Predictors of Psychological Distress Among Rural Family/Friend Caregivers of People Living With Dementia in the United States: Consequences of the COVID-19 Pandemic.

OBJECTIVES: Caregivers of persons living with dementia in rural United States are a vulnerable population. During the coronavirus disease 2019 (COVID-19) pandemic, rural communities experienced heightened disparities in social services, healthcare, suicides, and mortality. Guided by the Caregiving Stress Process Model, this study examines the relationship between the stressors and resources of rural caregivers of persons living with dementia and their experience of depression, stress, and COVID-19. METHODS: One hundred and fifty-two rural caregivers of persons living with dementia completed an online survey, March 1, 2021-April 30, 2022. Analyses used baseline responses to validated scales and an open-ended question, "How has COVID impacted your life as a caregiver?" Dependent variables were depressive symptoms and stress. Bivariate and hierarchical linear regression analyses examined associations of stressors and resources with depressive symptoms and stress. Thematic analysis examined open-ended question responses. RESULTS: Among examined stressors, high care burden (b = 1.94, p < .05) and loneliness (b = 0.76, p < .0001) were positively associated with depressive symptoms. Loneliness (b = 0.24, p < .05) and ≥41 hr spent caregiving per week (reference 10-20 hr; b = 0.99, p < .05) were associated with stress. Among examined resources, self-efficacy for caregiving (b = -0.21, p < .05) was inversely associated with stress. Qualitative results confirmed quantitative results and identified additional pandemic-related themes in stressors and resources. DISCUSSION: We found that caregiver burden, loneliness, and caregiving hours were associated with greater psychological distress among rural caregivers of persons living with dementia during the pandemic, whereas self-efficacy for caregiving was protective. Rural caregivers need increased support to address care burdens and enhance psychological resources for caregiving. CLINICAL TRIAL REGISTRATION NUMBER: NCT04428112.

Evaluating the implementation of Nuevo Amanecer-II in rural community settings using mixed methods and equity frameworks.

BACKGROUND: The 10-week Nuevo Amanecer-II intervention, tested through a randomized controlled trial, reduced anxiety and improved stress management skills among Spanish-speaking Latina breast cancer survivors. This paper describes the implementation and equity evaluation outcomes of the Nuevo Amanecer-II intervention delivered in three California rural communities. METHODS: Using implementation and equity frameworks, concurrent convergent mixed methods were applied to evaluate implementation (feasibility, fidelity, acceptability, adoption, appropriateness, and sustainability) and equity (shared power and capacity building) outcomes. Quantitative data were collected using tracking forms, fidelity rating forms, and program evaluation surveys; qualitative data were collected using semi-structured in-depth interviews. Respondents included community-based organization (CBO) administrators, recruiters, compañeras (interventionists), and program participants. RESULTS: Of 76 women randomized to the intervention, 65 (86%) completed at least 7 of 10 sessions. Participants' knowledge (85% correct of 7 questions) and skills mastery were high (85% able to correctly perform 14 skills). Mean fidelity ratings across compañeras ranged from 3.8 (modeled skills) to 5.0 (used supportive/caring communication); 1-5 scale. The program was rated as very good/excellent by 90% of participants. Participants and compañeras suggested including family members; compañeras suggested expanding content on managing thoughts and mood and healthy living and having access to participant's survivorship care plan to tailor breast cancer information. CBOs adopted the program because it aligned with their priority populations and mission. Building on CBOs' knowledge, resources, and infrastructure, implementation success was due to shared power, learning, responsibility, and co-ownership, resulting in a co-created tailored program for community and organizational contexts. Building intervention capacity prior to implementation, providing funding, and ongoing technical support to CBOs were vital for fidelity and enhancement of recruiter and compañera professional skills. Two of three CBOs created plans for program sustainability beyond the clinical trial; all administrators discussed the need for new funding sources to sustain the program as delivered. CONCLUSIONS: Building on community assets and using equitable participatory research processes were central to the successful implementation of a peer-delivered psychosocial intervention in three rural communities among Spanish-speaking Latinas with breast cancer.

Financial strain, neighborhood cohesion, and health-related quality of life among rural and urban Spanish-speaking Latina breast cancer survivors.

