Formative Evaluation of a Comprehensive Self-Management Intervention for Irritable Bowel Syndrome, Comorbid Anxiety, and Depression: Mixed Methods Study.

BACKGROUND: Irritable bowel syndrome (IBS) is a disorder of the gut-brain interaction that is associated with abdominal pain, altered bowel patterns, and reduced quality of life. Up to 50% of patients with IBS also report anxiety or depressive symptoms. Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider the unique needs of patients with comorbid IBS and anxiety or depression. OBJECTIVE: This study aimed to determine the anticipated acceptability, appropriateness, feasibility, and usability of a comprehensive self-management intervention using an implementation science and human-centered design approach among individuals with comorbid IBS and anxiety or depression and health care providers. METHODS: A convergent mixed methods design was used to elicit feedback on the comprehensive self-management intervention outline and content to identify refinement needs before testing. Patients with IBS and moderate to severe anxiety or depression and health care providers were purposefully sampled from primary care and gastroenterology settings. Participants completed semistructured interviews and surveys on anticipated acceptability, appropriateness, feasibility, and usability. RESULTS: Patient participants (n=12) were on average 36.8 (SD 12.2) years of age, and 42% (5/12) were currently receiving psychological therapy. Health care providers (n=14) were from primary care (n=7) and gastroenterology (n=7) settings. The mean usability scores (out of 100) were 52.5 (SD 14.5) for patients and 45.6 (SD 11.6) for providers. For patients and providers, qualitative data expanded the quantitative findings for acceptability and appropriateness. Acceptability findings were the comprehensive nature of the intervention and discussion of the gut-brain interaction. For appropriateness, participants reported that the intervention provided structure, accountability, and support. Feasibility was confirmed for patients, but there was a divergence of findings between quantitative and qualitative measures for providers. Patients focused on intervention feasibility, while providers focused on implementation feasibility in the clinic. Identified usability issues to address before implementation included the intervention delivery format, length, and lack of integration into health care settings that, if not addressed, may limit the reach of the intervention. CONCLUSIONS: Patients and health care providers found the intervention acceptable and appropriate. Several feasibility and usability issues were identified, including intervention delivery methods, length of intervention, and the best methods to implement in the clinic setting. The next steps are to refine the intervention to address the identified issues and test in a pilot study whether addressing usability issues leads to the anticipated improvements in implementation and uptake.

Comparative mortality risks in two independent bipolar cohorts.

OBJECTIVES: To compare mortality rates in bipolar disorder with common causes of mortality. METHODS: Observational data from the Prechter Longitudinal Study of Bipolar Disorder (PLS-BD) of 1128 participants including 281 controls was analyzed using logistical regression to quantify mortality rates in comparison with common comorbidities and causes of death. Outcome and treatment measures, including ASRM, GAD-7, PHQ-9 and medication use were used to stratify those with bipolar disorder (BD) that are alive or deceased. A larger cohort of 10,735 existing BD patients with 7,826 controls (no psychiatric diagnosis) from the University of Michigan Health (U-M Health) clinics was used as replication, observational secondary data analysis. RESULTS: The mortality rates are significantly different between those with BD and controls in both PLS-BD and U-M Health. Those with BD and are deceased have a higher percentage of elevated depression measures but show no difference in mania or anxiety measures nor medication use patterns. In both cohorts, a diagnosis of BD increases the odds of mortality greater than history of smoking or being older than ≥ 60-years of age. CONCLUSION: BD was found to increase odds of mortality significantly and beyond that of a history of smoking. This finding was replicated in an independent sample.

Utility of the CANUKA Scoring System in the Risk Assessment of Upper GI Bleeding.

