Understanding the financial cost of cancer clinical trial participation.

BACKGROUND: Though financial hardship is a well-documented adverse effect of standard-of-care cancer treatment, little is known about out-of-pocket costs and their impact on patients participating in cancer clinical trials. This study explored the financial effects of cancer clinical trial participation. METHODS: This cross-sectional analysis used survey data collected in December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a nonprofit organization providing social needs navigation and financial assistance to US adults with a chronic illness. Surveys included questions on cancer clinical trial participation, trial-related financial hardship, and sociodemographic data. Descriptive and bivariate analyses were conducted using Cramer's V to estimate the in-sample magnitude of association. Associations between trial-related financial hardship and sociodemographics were estimated using adjusted relative risks (aRR) and corresponding 95% confidence intervals (CI) from modified Poisson regression models with robust standard errors. RESULTS: Of 650 survey respondents, 18% (N = 118) reported ever participating in a cancer clinical trial. Of those, 47% (n = 55) reported financial hardship as a result of their trial participation. Respondents reporting trial-related financial hardship were more often unemployed or disabled (58% vs. 43%; V = 0.15), Medicare enrolled (53% vs. 40%; V = 0.15), and traveled >1 h to their cancer provider (45% vs. 17%; V = 0.33) compared to respondents reporting no hardship. Respondents who experienced trial-related financial hardship most often reported expenses from travel (reported by 71% of respondents), medical bills (58%), dining out (40%), or housing needs (40%). Modeling results indicated that respondents traveling >1 h vs. ≤30 min to their cancer provider had a 2.2× higher risk of financial hardship, even after adjusting for respondent race, income, employment, and insurance status (aRR = 2.2, 95% CI 1.3-3.8). Most respondents (53%) reported needing $200-$1000 per month to compensate for trial-related expenses. Over half (51%) of respondents reported less willingness to participate in future clinical trials due to incurred financial hardship. Notably, of patients who did not participate in a cancer clinical trial (n = 532), 13% declined participation due to cost. CONCLUSION: Cancer clinical trial-related financial hardship, most often stemming from travel expenses, affected almost half of trial-enrolled patients. Interventions are needed to reduce adverse financial participation effects and potentially improve cancer clinical trial participation.

Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial.

Importance: Following treatment, breast cancer survivors face challenges participating in valued activities. Objective: To determine whether a telephone-based coaching rehabilitation intervention enhances activity participation in the year following breast cancer treatment. Design, Setting, and Participants: In this multisite, single-blind randomized clinical trial (Optimizing Functional Recovery of Breast Cancer Survivors), recruitment occurred between August 28, 2019, and April 30, 2022. Data collection was completed by April 1, 2023. Participants were recruited from 2 cancer centers (Dartmouth College and the University of Alabama at Birmingham) and via social media advertisements. Women aged 18 years or older who had completed primary treatment for stage I to III breast cancer within 1 year and reported participation restrictions were eligible to participate. Randomization was stratified by site, treatment, and time since treatment. Interventions: The intervention, delivered via telephone over 9 sessions, used behavioral activation and problem-solving principles to promote activity participation. The education-based attention control condition was delivered via telephone at matched intervals. Main Outcomes and Measures: The primary outcome was participation, assessed using 5 measures, including Patient-Reported Outcomes Measurement Information System (PROMIS) social participation-satisfaction measure. One individualized outcome allowed participants to specify activities for which they wanted to foster recovery. Outcomes were collected by telephone by blinded coordinators at baseline and at 8, 20, and 44 weeks. The individualized outcome was assessed at the first and last intervention and control session. Results: Among 1996 patients identified, 303 were eligible and enrolled. Of these, 284 women (94%; mean [SD] age, 56.1 [10.2] years) completed baseline assessments and were randomized, and 81% or more of each group completed the final assessment with no adverse events. Of those who completed the final assessment, 118 of 114 (82%) were in the intervention group, and 113 of 140 (81%) were attention control participants. Between-group differences were not statistically significant for the main measures of PROMIS satisfaction (week 20: Cohen d, 0.1 [95% CI, -0.09 to 0.29] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]) and ability (week 20: Cohen d, 0.15 [95% CI, -0.06 to 0.37] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]). On the individualized outcome, intervention participants reported significantly greater improvements in activity satisfaction (Cohen d, 0.76 [95% CI, 0.48-1.02]) and performance (Cohen d, 0.60 [95% CI, 0.32-0.87]). Conclusions and Relevance: In this randomized clinical trial, the intervention catalyzed greater improvements in self-selected activity participation and goal disengagement but did not otherwise accelerate recovery compared with the control condition. Future research should determine what intervention features may lead to the greatest reductions in participation restrictions and other measures that may detect functional recovery. Trial Registration: ClinicalTrials.gov Identifier: NCT03915548.

