Qualitative study of Oncology Clinicians' Perceptions of Barriers to Offering Clinical Trials to Underserved Populations.

INTRODUCTION: Cancer clinical trials represent the "gold standard" for advancing novel cancer therapies. Optimizing trial participation is critical to ensuring the generalizability of findings across patients, yet trial enrollment rates, particularly among minority and socioeconomically disadvantaged populations, remain suboptimal. METHODS: We conducted in-depth interviews with oncologists at a large academic medical center to explore their (1) attitudes and perceived barriers to offering clinical trials to minority and socioeconomically disadvantaged patients, and (2) recommendations for improving the enrollment of minority and socioeconomically disadvantaged patients in cancer clinical trials. RESULTS: Of 23 medical oncologists approached, 17 enrolled (74% response rate; mean age = 47; female = 42%; White = 67%). Content analysis revealed several barriers to enrollment: (1) ethical dilemmas; (2) ambivalence about trial risks and benefits; and (3) concern about patient well-being. Concerns about the legitimacy of informed consent, perceived lack of equipoise, and fear of personal bias influenced clinicians' decisions to recommend trials during treatment discussions. Concerns about creating an imbalance between trial risks and benefits among patients with high-level needs, including patients with literacy, psychiatric, and other socioeconomic vulnerabilities, impacted clinicians' enthusiasm to engage in trial discussions. Clinicians identified patient, provider, and system-level solutions to address challenges, including increasing patient and clinician support as well as involving external personnel to support trial enrollment. CONCLUSION: Findings reveal multi-level barriers to offering cancer clinical trials to underrepresented patients. Targeted solutions, including system level changes to support clinicians, patient financial support, and implementation of clinical trial navigation programs were recommended to help reduce access barriers and increase enrollment of underrepresented patients into cancer clinical trials.

Representation of race and ethnicity among cancer survivors in trials of cognitive behavioral therapy for insomnia (CBT-I): A systematic review.

PURPOSE: For cancer survivors, insomnia is highly prevalent and debilitating. Although cognitive behavioral therapy for insomnia (CBT-I) is recognized as a gold standard treatment, it is unclear whether benefits of treatment generalize to racial and ethnic minorities in the USA. This systematic review characterizes the representation of racial and ethnic diversity among cancer survivors in CBT-I clinical trials and provides recommendations for research in sleep/cancer survivorship. METHODS: Literature searches were conducted in five electronic databases (PubMed, Cochrane Library via Ovid, PsycINFO via Ovid, Embase, Web of Science Core Collection) using concepts of CBT, insomnia, and cancer survivors. Information about CBT-I intervention details, sample racial demographics, and whether authors explicitly analyzed race and ethnicity were recorded. RESULTS: A total of 1673 citations were retrieved, and 967 citations were uploaded to Covidence. Of these, 135 articles went through full-text review and 13 studies were included. Race and ethnicity were reported in 11/13 trials (84.6%). Of those reporting race and ethnicity, 8/11 (72.7%) trials were comprised of samples that were ≥ 85% non-Hispanic White. Among the trials that explicitly analyzed race and ethnicity, CBT-I was more effective among cancer survivors who were White and highly educated, and non-White cancer survivors were less likely to have private insurance and ability to participate in clinical trials. CONCLUSION: Non-Hispanic White cancer survivors are overrepresented in CBT-I trials, the best available treatment for insomnia. Underrepresentation of racial and ethnic minorities likely contributes to barriers in access and uptake. Recommendations include implementing sustained efforts to expand diversity in CBT-I clinical trials for cancer survivors.

Do cancer curvivors and metavivors have distinct needs for stress management intervention? Retrospective analysis of a mind-body survivorship program.

PURPOSE: Cancer "curvivors" (completed initial curative intent treatment with surgery, radiation, chemotherapy, and/or other novel therapies) and "metavivors" (living with metastatic or chronic, incurable cancer) experience unique stressors, but it remains unknown whether these differences impact benefits from mind-body interventions. This study explored differences between curvivors and metavivors in distress (depression, anxiety, worry) and resiliency changes over the course of an 8-week group program, based in mind-body stress reduction, cognitive-behavioral therapy (CBT), and positive psychology. METHODS: From 2017-2021, 192 cancer survivors (83% curvivors; 17% metavivors) completed optional online surveys of resiliency (CES) and distress (PHQ-8, GAD-7, PSWQ-3) pre- and post- participation in an established clinical program. Mixed effect regression models explored curvivor-metavivor differences at baseline and in pre-post change. RESULTS: Compared to curvivors, metavivors began the program with significantly more resilient health behaviors (B = 0.99, 95% CI[0.12, 1.86], p = .03) and less depression (B = -2.42, 95%CI[-4.73, -0.12], p = .04), with no other significant differences. Curvivors experienced significantly greater reductions in depression (curvivor-metavivor difference in strength of change = 2.12, 95% CI [0.39, 3.83], p = .02) over the course of the program, with no other significant differences. Neither virtual delivery modality nor proportion of sessions attended significantly moderated strength of resiliency or distress change. CONCLUSION: Metavivors entering this mind-body program had relatively higher well-being than did curvivors, and both groups experienced statistically comparable change in all domains other than depression. Resiliency programming may thus benefit a variety of cancer survivors, including those living with incurable cancer.