BACKGROUND: The Canada-United Kingdom-Adelaide (CANUKA) score was developed to stratify patients who experience upper gastrointestinal bleeding (UGIB) to predict who could be discharged from the emergency department. Our aim was to determine if the CANUKA score could be utilized for UGIB in-patients undergoing endoscopy in predicting adverse outcomes. We additionally sought to establish a CANUKA score cut point to predict adverse outcomes and in-hospital mortality and compare this to established scoring systems. METHODS: Between January 1, 2018 to June 30, 2019 all patients who underwent upper endoscopy after admission for UGIB were identified. We assigned a CANUKA score and compared the area under the receiver operating curve to established scoring systems. RESULTS: Our data set included 641 patients, with a mean age of 59.5±14.5 years. A CANUKA score ≥10 was associated with an adverse outcome [unadjusted odds ratio, 3.08 (1.79, 5.27)]. No patients experienced an adverse outcome with a CANUKA score <4. No patients died with a CANUKA score <6. Those with a CANUKA score of <10 had an in-hospital mortality of 2.1% compared with 6.8% for those with a score ≥10 ( P =0.008). AIMS65 had the best area under the receiver operating characteristic curve (0.809) for predicting mortality. CONCLUSIONS: The CANUKA score may serve utility as a predictor of adverse outcomes and mortality in patients admitted with UGIB undergoing endoscopy. Future studies, ideally prospective and multicenter, will be needed to validate its clinical utility.

Usability Issues in Evidence-Based Psychosocial Interventions and Implementation Strategies: Cross-project Analysis.

BACKGROUND: People often prefer evidence-based psychosocial interventions (EBPIs) for mental health care; however, these interventions frequently remain unavailable to people in nonspecialty or integrated settings, such as primary care and schools. Previous research has suggested that usability, a concept from human-centered design, could support an understanding of the barriers to and facilitators of the successful adoption of EBPIs and support the redesign of EBPIs and implementation strategies. OBJECTIVE: This study aimed to identify and categorize usability issues in EBPIs and their implementation strategies. METHODS: We adapted a usability issue analysis and reporting format from a human-centered design. A total of 13 projects supported by the National Institute of Mental Health-funded Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness Center at the University of Washington used this format to describe usability issues for EBPIs and implementation strategies with which they were working. Center researchers used iterative affinity diagramming and coding processes to identify usability issue categories. On the basis of these categories and the underlying issues, we propose heuristics for the design or redesign of EBPIs and implementation strategies. RESULTS: The 13 projects reported a total of 90 usability issues, which we categorized into 12 categories, including complex and/or cognitively overwhelming, required time exceeding available time, incompatibility with interventionist preference or practice, incompatibility with existing workflow, insufficient customization to clients/recipients, intervention buy-in (value), interventionist buy-in (trust), overreliance on technology, requires unavailable infrastructure, inadequate scaffolding for client/recipient, inadequate training and scaffolding for interventionists, and lack of support for necessary communication. These issues range from minor inconveniences that affect a few interventionists or recipients to severe issues that prevent all interventionists or recipients in a setting from completing part or all of the intervention. We propose 12 corresponding heuristics to guide EBPIs and implementation strategy designers in preventing and addressing these usability issues. CONCLUSIONS: Usability issues were prevalent in the studied EBPIs and implementation strategies. We recommend using the lens of usability evaluation to understand and address barriers to the effective use and reach of EBPIs and implementation strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14990.

Cost-effectiveness of Implementing Smoking Cessation Interventions for Patients With Cancer.