A 2-year longitudinal randomized controlled trial examining the transfer of speed of processing training to secondary cognitive domains in middle-aged and older adults with HIV-associated neurocognitive disorder: Results of the think fast study.

OBJECTIVE: As people with HIV (PWH) age, they are at-risk of developing cognitive impairments compared to their seronegative counterparts. Although speed of processing (SOP) training may help improve this cognitive ability, less work has examined transfer to other cognitive domains. This study examined the effect of SOP training has on secondary cognitive domains in PWH aged 40+ years. METHOD: In this 3-group 2-year longitudinal study, 216 PWH with HIV-associated neurocognitive disorder (HAND) or borderline HAND were randomized to either: (1) 10 h of SOP training (n = 70); (2) 20 h of SOP training (n = 73); or (3) 10 h of an active control training (n = 73). Participants completed a comprehensive cognitive battery at baseline, immediately after training, and at 1 and 2 years. This battery yielded global and domain specific T-scores as well as a cognitive impairment variable. Generalized linear mixed-effect models were fitted to estimate between-group mean differences at the follow-up time-points adjusted for baseline. RESULTS: No clinically or statistically significant improvements in any of the cognitive outcomes were observed. A sensitivity analysis was conducted; conclusions replicated those of the main analysis, with two exceptions: Global Function T and Psychomotor Speed T showed relevant training improvements among the intervention groups over the control group at the immediate post time point. CONCLUSIONS: Although SOP training has been shown to improve cognitive abilities that correspond to driving and mobility, such training has limited therapeutic utility in improving cognition in other domains in PWH with HAND.

What Is Most Important to Family Caregivers When Helping Patients Make Treatment-Related Decisions: Findings from a National Survey.

Prioritizing patient values-who/what matters most-is central to palliative care and critical to treatment decision making. Yet which factors are most important to family caregivers in these decisions remains understudied. Using data from a U.S. national survey of cancer caregivers (N = 1661), we examined differences in factors considered very important by caregivers when partnering with patients in cancer treatment decision making by cancer stage and caregiver sociodemographics. Fifteen factors were rated on a 4-point Likert-scale from 'very unimportant' to 'very important.' Descriptive statistics were used to characterize caregiver factors and tabulate proportions of importance for each. Generalized linear mixed effect modeling was used to examine the importance of factors by cancer stage, and chi-square analyses were performed to determine associations between caregiver sociodemographics and the five most commonly endorsed factors: quality of life (69%), physical well-being (68%), length of life (66%), emotional well-being (63%), and opinions/feelings of oncology team (59%). Significant associations (all p's < 0.05) of small magnitude were found between the most endorsed factors and caregiver age, race, gender, and ethnicity, most especially 'opinions/feelings of the oncology team'. Future work is needed to determine the best timing and approach for eliciting and effectively incorporating caregiver values and preferences into shared treatment decision making.

Availability of Family Caregiver Programs in US Cancer Centers.

