Salivary, lacrimal and nasal (SALANS) measure to assess side effects following radioactive iodine treatment: development, psychometric properties, and factor structure.

PURPOSE: This study aimed to develop and psychometrically evaluate a patient-reported outcome measure (PROM), SAlivary, LAcrimal, NaSal (SALANS), to document patients' symptoms after radioactive iodine (RAI) treatment for differentiated thyroid cancer (DTC). METHODS: We generated and iteratively revised SALANS items based on expert input, focus group discussions and feedback from cognitive testing (n = 17). We administered an initial SALANS measure with 39 items to patients diagnosed with DTC in the past two years (n = 105). Exploratory factor analysis (EFA) examined the factor structure of the SALANS items. We assessed the consistency reliability and related the total and subscale scores of the final SALANS to existing PROMs to assess validity. RESULTS: The final SALANS consisted of 33 items and six subscales (sialadenitis, taste, xerostomia, dry eyes, epiphora, and nasal) with six factors extracted by EFA. The six subscales demonstrated good internal reliability (α range = 0.87-0.92). The SALANS total score showed good convergent validity with the Xerostomia Inventory (r = 0.86) and good discriminant validity with a measure of spirituality (r = - 0.05). The mean SALANS total score was significantly higher (d = 0.5, p < 0.04) among patients who had RAI compared to those who did not have RAI. CONCLUSION: Preliminary evidence suggests that SALANS is a novel and reliable PROM to assess the type and frequency all symptoms experienced after RAI treatment for DTC. Future work is needed to further validate and develop the scale.

PROMIS-29 in rheumatoid arthritis patients who screen positive or negative for fibromyalgia on MDHAQ FAST4 (fibromyalgia assessment screening tool) or 2011 fibromyalgia criteria.

BACKGROUND: PROMIS-29 T-scores query health-related quality of life (HRQL) in 7 domains, physical function, pain, fatigue, anxiety, depression, sleep quality, and social participation, to establish population norms. An MDHAQ (multidimensional health assessment questionnaire) scores these 7 domains and includes medical information such as a FAST4 (fibromyalgia assessment screening tool) index. We analyzed PROMIS-29 T-scores in rheumatoid arthritis (RA) patients vs population norms and for positive vs negative fibromyalgia (FM) screens and compared PROMIS-29 T-scores to MDHAQ scores to assess HRQL. METHODS: A cross-sectional study was performed at one routine visit of 213 RA patients, who completed MDHAQ, PROMIS-29, and reference 2011 FM Criteria. PROMIS-29 T-scores were compared in RA vs population norms and in FM+ vs FM- RA patients, based on MDHAQ/FAST4 and reference criteria. Possible associations between PROMIS-29 T-scores and corresponding MDHAQ scores were analyzed using Spearman correlations and multiple regressions. RESULTS: Median PROMIS-29 T-scores indicated clinically and statistically significantly poorer status in 26-29% FM+ vs FM- RA patients, with larger differences than in RA patients vs population norms for 6/7 domains. MDHAQ scores were correlated significantly with each of 7 corresponding PROMIS-29 domains (|rho|≥0.62, p<0.001). Linear regressions explained 55-73% of PROMIS-29 T-score variation by MDHAQ scores and 56%-70% of MDHAQ score variation by PROMIS-29 T-scores. CONCLUSIONS: Scores for 7 PROMIS-29 domains and MDHAQ were highly correlated. The MDHAQ is effective to assess HRQL and offers incremental medical information, including FAST4 screening. The results indicate the importance of assessing comorbidities such as fibromyalgia screening in interpreting PROMIS-29 T-scores.

A multilevel intervention in pediatric primary care for youth tobacco control: Outcomes of implementing an Ask, Advise, and Connect model.

Multilevel interventions in healthcare settings (e.g. Ask, Advise, and Connect; AAC) can reduce tobacco product use among adult patients: their effectiveness in pediatric practice is largely unknown. We implemented an AAC model in pediatric primary care to deter children's tobacco use, and evaluated its effectiveness in a single-arm trial. At wellness visits, young patients (ages 12-17) completed a tablet-based assessment (Ask) of lifetime and current tobacco use. These data were made available within the electronic health record to pediatric primary care providers for preventive counseling (Advise). Providers then referred patients to an e-health evidence-based tobacco control intervention (Connect). Tobacco control outcomes were examined in the clinic population (N = 2219) and in a sample of patients (N = 388, 62% female, 39% non-White, M age = 15) over time, along with intervention engagement. Population use of tobacco products decreased following introduction of AAC (more than 2-fold). At the patient level, most children (80.9%) engaged with the intervention: those who were Black or African American, who never used tobacco products/were not susceptible to use, and who used fewer non-cigarette tobacco products were more likely to engage, but only after multiple prompts versus a single prompt. Engagement was positively associated with lowering children's susceptibility to using tobacco at follow-up. A pediatric AAC model holds promise in deterring youth tobacco use, including among historically marginalized populations who may require additional support.

