta, Asian: - 1.68; p < 0.0001 for all comparisons). With the addition of health and demographic covariates to the model, associations between race/ethnicity and PWB score became attenuated for blacks and Asians (beta: - 0.63, p = 0.06; beta: - 0.68, p = 0.02, respectively) and, to a lesser extent, for Hispanic women (beta: - 1.06, p = 0.0003). Adjusting for IPC domains did not affect Hispanic-white differences (beta: - 1.08, p = 0.0002), and slightly attenuated black-white differences (beta: - 0.51, p = 0.14). Asian-white differences narrowed substantially (beta: - 0.31, p = 0.28). CONCLUSIONS: IPC domains, including those capturing perceived discrimination, respect, and clarity of communication, appeared to partly explain PWB differences for black and Asian women. Results highlight opportunities to improve providers' interactions with minority patients, and communication with minority patients about their supportive care needs.

Transcreation: an implementation science framework for community-engaged behavioral interventions to reduce health disparities.

BACKGROUND: Methods for translating evidence-based behavioral interventions into real-world settings seldom account for the special issues in reaching health disparity populations. MAIN TEXT: The objective of this article is to describe an innovative "transcreational" framework for designing and delivering interventions in communities to reduce health disparities. We define transcreation as the process of planning, delivering, and evaluating interventions so that they resonate with the community experiencing health disparities, while achieving intended health outcomes. The Transcreation Framework for Community-engaged Behavioral Interventions to Reduce Health Disparities comprises seven steps: 1) identify community infrastructure and engage partners; 2) specify theory; 3) identify multiple inputs for new program; 4) design intervention prototype; 5) design study, methods, and measures for community setting; 6) build community capacity for delivery; and 7) deliver transcreated intervention and evaluate implementation processes. Communities are engaged from the start and interventions are delivered by community-based interventionists and tested in community settings. The framework applies rigorous scientific methods for evaluating program effectiveness and implementation processes. It incorporates training and ongoing technical assistance to assure treatment fidelity and build community capacity. CONCLUSIONS: This framework expands the types of scientific evidence used and balances fidelity to evidence and fit to the community setting. It can guide researchers and communities in developing and testing behavioral interventions to reduce health disparities that are likely to be sustained because infrastructure development is embedded in the research.

Evaluating the Implementation of a Translational Peer-Delivered Stress Management Program for Spanish-Speaking Latina Breast Cancer Survivors.

Information is needed on implementation processes involved in translating evidence-based interventions (EBIs) into health disparity communities. In an RCT, Nuevo Amanecer, a cognitive-behavioral stress management (CBSM) program delivered by breast cancer survivors (compañeras) in community settings to Spanish-speaking Latina breast cancer survivors, was effective in improving quality of life and decreasing breast cancer concerns and depressive and bodily symptoms. Using mixed methods, we evaluated the processes of implementing Nuevo Amanecer. Program delivery was assessed by direct observation. Treatment receipt was assessed by participants' mastery and homework completion. Perceived benefits, quality, ease of use, usefulness of components, and suggested improvements were evaluated through participant surveys and semi-structured interviews of participants and compañeras. Eighty percent of women completed six or more of eight sessions. Observer ratings of program delivery indicated compañeras demonstrated fidelity 80-90% of the time for three components (e.g., following the manual), but only 10% for two components (e.g., modeling skills). Regarding treatment receipt, most participants completed all homework. Knowledge and skills mastery was high (mostly >85%). In program evaluations, 93% indicated the program helped them cope with breast cancer "quite a bit/extremely." Participants reported improved self-management skills and knowledge. Suggested improvements were to add more sessions to practice cognitive-behavioral coping skills and simplify exercises and homework. We conclude that CBSM programs can be delivered in community settings by trained peers with high fidelity, acceptability, and perceived usefulness. Results provided some areas where the program could be improved. Our rigorous evaluation illustrates methods for evaluating processes of translating EBIs for community implementation. TRIAL REGISTRATION: NCT01383174 (ClinicalTrials.gov).

Development of a survey instrument to measure patient experience of integrated care.