Importance: Family caregivers provide the majority of health care to the 18 million patients with cancer in the US. Yet despite providing complex medical and nursing care, a large proportion of caregivers report no formal support or training. In recognition of this gap, many interventions to support cancer caregivers have been developed and tested over the past 2 decades. However, there are few system-level data on whether US cancer centers have adopted and implemented these interventions. Objective: To describe and characterize the availability of family caregiver support programs in US cancer centers. Design, Setting, and Participants: This cross-sectional national survey study was conducted between September 1, 2021, and April 30, 2023. Participants comprised clinical and administrative staff of Commission on Cancer-accredited US cancer centers. Data analysis was performed in May and June 2023. Main Outcomes and Measures: Survey questions about the availability of 11 types of family caregiver programs (eg, peer mentoring, education classes, and psychosocial programs) were developed after literature review, assessment of similar program evaluation surveys, and discussions among a 13-member national expert advisory committee. Family caregiver programs were defined as structured, planned, and coordinated groups of activities and procedures aimed at specifically supporting family caregivers as part of usual care. Survey responses were tabulated using standard descriptive statistics, including means, proportions, and frequencies. Results: Of the surveys sent to potential respondents at 971 adult cancer centers, 238 were completed (response rate, 24.5%). After nonresponse weight adjustment, most cancer centers (75.4%) had at least 1 family caregiver program; 24.6% had none. The most common program type was information and referral services (53.6%). Cancer centers with no programs were more likely to have smaller annual outpatient volumes (χ2 = 11.10; P = .011). Few centers had caregiver programs on training in medical and/or nursing tasks (21.7%), caregiver self-care (20.2%), caregiver-specific distress screening (19.3%), peer mentoring (18.9%), and children caregiving for parents (8.3%). Very few programs were developed from published evidence in a journal (8.1%). The top reason why cancer centers selected their programs was community members requesting the program (26.3%); only 12.3% of centers selected their programs based on scientific evidence. Most programs were funded by the cancer center or hospital (58.6%) or by philanthropy (42.4%). Conclusions and Relevance: In this survey study, most cancer centers had family caregiver programs; however, a quarter had none. Furthermore, the scope of programming was limited and rarely evidence based, with few centers offering caregiving education and training. These findings suggest that implementation strategies are critically needed to foster uptake of evidence-based caregiver interventions.

Enhancing Efficiency and Reach Using Facebook to Recruit Breast Cancer Survivors for a Telephone-Based Supportive Care Randomized Trial During the COVID-19 Pandemic.

PURPOSE: Evidence supporting social media-based recruitment of cancer survivors is limited. This paper describes how we used Facebook during the COVID-19 pandemic to augment our recruitment of breast cancer survivors for our two-site telephone-based randomized clinical trial (RCT) at Dartmouth-Hitchcock Medical Center and the University of Alabama at Birmingham. METHODS: Originally a two-site RCT of a telephone-delivered breast cancer survivorship intervention, we extended our clinic-based recruitment to Facebook. Participant characteristics, geographic reach, and baseline outcomes were compared across recruitment sources (ie, two clinics and Facebook) using descriptive statistics and effect sizes. RESULTS: Enrollment rates (20%-29%) were comparable across recruitment sources. The 21-month Facebook marketing campaign accounted for 59% (n = 179/303) of our total sample and had the greatest geographic reach, recruiting women from 24 states. The Facebook campaign reached a total of 51,787 unique individuals and cost $88.44 in US dollars (USD) per enrolled participant. Clinic samples had a greater proportion of women who were widowed (8% v 1%; P = .03) and Facebook had a higher proportion of women with a household income over $40,000 USD (83% v 71%; P = .02). There were no statistically significant differences between Facebook and the two clinics on baseline survey scores. CONCLUSION: Augmenting traditional recruitment with Facebook increased our RCT's geographic and sociodemographic reach and supported meeting recruitment goals in a timely way. In the wake of the COVID-19 pandemic, cancer survivorship researchers should consider using social media as a recruitment strategy while weighing the advantages and potential biases introduced through such strategies.

Family caregiver roles and challenges in assisting patients with cancer treatment decision-making: Analysis of data from a national survey.