By implementing a multilevel Ask, Advise, and Connect intervention, pediatric tobacco use declined in a clinical population, with high intervention engagement and improved outcomes.

Multilevel approaches to address disparities in lung cancer screening: a study protocol.

BACKGROUND: Low-dose computed tomography (lung cancer screening) can reduce lung cancer-specific mortality by 20-24%. Based on this evidence, the United States Preventive Services Task Force recommends annual lung cancer screening for asymptomatic high-risk individuals. Despite this recommendation, utilization is low (3-20%). Lung cancer screening may be particularly beneficial for African American patients because they are more likely to have advanced disease, lower survival, and lower screening rates compared to White individuals. Evidence points to multilevel approaches that simultaneously address multiple determinants to increase screening rates and decrease lung cancer burden in minoritized populations. This study will test the effects of provider- and patient-level strategies for promoting equitable lung cancer screening utilization. METHODS: Guided by the Health Disparities Research Framework and the Practical, Robust Implementation and Sustainability Model, we will conduct a quasi-experimental study with four primary care clinics within a large health system (MedStar Health). Individuals eligible for lung cancer screening, defined as 50-80 years old, ≥ 20 pack-years, currently smoking, or quit < 15 years, no history of lung cancer, who have an appointment scheduled with their provider, and who are non-adherent to screening will be identified via the EHR, contacted, and enrolled (N = 184 for implementation clinics, N = 184 for comparison clinics; total N = 368). Provider participants will include those practicing at the partner clinics (N = 26). To increase provider-prompted discussions about lung screening, an electronic health record (EHR) clinician reminder will be sent to providers prior to scheduled visits with the screening-eligible participants. To increase patient-level knowledge and patient activation about screening, an inreach specialist will conduct a pre-visit phone-based educational session with participants. Patient participants will be assessed at baseline and 1-week post-visit to measure provider-patient discussion, screening intentions, and knowledge. Screening referrals and screening completion rates will be assessed via the EHR at 6 months. We will use mixed methods and multilevel assessments of patients and providers to evaluate the implementation outcomes (adoption, feasibility, acceptability, and fidelity). DISCUSSION: The study will inform future work designed to measure the independent and overlapping contributions of the multilevel implementation strategies to advance equity in lung screening rates. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04675476. Registered December 19, 2020.

The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial.

Although lung cancer screening (LCS) using low-dose CT is recommended for high-risk individuals, screening adherence remains low. We conducted a randomized trial to compare two methods of providing LCS education to Maryland Tobacco Quitline (MTQ) callers in order to assess whether this setting may serve as a teachable moment for LCS-eligible individuals. MTQ callers (50-80 years, 20+ pack-years, prior LCS ≥12 months) completed the baseline and were randomized to the Print- or Web-based version of ShouldIScreen.com. Participants completed 1- and 4-month follow-up assessments to evaluate intervention engagement and LCS-related outcomes. Participants (Print = 152, Web = 146) were 61.7 (SD = 6.3) years old and reported 63.5 pack-years (SD = 36.0). Most identified as Black (54.2%), female (66.1%), having internet access (78.9%), completing other recommended cancer screenings (86.3%), and that they would undergo LCS if recommended by their provider (91.3%). By 4 months, significantly more Print (75.0%) than Web (61.6%) participants had read the materials (P = .01). Most reported the interventions contained "the right amount" of information (92.6%) and prepared them to talk with their doctor (57.2%). Regarding screening-related outcomes, 42.8% (Print) and 43.8% (Web) had scheduled or completed a low-dose CT scan or a shared decision-making visit (P = .86). In a racially diverse sample of LCS-eligible quitline callers, offering LCS educational materials resulted in high intervention engagement and screening-related appointments. As >20% did not have internet access, providing participants' preferred modality (web/print) may improve intervention engagement and knowledge. Improving LCS awareness represents an important opportunity to increase screening among eligible but unscreened quitline callers.