Sources of informal financial support among adolescent and young adult cancer survivors: a mixed methods analysis from the HIAYA CHAT study.

PURPOSE: The purpose of this exploratory sequential mixed methods study was to describe the sources of informal financial support used by adolescent and young adult (AYA) cancer survivors and how financial toxicity and demographic factors were associated with different types and magnitudes of informal financial support. METHODS: This analysis is part of a larger health insurance literacy study that included pre-trial interviews and a randomized controlled trial (RCT) for AYA cancer survivors. Eligible study participants were 18 years of age, diagnosed with cancer as an AYA (15-39 years), insured, and for the RCT sample less than 1 year from diagnosis. Interview audio was transcribed, quality checked, and thematically analyzed. RCT baseline and follow-up surveys captured informal financial support use. Chi-squared and Fisher's exact tests were used to assess differences in informal financial support type use and frequency by financial toxicity and AYA demographics. RESULTS: A total of N = 24 and N = 86 AYAs participated in pre-trial interviews and the RCT respectively. Interview participants reported a variety of informal financial support sources including savings, community, family/friends, and fundraisers. However, only half of participants reported their informal financial support to be sufficient. High financial toxicity was associated with the most types of informal financial support and a higher magnitude of use. The lowest income group accessed informal financial supports less frequently than higher income groups. CONCLUSION: Our study demonstrates that AYA survivors experiencing financial toxicity frequently turn to informal sources of financial support and the magnitude is associated with financial toxicity. However, low-income survivors, and other at-risk survivors, may not have access to informal sources of financial support potentially widening inequities.

Internalized stigma among cancer patients enrolled in a smoking cessation trial: The role of cancer type and associations with psychological distress.

PURPOSE: Cancer patients who smoke may experience significant stigma due both to their disease, and negative attitudes and beliefs regarding smoking. We investigated whether internalized stigma differed between currently smoking cancer patients diagnosed with lung or head and neck cancers, other smoking related cancers, and non smoking-related cancers, and whether internalized stigma was associated with psychological distress. METHODS: This cross-sectional analysis used baseline data on 293 participants enrolled in a multi-site randomized smoking cessation intervention trial of patients with recently diagnosed cancer. Internalized stigma was assessed using five Internalized Shame items from the Social Impact of Disease Scale. Smoking-related cancers included lung, head and neck, esophageal, bladder, kidney, liver, pancreatic, colorectal, anal, small intestinal, gastric, and cervical. We used multivariable linear regression to examine whether mean internalized stigma levels differed between individuals with lung and head and neck cancers, other smoking-related cancers, and non smoking-related cancers, adjusting for potential confounders. We further examined the association of internalized stigma with depression, anxiety, and perceived stress, overall and among cancer type groups. RESULTS: Thirty-nine percent of participants were diagnosed with lung or head and neck cancer, 21% with another smoking-related cancer, and 40% with a non smoking-related cancer. In multivariable-adjusted models, participants with lung or head and neck cancers (11.6, 95% confidence intervals (CI) = 10.8-12.2; p < 0.0001) or other smoking-related cancers (10.7, 95% CI = 9.8-11.7; p = 0.03) had higher mean internalized stigma scores compared to those non-smoking-related cancers (9.3, 95% CI = 8.6-10.0). We observed similar positive associations between internalized stigma and depressive symptoms, anxiety, and perceived stress among participants with smoking-related and non smoking-related cancers. CONCLUSIONS: Among smokers, those with smoking-related cancers experienced the highest levels of internalized stigma, and greater internalized stigma was associated with greater psychological distress across cancer types. Providers should assess patients for internalized and other forms of stigma, refer patients for appropriate psychosocial support services, and address stigma in smoking cessation programs.

Longitudinal Electronic Cigarette Use Among Patients Recently Diagnosed With Cancer Enrolled in a Smoking Cessation Trial.