BACKGROUND: We aimed to describe the roles and challenges of family caregivers involved in patients' cancer treatment decision-making. METHODS: Family caregiver-reported data were analyzed from a national survey conducted in the United States by CancerCare® (2/2021-7/2021). Four select-all-that-apply caregiver roles were explored: (1) observer (patient as primary decision-maker); (2) primary decision-maker; (3) shared decision-maker with patient and (4) decision delegated to healthcare team. Roles were compared across five treatment decisions: where to get treatment, the treatment plan, second opinions, beginning treatment and stopping treatment. Ten challenges faced by caregivers (e.g., information, cost, treatment understanding) were then examined. χ2 and regression analyses were used to assess associations between roles, decision areas, challenges and caregiver sociodemographics. RESULTS: Of 2703 caregiver respondents, 87.6% reported involvement in patient decisions about cancer treatment, including 1661 who responded to a subsection further detailing their roles and challenges with specific treatment decisions. Amongst these 1661 caregivers, 22.2% reported an observing role, 21.3% a primary decision-making role, 53.9% a shared decision-making role and 18.1% a role delegating decisions to the healthcare team. Most caregivers (60.4%) faced ≥1 challenge, the most frequent being not knowing how treatments would affect the patient's physical condition (24.8%) and quality of life (23.2%). In multivariable models, being Hispanic/Latino/a was the strongest predictor of facing at least one challenge (b = -0.581, Wald = 10.69, p < .01). CONCLUSIONS: Most caregivers were involved in patients' cancer treatment decisions. The major challenge was not understanding how treatments would impact patients' physical health and quality of life. Challenges may be more commonly faced by Hispanic/Latino/a caregivers. PATIENT OR PUBLIC CONTRIBUTION: The CancerCare® survey was developed in partnership with caregiving services and research experts to describe the role of cancer family caregivers in patient decision-making and assess their needs for support. All survey items were reviewed by a CancerCare advisory board that included five professional patient advocates and piloted by a CancerCare social worker and other staff who provide counselling to cancer caregivers.

Evaluating Nurses' Time to Response by Severity and Cancer Stage in a Remote Symptom Monitoring Program for Patients With Breast Cancer.

PURPOSE: Remote symptom monitoring (RSM) using electronic patient-reported outcomes enables patients with cancer to communicate symptoms between in-person visits. A better understanding of key RSM implementation outcomes is crucial to optimize efficiency and guide implementation efforts. This analysis evaluated the association between the severity of patient-reported symptom alerts and time to response by the health care team. METHODS: This secondary analysis included women with stage I-IV breast cancer who received care at a large academic medical center in the Southeastern United States (October 2020-September 2022). Symptom surveys with at least one severe symptom alert were categorized as severe. Response time was categorized as optimal if the alert was closed by a health care team member within 48 hours. Odds ratios (ORs), predicted probabilities, and 95% CIs were estimated using a patient-nested logistic regression model. RESULTS: Of 178 patients with breast cancer included in this analysis, 63% of patients identified as White and 85% of patients had a stage I-III or early-stage cancer. The median age at diagnosis was 55 years (IQR, 42-65). Of 1,087 surveys included, 36% reported at least one severe symptom alert and 77% had an optimal response time by the health care team. When compared with surveys that had no severe symptom alerts, surveys with at least one severe symptom alert had similar odds of having an optimal response time (OR, 0.97; 95% CI, 0.68 to 1.38). The results were similar when stratified by cancer stage. CONCLUSION: Response times to symptom alerts were similar for alerts with at least one severe symptom compared with alerts with no severe symptoms. This suggests that alert management is being incorporated into routine workflows and not prioritized based on disease or symptom alert severity.

Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.