PURPOSE: Among Latina breast cancer survivors, explore associations between rural/urban residence and health-related quality of life (HRQL), and whether associations are moderated by financial strain and low neighborhood cohesion. METHODS: We combined baseline data from two randomized controlled trials of a stress management intervention conducted among 151 urban and 153 rural dwelling Latinas with nonmetastatic breast cancer. Generalized linear models estimated associations between rural/urban status and HRQL (overall, emotional, social-family, physical, and functional well-being), and we examined moderation effects of financial strain and low neighborhood cohesion, controlling for age, marital status, and breast cancer characteristics. RESULTS: Rural women reported better emotional (ß = 1.85; 95% CI = 0.37, 3.33), functional (ß = 2.23; 95% CI = 0.69, 3.77), and overall (ß = 5.68; 95% CI = 1.12, 10.25) well-being than urban women, regardless of degree of financial strain or neighborhood cohesion; moderation effects were not statistically significant. Financial strain was inversely associated with emotional (ß = -2.34; 95% CI = 3.63, -1.05), physical (ß = -2.56; 95% CI = -4.12, -1.01), functional (ß = -1.61; 95% CI = -2.96, -0.26), and overall (ß = -6.67; 95% CI = -10.96, -2.98) well-being. Low neighborhood cohesion was inversely associated with emotional (ß = -1.27; 95% CI = -2.50, -0.04), social-family (ß = -1.72; 95% CI = -3.02, -0.42), functional (ß = -1.63; 95% CI = -2.92, -0.34), and overall (ß = -5.95; 95% CI = 9.76, -2.14) well-being. CONCLUSIONS: Rural Latina breast cancer survivors reported better emotional, functional and overall well-being than their urban counterparts. Greater financial strain and less neighborhood cohesion were associated with worse HRQL on most domains regardless of rural/urban context. IMPLICATIONS FOR CANCER SURVIVORS: Interventions that focus on increasing perceived neighborhood cohesion and reducing or better managing financial strain, could help improve Latina cancer survivors' well-being.

An Ecologic Model for Identifying Coping Resources to Manage Psychological Distress Among Spanish-Speaking Latina Women Newly Diagnosed With Breast Cancer.

OBJECTIVES: To examine associations of coping resources for psychological distress among newly diagnosed Spanish-speaking Latina women with breast cancer (LWBC). SAMPLE & SETTING: Analyses used baseline data from a randomized controlled trial of a stress management intervention among 151 LWBC. METHODS & VARIABLES: Dependent variables were health distress and anxiety. Coping resources at the intrapersonal, interpersonal, and organizational/community levels were included. RESULTS: At the intrapersonal level, self-efficacy for coping with breast cancer treatment was associated inversely with health distress and anxiety, and coping confidence with general problems was associated inversely with health distress. At the interpersonal level, having a sense of neighborhood cohesion was associated inversely with health distress. No organizational/community level resources were associated with health distress or anxiety. IMPLICATIONS FOR NURSING: Interventions that enhance self-efficacy in coping and foster skills to identify sources of neighborhood support may decrease psychological distress for Spanish-speaking LWBC.

Study protocol for a hybrid effectiveness-implementation trial of the Building Better Caregivers online workshop for rural family/friend caregivers of people living with dementia.

INTRODUCTION: Dementia caregiving is complex and disproportionally burdens caregivers living in rural areas due to fewer resources and formal support systems. There is an immediate need to identify effective, scalable, and accessible online programs to support rural caregivers' well-being. Building Better Caregivers (BBC), a possible solution, is an asynchronous online 6-week, interactive, and skills-building workshop developed for caregivers of persons with dementia. This research aims to assess the effectiveness and implementation of the BBC workshop when delivered among rural dementia caregivers in the United States. METHODS: A hybrid effectiveness and implementation trial applying mixed methods will be conducted in collaboration with local, state, and national partnering organizations. Eligible participants live in a rural area of the United States, give care at least 10 h a week for a family member or friend with dementia, and have internet access. Evaluation is based on the RE-AIM framework. Effectiveness outcomes are assessed using a randomized control trial. Caregivers are randomly assigned to the BBC workshop (intervention) or attention control group. Implementation outcomes are assessed using surveys and debriefing interviews from partnering organizations and participants. The study protocol including the study design, methods of recruitment and assessment, and outcomes are described. CONCLUSION: This is the first known study to evaluate both the effectiveness and implementation of a caregiver support intervention under real-world conditions in rural areas. If successful, this online workshop will be a practical and acceptable approach for promoting the health and well-being of geographically isolated rural dementia caregivers.