INTRODUCTION: Many cancer patients who smoke report concurrent e-cigarette use. Using a mixed-methods approach, we aimed to (1) describe longitudinal e-cigarette use over 6 months after a cancer diagnosis and (2) assess the association between e-cigarette use and smoking cessation, among cancer patients in a smoking cessation trial. AIMS AND METHODS: Data were from a 2-site randomized controlled trial of Standard (brief counseling) versus Intensive treatment (sustained counseling plus smoking cessation medication) in individuals who smoke recently diagnosed with cancer. Participants (n = 303) reported e-cigarette use at baseline, 3 months, and 6 months. Biochemically-verified past 7-day cigarette abstinence was collected at 6 months. Qualitative interviews at 6 months explored factors related to e-cigarette use. RESULTS: E-cigarette use prevalence was highest between baseline and 3 months (16%) and declined over time. Participants using e-cigarettes at follow-up had higher baseline cigarette dependence and smoked more heavily. Multivariable analyses found no significant association between follow-up e-cigarette use and 6-month cigarette abstinence. E-cigarette use at follow-up was higher in the Standard versus Intensive treatment group (p = .003 and .001 at 3 and 6 mo, respectively). Smoking cessation and health concerns were primary reasons for using e-cigarettes. CONCLUSIONS: Among individuals who smoke recently diagnosed with cancer and enrolled in a smoking cessation intervention trial, e-cigarette use during trial participation was not associated with smoking abstinence. Individuals who chose to use e-cigarettes were less likely to be receiving intensive cessation support as part of the trial. Further studies are needed to evaluate the association between e-cigarette use and smoking cessation in cancer patients. IMPLICATIONS: E-cigarette use was not associated with cigarette abstinence at 6 months among adults who smoke recently diagnosed with cancer enrolled in a smoking cessation trial. Individuals with easier access to evidence-based smoking cessation treatment may be less likely to use e-cigarettes.

Testing psychosocial mediators of a mind-body resiliency intervention for cancer survivors.

PURPOSE: Group-based mind-body interventions such as the Stress Management and Resiliency Training-Relaxation Response Resiliency Program (SMART-3RP) hold promise for enhancing resiliency among cancer survivors. Mechanisms underlying improvements in psychological outcomes are theoretically established but remain unexamined empirically. METHODS: Adult cancer survivors (n = 105) participating in the SMART-3RP completed surveys of resiliency and five hypothesized mediators: coping (ability to relax physical tension and assertive social support-seeking), mindfulness, positive affect, and worry. Pre-post intervention changes were assessed using repeated-measures t-tests. Bivariate correlations between change scores and a more conservative within-person parallel mediation model tested covariance between resiliency and mediators. RESULTS: Participants experienced moderate to large improvements in all patient-reported outcomes (ds = 1.01-0.46). Increased resiliency was significantly associated with increases in mindfulness, positive affect, and assertive social support-seeking (rs = 0.36-0.50); smaller associations with increased relaxation and decreased worry were not significant. Mindfulness and positive affect explained the largest proportion of variance in resiliency increase in the full multivariate model. CONCLUSIONS: Cancer survivors completing the SMART-3RP had increased resiliency, which was associated with improvements in mindfulness, positive affect, and the ability to assertively seek social support. Enhancing mindfulness and positive affect were critical components for enhancing resiliency. Implications for resiliency interventions with cancer survivors are discussed.

"I thought there would be more I understood": health insurance literacy among adolescent and young adult cancer survivors.

BACKGROUND: Health insurance literacy is crucial for navigating the US healthcare system. Low health insurance literacy may be especially concerning for adolescent and young adult (AYA) cancer survivors. To describe AYAs' health insurance literacy, we conducted semi-structured interviews with AYA survivors, on and off of treatment. METHODS: We interviewed 24 AYA cancer survivors (aged 18-39 years) between November 2019 and March 2020. Interviews were recorded, transcribed, and quality-checked. Using two cycles of structured coding, we explored AYAs' health insurance literacy and examined thematic differences by policy holder status and age. RESULTS: AYAs were 58.3% female, 79.2% non-Hispanic White, 91.7% heterosexual, and 62.5% receiving cancer treatment. Most participants had employer-sponsored health insurance (87.5%), and 41.7% were their own policy holder. Four themes emerged; in the first theme, most AYAs described beginning their cancer treatment with little to no understanding of their health insurance. This led to the three subsequent themes in which AYAs reported: unclear expectations of what their insurance would cover and their out-of-pocket costs; learning about insurance and costs by trial and error; and how their health insurance literacy negatively impacted their ability to navigate the healthcare system. CONCLUSIONS: Our findings, while requiring confirmation in larger samples and in other health systems, suggest that the health insurance literacy needed to navigate insurance and cancer care is low among US AYA survivors and may have health and financial implications. As the burden of navigating insurance is often put on patients, health insurance education is an important supportive service for AYA survivors on and off of treatment.