BACKGROUND: Patients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAre Supporters Coached to be Adept DEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components. METHODS: This is a 2-site, single-blind, 24 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients with newly-diagnosed advanced cancer delivered by specially-trained, telehealth, palliative care lay coaches over 24 weeks. Family caregivers (target N = 352) are randomly assigned to one of 16 combinations of four components with two levels each: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision support communication training (1 session vs. none); 3) Ottawa Decision Guide training (1 session vs. none) and 4) monthly follow-up (1 call vs. calls for 24 weeks). The primary outcome is patient-reported decisional conflict at 24 weeks. Secondary outcomes include patient distress, healthcare utilization, caregiver distress, and quality of life. Mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) will be explored between intervention components and outcomes. Results will be used to build two versions of CASCADE: one with only effective components (d ≥ 0.30) and another optimized for scalability and cost. DISCUSSION: This protocol describes the first factorial trial, informed by the multiphase optimization strategy, of a palliative care decision-support intervention for advanced cancer family caregivers and will address the field's need to identify effective components that support serious illness decision-making. TRIAL REGISTRATION: NCT04803604.

Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use.

BACKGROUND: Despite the demonstrated value of opioid overdose education and naloxone distribution (OEND) programs, uptake and utilization remains low. Accessibility to OEND is limited and traditional programs may not reach many high-risk individuals. This study evaluated the effectiveness of online opioid overdose and naloxone administration education and the impact of naloxone possession. METHODS: Individuals with self-reported illicit use of opioids were recruited via Craigslist advertisements and completed all assessments and education online via REDCap. Participants watched a 20-minute video outlining signs of opioid overdose and how to administer naloxone. They were then randomized to either receive a naloxone kit or be given instructions on where to obtain a kit. Effectiveness of training was measured with pre- and post-training knowledge questionnaires. Naloxone kit possession, overdoses, opioid use frequency, and treatment interest were self-reported on monthly follow-up assessments. RESULTS: Mean knowledge scores significantly increased from 6.82/9.00 to 8.22 after training (t(194)=6.85, p <0.001, 95% CI[1.00, 1.81], Cohen's d=0.85). Difference in naloxone possession between randomized groups was significant with a large effect size (p <0.001, diff=0.60, 95% CI[0.47, 0.73]). A bidirectional relationship was found between naloxone possession and frequency of opioid use. Overdoses and treatment interest were similar across possession status. CONCLUSIONS: Overdose education is effective in online video format. Disparity in naloxone possession across groups indicates barriers to obtaining naloxone from pharmacies. Naloxone possession did not influence risky opioid use or treatment interest and its impact on frequency of use warrants further investigation. TRIAL REGISTRATION: Clinitaltrials.gov-NCT04303000.

Total added sugar consumption is not significantly associated with risk for prediabetes among U.S. adults: National Health and Nutrition Examination Survey, 2013-2018.

Prediabetes affects 38% of U.S. adults and is primarily linked to added sugars consumed from sugar-sweetened beverages. It is unclear if total dietary intake of added sugar also increases the risk for prediabetes. This study examined if total (g/day) and percent intakes of <10%, 10-15%, or >15% added sugar increase the odds for prediabetes in U.S. adults. A cross-sectional, secondary analysis using 2013-2018 NHANES data was conducted. This study included data from U.S. adults ≥ 20 years with normoglycemia (N = 2,154) and prediabetes (N = 3,152) with 1-2 days of dietary recall information. Prediabetes was defined as a hemoglobin A1c of 5.7%-6.4% or a fasting plasma glucose of 100-125 mg/dL. Survey-weighted logistic regression was used to estimate odds ratios of prediabetes based on usual intakes of added sugar (total and percent intakes) using the National Cancer Institute Method. Differences in prediabetes risk and total and percent intakes of added sugar were compared by race/ethnicity. The sample's total energy intake from added sugar was 13.9%. Total (unadjusted: OR: 1.01, 95% CI: .99-1.00, p = .26; adjusted: OR: 1.00, 95% CI: .99-1.00, p = .91) and percent intakes of added sugar (unadjusted [<10%: (ref); 10-15%: OR: .93, 95% CI: .77-1.12, p = .44; >15%: OR: 1.03, 95% CI: .82-1.28, p = .82] and adjusted [<10%: (ref); 10-15%: OR: .82, 95% CI: .65-1.04, p = .09; >15%: OR: .96, 95% CI: .74-1.24, p = .73]) were not significantly associated with an increased odds of prediabetes. Prediabetes risk did not differ by race/ethnicity for total (unadjusted model [p = .65]; adjusted model [p = .51]) or percent (unadjusted model [p = .21]; adjusted model [p = .11]) added sugar intakes. In adults ≥20 years with normoglycemia and prediabetes, total added sugar consumption did not significantly increase one's risk for prediabetes and risk estimates did not differ by race/ethnicity. Experimental studies should expand upon this work to confirm these findings.