Cortisol levels in rural Latina breast cancer survivors participating in a peer-delivered cognitive-behavioral stress management intervention: The Nuevo Amanecer-II RCT.

Background: Compared to their White counterparts, Latina breast cancer survivors have poorer survival rates and health-related quality of life, and higher rates of depression and anxiety which may be a result of chronic stress. Chronic stress impacts the hypothalamic-pituitary-adrenal (HPA) axis, resulting in cortisol dysregulation which may be associated with breast cancer survival. However, cortisol levels and cortisol profiles of Latina breast cancer survivors are poorly characterized due to their underrepresentation in biomedical research. Objective: The objective of this study was to describe cortisol levels and patterns of cortisol secretions in rural Latina breast cancer survivors participating in an RCT study of Nuevo Amanecer-II, an evidence-based peer-delivered cognitive behavioral stress management intervention. Methods: Participant-centered recruitment and collection strategies were used to obtain biospecimens for cortisol analysis. Nine saliva samples (3/day for 3 days) and a hair sample were obtained at baseline and 6-months (3-months post-intervention). We describe cortisol levels and profiles, explore correlations of biomarkers with self-report measures of stress and psychological distress, and compare women who received the intervention with a delayed intervention group on biomarkers of stress. Mean hair cortisol concentration (HCC) was used to assess chronic stress. Based on daily measures of cortisol (awakening, 30 min post-awakening, and bedtime), we calculated three summary measures of the dynamic nature of the cortisol awakening response (CAR): 1) the CAR slope, 2) whether CAR demonstrates a percent change ≥40, and 3) total daily cortisol output (AUCg). Linear and log-binomial regression, accounting for multiple samples per participant, were used to compare cortisol measures at 6-month follow-up by treatment arm. Results: Participants (n = 103) were from two rural California communities; 76 provided at least one saliva sample at baseline and follow-up and were included in the analysis. At baseline, mean age was 57 years, mean years since diagnosis was 2 years, 76% had a high school education or less, and 34% reported financial hardship. The overall median CAR slope was 0.10, and median cortisol AUCg (in thousands) was 11.34 (range = 0.93, 36.66). Mean hair cortisol concentration was 1751.6 pg/mg (SD = 1148.6). Forty-two percent of samples had a ≥40% change in CAR. We found no statistically significant correlations between the cortisol measures and self-reported measures of stress and psychological distress. At follow-up, no differences were seen in HCC (mean difference between intervention and control: -0.11, 95% CI -0.48, 0.25), CAR slope (0.001, 95% CI -0.005, 0.008), cortisol AUCg (-0.15, 95% CI -0.42, 0.13), or ≥40% change in CAR (prevalence ratio 0.87, 95% CI 0.42, 1.77) between treatment arms. Conclusion: Our findings of flattened cortisol profiles among more than half of the sample suggest potential HPA-axis dysregulation among rural Spanish-speaking Latina breast cancer survivors that merits further study due to its implications for long-term survival. Trial registration: http://www.ClinicalTrials.gov identifier NCT02931552.

Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study.