Importance: Guidelines recommend cancer care clinicians offer smoking cessation treatment. Cost analyses will help stakeholders understand and plan for implementation of cessation programs. Objective: To estimate the incremental cost per quit (ICQ) of adopting an intensive smoking cessation intervention among patients undergoing treatment at cancer care clinics, from a clinic perspective. Design, Setting, and Participants: This economic evaluation, a secondary analysis of the Smokefree Support Study (conducted 2013-2018; completed 2021), used microcosting methods and sensitivity analyses to estimate the ICQ of the interventions. Participants included patients undergoing treatment for a broad range of solid tumors and lymphomas who reported current smoking and were receiving care at cancer care clinics within 2 academic medical centers. Exposures: Intensive smoking cessation treatment (up to 11 counseling sessions with free medications), standard of care (up to 4 counseling sessions with medication advice), or usual care (referral to the state quitline). Main Outcomes and Measures: Total costs, component-specific costs, and the ICQ of the intensive smoking cessation treatment relative to both standard of care (comparator in the parent randomized trial) and usual care (a common comparator outside this trial) were calculated. Overall and post hoc site-specific estimates are provided. Because usual care was not included in the parent trial, sensitivity analyses were conducted to assess how assumptions about usual care quit rates affected study outcomes (ie, base case [from a published smoking cessation trial among patients with thoracic cancer], best case, and conservative case scenarios). Results: The per-patient costs of offering intensive smoking cessation treatment, standard of care, and usual care were $1989, $1482, and $0, respectively. For intensive treatment, the dominant costs were treatment (35%), staff supervision (26%), and patient enrollment (24%). Relative to standard of care, intensive treatment had an overall ICQ of $3906, and one site had an ICQ of $2892. Relative to usual care, intensive treatment had an ICQ of $9866 overall (base case), although at one site, the ICQ was $5408 (base case) and $3786 (best case). Conclusions and Relevance: In this economic evaluation study, implementation of an intensive smoking cessation treatment intervention was moderately to highly cost-effective, depending on existing smoking cessation services in place.

Long-term follow-up of smokers following lung and colorectal cancer diagnosis.

BACKGROUND: Continued smoking after a cancer diagnosis limits the effectiveness of treatment, increases the risk of cancer recurrence or secondary malignancies, and is associated with poorer quality of life and survival. A cancer diagnosis may provide a meaningful timepoint for quitting, but the prevalence and characteristics of continued smoking through survivorship are poorly understood. METHODS: In the multi-regional Cancer Care Outcomes Research and Surveillance (CanCORS) cohort, we examined smoking rates and factors associated with continued smoking at long-term follow-up among lung and colorectal cancer patients. This paper builds upon previous CanCORS participant data addressing quit rates and associated characteristics at baseline and 5 months post-diagnosis. RESULTS: At long-term follow-up (median 7.3 years post-diagnosis [IQR = 5.9-8.7]), 16.7% of lung cancer and 11.6% of colorectal cancer survivors continued to smoke combustible cigarettes. Factors independently associated with continued smoking at long-term follow-up included being male, younger, not married or partnered, having Medicare, Medicaid/other public or no insurance, more depression symptoms, smoking more cigarettes per day, and having a history of lung disease (p < .05). Continued smoking did not vary by lung vs. colorectal cancer diagnosis. CONCLUSION: Of active smokers at the time of diagnosis, an important minority of lung and colorectal cancer survivors continued to smoke well into survivorship. Understanding characteristics associated with continued smoking after a cancer diagnosis may help inform the development of tobacco treatment programs for cancer patients and survivors. IMPLICATIONS FOR SURVIVORS: While addressing smoking cessation at the time of diagnosis is critical to ensure better long-term treatment outcomes and quality of life, it is essential to continue smoking cessation discussions and efforts throughout care and survivorship.

Perceptions of somatic and affective symptoms and psychosocial care utilization in younger and older survivors of lung cancer.

OBJECTIVE: Rates of depression identification in oncology settings and referral to psychosocial services remain low. Patients with lung cancer face an elevated risk of depression relative to patients with other cancers. This study explored perceptions of somatic and affective symptoms and psychosocial care utilization among younger and older lung cancer survivors. METHODS: We conducted in-depth interviews with 20 adults at two academic medical centers in Boston, MA, who had received a lung cancer diagnosis in the past 24 months. A semi-structured interview guide was used to assess experiences with, and perceptions of, depression symptoms and psychosocial services. Interviews were audio-recorded, transcribed, and coded to identify themes. We also explored differences between younger (<65years; N=9) and older (>65years; N=11) patients. RESULTS: Participants commonly described somatic symptoms (i.e., changes in appetite, sleep, or energy levels) and affective symptoms (i.e., worry, fear, sadness) as side effects of cancer treatment. Older participants more commonly contextualized these symptoms with information about how they impacted daily life. Both younger and older participants faced barriers to accessing psychosocial services, with older adults more commonly referencing stigma of service referral and utilization. DISCUSSION: Patients with lung cancer associated both somatic and affective symptoms with their cancer and its treatment, with age differences in how symptoms were described and how psychosocial referrals may be perceived. More systematic integration of psychosocial care into cancer care may help to increase the identification of depression in lung cancer and reduce barriers to psychosocial service utilization.