Using item response theory to develop a shortened practice environment scale of the nursing work index.

The 31-item Practice Environment Scale of the Nursing Work Index (PES-NWI) has been frequently used globally to measure the nurse work environment. However, due to its length and subsequent respondent burden, a more parsimonious version of the PES-NWI may be desirable. Item response theory (IRT) is a statistical technique that assists in decreasing the number of items in an instrument without sacrificing reliability and validity. Two separate samples of nurses in the United States (one called the "internal data source" and the other called "external data source"; sample sizes = 843 and 722, respectively) were analyzed. The internal data source was randomly split into training (n = 531) and validating data sets (n = 312), while a separate whole external data source was used as the final validating data set. Using IRT with training data, we removed nine items; two additional items were removed based on recommendations from a previous study. Confirmatory factor analyses supported the validity of the measurement model with the 20-item of PES-NWI in both internal and external validation data sources. The correlations among subscales between 31- and 20-item versions were high magnitude for five subscales in both validation data sets (τ = 0.84-0.89). Ultimately, we identified a 20-item version of the PES-NWI which demonstrated adequate validity and reliability properties while decreasing data collection burden yet maintaining a similar factor structure to the original instrument. Additional research may be necessary to update the items themselves on the PES-NWI.

Two-year clinical trial examining the effects of speed of processing training on everyday functioning in adults with human immunodeficiency virus-associated neurocognitive disorder (HAND) and borderline HAND in the U.S. Deep South: Findings of the Think Fast Study.

Many people living with human immunodeficiency virus (HIV) (PLWH) experience cognitive decline that impairs everyday functioning. Cognitive training approaches, such as speed of processing (SOP) training, may reduce the impact of HIV-Associated Neurocognitive Disorder (HAND) on everyday functioning. In this experimental design study called the Think Fast Study, 216 participants age 40 and older with HAND or borderline HAND were randomized to one of three groups: (1) 10 h of SOP training (n = 70); (2) 20 h of SOP training (n = 73); or (3) 10 h of Internet Navigation Control Training (a contact control group; n = 73). Participants completed several everyday functioning measures at baseline, posttest, and year 1 and year 2 follow ups, which included: (a) Modified Lawton and Brody Activities of Daily Living (ADL) Questionnaire; (b) Timed Instrumental Activities of Daily Living (TIADL) Test; (c) Patient's Assessment of Own Functioning (PAOFI); (d) Medication Adherence Questionnaire (MAQ); and (e) Medication Adherence Visual Analog Scale (VAS). Linear mixed-effect models and generalized estimating equation models were fitted to estimate between group differences at all follow-up time points. At follow-up timepoints, those in the 10-h and 20-h training groups had better scores on medication adherence measures (MAQ and VAS) than those in the control group, with effects (Cohen's d) ranging 0.13-0.41 for MAQ and 0.02-0.43 for VAS. In conclusion, SOP training improved some indicators of everyday functioning, specifically medication adherence; however, the therapeutic effects diminished over time. Implications for practice and research are posited.

Using digital phenotyping to understand health-related outcomes: A scoping review.