BACKGROUND: An often heard and justifiable concern of ethnic minorities is related to researchers' lack of attention to sharing the results of a study with participants after the study has concluded. Few studies have examined the effects of returning overall study results on participants' attitudes, especially among populations underrepresented in research. Among Latina research participants, providing a summary of study results could enhance participation in research. We assess Latina breast cancer survivors' reactions to receiving study results and their attitudes about participating in future studies. METHODS: For this cross-sectional survey study, all women who had participated in two behavioral randomized controlled trials (RCTs) were mailed a letter summarizing the study results (using written and graphic formats) and a questionnaire assessing problems and understanding the results, importance of sharing results, willingness to participate in future studies, and format preferences for receiving the results. A postage-paid envelope for returning the completed questionnaire was included. Logistic regression examined the associations of age, education, and rural/urban residence on format preferences and willingness to participate. The survey sample consisted of 304 low-income, predominantly Spanish-speaking Latina breast cancer survivors (151 from urban and 153 from rural communities) who had participated in two RCTs testing a stress management program designed for Latina breast cancer survivors. RESULTS: Ninety-two women returned the questionnaires (30.3%). Most of the women (91.1%) indicated that they had no trouble understanding the results of the study, and 97% agreed that it is very/extremely important for researchers to share the study result with the participants. The majority (60.2%) reported that receiving the results increased their willingness to participate in future studies. About half (51.7%) did not have a format preference, 37.4% preferred written summaries, and 10.9% preferred graphs. CONCLUSIONS: This study is an important first step to understanding the impact of returning study results among a population that is underrepresented in research. Returning the results of studies and understanding the impact of doing so is consistent with maintaining community involvement in all phases of research. The findings suggest that sharing aggregate research results in simple language yields few problems in participants' understanding of the results and is viewed as important by participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT02931552 Date registered: October 13, 2016 and NCT01383174 Date registered: June 28, 2011.

Self-Efficacy for Coping with Breast Cancer Treatment Among Spanish-Speaking Latinas.

Background: Cancer-related self-efficacy, a multidimensional construct, is the confidence that one can overcome challenges associated with cancer and its treatment; higher levels have been associated with better psychosocial outcomes of breast cancer survivors. Little is known about factors that influence it among Latina breast cancer survivors. Purpose: Assess associations of several aspects of health care processes and of spirituality with self-efficacy for coping with breast cancer treatment among primarily Spanish-speaking Latina breast cancer survivors. Methods: We analyzed baseline data from a randomized controlled trial of a cognitive-behavioral stress management intervention that enrolled 151 Spanish-speaking Latinas within 1 year of breast cancer diagnosis. Multivariate linear regression models examined associations of health care processes (quality of breast cancer care and information, participating in medical care, difficulty engaging with doctors) and spirituality (meaning/peace, faith, acceptance) with self-efficacy for coping with breast cancer treatment. Results: Mean age was 51 (standard deviation [SD]=11), 66% completed high school or less, and most reported financial hardship in the past year (78%). Average time since diagnosis was 3.8 months (SD=2.7). In bivariate analyses, all six determinants were significantly associated with self-efficacy for coping with breast cancer treatment; participating in medical care (B=0.56, p<0.001) and having a sense of meaning/peace (B=0.76; p<0.001) were independently associated, controlling for sociodemographic and treatment characteristics. Discussion: Interventions that promote participation in treatment decisions and sense of meaning and peace could improve confidence in coping with breast cancer treatment, and potentially quality of life, among Latinas living with breast cancer (Trial Registration Number: NCT01383174 [ClinicalTrials.gov]).

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.

Guidelines for Evaluating the Feasibility of Recruitment in Pilot Studies of Diverse Populations: An Overlooked but Important Component.

Background: In health disparities research, studies often fall short of their recruitment goals. Conducting a pilot feasibility study of recruitment in which data are collected systematically on recruitment processes can help investigators refine methods for the larger study. However, there are few guidelines for conducting pilot feasibility studies, and recruitment methods are seldom the focus. Feasibility indicators differ from traditional reports of recruitment results by focusing on the extent to which recruitment goals are met. Methods: We present an organizing framework for assessing the feasibility of recruitment that includes eight steps, briefly: 1) specify recruitment goals; 2) specify recruitment processes; 3) establish a tracking system for each individual; 4) establish a tracking database for monitoring processes and results; 5) implement recruitment and track each individual's progress; 6) summarize recruitment results; 7) calculate and interpret feasibility measures - were goals met; and 8) if goals were not met, utilize tracking data to modify methods for the larger study. We describe methods within each step, with added details for steps 2-5 (the specific processes). The framework draws from a small literature on recruitment feasibility with a focus on health disparities populations. The guidelines blend well-known methods of recruitment with additional information on calculating feasibility indicators. Conclusions: These guidelines provide a first step in thinking systematically about recruitment feasibility, to advance the field of measuring feasibility. Feasibility indicators also can be used to track the effectiveness of innovative recruitment strategies as part of building the science of recruitment, especially in disparities populations.