Although annual lung cancer screening (LCS) using low-dose CT is recommended for high-risk individuals, screening adherence remains low. In partnership with the Maryland Tobacco Quitline (MTQ), we compared Print (N = 152) versus Web (N = 146) methods for educating quitline callers about LCS. MTQ callers (50­80 years, 20+ pack-years) completed the baseline and the 1- and 4-month follow-up assessments to evaluate intervention engagement and LCS-related outcomes. Over half of participants identified as Black (54.4%), female (66.2%), and reported having internet access (78.9%), completing other recommended cancer screenings (86%), and would undergo LCS if recommended by their provider (91%). Significantly more Print (75.0%) than Web (61.9%) participants read the materials. Half of participants reported the interventions prepared them to talk with their doctor (57.4%). Regarding screening-related outcomes, 42.8% (Print) and 43.8% (Web) had scheduled or completed a CT scan or a shared decision-making visit. In a racially diverse sample of LCS-eligible quitline callers, offering LCS educational materials resulted in high intervention engagement and screening-related appointments. As >20% did not have internet access, offering the preferred intervention modality may result in improved intervention engagement and knowledge. Effectively improving awareness represents an opportunity to increase screening among LCS-eligible quitline callers.

Patterns of Screening Mammography and Breast MRI During the COVID-19 Pandemic: A Retrospective, Chart-Review Study.

Objective: This study examined patterns of breast cancer screening during the COVID-19 pandemic. Methods: This retrospective study was approved by the Georgetown University IRB. Review of electronic medical records identified screening mammograms and breast MRIs between March 13, 2018 and December 31, 2020, for female patients aged 18 to 85 years. Descriptive statistics characterized patterns of breast cancer screening before and during the COVID-19 pandemic. Logistic regression analyses examined whether receipt of breast MRI differed over time and demographic and clinical factors associated with receipt of breast MRI in 2020. Results: Data included 47 956 mammography visits in 32 778 patients and 407 screening breast MRI visits in 340 patients. After an initial decrease following the declaration of the COVID-19 pandemic, both screening mammograms and screening breast MRI demonstrated early recovery. Although the mammography receipt remained sustained, the receipt of screening breast MRI decreased in late 2020. Odds of having a breast MRI did not differ between 2018 and 2019 (OR = 1.07; 95% CI = 0.92%-1.25%; P = 0.384) but were significantly lower in 2020 versus 2019 (OR = 0.76; 95% CI = 0.61%-0.94%; P = 0.011). No demographic or clinical factors were associated with receipt of breast MRI during the COVID-19 pandemic (all P-values ≥0.225). Conclusion: Breast cancer screening decreased following the declaration of the COVID-19 pandemic. Although both procedures demonstrated early recovery, the rebound in screening breast MRI was not sustained. Interventions promoting return to screening breast MRI may be needed for high-risk women.

Results of a randomized controlled trial of a decision support intervention for disclosing maternal BRCA genetic test results to children and adolescents.

Objective: Evaluate the impact of a targeted family communication intervention for mothers undergoing genetic counseling and testing (GCT) for BRCA gene alterations. Methods: Following BRCA GCT, mothers (N = 204; M age = 45 y) were randomized to either a control condition (self-help print materials) or intervention (printed decision support guide, based on behavioral decision making theory in health care) for supporting choices about disclosing maternal genetic test results to children and adolescents. Behavioral assessments were administered prior to maternal GCT and after receipt of results: primary outcomes were maternal disclosure to children and parent-child communication quality. Results: Mothers in the intervention were > 2x likely to disclose their BRCA test results to their children compared to those in the control condition (odds ratio [OR] = 2.33, 95% confidence interval [CI] = 1.06, 5.10; p = .04). This effect was moderated by children's ages: mothers of preteens (<13 y) assigned to the intervention were >3x likely to disclose their results (OR = 3.74, 95% CI = 1.49, 9.41; p = .005). In adjusted models, intervention was also associated with favorable changes in the quality of parent-child communication (95% CI = 0.30, 9.00; p < .05). Conclusion: Decision support improves parent-child communication outcomes about GCT for hereditary breast-ovarian cancer. Innovation: This trial is among the first to empirically evaluate the outcomes of a behavioral intervention to support family communication of maternal BRCA risk information to children.

A Novel Methodological Approach to Measure Linear Trends in Health Inequalities: Proof of Concept With Adolescent Smoking in Europe.