Material, behavioral, and psychological financial hardship among survivors of childhood cancer in the Childhood Cancer Survivor Study.

BACKGROUND: Medical financial burden includes material, behavioral, and psychological hardship and has been underinvestigated among adult survivors of childhood cancer. METHODS: A survey from 698 survivors and 210 siblings from the Childhood Cancer Survivor Study was analyzed. The intensity of financial hardship was estimated across 3 domains: 1) material, including conditions that arise from medical expenses; 2) behavioral, including coping behaviors to manage medical expenses; and 3) psychological hardship resulting from worries about medical expenses and insurance, as measured by the number of instances of each type of financial hardship (0, 1-2, and ≥3 instances). Multivariable logistic regressions were conducted to examine the clinical and sociodemographic predictors of experiencing financial hardship (0-2 vs ≥3 instances). RESULTS: The intensity of financial hardship did not significantly differ between survivors and siblings. Survivors reported more instances of material hardship than siblings (1-2 instances: 27.2% of survivors vs 22.6% of siblings; ≥3 instances: 15.9% of survivors vs 11.4% siblings; overall P = .03). In multivariable regressions, insurance was protective against all domains of financial hardship (behavioral odds ratio [OR], 0.12; 95% confidence interval [CI], 0.06-0.22; material OR, 0.37; 95% CI, 0.19-0.71; psychological OR, 0.10; 95% CI, 0.05-0.21). Survivors who were older at diagnosis, female, and with chronic health conditions generally had higher levels of hardship. Brain radiation and alkylating agents were associated with higher levels of hardship. CONCLUSIONS: Material, behavioral, and psychological financial burden among survivors of childhood cancer is common.

Moving forward on all fronts: impact, patterns, and barriers to exercise in cancer survivors and patients living with advanced disease.

INTRODUCTION: Exercise is recommended for all patients with cancer, but there has been limited study of exercise habits in patients across the spectrum of illness. PURPOSE: This pragmatic survey aimed to identify the unmet supportive care needs, self-reported symptoms, and exercise habits among both cancer survivors and patients living with advanced disease to determine adherence to exercise guidelines and to identify barriers and opportunities to improve exercise. METHODS: An anonymous cross-sectional self-administered paper survey was distributed to patients with cancer presenting for oncology clinic visits at an academic cancer center. Survey measures included presence of symptoms and health problems in addition to weekly time spent exercising, change in exercise levels since diagnosis, interest in exercise, and self-reported barriers. Participants reporting at least 150 min of exercise per week were characterized as adherent to guidelines. RESULTS: Among 640 survey respondents, 570 (89%) completed questions about exercise. Only 44% of cancer survivors and 34% of patients living with advanced disease met current guidelines. Survivors who met exercise guidelines had a lower prevalence of fatigue and memory impairments, but this finding was not seen among patients with advanced cancer. Over 70% of patients with advanced disease and 47% of survivors reported decreasing exercise post-diagnosis compared to pre-diagnosis. Prominent barriers to exercise among both groups included burden of illness and time constraints but interest in increasing exercise was high. CONCLUSIONS: There is an opportunity to improve exercise and related outcomes among a large percentage of both cancer survivors and patients living with advanced disease.

A Virtual Resiliency Intervention Promoting Resiliency for Parents of Children with Learning and Attentional Disabilities: A Randomized Pilot Trial.