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.

Participant-Centered Strategies for Overcoming Barriers to Biospecimen Collection among Spanish-Speaking Latina Breast Cancer Survivors.

BACKGROUND: Latinos are underrepresented in biomedical research, particularly biomarker research, yet they constitute the nation's largest ethnic/racial minority. Optimal methods for obtaining biospecimens for biomarker research among Latinos need to be identified. To minimize barriers and enhance participation, this study developed and tested tailored strategies for collecting biomarkers of chronic stress and premature aging among Spanish-speaking Latina breast cancer survivors. METHODS: This study used a community-based participatory approach and selected hair and saliva as noninvasive biospecimens to assess telomere length, the cortisol awakening response (CAR), and hair cortisol concentration. We developed bilingual multimedia instructional materials, and community health workers assisted in collections. Telephone surveys assessed willingness to participate in future studies, barriers to sample collection, and recommendations for improving the strategies. RESULTS: A total of 103 participants were recruited over 18 months from two rural sites in California, and 88 were retained at 6-month follow-up. At baseline, rates of donating salivary DNA for telomere length measurement, saliva for CAR analysis, and hair for cortisol concentration were 98%, 89%, and 52%, respectively. At follow-up, rates were 83%, 76%, and 55%, respectively. The majority of participants reported being very willing to provide hair (72%) or saliva (74%) for future studies. CONCLUSIONS: Our results support the feasibility of including minorities in biomedical research. We report excellent rates of saliva collection when community partners are engaged in the process, and when patient-centered and culturally tailored recruitment methods are implemented. IMPACT: The development of methods to facilitate the inclusion of minorities in biomedical research is critical to eliminate racial/ethnic health disparities.

Translating a stress management intervention for rural Latina breast cancer survivors: The Nuevo Amanecer-II.

OBJECTIVES: Adapt a cognitive-behavioral stress management program (Nuevo Amanecer or NA) to be generalizable to rural, low literacy Spanish-speaking Latinas with breast cancer survivors at all phases of survivorship. METHODS: Apply the Transcreation Framework, a community-engaged translational model, to develop the adapted program (Nuevo Amanecer or NA-II), design a randomized controlled trial for community settings, identify recruiters and interventionists, and recruit participants into the trial. RESULTS: Adaptations included expanding the program from eight to ten weeks, simplifying materials, and increasing skills practice. We added stress management videos, healthy lifestyles information, and survivorship information. Interventionists were trained Latina breast cancer survivors. All core components of NA were retained in NA-II including managing the impact of cancer, information on breast cancer and its treatment, finding cancer information, getting support, managing thoughts, stress management techniques, and setting goals. Participants receive a program manual. Each session includes a review of that week's content using the manual, practicing a stress-management skill, setting a specific goal, and reviewing videos. Spanish-speaking Latinas with non-metastatic breast cancer were recruited by community recruiters. Of 231 women approached, 24% refused, 10% were ineligible, and 153 (66%) were randomized to the intervention or a wait-list control group. The sample was vulnerable: 69% had < high school education, more than half had only Medicaid or no insurance, 91% was foreign born, and 48% reported financial hardship in the past year. CONCLUSIONS: Applying the Transcreation Framework to engage stakeholders in designing community-based RCTs enhanced congruence with community contexts and recruitment of this vulnerable population.

Feasibility of a Mobile Phone App and Telephone Coaching Survivorship Care Planning Program Among Spanish-Speaking Breast Cancer Survivors.