US state variations in food bank donation policy and implications for nutrition.

Food insecurity has increased dramatically in 2020 as a result of the COVID-19 public health and economic crisis. Many more families in the United States are turning to the charitable food system to help meet their needs. However, little is known about the policies that influence food bank donations and whether they promote healthy food donations. The purpose of this study was to explore state variation in food donation policies and secondarily to assess whether policies promoted the donation of healthy foods and beverages. We reviewed donation policies for all states in the United States and Washington, DC (hereafter "states") in fall 2020. Two reviewers independently assessed donation policies using two legal databases; we reconciled discrepancies via team discussion. We then grouped them into 10 distinct categories based on common purpose and theme. We identified 252 state policies from 51 states. Policies fell into all 10 categories. The largest category was "liability protection," with all states having a policy in this category. The second largest category was date labeling; 32 states had requirements or policies restricting the donation of past-dated foods. However, across all categories, we found that only two policies explicitly promoted the donation of healthy foods and beverages. Although all states had some policies governing food donations, few promoted healthier foods and beverages. States could encourage healthy donations through policy to help ensure that all families have access to nutritious foods and beverages.

Modernizing Training in Psychotherapy Competencies With Adaptive Learning Systems: Proof of Concept.

PURPOSE: This proof-of-concept study assessed the feasibility, acceptability, and effectiveness of an intelligent tutoring system (ITS) as a classroom adjunct to improve training bachelor of social work (BSW) students in client engagement strategies. METHODS: We codeveloped the ITS with 11 undergraduate students and pilot tested it with six BSW students enrolled in a class on telephone-based cognitive behavioral therapy (tCBT). Student competencies in tCBT were assessed by expert review of role-plays. We also examined time spent using ITS and relation with competency. RESULTS: The majority of students (81.8%) in Wave 1 and all of the students who submitted role-plays in Wave 2 passed the clinical skills role-play. Students advancing through the ITS more quickly had better tCBT competency ratings than those progressing more slowly. DISCUSSION: One of the most challenging aspects of training is how to competently deliver evidence-based practices. ITS has the potential to streamline and scale such training.

Mental Health and the Perceived Usability of Digital Mental Health Tools Among Essential Workers and People Unemployed Due to COVID-19: Cross-sectional Survey Study.

