Effects of vitamin D supplementation on a deep learning-based mammographic evaluation in SWOG S0812.

Deep learning-based mammographic evaluations could noninvasively assess response to breast cancer chemoprevention. We evaluated change in a convolutional neural network-based breast cancer risk model applied to mammograms among women enrolled in SWOG S0812, which randomly assigned 208 premenopausal high-risk women to receive oral vitamin D3 20 000 IU weekly or placebo for 12 months. We applied the convolutional neural network model to mammograms collected at baseline (n = 109), 12 months (n = 97), and 24 months (n = 67) and compared changes in convolutional neural network-based risk score between treatment groups. Change in convolutional neural network-based risk score was not statistically significantly different between vitamin D and placebo groups at 12 months (0.005 vs 0.002, P = .875) or at 24 months (0.020 vs 0.001, P = .563). The findings are consistent with the primary analysis of S0812, which did not demonstrate statistically significant changes in mammographic density with vitamin D supplementation compared with placebo. There is an ongoing need to evaluate biomarkers of response to novel breast cancer chemopreventive agents.

Efficacy of Cobas HPV testing for predicting grade 2+ cervical intraepithelial neoplasia in a cancer prevention center and a gynecologic oncology clinic: A single-institution experience.

BACKGROUND: To evaluate the efficacy of Cobas human papillomavirus (HPV) testing to predict cervical intraepithelial neoplasia of grade 2 or higher (CIN2+), Cobas HPV testing results were correlated with follow-up biopsy in patients from Cancer Prevention Center (CPC) and Gynecologic Oncology Clinic (GOC) of The University of Texas MD Anderson Cancer Center. METHODS: Institutional data for patients who underwent Cobas HPV and Papanicolaou (Pap) cytology cotesting from 2019 to 2020 were retrospectively reviewed. Surgical follow-up results were compared with Cobas HPV testing results in two populations. RESULTS: A total of 2226 patients, including 921 women (mean age, 55.2 years) seen at the CPC and 1305 women (mean age, 49.3 years) seen at the GOC, were included. Specimens from GOC patients had a significantly higher HPV positivity rate than did those from CPC patients (22.9% vs. 10.1%; p < .001). Cobas HPV testing was positive in all seven CPC patients with surgical follow-up results showing CIN2+. Among 36 GOC patients with CIN2+ lesions, five patients had HPV-/Pap+ testing results. Although only seven CPC patients had CIN2+, Cobas HPV testing showed 100% sensitivity for predicting CIN2+ in this group. Sensitivity for CIN2+ was 86.5% in the GOC group, whereas 13.9% of GOC patients with CIN2+ had negative HPV testing results. CONCLUSIONS: Cobas HPV testing was highly efficacious for predicting CIN2+ lesions in the low-risk CPC population, which supports HPV primary screening for cervical cancer in low-risk populations. For high-risk patients, especially those with a history of CIN2+/cervical cancer, HPV/Pap cotesting may still be necessary to maintain a high clinical sensitivity for CIN2+.

Talking numbers: how women and providers use risk scores during and after risk counseling - a qualitative investigation from the NRG Oncology/NSABP DMP-1 study.

OBJECTIVES: Little research exists on how risk scores are used in counselling. We examined (a) how Breast Cancer Risk Assessment Tool (BCRAT) scores are presented during counselling; (b) how women react and (c) discuss them afterwards. DESIGN: Consultations were video-recorded and participants were interviewed after the consultation as part of the NRG Oncology/National Surgical Adjuvant Breast and Bowel Project Decision-Making Project 1 (NSABP DMP-1). SETTING: Two NSABP DMP-1 breast cancer care centres in the USA: one large comprehensive cancer centre serving a high-risk population and an academic safety-net medical centre in an urban setting. PARTICIPANTS: Thirty women evaluated for breast cancer risk and their counselling providers were included. METHODS: Participants who were identified as at increased risk of breast cancer were recruited to participate in qualitative study with a video-recorded consultation and subsequent semi-structured interview that included giving feedback and input after viewing their own consultation. Consultation videos were summarised jointly and inductively as a team.tThe interview material was searched deductively for text segments that contained the inductively derived themes related to risk assessment. Subgroup analysis according to demographic variables such as age and Gail score were conducted, investigating reactions to risk scores and contrasting and comparing them with the pertinent video analysis data. From this, four descriptive categories of reactions to risk scores emerged. The descriptive categories were clearly defined after 19 interviews; all 30 interviews fit principally into one of the four descriptive categories. RESULTS: Risk scores were individualised and given meaning by providers through: (a) presenting thresholds, (b) making comparisons and (c) emphasising or minimising the calculated risk. The risk score information elicited little reaction from participants during consultations, though some added to, agreed with or qualified the provider's information. During interviews, participants reacted to the numbers in four primary ways: (a) engaging easily with numbers; (b) expressing greater anxiety after discussing the risk score; (c) accepting the risk score and (d) not talking about the risk score. CONCLUSIONS: Our study highlights the necessity that patients' experiences must be understood and put into relation to risk assessment information to become a meaningful treatment decision-making tool, for instance by categorising patients' information engagement into types. TRIAL REGISTRATION NUMBER: NCT01399359.