BACKGROUND: Spanish-speaking Latina breast cancer survivors experience disparities in knowledge of breast cancer survivorship care, psychosocial health, lifestyle risk factors, and symptoms compared with their white counterparts. Survivorship care planning programs (SCPPs) could help these women receive optimal follow-up care and manage their condition. OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of a culturally and linguistically suitable SCPP called the Nuevo Amanecer (New Dawn) Survivorship Care Planning Program for Spanish-speaking breast cancer patients in public hospital settings, approaching the end of active treatment. METHODS: The 2-month intervention was delivered via a written bilingual survivorship care plan and booklet, Spanish-language mobile phone app with integrated activity tracker, and telephone coaching. This single-arm feasibility study used mixed methods to evaluate the intervention. Acceptability and feasibility were examined via tracking of implementation processes, debriefing interviews, and postintervention satisfaction surveys. Preliminary efficacy was assessed via baseline and 2-month interviews using structured surveys and pre- and postintervention average daily steps count based on activity tracker data. Primary outcomes were self-reported fatigue, health distress, knowledge of cancer survivorship care, and self-efficacy for managing cancer follow-up health care and self-care. Secondary outcomes were emotional well-being, depressive and somatic symptoms, and average daily steps. RESULTS: All women (n=23) were foreign-born with limited English proficiency; 13 (57%) had an elementary school education or less, 16 (70%) were of Mexican origin, and all had public health insurance. Coaching calls lasted on average 15 min each (SD 3.4). A total of 19 of 23 participants (83%) completed all 5 coaching calls. The majority (n=17; 81%) rated the overall quality of the app as "very good" or "excellent" (all rated it as at least "good"). Women checked their daily steps graph on the app between 4.2 to 5.9 times per week. Compared with baseline, postintervention fatigue (B=-.26; P=.02; Cohen d=0.4) and health distress levels (B=-.36; P=.01; Cohen d=0.3) were significantly lower and knowledge of recommended follow-up care and resources (B=.41; P=.03; Cohen d=0.5) and emotional well-being improved significantly (B=1.42; P=.02; Cohen d=0.3); self-efficacy for managing cancer follow-up care did not change. Average daily steps increased significantly from 6157 to 7469 (B=1311.8; P=.02; Cohen d=0.5). CONCLUSIONS: We found preliminary evidence of program feasibility, acceptability, and efficacy, with significant 2-month improvements in fatigue, health distress, and emotional well-being and increased knowledge of recommended follow-up care and average daily steps. Tailored mobile phone and health coaching SCPPs could help to ensure equitable access to these services and improve symptoms and physical activity levels among Spanish-speaking Latina breast cancer survivors.

A Pragmatic Cluster Randomized Trial of an Electronic Clinical Decision Support System to Improve Chronic Kidney Disease Management in Primary Care: Design, Rationale, and Implementation Experience.

BACKGROUND: The diagnosis of chronic kidney disease (CKD) is based on laboratory results easily extracted from electronic health records; therefore, CKD identification and management is an ideal area for targeted electronic decision support efforts. Early CKD management frequently occurs in primary care settings where primary care providers (PCPs) may not implement all the best practices to prevent CKD-related complications. Few previous studies have employed randomized trials to assess a CKD electronic clinical decision support system (eCDSS) that provided recommendations to PCPs tailored to each patient based on laboratory results. OBJECTIVE: The aim of this study was to report the trial design and implementation experience of a CKD eCDSS in primary care. METHODS: This was a 3-arm pragmatic cluster-randomized trial at an academic general internal medicine practice. Eligible patients had 2 previous estimated-glomerular-filtration-rates by serum creatinine (eGFRCr) <60 mL/min/1.73m2 at least 90 days apart. Randomization occurred at the PCP level. For patients of PCPs in either of the 2 intervention arms, the research team ordered triple-marker testing (serum creatinine, serum cystatin-c, and urine albumin-creatinine-ratio) at the beginning of the study period, to be completed when acquiring labs for regular clinical care. The eCDSS launched for PCPs and patients in the intervention arms during a regular PCP visit subsequent to completing the triple-marker testing. The eCDSS delivered individualized guidance on cardiovascular risk-reduction, potassium and proteinuria management, and patient education. Patients in the eCDSS+ arm also received a pharmacist phone call to reinforce CKD-related education. The primary clinical outcome is blood pressure change from baseline at 6 months after the end of the trial, and the main secondary outcome is provider awareness of CKD diagnosis. We also collected process, patient-centered, and implementation outcomes. RESULTS: A multidisciplinary team (primary care internist, nephrologists, pharmacist, and informaticist) designed the eCDSS to integrate into the current clinical workflow. All 81 PCPs contacted agreed to participate and were randomized. Of 995 patients initially eligible by eGFRCr, 413 were excluded per protocol and 58 opted out or withdrew, resulting in 524 patient participants (188 usual care; 165 eCDSS; and 171 eCDSS+). During the 12-month intervention period, 53.0% (178/336) of intervention patient participants completed triple-marker labs. Among these, 138/178 (77.5%) had a PCP appointment after the triple-marker labs resulted; the eCDSS was opened for 73.9% (102/138), with orders or education signed for 81.4% (83/102). CONCLUSIONS: Successful integration of an eCDSS into primary care workflows and high eCDSS utilization rates at eligible visits suggest this tailored electronic approach is feasible and has the potential to improve guideline-concordant CKD care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02925962; https://clinicaltrials.gov/ct2/show/NCT02925962 (Archived by WebCite at http://www.webcitation.org/78qpx1mjR). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14022.