OBJECTIVES: One in five children have a learning and attentional disability (LAD). Parents of children with LAD are vulnerable to distress, but an evidence-based treatment has not been developed. METHODS: From June 2016 to November 2017, we conducted a mixed methods study to adapt and assess the virtual delivery of a mind-body group resiliency program, the Stress Management and Resiliency Training-Relaxation Response Resiliency Program (SMART-3RP), to meet the needs of parents of children with LAD; this is an 8-session weekly group intervention. In the first phase, we conducted 4 parent focus group interviews, 2 professional focus group interviews, and 5 professional individual interviews, and 1 pilot group to adapt the SMART-3RP to target the needs of parents of children with LAD. In the second phase, we conducted a pilot wait-list controlled study to assess the feasibility, acceptability, and preliminary efficacy of a videoconferencing delivery of the adapted program. Parents were randomized to an immediate intervention group (IG) or wait-list control group (WC). Surveys were administered at baseline (time 1), end of intervention for the IG or 3 months post-baseline for the WC (time 2), and 3 months post treatment for the IG or end of intervention for the WC (time 3). RESULTS: Qualitative findings illustrated high levels of parental stress, with primary stressors including navigating the educational system, interactions with other parents, familial concerns, and financial and professional sacrifices. We adapted the manual to target these stressors and modified session logistics and delivery. Fifty-three parents (mean age = 46.8; 90.6% female) participated nationally in the pilot trial. 62.5% of participants completed ≥ 6/8 sessions; 81.8% reported continued daily/weekly relaxation response exercise practice. T1-T2 comparisons found that IG versus WC participants showed significant improvements in distress [VAS], ∆M = - 1.95; d = .83 and resilience [CES], ∆M = 6.38; d = .83, as well as stress coping [MOCS-A] ∆M = 8.69; d = 1.39; depression and anxiety [PHQ-4], ∆M = - 1.79; d = .71; social support [MOS-SSS], ∆M = 5.47; d = .71; and empathy [IRI], ∆M = 3.17; d = .77; improvements were sustained at the 3 month post intervention follow-up. CONCLUSION: Pilot wait-list randomized trial findings showed promising feasibility, acceptability, and preliminary efficacy for the SMART-3RP intervention adapted for parents of children with LAD. This virtually-delivered resiliency intervention improved parents' distress, resiliency, and stress coping, which were sustained. CLINICAL TRIALS ID: NCT02772432.

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.

Bridge: Person-Centered Collaborative Care for Patients with Serious Mental Illness and Cancer.

BACKGROUND: Individuals with serious mental illness (SMI) experience increased cancer mortality due to inequities in cancer treatment. Psychiatric care at cancer diagnosis may improve care delivery, yet models for integrating psychiatry and cancer care are lacking. We assessed the feasibility and acceptability of a person-centered collaborative care trial for SMI and cancer. SUBJECTS, MATERIALS, AND METHODS: We developed the Bridge intervention for patients with SMI (schizophrenia, bipolar disorder, and severe major depression) and cancer. Bridge includes proactive identification of SMI, person-centered care from a psychiatrist and case manager, and collaboration with oncology. We conducted a 12-week, single-group trial in patients with SMI and a new breast, gastrointestinal, lung, or head/neck cancer. We assessed the feasibility of patient identification, enrollment and study completion; evaluated acceptability and perceived benefit with exit interviews with patients, caregivers, and oncology clinicians; and examined change in psychiatric symptoms with the Brief Psychiatric Rating Scale (BPRS). RESULTS: From November 2015 to April 2016, 30/33 eligible patients (90.9%) enrolled, and 25/29 (86.2%) completed assessments at all timepoints, meeting feasibility criteria. Of 24 patients, 23 (95.8%) found meeting with the psychiatrist helpful; 16/19 caregivers (84.2%) shared that Bridge addressed key caregiving challenges. Oncology clinicians evaluated Bridge as "very" or "most" useful for 94.3% of patients. Exit interviews with all participant groups suggested that Bridge fostered patient-clinician trust, increased access to psychiatric treatment, and enabled patients to initiate and complete cancer treatment. Psychiatric symptoms on the BPRS improved from baseline to 12 weeks. CONCLUSION: Bridge is a feasible and acceptable care delivery model for patients with SMI, their caregivers, and oncology clinicians. Randomized trials are warranted to assess the efficacy of improving cancer outcomes in this underserved population. IMPLICATIONS FOR PRACTICE: Serious mental illness affects 13 million U.S. adults who experience increased cancer mortality. To improve outcomes, new models of integrated oncology and mental health care are urgently needed. This study found that it was feasible to identify, enroll, and retain patients with serious mental illness and a new cancer in a trial of integrated mental health and cancer care (Bridge). Patients, caregivers, and oncologists reported that Bridge facilitated the initiation and completion of cancer care. Randomized trials are warranted to investigate the impact on cancer outcomes. Trial procedures may inform consent, engagement, and trial retention for patients with mental illness.

Randomized Trial of a Tailored Cognitive-Behavioral Therapy Mobile Application for Anxiety in Patients with Incurable Cancer.