We describe a new method for presenting and interpreting linear trends in health inequalities, and present a proof-of-concept analysis of inequalities in smoking among adolescents in Europe. We estimated the regression line of the assumed linear relationship between smoking prevalence in low- and high-socioeconomic status (SES) youth over time. Using simulation, we constructed a 95% confidence interval (CI) for the smoking prevalence in low-SES youth for when this would be 0% in high-SES youth, and we calculated the likelihood of eradicating smoking inequality (<5% for both low and high SES). This method was applied to data on adolescents aged 15-16 years (n = 250,326) from 23 European countries, derived from the 2003-2015 European Survey Project on Alcohol and Other Drugs. Smoking prevalence decreased more slowly among low- than among high-SES adolescents. The estimated smoking prevalence was 9.4% (95% CI: 6.1, 12.7) for boys and 5.4% (95% CI: 1.4, 9.2) for girls with low SES when 0% with high SES. The likelihood of eradicating smoking inequality was <1% for boys and 37% for girls. We conclude that this novel methodological approach to trends in health inequalities is feasible in practice. Applying it to trends in smoking inequalities among adolescents in Europe, we found that Europe is currently not on track to eradicate youth smoking across SES groups.

Development and Evaluation of Brief Web-Based Education for Primary Care Providers to Address Inequities in Lung Cancer Screening and Smoking Cessation Treatment.

Annual lung cancer screening (LCS) is recommended for individuals at high risk for lung cancer. However, primary care provider-initiated discussions about LCS and referrals for screening are low overall, particularly among Black or African Americans and other minoritized racial and ethnic groups. Disparities also exist in receiving provider advice to quit smoking. Effective methods are needed to improve provider knowledge about LCS and tobacco-related disparities, and to provide resources to achieve equity in LCS rates. We report the feasibility and impact of pairing a self-directed Lung Cancer Health Disparities (HD) Web-based course with the National Training Network Lung Cancer Screening (LuCa) course on primary care providers' knowledge about LCS and the health disparities associated with LCS. In a quasi-experimental study, primary care providers (N = 91) recruited from the MedStar Health System were assigned to complete the LuCa course only vs. the LuCa + HD courses. We measured pre-post-LCS-related knowledge and opinions about the courses. The majority (60.4%) of providers were resident physicians. There was no significant difference between groups on post-test knowledge (p > 0.05). However, within groups, there was an improvement in knowledge from pre- to post-test (LuCa only (p = 0.03); LuCa + HD (p < 0.001)). The majority of providers (81%) indicated they planned to improve their screening and preventive practices after having reviewed the educational modules. These findings provide preliminary evidence that this e-learning course can be used to educate providers on LCS, smoking cessation, and related disparities impacting patients.

Using Protection Motivation Theory to Predict Intentions for Breast Cancer Risk Management: Intervention Mechanisms from a Randomized Controlled Trial.

The purpose of this study is to evaluate the direct and indirect effects of a web-based, Protection Motivation Theory (PMT)-informed breast cancer education and decision support tool on intentions for risk-reducing medication and breast MRI among high-risk women. Women with ≥ 1.67% 5-year breast cancer risk (N = 995) were randomized to (1) control or (2) the PMT-informed intervention. Six weeks post-intervention, 924 (93% retention) self-reported PMT constructs and behavioral intentions. Bootstrapped mediations evaluated the direct effect of the intervention on behavioral intentions and the mediating role of PMT constructs. There was no direct intervention effect on intentions for risk-reducing medication or MRI (p's ≥ 0.12). There were significant indirect effects on risk-reducing medication intentions via perceived risk, self-efficacy, and response efficacy, and on MRI intentions via perceived risk and response efficacy (p's ≤ 0.04). The PMT-informed intervention effected behavioral intentions via perceived breast cancer risk, self-efficacy, and response efficacy. Future research should extend these findings from intentions to behavior. ClinicalTrials.gov Identifier: NCT03029286 (date of registration: January 24, 2017).

Patient global assessment is elevated by up to 5 of 10 units in patients with inflammatory arthritis who screen positive for fibromyalgia (by FAST4) and/or depression (by MDS2) on a single MDHAQ.