BACKGROUND: COVID-19 has created serious mental health consequences for essential workers or people who have become unemployed as a result of the pandemic. Digital mental health tools have the potential to address this problem in a timely and efficient manner. OBJECTIVE: The purpose of this study was to document the extent of digital mental health tool (DMHT) use by essential workers and those unemployed due to COVID-19, including asking participants to rate the usability and user burden of the DMHT they used most to cope. We also explored which aspects and features of DMHTs were seen as necessary for managing stress during a pandemic by having participants design their own ideal DMHT. METHODS: A total of 2000 people were recruited from an online research community (Prolific) to complete a one-time survey about mental health symptoms, DMHT use, and preferred digital mental health features. RESULTS: The final sample included 1987 US residents that identified as either an essential worker or someone who was unemployed due to COVID-19. Almost three-quarters of the sample (1479/1987, 74.8%) reported clinically significant emotional distress. Only 14.2% (277/1957) of the sample used a DMHT to cope with stress associated with COVID-19. Of those who used DMHTs to cope with COVID-19, meditation apps were the most common (119/261, 45.6%). Usability was broadly in the acceptable range, although participants unemployed due to COVID-19 were less likely to report user burden with DMHTs than essential workers (t198.1=-3.89, P<.001). Individuals with emotional distress reported higher financial burden for their DMHT than nondistressed individuals (t69.0=-3.21, P=.01). When the sample was provided the option to build their own DMHT, the most desired features were a combination of mindfulness/meditation (1271/1987, 64.0%), information or education (1254/1987, 63.1%), distraction tools (1170/1987, 58.9%), symptom tracking for mood and sleep (1160/1987, 58.4%), link to mental health resources (1140/1987, 57.4%), and positive psychology (1131/1986, 56.9%). Subgroups by employment, distress, and previous DMHT use status had varied preferences. Of those who did not use a DMHT to cope with COVID-19, most indicated that they did not consider looking for such a tool to help with coping (1179/1710, 68.9%). CONCLUSIONS: Despite the potential need for DMHTs, this study found that the use of such tools remains similar to prepandemic levels. This study also found that regardless of the level of distress or even past experience using an app to cope with COVID-19, it is possible to develop a COVID-19 coping app that would appeal to a majority of essential workers and unemployed persons.

Using Real-world Data for Decision Support: Recommendations from a Primary Care Provider Survey.

INTRODUCTION: The use of data from wearable sensors, smartphones, and apps holds promise as a clinical decision-making tool in health and mental health in primary care medicine. The aim of this study was to determine provider perspectives about the utility of these data for building digitally based decision-making tools. METHODS: This mixed quantitative and qualitative cross-sectional survey of a convenience sample of primary-care clinicians at Kaiser Permanente Northwest was conducted between April and July 2019 online via Institute for Translational Health Sciences' Research Electronic Data Capture. Study outcomes were 1) attitudes toward digital data, 2) willingness to use digital data to support clinical decision making, and 3) concerns and recommendations about implementing a digital tool for clinical decision making. RESULTS: This sample of 131 clinicians was largely white (n = 98) female (n = 91) physicians (n = 86). Although respondents (75.7%, n = 87) had a positive attitude toward using digital tools in their practice, 88 respondents (67.3%) voiced concerns about the possible lack of clinical utility, suspected difficulty in integration with clinical workflows, and worried about the potential burden placed on patients. Participants indicated that the accuracy of the data in detecting the need for treatment adjustments would need to be high and the tool should be clinically tested. CONCLUSIONS: Primary care providers find value in collecting real-world patient data to assist in clinical decision making, provided such information does not interfere with provider workflow or impose undue burden on patients. In addition, digital tools will need to demonstrate high accuracy, be able to integrate into current clinical workflows, and maintain the privacy and security of patients' data.

Understanding Psychological Distress and Protective Factors Amongst Older Adults During the COVID-19 Pandemic.

OBJECTIVES: This study examined the emotional distress and loneliness during COVID-19 and the roles of resiliency and activities. DESIGN: A cross-sectional national survey. SETTING: Amazon Mechanical Turk (mTurk) and Prolific Research Platforms. PARTICIPANTS: Five hundred and one U.S. dwelling English-speaking adults 60 years old and older. MEASUREMENTS: Participants completed an online survey with the PHQ-9; GAD-7; Short Health Anxiety Inventory; 3-item UCLA Loneliness scale; PROMIS measures of global health, instrumental, and emotional support; 10-item Connor-Davidson Resilience Scale; and COVID-19 needs assessment. RESULTS: Across the sample 13% reported moderate depressive symptoms, 9% reported moderate anxiety symptoms, and 26% endorsed being "lonely." The emotionally distressed group endorsed more loneliness, lower resiliency, less physical exercise, and worse physical health. The low Socio-Economic Status group endorsed less loneliness, less likely to engage in physical exercise and worse physical health.The lonely group endorsed less resilience, less physical exercise, and worse physical health. A multiple logistic regression found that resilience, socioeconomic status, and physical health were significant predictors of loneliness, whereas global health was the best predictor of emotional distress. CONCLUSIONS: Even after prolonged social distancing, older adults in this study did not report greater psychological distress compared to earlier studies of older adults during COVID-19. Older adults with lower SES, worse physical health, and less resiliency, were more likely to report more loneliness. It is this group that should be the focus of intervention.