NCCN Guidelines® Insights: Breast Cancer Screening and Diagnosis, Version 1.2023.

The NCCN Guidelines for Breast Cancer Screening and Diagnosis provide health care providers with a practical, consistent framework for screening and evaluating a spectrum of clinical presentations and breast lesions. The NCCN Breast Cancer Screening and Diagnosis Panel is composed of a multidisciplinary team of experts in the field, including representation from medical oncology, gynecologic oncology, surgical oncology, internal medicine, family practice, preventive medicine, pathology, diagnostic and interventional radiology, as well as patient advocacy. The NCCN Breast Cancer Screening and Diagnosis Panel meets at least annually to review emerging data and comments from reviewers within their institutions to guide updates to existing recommendations. These NCCN Guidelines Insights summarize the panel's decision-making and discussion surrounding the most recent updates to the guideline's screening recommendations.

Isolated Flat Epithelial Atypia: Upgrade Outcomes After Multidisciplinary Review-Based Management Using Excision or Imaging Surveillance.

Objective: To compare flat epithelial atypia (FEA) upgrade rates after excision versus surveillance and to identify variables associated with upgrade. Methods: This single-institution retrospective study identified isolated FEA cases determined by percutaneous biopsy from April 2005 through July 2022 with excision or ≥2 years surveillance. All cases were recommended for excision or surveillance based on multidisciplinary discussion of clinical, imaging, and pathologic variables with emphasis on sampling adequacy and significant atypia. Truth was determined by pathology at excision or the absence of cancer on surveillance. Upgrade was defined as cancer occurring ≤2 cm from the biopsy site. Demographic, imaging, and biopsy variables were compared between those that did and did not upgrade. Results: Among 112 cases of isolated FEA, imaging findings included calcifications in 81.3% (91/112), MRI lesions in 11.6% (13/112), and distortions or masses in 7.1% (8/112). Excision was recommended in 12.5% (14/112) and surveillance in 87.5% (98/112) of cases. Among those recommended for excision, 28.6% (4/14) of cases were upgraded, all to ductal carcinoma in situ. In those recommended for surveillance, 1.0% (1/98) were upgraded to invasive cancer. Overall, FEA had a 4.5% (5/112) upgrade rate, and 2.7% (3/112) also developed cancer >2 cm from the FEA. There were no significant differences in demographic, imaging, and biopsy variables between those that did and did not upgrade to cancer. Conclusion: Multidisciplinary management of isolated FEA distinguishes those at higher risk of upgrade to cancer (28.6%) in whom surgery is warranted from those at low risk of upgrade (1.0%) who can be managed non-operatively.

Nipple Discharge Imaging Evaluation with Mammography, Ultrasound, Galactography, and MRI.

RATIONALE AND OBJECTIVE: To determine the diagnostic yield of various imaging tests used to evaluate nipple discharge. MATERIALS AND METHODS: A single institution, IRB-approved, retrospective study was performed of 320 consecutive patients presenting with nipple discharge. Imaging and pathology were reviewed to determine the yield for malignancy, atypical high-risk lesions (HRLs), and intraductal papillomas (IDPs). RESULTS: Of the 320 patients, pathology or follow up confirmed 40 breast malignancies (40/320, 12.5%),14 atypical HRLs (14/320, 4.4%), 71 IDPs (71/320, 22.2%), 48 other benign pathologies (48/320,15.0%), and 147 unknown but benign cases (147/320, 45.9%). Physiologic discharge characteristics were observed in a minority of malignant cases: nonspontaneous (4/40, 10.0%); neither bloody nor clear (4/40, 10.0%); bilateral (3/40, 7.5%). Malignancy was associated with older age (p < 0.001) and bloody discharge (odds ratio 6.5, p < 0.0001). The combination of digital mammography and ultrasound had a 93% sensitivity and a 98% NPV, while contrast enhanced MRI (CE-MRI) had a 100% sensitivity and a 100% NPV for malignancy. Only three galactography examinations were performed among the malignant cohort, with minimal contribution (1 of 3) to the diagnostic evaluation. In this case, galactography findings helped determine imaging-pathology discordance, prompting a recommendation for surgical excision and subsequently a malignant diagnosis. CONCLUSION: The combination of mammography and ultrasonography detected 93% of breast malignancies associated with nipple discharge and had a 98% NPV for malignancy. The value of CE-MRI is its ability to detect the remaining malignancies, not detected on mammography or ultrasound, and its ability to obviate the need for surgical duct excision.