BACKGROUND: Patient global assessment (PATGL) is a component of rheumatoid arthritis (RA) and spondyloarthritis (SpA) activity indices, reflecting inflammation in selected clinical trial patients. In routine care, PATGL often may be elevated independently of inflammatory activity by fibromyalgia (FM) and/or depression, leading to complexities in interpretation. A feasible method to screen for FM and/or depression could help to clarify interpretation of high PATGL and index scores, including explanation of apparent limited responses to anti-inflammatory therapies. PATIENTS AND METHODS: Patients with RA or SpA in routine care in Barcelona, Chicago, and Sydney complete a 2-page multidimensional health assessment questionnaire (MDHAQ) in 5-10 min. The MDHAQ includes PATGL and three indices, RAPID3 (routine assessment of patient index data) to assess clinical status, FAST4 (0-4 fibromyalgia assessment screening tool) and MDS2 (0-2 MDHAQ depression screen). PATGL was compared for each diagnosis at each site and pooled data in FAST4 positive (+) vs negative (-) and/or MDS2+ vs MDS2- patients using medians and median regressions. RESULTS: Median PATGL was 5.0 in 393 RA and 175 SpA patients; 2.0-3.0 in 305 (58.9%) FAST4-,MDS2- patients, 5.5-6.0 in 71 (13.7%) FAST4-,MDS2+ patients, 7.0-7.5 in 50 (9.7%) FAST4+,MDS2- patients, and 7.0-8.0 in 92 (17.8%) FAST4+,MDS2+ patients. Positive FAST4 and/or MDS2 screens were seen in 41% of patients. Results were similar in RA and SpA at 3 settings on 3 continents. CONCLUSION: Median 0-10 PATGL varied from 2-3/10 to 5.5-8/10, according to negative vs positive screening for FM and/or depression on a single MDHAQ for busy clinical settings.

Long-Term Adaptation Among Adolescent and Young Adult Children to Familial Cancer Risk.

BACKGROUND: It is important to examine adolescent and young adult (AYA) children's long-term psychosocial and behavioral adaptation to disclosure of maternal BRCA-positive carrier status (BRCA+) to inform approaches for familial cancer risk communication, education, and counseling. METHODS: Mothers underwent BRCA genetic testing 1 to 5 years earlier. Group differences in AYAs' self-reported outcomes were analyzed by maternal health and carrier status, and child age and sex. RESULTS: A total of N = 272 AYAs were enrolled: 76.1% of their mothers were breast or ovarian cancer survivors and 17.3% were BRCA+. AYAs' cancer risk behavior (tobacco and alcohol use, physical activity) and psychologic distress levels did not vary by maternal status. In bivariate analyses, AYAs of cancer-surviving mothers believed themselves to be at greater risk for, and were more knowledgeable about, cancer than AYAs of mothers without cancer. AYAs of BRCA+ mothers were more concerned about cancer, held stronger beliefs about genetic risk, and placed a higher value on learning about genetics. In adjusted models, maternal cancer history (not BRCA+) remained associated with AYAs' greater perceptions of cancer risk (P = .002), and knowledge about cancer (P = .03) and its causes (P = .002). CONCLUSIONS: Disclosing maternal BRCA+ status did not influence children's lifestyle behavior or adversely affect quality of life long term. AYAs of BRCA+ mothers were more aware of and interested in genetic risk information. Such families may benefit from support to promote open communication about genetic testing choices.

A Randomized Trial of Telephone-Based Smoking Cessation Treatment in the Lung Cancer Screening Setting.

BACKGROUND: Lung cancer mortality is reduced via low-dose computed tomography screening and treatment of early-stage disease. Evidence-based smoking cessation treatment in the lung screening setting can further reduce mortality. We report the results of a cessation trial from the National Cancer Institute's Smoking Cessation at Lung Examination collaboration. METHODS: Eligible patients (n = 818) aged 50-80 years were randomly assigned (May 2017-January 2021) to the intensive vs minimal arms (8 vs 3 phone sessions plus 8 vs 2 weeks of nicotine patches, respectively). Bio-verified (primary) and self-reported 7-day abstinence rates were assessed at 3, 6, and 12 months post random assignment. Logistic regression analyses evaluated the effects of study arm. All statistical tests were 2-sided. RESULTS: Participants reported 48.0 (SD = 17.2) pack-years, and 51.6% were not ready to quit in less than 30 days. Self-reported 3-month quit rates were statistically significantly higher in the intensive vs minimal arm (14.3% vs 7.9%; odds ratio [OR] = 2.00, 95% confidence interval [CI] = 1.26 to 3.18). Bio-verified abstinence was lower but with similar relative differences between arms (9.1% vs 3.9%; OR = 2.70, 95% CI = 1.44 to 5.08). Compared with the minimal arm, the intensive arm was more effective among those with greater nicotine dependence (OR = 3.47, 95% CI = 1.55 to 7.76), normal screening results (OR = 2.58, 95% CI = 1.32 to 5.03), high engagement in counseling (OR = 3.03, 95% CI = 1.50 to 6.14), and patch use (OR = 2.81, 95% CI = 1.39 to 5.68). Abstinence rates did not differ statistically significantly between arms at 6 months (OR = 1.2, 95% CI = 0.68 to 2.11) or 12 months (OR = 1.4, 95% CI = 0.82 to 2.42). CONCLUSIONS: Delivering intensive telephone counseling and nicotine replacement with lung screening is an effective strategy to increase short-term smoking cessation. Methods to maintain short-term effects are needed. Even with modest quit rates, integrating cessation treatment into lung screening programs may have a large impact on tobacco-related mortality.