BACKGROUND: The aim of this study was to test the efficacy of a tailored cognitive-behavioral therapy (CBT) mobile application (app) to treat anxiety in patients with incurable cancer. MATERIALS AND METHODS: Patients with incurable cancers (n = 145) who reported elevated anxiety symptoms at two cancer centers were randomized to receive either the CBT mobile app for anxiety or a mobile health education program (control) delivered via tablet computers, which patients self-administered over 12 weeks. To assess anxiety, depression symptoms, and quality of life (QOL), we used the Hamilton Anxiety Rating Scale (HAM-A, primary outcome), Clinical Global Impression Scale, Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire-9, and Functional Assessment of Cancer Therapy-General at baseline and 12 weeks. Analysis of covariance models were calculated to assess intervention effects on patient outcomes. RESULTS: Patients (73.8% female; 91.0% white; mean age = 56.45 years, SD = 11.30) in both study groups reported improvements in anxiety, depression symptoms, and QOL from baseline to postassessment, with no significant differences in any outcome measure between groups. Secondary analyses showed that, among the subgroup of patients with severe baseline anxiety, those randomized to the CBT app had greater improvements on the HAM-A (Mean Difference = 7.44, standard error [SE] = 3.35, p = .037) and HADS-Anxiety Subscale (Mean Difference = 4.44, SE = 1.60, p = .010) compared with the control group. CONCLUSION: Both the tailored CBT app for anxiety and the health education program were associated with improvements in anxiety, mood, and QOL, but these outcomes did not differ between study groups. The CBT app was more beneficial than health education for patients with severe baseline anxiety. IMPLICATIONS FOR PRACTICE: A cognitive-behavioral therapy mobile application tailored to treat anxiety in patients with advanced cancer helps improve access to evidence-based supportive care in a convenient, private, and timely manner.

Cluster Analysis Demonstrates the Need to Individualize Care for Cancer Survivors.

BACKGROUND: In efforts to inform clinical screening and development of survivorship care services, we sought to characterize patterns of health care needs among cancer survivors by (a) identifying and characterizing subgroups based on self-reported health care needs and (b) assessing sociodemographic, clinical, and psychosocial factors associated with these subgroups. METHODS: We conducted a cross-sectional self-administered survey among patients presenting for routine follow-up care for early-stage cancer at our academic medical center. Latent class cluster analysis was used to identify clusters of survivors based on survivorship care needs within seven domains. Multiple logistic regression analyses were used to assess factors associated with these clusters. RESULTS: Among 292 respondents, the highest unmet needs were related to the domains of side effects (53%), self-care (51%), and emotional coping (43%). Our analysis identified four clusters of survivors: (a) low needs (n = 123, 42%), (b) mainly physical needs (n = 46, 16%), (c) mainly psychological needs (n = 57, 20%), and (d) both physical and psychological needs (n = 66, 23%). Compared with cluster 1, those in clusters 2, 3, and 4 were younger (p < .03), those in clusters 3 and 4 had higher levels of psychological distress (p < .05), and those in clusters 2 and 4 reported higher levels of fatigue (p < .05). CONCLUSION: Unmet needs among cancer survivors are prevalent; however, a substantial group of survivors report low or no health care needs. The wide variation in health care needs among cancer survivors suggests a need to screen all patients, followed by tailored interventions in clinical care delivery and research. IMPLICATIONS FOR PRACTICE: The characterization of patients as having few needs, predominantly physical needs, predominantly psychological needs, or substantial needs that are both physical and psychological provides a productive framework for clinical care of cancer survivors and to guide further research in this field. Further research is needed to define the tailored information and services appropriate for each group of patients and to define optimal screening tools to efficiently identify the needs of individuals in oncology practice.

Racial Differences in Tobacco Cessation and Treatment Usage After Lung Screening: An Examination of the National Lung Screening Trial.