Preference for Telehealth Sustained Over Three Months at an Outpatient Center for Integrative Medicine.

BACKGROUND: Integrative medicine is a key framework for the treatment of chronic medical conditions, particularly chronic pain conditions. The COVID-19 pandemic prompted rapid implementation of telehealth services. OBJECTIVE: We present outcomes of a complete and rapid transition to telehealth visits at an outpatient integrative medicine center in the Southeastern United States. METHOD: Patients and administrative staff took surveys comparing telehealth to in-person visits within four weeks of our clinic's transition to telehealth and three months later. Beginning four weeks after the clinic's telehealth conversion in March 2020, patients who had a telehealth visit at the center completed a survey about their telehealth experience and another survey three months later. RESULTS: Patient quality judgements significantly favored telehealth at baseline, B = .77 [0.29 - 1.25], SE = .25, t(712) = 3.15, p = .002, and increased at three months, B = .27 [-0.03 - 0.57], SE = .15, t(712) = 1.76, p = .079. Telehealth technology usability and distance from the center predicted patient ratings of telehealth favorability. Providers favored in-person visits more than patients, B = -1.00 [-1.56 - -0.44], SE = .29, t(799) = -3.48, p < .001, though did not favor either in-person or telehealth more than the other. Patient discrete choice between telehealth and in-person visits was split at baseline (in-person: n = 86 [54%]; telehealth: n = 73 [46%]), but favored telehealth at three months (in-person: n = 17 [40%]; telehealth: n = 26 [60%]). Overall, discrete choice favored telehealth at follow-up across providers and patients, OR = 2.69 [.1.18 - 6.14], z = 2.36, p = .018. Major qualitative themes highlight telehealth as acceptable and convenient, with some challenges including technological issues. Some felt a loss of interpersonal connection during telehealth visits, while others felt the opposite. CONCLUSION: We report converging mixed-method data on the successful and sustained implementation of telehealth with associated policy and clinical implications during and beyond the COVID-19 pandemic.

Food Bank Donations in the United States: A Landscape Review of Federal Policies.

Rates of food insecurity have increased substantially in the United States (US), and more families are turning to the charitable food system to help meet their needs. Prior studies have examined the nutritional quality of foods offered through food banks, but little is known about what government policies may shape the healthy food donation landscape. The purpose of this study was to review US federal policies that impact food and beverage donations to food banks and assess whether policies encourage healthy food donations. In spring 2020, two researchers independently reviewed federal food and beverage donation policies using predefined search terms in two legal databases. We identified six categories of policies based on the existing food donation literature and themes that emerged in the policy review. We identified 42 federal policies spanning six categories that addressed food and beverage donations to food banks. The largest category was "government programs," with 19 (45%) policies. The next largest category was "donation via schools," with 12 (29%) policies. However, no policies specifically addressed the nutritional quality of food donations. There is an opportunity for the federal government to strengthen food bank donation policies and improve the nutritional quality of donated foods and beverages.

Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial.

Importance: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care. Objective: To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking. Design, Setting, and Participants: This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018. Interventions: Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline). Main Outcome and Measures: The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates. Results: Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2). Conclusions and Relevance: Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research. Trial Registration: ClinicalTrials.gov Identifier: NCT01871506.

Sub-study Correction: Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability.

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Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability.