Race & sex disparities related to low-dose computed tomography lung cancer screening eligibility criteria: A lung cancer cases review.

INTRODUCTION: The United States Preventive Services Task Force (USPSTF) recommendations do not account for race and sex differences in lung cancer risk. We compared the sensitivity for finding lung cancer cases eligible for lung cancer screening (LCS) by USPSTF 2013 recommendations versus the PLCOm2012 model at an equivalent threshold. METHODS: Using Georgetown University Hospital tumor registry, we identified lung cancer cases (≥55 years old) between 2014 and 2018. Medical chart review collected age, sex, race, education, smoking, and clinical characteristics. We compared the percentage meeting eligibility criteria overall, and by race and sex. RESULTS: The cases (N = 447) were 36.6% Black and 52.6% female. The PLCOm2012 and USPSTF 2013 criteria identified 71.4% and 45.6% of cases, respectively (p < 0.0001). This difference was consistent across race and sex sub-groups (p < 0.0001). The PLCOm2012 was more sensitive than the USPSTF in Blacks (69.9% vs. 46.6%, p < 0.0001) and in women (69.8% vs. 41.3%, p < 0.0001). The USPSTF had poor sensitivity for both race groups (Black 46.6%, White 45.9%, p = 0.886) and had lower sensitivity in women vs. men (41.3% vs. 51.4%, p = 0.032). The PLCOm2012 had higher sensitivities in women and men, and difference between sexes was not significant (69.8% vs. 72.6%, p = 0.506). CONCLUSIONS: Compared to the USPSTF 2013 recommendations, the PLCOm2012 model selected a larger proportion of lung cancer cases in all race-sex strata and removed the sex disparity observed for the USPSTF. The PLCOm2012 risk model could be used to identify those who will benefit from LCS.

Psychological predictors of delayed active treatment following active surveillance for low-risk prostate cancer: The Patient REported outcomes for Prostate cARE prospective cohort study.

Objectives: In a prospective, comparative effectiveness study, we assessed clinical and psychological factors associated with switching from active surveillance (AS) to active treatment (AT) among low-risk prostate cancer (PCa) patients. Methods: Using ultra-rapid case identification, we conducted pretreatment telephone interviews (N = 1139) with low-risk patients (PSA ≤ 10, Gleason≤6) and follow-up interviews 6-10 months post-diagnosis (N = 1057). Among men remaining on AS for at least 12 months (N = 601), we compared those who continued on AS (N = 515) versus men who underwent delayed AT (N = 86) between 13 and 24 months, using Cox proportional hazards models. Results: Delayed AT was predicted by time dependent PSA levels (≥10 vs. <10; HR = 5.6, 95% CI 2.4-13.1) and Gleason scores (≥7 vs. ≤6; adjusted HR = 20.2, 95% CI 12.2-33.4). Further, delayed AT was more likely among men whose urologist initially recommended AT (HR = 2.13, 95% CI 1.07-4.22), for whom tumour removal was very important (HR = 2.18, 95% CI 1.35-3.52), and who reported greater worry about not detecting disease progression early (HR = 1.67, 1.05-2.65). In exploratory analyses, 31% (27/86) switched to AT without evidence of progression, while 4.7% (24/515) remained on AS with evidence of progression. Conclusions: After adjusting for clinical evidence of disease progression over the first year post-diagnosis, we found that urologists' initial treatment recommendation and patients' early treatment preferences and concerns about AS each independently predicted undergoing delayed AT during the second year post-diagnosis. These findings, along with almost one-half undergoing delayed AT without evidence of progression, suggest the need for greater decision support to remain on AS when it is clinically indicated.