BACKGROUND: Black smokers have demonstrated greater lung cancer disease burden and poorer smoking cessation outcomes compared with whites. Lung cancer screening represents a unique opportunity to promote cessation among smokers; however, little is known about the differential impact of screening on smoking behaviors among black and white smokers. Using data from the National Lung Screening Trial (NLST), we examined the racial differences in smoking behaviors after screening. METHODS: We examined racial differences in smoking behavior and cessation activity among 6,316 white and 497 black (median age, 60 and 59 years, respectively) NLST participants who were current smokers at screening using a follow-up survey on 24-hour and 7-day quit attempts, 6-month continuous abstinence, and the use of smoking cessation programs and aids at 12 months after screening. Using multiple regression analyses, we examined the predictors of 24-hour and 7-day quit attempts and 6-month continuous abstinence. RESULTS: At 12 months after screening, blacks were more likely to report a 24-hour (52.7% vs. 41.2%, p < .0001) or 7-day (33.6% vs. 27.2%, p = .002) quit attempt. However, no significant racial differences were found in 6-month continuous abstinence (5.6% blacks vs. 7.2% whites). In multiple regression, black race was predictive of a higher likelihood of a 24-hour (odds ratio [OR], 1.6, 95% confidence interval [CI], 1.2-2.0) and 7-day (OR, 1.5, 95% CI, 1.1-1.8) quit attempt; however, race was not associated with 6-month continuous abstinence. Only a positive screening result for lung cancer was significantly predictive of successful 6-month continuous abstinence (OR, 2.3, 95% CI, 1.8-2.9). CONCLUSION: Although blacks were more likely than whites to have 24-hour and 7-day quit attempts, the rates of 6-month continuous abstinence did not differ. Targeted interventions are needed at the time of lung cancer screening to promote abstinence among all smokers. IMPLICATIONS FOR PRACTICE: Among smokers undergoing screening for lung cancer, blacks were more likely than whites to have 24-hour and 7-day quit attempts; however, these attempts did not translate to increased rates of 6-month continuous abstinence among black smokers. Targeted interventions are needed at the time of lung cancer screening to convert quit attempts to sustained smoking cessation among all smokers.

Development and feasibility of a virtual, synchronous mind-body resiliency intervention for fathers of children and youth with special healthcare needs.

Background: Fathers of children and youth with special healthcare needs (FCYSHCN) are an overlooked population at risk for chronic stress. Mind-body practices offer a patient-centered approach to foster coping and resiliency, yet low engagement from fathers in existing programs suggests adaptation is needed. This multiphase study examines the feasibility of a synchronous, virtual mind-body intervention adapted for FCYSHCN. Methods: 31 FCYSHCN were recruited online via community partners and recruitment portals in an academic medical center in Boston, MA. Phase 1 consisted of individual interviews (N = 17) to determine fathers' stressors, coping strategies, program needs, and suggested adaptations to the intervention protocol. The Phase 2 single arm pilot feasibility trial (N = 14) consisted of eight weekly 60-minute group sessions delivered virtually. Primary feasibility metrics were attendance (benchmark: mean=6 sessions) and electronic survey completion at baseline and post-intervention. Acceptability was assessed using post-session ratings of program satisfaction (4-point Likert scale; scores ≥3 coded as helpful) and helpfulness (e.g., group structure). Exploratory outcomes included validated measures of stress coping, resiliency, parental stress, depression, anxiety, which were analyzed using paired-samples t-tests (alpha=.05) to generate effect sizes (η2). Results: In Phase 1, FCYSHCN discussed primary stressors (e.g., perceived inadequacy as a father) and multifaceted impacts of these stressors on physical, cognitive, emotional, and social wellbeing. Fathers also described coping strategies deemed helpful (e.g., humor) and unhelpful (e.g., "shutting down" from others). Qualitative findings informed intervention modifications. In Phase 2, most FCYSHCN (79%) attended ≥ 6 intervention sessions (mean=7). Follow-up survey completion was high (86%). Session satisfaction was high, with 7/8 sessions rated as helpful by most fathers. Program components deemed most helpful were the group structure, virtual delivery, exposure to a variety of relaxation and meditation skills, and the length of sessions. Although we were not powered to observe pre-post change, stress coping improved (p = .02, η2 = 0.42) and confidence increased in applying relaxation (p = .04, η2 = 0.34) and assertiveness techniques (p = .05, η2 = 0.31). Conclusions: The first mind-body resiliency program for FCYSHCN is feasible and acceptable. Further testing is warranted in randomized trials with diverse samples of fathers, an appropriate comparison arm, and longitudinal assessments of psychosocial and biobehavioral outcomes.

Health Insurance Literacy Improvements Among Recently Diagnosed Adolescents and Young Adults With Cancer: Results From a Pilot Randomized Controlled Trial.