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.

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).

Post-Treatment Survivorship Care Needs of Spanish-speaking Latinas with Breast Cancer.

BACKGROUND: A comprehensive assessment of Spanish-speaking breast cancer survivors' (SSBCS) survivorship needs is lacking. OBJECTIVE: Assess SSBCS' post-treatment symptom management, psychosocial, and informational needs. METHODS: 118 telephone surveys and 25 in-person semi-structured interviews with SSBCS, and semi-structured interviews with 5 support providers and 4 physicians who serve SSBCS from 5 Northern California counties. RESULTS: Surveys identified the most bothersome (bothered by it in the past month "somewhat/quite a bit/a lot") physical symptoms as: joint pain, fatigue, hot flashes, numbness in hands/feet, and vaginal dryness. The most bothersome emotional symptoms were thoughts of recurrence/new cancers, depression/sadness, anxieties, and stress. Seven themes emerged from interviews: 1) unmet physical symptom management needs; 2) social support from family/friends often ends when treatment is completed; 3) challenges resuming roles; 5) sense of abandonment by health care system when treatment ends; 6) need for formal transition from active treatment to follow-up care; 6) fear of recurrence especially when obtaining follow-up care; and 7) desire for information on late effects of initial treatments and side effects of hormonal treatments. Based on survey and interview results, we present a conceptual framework for survivorship care interventions for SSBCS. LIMITATIONS: Sample may not represent SSBCS' concerns seen outside of Northern California hospitals. CONCLUSIONS: Physical and psychosocial symptoms were common. SSBCS need culturally appropriate survivorship care programs that address symptom management, psychosocial concerns, follow-up care, and healthy lifestyles.

Do coping strategies mediate the effects of emotional support on emotional well-being among Spanish-speaking Latina breast cancer survivors?

OBJECTIVE: This study aimed to assess the relationship between emotional social support and emotional well-being among Latina immigrants with breast cancer and test whether two culturally relevant coping strategies, fatalism and acceptance, mediate this relationship. METHODS: One hundred fifty Spanish-speaking Latinas within 1 year of breast cancer diagnosis participating in a randomized trial of a stress management intervention were assessed in person at baseline and via telephone 6 months later. Survey measures included baseline emotional support, fatalism, and acceptance and emotional well-being 6 months later. Generalized linear models estimated direct effects of emotional support on emotional well-being and indirect effects through fatalism and acceptance. RESULTS: Mean age was 50.1 (SD = 10.9) years; most women had low education and acculturation levels. Emotional support was negatively associated with fatalism (r = -0.24, p < 0.01) and positively associated with acceptance (r = 0.30, p < 0.001). Emotional support (r = 0.23, p = 0.005) and acceptance (r = 0.28, p = 0.001) were positively associated with emotional well-being, whereas fatalism (r = -0.36, p < 0.0001) was negatively associated with emotional well-being. In multivariable models, emotional support was associated with emotional well-being (b = 0.88, 95% CI: 0.24, 1.52). This direct effect remained significant when additionally controlling for fatalism (b = 0.66, 95% CI: 0.03, 1.30) and acceptance (b = 0.73, 95% CI: 0.09, 1.37) in separate models. There was a significant indirect effect of emotional support on emotional well-being through fatalism (b = 0.21, 95% CI: 0.04, 0.51) as well as a marginally significant effect through acceptance (b = 0.15, 95% CI: 0.001, 0.43). CONCLUSIONS: Emotional support may increase well-being among Spanish-speaking Latina cancer survivors by reducing cancer fatalism.Copyright © 2015 John Wiley & Sons, Ltd.

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.