BACKGROUND: Healthcare systems are working to move towards more integrated, patient-centered care. This study describes the development and testing of a multidimensional self-report measure of patients' experiences of integrated care. METHODS: Random-digit-dial telephone survey in 2012 of 317 adults aged 40 years or older in the San Francisco region who had used healthcare at least twice in the past 12 months. One-time cross-sectional survey; psychometric evaluation to confirm dimensions and create multi-item scales. Survey data were analyzed using VARCLUS and confirmatory factor analysis and internal consistency reliability testing. RESULTS: Scales measuring five domains were confirmed: coordination within and between care teams, navigation (arranging appointments and visits), communication between specialist and primary care doctor, and communication between primary care doctor and specialist. Four of these demonstrated excellent internal consistency reliability. Mean scale scores indicated low levels of integration. CONCLUSION: These scales measuring integrated care capture meaningful domains of patients' experiences of health care. The low levels of care integration reported by patients in the study sample suggest that these types of measures should be considered in ongoing evaluations of health system performance and improvement. Further research should examine whether differences in patient experience of integrated care are associated with differences in the processes and outcomes of care received.

Development of the Stress of Immigration Survey: A Field Test Among Mexican Immigrant Women.

The Stress of Immigration Survey (SOIS) is a screening tool used to assess immigration-related stress. The mixed methods approach included concept development, pretesting, field testing, and psychometric evaluation in a sample of 131 low-income women of Mexican descent. The 21-item SOIS screens for stress related to language, immigrant status, work issues, yearning for family and home country, and cultural dissonance. Mean scores ranged from 3.6 to 4.4 (a scale of 1-5, higher is more stress). Cronbach α values were more than 0.80 for all subscales. The SOIS may be a useful screening tool for detecting high levels of immigration-related stress in low-income Mexican immigrant women.

Physician counseling on colorectal cancer screening and receipt of screening among Latino patients.

BACKGROUND: Latinos have lower rates of colorectal cancer (CRC) screening and later stage diagnosis than Whites, which may be partially explained by physician communication factors. OBJECTIVE: We assessed associations between patient-reported physician counseling regarding CRC screening and receipt of CRC screening among Latino primary care patients. DESIGN: This was a cross-sectional telephone survey. PARTICIPANTS: The participants of this study were Latino primary care patients 50 years of age or older, with one or more visits during the preceding year. MAIN MEASURES: We developed patient-reported measures to assess whether physicians provided explanations of CRC risks and tests, elicited patients' barriers to CRC screening, were responsive to patients' concerns about screening, and encouraged patients to be screened. Outcomes were patient reports of receipt of endoscopy (sigmoidoscopy or colonoscopy) and fecal occult blood test (FOBT) within recommended guidelines. KEY RESULTS: Of 817 eligible patients contacted, 505 (62 %) completed the survey; mean age was 61 years (SD 8.4), 69 % were women, and 53 % had less than high school education. Forty-six percent reported obtaining endoscopy (with or without FOBT), 13 % reported FOBT only, and 41 % reported no CRC screening. In bivariate analyses, physician explanations, elicitation of barriers, responsiveness to concerns, and greater encouragement for screening were associated with receipt of endoscopy (p < 0.001), and explanations (p < 0.05) and encouragement (p < 0.001) were associated with FOBT. Adjusting for covariates, physician explanations (OR = 1.27; 95 % CI 1.03, 1.58) and greater physician encouragement (OR = 6.74; 95 % CI 3.57, 12.72) were associated with endoscopy; patients reporting quite a bit/a lot of physician encouragement had six times higher odds of obtaining the FOBT as those reporting none/a little encouragement (OR = 6.54; 95 % CI 2.76, 15.48). CONCLUSIONS: Among primarily lower-socioeconomic status Latino patients, the degree to which patients perceived that physicians encouraged CRC screening was more strongly associated with screening than with providing risk information, eliciting barriers, and responding to their concerns about screening.

Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer.

OBJECTIVES: We evaluated a community-based, translational stress management program to improve health-related quality of life in Spanish-speaking Latinas with breast cancer. METHODS: We adapted a cognitive-behavioral stress management program integrating evidence-based and community best practices to address the needs of Latinas with breast cancer. Spanish-speaking Latinas with breast cancer were randomly assigned to an intervention or usual-care control group. Trained peers delivered the 8-week intervention between February 2011 and February 2014. Primary outcomes were breast cancer-specific quality of life and distress, and general symptoms of distress. RESULTS: Of 151 participants, 95% were retained at 6 months (between May 2011 and May 2014). Improvements in quality of life from baseline to 6 months were greater for the intervention than the control group on physical well-being, emotional well-being, breast cancer concerns, and overall quality of life. Decreases from baseline to 6 months were greater for the intervention group on depression and somatization. CONCLUSIONS: Results suggest that translation of evidence-based programs can reduce psychosocial health disparities in Latinas with breast cancer. Integration of this program into community-based organizations enhances its dissemination potential.