PURPOSE: Adolescents and young adults (AYAs; age 18-39 years) with cancer report needing support with health insurance. We conducted a pilot randomized controlled trial to assess the feasibility and acceptability of a virtual health insurance navigation intervention (HIAYA CHAT) to improve health insurance literacy (HIL), awareness of Affordable Care Act (ACA) protections, financial toxicity, and stress. MATERIALS AND METHODS: HIAYA CHAT is a four-session navigator delivered program; it includes psychoeducation on insurance, navigating one's plan, insurance-related laws, and managing costs. Participants were eligible if they could access an internet-capable device, were <1 year from diagnosis, and received treatment from University of Utah Healthcare or Intermountain Health systems. We assessed the feasibility, acceptability, and preliminary efficacy of HIAYA CHAT compared with usual navigation care, including HIL (nine items), insurance knowledge (13 items), ACA protections (eight items), COmprehensive Score for financial Toxicity (COST; 11 items), and Perceived Stress Scale (PSS; four items), using t tests and Cohen's d. RESULTS: From November 2020 to December 2021, N = 86 AYAs enrolled (44.6% participation) and 89.3% completed the 5-month follow-up survey; 68.6% were female, 72.1% were White, 23.3% were Hispanic, 65.1% were age 26-39 years, and 87.2% were privately insured. Of intervention participants (n = 45), 67.4% completed all four sessions; among an exit interview subset (n = 10), all endorsed the program (100%). At follow-up, compared with usual navigation care, intervention participants had greater improvements in HIL, insurance and ACA protections knowledge, and PSS; effect sizes ranged from moderate to large (0.42-0.77). COST did not differ. CONCLUSION: The results support the feasibility and acceptability of HIAYA CHAT with related improvements in HIL.

Health Insurance Navigation Tools Intervention: A Pilot Trial Within the Childhood Cancer Survivor Study.

PURPOSE: Childhood cancer survivors are at increased risk for underinsurance and health insurance-related financial burden. Interventions targeting health insurance literacy (HIL) to improve the ability to understand and use health insurance are needed. METHODS: We codeveloped a four-session health insurance navigation tools (HINT) intervention, delivered synchronously by a patient navigator, and a corresponding booklet. We conducted a randomized pilot trial with survivors from the Childhood Cancer Survivor Study comparing HINT with enhanced usual care (EUC; booklet). We assessed feasibility, acceptability, and preliminary efficacy (HIL, primary outcome; knowledge and confidence with health insurance terms and activity) on a 5-month survey and exit interviews. RESULTS: Among 231 invited, 82 (32.5%) survivors enrolled (53.7% female; median age 39 years, 75.6% had employer-sponsored insurance). Baseline HIL scores were low (mean = 28.5; 16-64; lower scores better); many lacked knowledge of Affordable Care Act (ACA) provisions. 80.5% completed four HINT sessions, and 93.9% completed the follow-up survey. Participants rated HINT's helpfulness a mean of 8.9 (0-10). Exit interviews confirmed HINT's acceptability, specifically its virtual and personalized delivery and helpfulness in building confidence in understanding one's coverage. Compared with EUC, HINT significantly improved HIL (effect size = 0.94. P < .001), ACA provisions knowledge (effect size = 0.73, P = .003), psychological financial hardship (effect size = 0.64, P < .006), and health insurance satisfaction (effect size = 0.55, P = .03). CONCLUSION: Results support the feasibility and acceptability of a virtual health insurance navigation program targeted for childhood survivors to improve HIL. Randomized trials to assess the efficacy and sustainability of health insurance navigation on HIL and financial burden are needed.

Do Tobacco Treatment Trials Address Disparities in Smoking Outcomes Among Black and Hispanic Cancer Patients? A Systematic Review of Smoking Cessation Interventions for Black and Hispanic Patients Diagnosed with Cancer.

OBJECTIVE: To characterize the representation of Black and Hispanic cancer patients in tobacco treatment trials, and to offer recommendations for future research. METHODS: We conducted two systematic searches of the literature (2018, 2021) using 5 databases (MEDLINE via EBSCO, Pubmed, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE)) to examine the prevalence of tobacco trials that included Black or Hispanic cancer patients. Two coders independently screened all articles at title, abstract, and full-text to identify eligible trials. Information about the proportion of Black and Hispanic patients included, trial design features, and whether the authors analyzed outcomes for Black and Hispanic patients were documented. RESULTS: Of 4682 identified studies, only 10 published trials included and reported on the rates of Black or Hispanic cancer patients enrolled in their tobacco trial. The proportion of enrolled Black cancer patients ranged from 2 to 55.6%. Only our studies documented enrollment rates for Hispanics, and rates were less than 6%. None of the studies offered strategies to promote or the accrual of Black or Hispanic patients. DISCUSSION: There remains a large gap in the literature regarding the reach and efficacy of tobacco treatment for Black and Hispanic cancer patients. Black and Hispanic cancer patients remain largely under-represented in tobacco cessation trials, limiting the applicability of existing, evidence-based treatments. To optimize intervention generalizability, future studies should emphasize the targeted recruitment and engagement of these patients in tobacco trials.