Engaging Patients in Smoking Cessation Treatment within the Lung Cancer Screening Setting: Lessons Learned from an NCI SCALE Trial.

Offering smoking cessation treatment at lung cancer screening (LCS) will maximize mortality reduction associated with screening, but predictors of treatment engagement are not well understood. We examined participant characteristics of engagement in an NCI SCALE cessation trial. Eligible LCS patients (N = 818) were randomized to the Intensive arm (8 phone counseling sessions +8 weeks of nicotine replacement therapy (NRT)) vs. Minimal arm (3 sessions + 2 weeks of NRT). Engagement was measured by number of sessions completed (none, some, or all) and NRT mailed (none vs. any) in each arm. In the Intensive arm, those with ≥some college (OR = 2.1, 95% CI = 1.1, 4.0) and undergoing an annual scan (OR = 2.1, 95% CI = 1.1, 4.2) engaged in some counseling vs. none. Individuals with higher nicotine dependence were more likely (OR = 2.8, 95% CI = 1.3, 6.2) to request NRT. In the Minimal arm, those with higher education (OR = 2.1, 95% CI = 1.1, 3.9) and undergoing an annual scan (OR = 2.0, 95% CI = 1.04, 3.8) completed some sessions vs. none. Requesting NRT was associated with more pack-years (OR = 1.9, 95% CI = 1.1, 3.5). Regardless of treatment intensity, additional strategies are needed to engage those with lower education, less intensive smoking histories, and undergoing a first scan. These efforts will be important given the broader 2021 LCS guidelines.

Improved motivation and readiness to quit shortly after lung cancer screening: Evidence for a teachable moment.

BACKGROUND: For patients at high risk for lung cancer, screening using low-dose computed tomography (lung cancer screening [LCS]) is recommended. The purpose of this study was to examine whether screening may serve as a teachable moment for smoking-related outcomes. METHODS: In a smoking-cessation trial, participants (N = 843) completed 2 phone interviews before randomization: before LCS (T0) and after LCS (T1). By using logistic and linear regression, the authors examined teachable moment variables (perceived risk, lung cancer worry) and outcomes (readiness, motivation, and cigarettes per day [CPD]). RESULTS: Participants were a mean ± SD age of 63.7 ± 5.9 years, had 47.8 ± 7.1 pack-years of smoking, 35.2% had a high school diploma or General Educational Development (high school equivalency) degree or less, and 42.3% were undergoing their first scan. Between T0 and T1, 25.7% of participants increased readiness to quit, 9.6% decreased readiness, and 64.7% reported no change (P < .001). Motivation to quit increased (P < .05) and CPD decreased between assessments (P < .001), but only 1.3% self-reported quitting. Compared with individuals who reported no lung cancer worry/little worry, extreme worry was associated with readiness to quit in the next 30 days (odds ratio, 1.8; 95% CI, 1.1-3.0) and with higher motivation (b = 0.83; P < .001) at T1. Individuals undergoing a baseline (vs annual) scan were more ready to quit in the next 30 days (odds ratio, 1.8; 95% CI, 1.3-2.5). CONCLUSIONS: During the brief window between registering for LCS and receiving the results, the authors observed that very few participants quit smoking, but a significant proportion improved on readiness and motivation to quit, particularly among individuals who were undergoing their first scan and those who were extremely worried about lung cancer. These results indicate that providing evidence-based tobacco treatment can build upon this teachable moment.

Lung cancer screening use and implications of varying eligibility criteria by race and ethnicity: 2019 Behavioral Risk Factor Surveillance System data.