BACKGROUND: Digital phenotyping may detect changes in health outcomes and potentially lead to proactive measures to mitigate health declines and avoid major medical events. While health-related outcomes have traditionally been acquired through self-report measures, those approaches have numerous limitations, such as recall bias, and social desirability bias. Digital phenotyping may offer a potential solution to these limitations. OBJECTIVES: The purpose of this scoping review was to identify and summarize how passive smartphone data are processed and evaluated analytically, including the relationship between these data and health-related outcomes. METHODS: A search of PubMed, Scopus, Compendex, and HTA databases was conducted for all articles in April 2021 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review (PRISMA-ScR) guidelines. RESULTS: A total of 40 articles were included and went through an analysis based on data collection approaches, feature extraction, data analytics, behavioral markers, and health-related outcomes. This review demonstrated a layer of features derived from raw sensor data that can then be integrated to estimate and predict behaviors, emotions, and health-related outcomes. Most studies collected data from a combination of sensors. GPS was the most used digital phenotyping data. Feature types included physical activity, location, mobility, social activity, sleep, and in-phone activity. Studies involved a broad range of the features used: data preprocessing, analysis approaches, analytic techniques, and algorithms tested. 55% of the studies (n = 22) focused on mental health-related outcomes. CONCLUSION: This scoping review catalogued in detail the research to date regarding the approaches to using passive smartphone sensor data to derive behavioral markers to correlate with or predict health-related outcomes. Findings will serve as a central resource for researchers to survey the field of research designs and approaches performed to date and move this emerging domain of research forward towards ultimately providing clinical utility in patient care.

Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial.

Drug overdose is the leading cause of accidental death in the United States, with over 70% of drug related fatalities resulting from the use of opioids. Federal agencies have responded to this crisis with various recommendations including enhancing harm reduction approaches such as training laypersons to administer naloxone through Opioid Overdose Education and Naloxone Distribution (OEND) programs. Several studies have demonstrated that OEND programs effectively reduce opioid overdose mortality and are both safe and cost-effective, however, they are typically implemented in urban areas as part of large medical center research programs, needle exchanges, or drug treatment programs. Individuals living in areas without these programs or services lack access to critical and life-saving OEND. The current study examined the acceptability and feasibility of online recruitment, online opioid overdose education, and remote distribution of naloxone kits. Persons who illicitly use opioids and are at risk for overdose were recruited through online media and completed an opioid use questionnaire. If interested in receiving opioid overdose and naloxone administration training, participants completed pre- and post-intervention knowledge questionnaires, engaged in audiovisual training, and were randomized to either receive a naloxone kit or be given information on where they could obtain one. Preliminary results indicate feasibility and acceptability as evidenced by strong recruitment and retention, as well as high participant satisfaction ratings. Successful implementation of remote OEND through this project supports future employment of similar remote programs to expand this critical harm reduction strategy to high-risk individuals in areas lacking traditional OEND programs. Trial Registration #: Clinitaltrials.gov- NCT04303000.

Associations Between Patient-Perceived Cancer Curability and Advance Directive Completion.

Background: Despite Advance Care Planning recommendations for patients with cancer, many lack Advance Directives (ADs). AD disparities persist among Black, Indigenous, or People of Color (BIPOC) patients. Based on a hypothesized correlation, we examined the association between patient-perceived cancer incurability and AD completion. Methods: This cross-sectional study obtained self-reported AD completion and incurability perception from routine care surveys. AD completion by incurability perception was estimated using modified Poisson regression. Subgroup analyses examined patients who were BIPOC, White, and had solid organ malignancies. Results: Our sample (N = 1209) was predominantly female (70%), White (73%) with early-stage disease (60%), and solid organ malignancies (82%). AD completion was 42%, and 40% of patients reported their cancer incurable. Patient-perceived incurability was not associated with increased AD completion (likelihood ratio 0.94, 95% confidence interval 0.78-1.13) in overall or subgroup analyses. Conclusion: Patient-perceived cancer incurability was not associated with AD completion, even accounting for race/ethnicity and cancer type.

The Subjective Component of the Dutch Objective Burden Inventory: A Psychometric Analysis.