Defining novel health-related quality of life domains in lung transplantation: a qualitative analysis.

PURPOSE: Health-related quality of life (HRQL) domains vary across disease conditions and are determined by standards, values, and priorities internal to patients. Although the clinical goals of lung transplantation are to improve patient survival and HRQL, what defines HRQL in lung transplantation is unknown. Employing a qualitative approach, we aimed to identify HRQL domains important in lung transplantation. METHODS: We conducted semi-structured interviews in purposefully sampled lung transplant recipients (n = 8) representing a spectrum of ages, gender, indications for transplantation, and time since transplantation as well as healthcare practitioners representing a spectrum of practitioner types (n = 9). Grounded theory was used to identify HRQL domains important in lung transplantation, building on but going beyond domains already defined in the SF-36, the most commonly used instrument in this population. RESULTS: In addition to confirming the relevance of the eight SF-36 domains, we identified 11 novel HRQL domains. Palliation of respiratory symptoms was identified as important. After transplant surgery, new HRQL domains emerged including: distressing symptoms spanning multiple organ systems, worry about infection and acute rejection, treatment burden, and depression. Further, patients identified challenges to intimacy, changes in social relationships, and problems with cognitive functioning. Saliently, worry about limited life expectancy was pervasive and impaired life planning. CONCLUSIONS: We found that HRQL in lung transplantation is defined by both generic and transplant-specific domains. Delineating and refining these domains can inform efforts to improve clinical outcomes and HRQL measurement in lung transplantation.

Study protocol for a cluster randomized trial of the Community of Voices choir intervention to promote the health and well-being of diverse older adults.

BACKGROUND: Older adults are the fastest growing segment of the United States population. There is an immediate need to identify novel, cost-effective community-based approaches that promote health and well-being for older adults, particularly those from diverse racial/ethnic and socioeconomic backgrounds. Because choral singing is multi-modal (requires cognitive, physical, and psychosocial engagement), it has the potential to improve health outcomes across several dimensions to help older adults remain active and independent. The purpose of this study is to examine the effect of a community choir program (Community of Voices) on health and well-being and to examine its costs and cost-effectiveness in a large sample of diverse, community-dwelling older adults. METHOD/DESIGN: In this cluster randomized controlled trial, diverse adults age 60 and older were enrolled at Administration on Aging-supported senior centers and completed baseline assessments. The senior centers were randomly assigned to either start the choir immediately (intervention group) or wait 6 months to start (control). Community of Voices is a culturally tailored choir program delivered at the senior centers by professional music conductors that reflects three components of engagement (cognitive, physical, and psychosocial). We describe the nature of the study including the cluster randomized trial study design, sampling frame, sample size calculation, methods of recruitment and assessment, and primary and secondary outcomes. DISCUSSION: The study involves conducting a randomized trial of an intervention as delivered in "real-world" settings. The choir program was designed using a novel translational approach that integrated evidence-based research on the benefits of singing for older adults, community best practices related to community choirs for older adults, and the perspective of the participating communities. The practicality and relatively low cost of the choir intervention means it can be incorporated into a variety of community settings and adapted to diverse cultures and languages. If successful, this program will be a practical and acceptable community-based approach for promoting health and well-being of older adults. TRIAL REGISTRATION: ClinicalTrials.gov NCT01869179 registered 9 January 2013.

Randomized controlled trial of Nuevo Amanecer: a peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer.

BACKGROUND: Latinas with breast cancer suffer symptom and psychosocial health disparities. Effective interventions have not been developed for or tested in this population. PURPOSE: We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program, a culturally tailored, peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer, and unique considerations in implementing a randomized controlled trial to test the program in community settings. METHODS: We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial, emphasizing community engagement processes. RESULTS: In phase 1, we established project infrastructure: academic and community co-principal investigators, community partners, community advisory board, steering committee, and funding. In phase 2, we identified three program inputs: formative research, a community best-practices model, and an evidence-based intervention tested in non-Latinas. In phase 3, we created the new program by integrating and adapting intervention components from the three sources, making adaptations to accommodate low literacy, Spanish language, cultural factors, community context, and population needs. In phase 4, we built community capacity for the program and trial by training field staff (recruiters and interventionists embedded in community sites), compensating field staff, and creating a system for identifying potential participants. In phase 5, we implemented and monitored the program and trial. Engaging community partners in all phases has resulted in a new, culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners. Lessons learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings. Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation. Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues. Randomization was challenging due to community concerns about assigning women to a control group. Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment. LIMITATIONS: These were resource-intensive processes to develop and implement the program that need to be compared to less-intensive alternatives. CONCLUSION: Engaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context. If the randomized trial demonstrates that the intervention is effective, it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer.