BACKGROUND: In 2021, the US Preventive Services Task Force (USPSTF) expanded the eligibility criteria for low-dose computed tomographic lung cancer screening (LCS) to reduce racial disparities that resulted from the 2013 USPSTF criteria. The annual LCS rate has risen slowly since the 2013 USPSTF screening recommendations. Using the 2019 Behavioral Risk Factor Surveillance System (BRFSS), this study 1) describes LCS use in 2019, 2) compares the percent eligible for LCS using the 2013 versus 2021 USPSTF criteria, and 3) determines the percent eligible using the more detailed PLCOm2012Race3L risk-prediction model. METHODS: The analysis included 41,544 individuals with a smoking history from states participating in the BRFSS LCS module who were ≥50 years old. RESULTS: Using the 2013 USPSTF criteria, 20.7% (95% confidence interval [CI], 19.0-22.4) of eligible individuals underwent LCS in 2019. The 2013 USPSTF criteria was compared to the 2021 USPSTF criteria, and the overall proportion eligible increased from 21.0% (95% CI, 20.2-21.8) to 34.7% (95 CI, 33.8-35.6). Applying the 2021 criteria, the proportion eligible by race was 35.8% (95% CI, 34.8-36.7) among Whites, 28.5% (95% CI, 25.2-31.9) among Blacks, and 18.0% (95% CI, 12.4-23.7) among Hispanics. Using the 1.0% 6-year threshold that is comparable to the 2021 USPSTF criteria, the PLCOm2012Race3L model selected more individuals overall and by race. CONCLUSIONS: Using data from 20 states and using multiple imputation, higher LCS rates have been reported compared to prior BRFSS data. The 2021 expanded criteria will result in a greater number of screen-eligible individuals. However, risk-based screening that uses additional risk factors may be more inclusive overall and across subgroups. LAY SUMMARY: In 2013, lung cancer screening (lung screening) was recommended for high risk individuals. The annual rate of lung screening has risen slowly, particularly among Black individuals. In part, this racial disparity resulted in expanded 2021 criteria. Survey data was used to: 1) describe the number of people screened in 2019, 2) compare the percent eligible for lung screening using the 2013 versus 2021 guidelines, and 3) determine the percent eligible using more detailed criteria. Lung screening rates increased in 2019, and the 2021 criteria will result in more individuals eligible for screening. Using additional criteria may identify more individuals eligible for lung screening.

Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study's two-arm randomized controlled trial.

BACKGROUND: During, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life. To address these survivorship problems, we developed a low-burden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early post-transplant period, when symptoms peak, and when intervention could prevent development of persistent symptoms. METHODS: WISE is a multi-site, two-arm randomized controlled efficacy trial. Adult hematological cancer patients scheduled for a hematopoietic stem cell transplant will complete baseline measures and then, after hospitalization but prior to transplant, they will be randomized to complete either expressive helping or a time and attention "neutral writing" task. Both expressive helping and neutral writing involve four brief writing sessions, beginning immediately after randomization and ending approximately 4 weeks after hospital discharge. Measures of symptom burden (primary outcome), distress, health-related quality of life, and fatigue (secondary outcomes) will be administered in seven assessments coinciding with medically relevant time points from baseline and to a year post-intervention. DISCUSSION: The steady and continuing increase in use of stem cell transplantation has created growing need for efficacious, accessible interventions to reduce the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment. Expressive helping is a psychological intervention that was designed to fill this gap. It has been shown to be efficacious in long-term transplant survivors but could have even greater impact if it is capable of reducing symptoms during and soon after transplant. The WISE study will evaluate these benefits in a rigorous randomized controlled trial. TRIAL REGISTRATION: Clinicaltrial.gov NCT03800758 . Registered January 11, 2019.

Effect of a Randomized Trial of a Web-Based Intervention on Patient-Provider Communication About Breast Density.

Background: Breast density increases breast cancer risk and decreases mammographic detection. We evaluated a personalized web-based intervention designed to improve breast cancer risk communication between women and their providers. Materials and Methods: This was a secondary outcome analysis of an online randomized trial. Women aged 40-69 years were randomized, February 2017-May 2018, to a control (n = 503) versus intervention website (n = 492). The intervention website included information about breast density, personalized breast cancer risk, chemoprevention, and magnetic resonance imaging. Participants self-reported communication about density with providers (yes/no) at 6 weeks and 12 months. We used logistic regression with generalized estimating equations to evaluate the association of study arm with density communication. In secondary analyses, we tested if the intervention was associated with indicators of patient activation (breast cancer worry, perceived risk, or health care use). Results: Women (mean age 62 years) in the intervention versus control arm were 2.39 times (95% confidence interval [CI] = 1.37-4.18) more likely to report density communication at 6 weeks; this effect persisted at 12 months (odds ratio [OR] = 1.71, 95% CI = 1.25-2.35). At 6 weeks, this effect was only significant among women who reported (OR = 3.23, 95% CI = 1.24-8.40) versus did not report any previous density discussions (OR = 1.64, 95% CI = 0.83-3.26). A quarter of women in each arm never had a density conversation at any time during the study. Conclusions: Despite providing personalized density and risk information, the intervention did not promote density discussions between women and their providers who had not had them previously. This intervention is unlikely to be used clinically to motivate density conversations in women who have not had them before. Clinical trial registration number NCT03029286.