BACKGROUND: The reliability and validity of the subjective component of the Dutch Objective Burden Inventory (DOBI) are unknown. OBJECTIVE: The validity and reliability of the subjective component of the DOBI were examined in caregivers of individuals with heart failure, using the original 38- and a 24-item version. METHODS: In an online cross-sectional investigation, confirmatory factor analysis was used to examine factorial validity. In examining convergent validity, corrected item-dimension correlations assessed item performance and associations between subjective subscale scores and the Bakas Caregiving Outcomes Scale. Cronbach's α examined internal consistency. RESULTS: The original 4-factor solution was retained and both the original and shorter versions of the subjective component of the DOBI supported adequate construct validity and internal consistency. CONCLUSIONS: Both the 38- and 24-item forms of the subjective DOBI supported construct validity and reliability. Further studies examining the usefulness of both versions are needed in carers of individuals with more severe HF.

Association between personality and cognitive performance in middle-aged and older adults with human immunodeficiency virus (HIV).

BACKGROUND: Nearly half of adults with human immunodeficiency virus (HIV) experience HIV-Associated Neurocognitive Disorder (HAND), characterized by cognitive impairments in two or more cognitive domains, which can interfere with everyday functioning. Many factors are thought to influence such cognitive impairments in adults with HIV; one factor seldom examined is personality. OBJECTIVE: This study investigated the association between five major dimensions of personality (openness, conscientiousness, extraversion, agreeableness, and neuroticism) and cognitive function in older adults with HIV. METHODS: In this cross-sectional study, a secondary data analysis was conducted on 261 HIV + participants. Participants completed a norm-based cognitive battery covering seven cognitive domains, which yielded the following indices: global cognitive impairment, and global and domain-specific T-scores. The Big Five Inventory was used to assess personality traits. RESULTS: Higher openness, conscientiousness, and agreeableness were associated with better performance on individual cognitive domains while agreeableness and openness were also positively associated with global cognitive T-scores (p < .01). Only openness significantly predicted global cognition when adjusting for covariates (p < .01). DISCUSSION: Openness was associated with better global cognitive function in persons with HIV. This study provides a basis for further investigation of potential mechanisms for the association between personality and cognition in people with HIV in order to ultimately inform intervention strategies.

African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial.

BACKGROUND: Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge. OBJECTIVES: Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs. METHODS: This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials. RESULTS: Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%; P FDR = .001), were younger (62.7 + 8; P FDR = .03), had a lower ejection fraction (39.1 + 15.4; PFDR = .03), were more likely to be single (P FDR = .001), and lack an advanced directive (16.4%; P FDR < .001). AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more "denial" coping strategies (0.8 + 1; P FDR = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores. CONCLUSION: ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02505425.

Bias reported by family caregivers in support received when assisting patients with cancer-related decision-making.

BACKGROUND: Family caregivers play an increasing role in cancer treatment decision-making. We examined bias reported by family caregivers in the support they and their patient received from their healthcare team when making these decisions, including associations with distress. METHODS: Analysis of 2021 national survey data of family caregivers of patients with cancer (N = 2703). Bias experienced in decision support was assessed with the item: "Have you felt that the support you and the person with cancer have received for making cancer-related decisions by your doctor or healthcare team has been negatively affected by any of the following?" Check-all-that-apply response options included: age, race, language, education, political affiliation, body weight, insurance type or lack of insurance, income, religion, sexual orientation, and gender/sex. Chi-square and regression analyses assessed associations between bias and caregiver distress (GAD-2, PHQ-2). RESULTS: Of 2703 caregiver respondents, 47.4% (n = 1281) reported experiencing ≥1 bias(es) when receiving decision support for making cancer-related decisions. Bias was more prevalent among younger caregivers, males, transwomen/men or gender non-conforming caregivers, racial/ethnic minorities, and those providing care over a longer time period. The odds of having high anxiety (GAD-2 scores ≥ 3) were 2.1 times higher for caregivers experiencing one type of bias (adjusted OR, 2.1; 95% CI, 1.6-2.8) and 4.2 times higher for caregivers experiencing ≥2 biases (adjusted OR, 4.2; 95% CI, 3.4-5.3) compared to none. Similar results were found for high depression scores (PHQ-2 scores ≥ 3). CONCLUSIONS: Nearly half of caregivers involved in their care recipients' cancer-related decisions report bias in decision support received from the healthcare team. Experiencing bias was strongly associated with high psychological distress.