Age-related differences in the association between financial hardship and weight change during the COVID-19 pandemic.

Objective: To examine the association of financial hardship with weight changes in the US during the COVID-19 pandemic. Methods: We used data from the COVID-19's Unequal Racial Burden survey, a nationally representative, cross-sectional, online survey of diverse adults living in the US, 12/2020-2/2021. This study included 1000 Asian, Black, Latino (half Spanish-speaking), and White adults and 500 American Indian or Alaska Native, Native Hawaiian or Pacific Islander, and multiracial adults (5500 total). Age-specific (18-39, 40-59, ≥60) associations between financial hardship domains and weight change were estimated using multinomial logistic regression, adjusted for demographic and health characteristics. Results: Financial hardship during the COVID-19 pandemic was prevalent across all age groups (18-39: 76.2 %; 40-59: 75.6 %; ≥60: 50.6 %). Among adults aged 18-39 and ≥ 60 years old, food insecurity was significantly associated with weight loss (18-39: aOR = 1.42, 95 % CI = 1.04, 1.95; ≥60: aOR = 3.67, 95 % CI = 1.50, 8.98). Among all age groups, unmet healthcare expenses was also associated with weight loss (18-39: aOR = 1.31, 95 % CI = 1.01, 1.70; 40-59: aOR = 1.49, 95 % CI = 1.06, 2.08; ≥60: aOR = 1.73, 95 % CI = 1.03, 2.91). Among adults aged 18-39 and ≥ 60 years old, lost income was significantly associated with weight gain (18-39: aOR = 1.36, 95 % CI = 1.09-1.69; ≥60: aOR = 1.46, 95 % CI = 1.04, 2.06), and among adults 40-59 years old, experiencing increased debt was significantly associated with weight gain (aOR = 1.50, 95 % CI = 1.13, 1.99). Conclusions: For those aged 18-39 and ≥ 60 years old experiencing financial hardship during the COVID-19 pandemic was associated with both weight loss and weight gain. Less correlation was observed among adults aged 40-59.

Patient-physician interaction and quality of life in recently diagnosed breast cancer patients.

Few studies have explored how patient-physician interactions influence patients' quality of life (QOL). In a prospective cohort study of 1,855 women diagnosed with invasive breast cancer in the Kaiser Permanente Northern California Medical Care Program from 2006 to 2011, we examined associations between patient-physician interactions during cancer treatment and QOL, overall and by racial/ethnic group. Participants completed the interpersonal processes of care (IPC) survey at approximately 8 months post-diagnosis to assess specific domains of the patient-physician interaction during the months after cancer diagnosis. Domains included: compassion, elicited concerns, explained results, decided together, lack of clarity, discrimination due to race/ethnicity, and disrespectful office staff. The functional assessment of cancer therapy-breast cancer was completed concurrently to measure QOL. Linear regression models examined the association of IPC with QOL, first adjusting for patient covariates including age, race, clinical factors, and psychosocial measures and then for physician characteristics such as age, sex, race/ethnicity, and specialty. For all participants (n = 1,855), IPC scores suggesting greater lack of clarity, discrimination due to race/ethnicity, and disrespectful office staff in patient-physician interactions were associated with lower QOL (P< 0.01). IPC scores suggesting physicians demonstrating compassion, eliciting concerns, or explaining results were associated with higher QOL (P< 0.01). Among Whites (n = 1,306), only the associations with higher QOL remained. African Americans (n = 110) who reported higher scores on physician compassion and elicited concerns had higher QOL, whereas higher scores for disrespectful office staff had lower QOL. No associations were observed among Asians (n = 201) and Hispanics (n = 186). After further adjustment for physician factors, the associations among Whites remained, whereas those among African Americans disappeared. In the breast cancer treatment setting, characteristics of the patient-physician interaction as perceived by the patient are associated with QOL, yet were not specific to patient race/ethnicity.