BACKGROUND: This paper presents the protocol for the National Institute of Mental Health (NIMH)-funded University of Washington's ALACRITY (Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness) Center (UWAC), which uses human-centered design (HCD) methods to improve the implementation of evidence-based psychosocial interventions (EBPIs). We propose that usability-the degree to which interventions and implementation strategies can be used with ease, efficiency, effectiveness, and satisfaction-is a fundamental, yet poorly understood determinant of implementation. OBJECTIVE: We present a novel Discover, Design/Build, and Test (DDBT) framework to study usability as an implementation determinant. DDBT will be applied across Center projects to develop scalable and efficient implementation strategies (eg, training tools), modify existing EBPIs to enhance usability, and create usable and nonburdensome decision support tools for quality delivery of EBPIs. METHODS: Stakeholder participants will be implementation practitioners/intermediaries, mental health clinicians, and patients with mental illness in nonspecialty mental health settings in underresourced communities. Three preplanned projects and 12 pilot studies will employ the DDBT model to (1) identify usability challenges in implementing EBPIs in underresourced settings; (2) iteratively design solutions to overcome these challenges; and (3) compare the solution to the original version of the EPBI or implementation strategy on usability, quality of care, and patient-reported outcomes. The final products from the center will be a streamlined modification and redesign model that will improve the usability of EBPIs and implementation strategies (eg, tools to support EBPI education and decision making); a matrix of modification targets (ie, usability issues) that are both common and unique to EBPIs, strategies, settings, and patient populations; and a compilation of redesign strategies and the relative effectiveness of the redesigned solution compared to the original EBPI or strategy. RESULTS: The UWAC received institutional review board approval for the three separate studies in March 2018 and was funded in May 2018. CONCLUSIONS: The outcomes from this center will inform the implementation of EBPIs by identifying cross-cutting features of EBPIs and implementation strategies that influence the use and acceptability of these interventions, actively involving stakeholder clinicians and implementation practitioners in the design of the EBPI modification or implementation strategy solution and identifying the impact of HCD-informed modifications and solutions on intervention effectiveness and quality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03515226 (https://clinicaltrials.gov/ct2/show/NCT03515226), NCT03514394 (https://clinicaltrials.gov/ct2/show/NCT03514394), and NCT03516513 (https://clinicaltrials.gov/ct2/show/NCT03516513). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14990.

Fear of recurrence or progression as a link between somatic symptoms and perceived stress among cancer survivors.

PURPOSE: Many cancer survivors report experiencing somatic symptoms as well as elevated stress. Theoretical models have suggested that physical symptoms generate subjective stress via fears of recurrence or progression. To date, this indirect effect has not been established empirically. This study aimed to provide preliminary evidence as to whether fear of recurrence or progression is an intermediary between somatic symptom severity and perceived stress among heterogeneous cancer survivors. METHODS: Adult cancer survivors (N = 67; median 2.4 years since diagnosis; 34% male) presenting at a hospital survivorship clinic completed measures assessing somatic symptom severity (Patient Health Questionnaire-15 (PHQ-15)), perceived stress (four-item Perceived Stress Scale (PSS-4)), and fear of recurrence or progression (Assessment of Survivor Concerns (ASC)). Interrelatedness among variables was assessed using Pearson correlations. Indirect effects were modeled using 5000-iteration bootstrapping. RESULTS: Survivors endorsed a range of somatic symptom severity (29% minimal, 39% low, 18% medium, and 14% high). Somatic symptoms, perceived stress, and fear of recurrence or progression were all significantly positively correlated (rs 0.29 to 0.47). Controlling for time since diagnosis, there was a significant indirect effect of somatic symptom severity on stress via fear of recurrence or progression [B = 0.06, SE = 0.04 (95% CI 0.01-0.16)]. The model accounted for more than one third of the variance in perceived stress [R 2 = 0.35, F(3,54) = 9.59, p < 0.001]. CONCLUSIONS: Survivors with greater somatic symptoms tended to report higher levels of stress, due in part to elevated fears of recurrence or progression. Our findings support concerns about recurrence or progression as a mechanism underlying stress states in cancer survivors. Efforts to assist survivors with stress management should teach strategies for managing cancer-related uncertainties stemming from somatic symptoms.