Aromatase inhibitors and contralateral breast cancer in BRCA mutation carriers.

BACKGROUND: Deleterious BRCA mutations confer a significant lifetime risk of breast cancer (BC) as well as contralateral BC (CBC) in patients who do not undergo prophylactic mastectomy. Prior reports have suggested that tamoxifen reduces the risk of CBC in BRCA mutation carriers. Whether aromatase inhibitors (AI) have the same effect is unknown. METHODS: This is a retrospective review of patients diagnosed with non-metastatic ER+ BC between 2004 and 2014 with known BRCA mutation status. Patients were followed from primary diagnosis until CBC diagnosis or death. Median follow-up was 11.5 years. Risk of CBC was evaluated as time to event. RESULTS: 935 subjects were included in this analysis, with 53 BRCA1 mutation carriers, and 94 BRCA2 mutation carriers. Median age at diagnosis was 42.7 years. Seventy-two percent (676) received tamoxifen and 43% (405) received AI. A total of 66 CBCs occurred, of which 10% (15/147) occurred in BRCA mutation carriers vs 6.5% (51/788) in BRCA wild type. Multivariate analyses indicated that BRCA status and AI use were significantly associated with CBC risk. AI use resulted in a significant reduction in risk of CBC (HR 0.44, p = 0.004) regardless of the BRCA mutation status. Tamoxifen use was not associated with reduced risk of CBC. CONCLUSIONS: This is the first report showing that AIs reduce the risk of CBC in BRCA mutation carriers. The potential role of AIs as chemoprevention should be validated in larger independent cohorts.

Salutary effects of moderate but not high intensity aerobic exercise training on the frequency of peripheral T-cells associated with immunosenescence in older women at high risk of breast cancer: a randomized controlled trial.

BACKGROUND: Immunosenescence is described as age-associated changes within the immune system that are responsible for decreased immunity and increased cancer risk. Physically active individuals have fewer 'senescent' and more naïve T-cells compared to their sedentary counterparts, but it is not known if exercise training can rejuvenate 'older looking' T-cell profiles. We determined the effects of 12-weeks supervised exercise training on the frequency of T-cell subtypes in peripheral blood and their relationships with circulating levels of the muscle-derived cytokines (i.e. 'myokines') IL-6, IL-7, IL-15 and osteonectin in older women at high risk of breast cancer. The intervention involved 3 sessions/week of either high intensity interval exercise (HIIT) or moderate intensity continuous exercise (MICT) and were compared to an untrained control (UC) group. RESULTS: HIIT decreased total granulocytes, CD4+ T-cells, CD4+ naïve T-cells, CD4+ recent thymic emigrants (RTE) and the CD4:CD8 ratio after training, whereas MICT increased total lymphocytes and CD8 effector memory (EM) T-cells. The change in total T-cells, CD4+ naïve T-cells, CD4+ central memory (CM) T-cells and CD4+ RTE was elevated after MICT compared to HIIT. Changes in [Formula: see text] after training, regardless of exercise prescription, was inversely related to the change in highly differentiated CD8+ EMRA T-cells and positively related to changes in ß2-adrenergic receptor (ß2-AR) expression on CM CD4+ and CM CD8+ T-cells. Plasma myokine levels did not change significantly among the groups after training, but individual changes in IL-7 were positively related to changes in the number of ß2-AR expressing CD4 naïve T cells in both exercise groups but not controls. Further, CD4 T-cells and CD4 naive T-cells were negatively related to changes in IL-6 and osteonectin after HIIT but not MICT, whereas CD8 EMRA T-cells were inversely related to changes in IL-15 after MICT but not HIIT. CONCLUSIONS: Aerobic exercise training alters the frequency of peripheral T-cells associated with immunosenescence in middle aged/older women at high risk of breast cancer, with HIIT (pro-senescent) and MICT (anti-senescent) evoking divergent effects. Identifying the underlying mechanisms and establishing whether exercise-induced changes in peripheral T-cell numbers can alter the risk of developing breast cancer warrants investigation.

Perceptions of Conflicting Breast Cancer Screening Recommendations Among Racially/Ethnically Diverse Women: a Multimethod Study.

BACKGROUND: Conflicting breast cancer screening recommendations have the potential to diminish informed decision making about screening. OBJECTIVE: We examined the knowledge, attitudes, and intentions related to divergent recommendations for breast cancer screening among racially/ethnically diverse women. DESIGN: We used a multimethod study design employing focus groups and questionnaires. Focus groups included: (1) two 10-min presentations on the national screening recommendations and the potential benefits and harms of screening and (2) an interactive discussion. Data were collected: 8/3/2017 to 11/19/2019. Analysis occurred from 1/21/2019 to 7/24/2020. PARTICIPANTS: Participants were (1) women 40-75 years; (2) English or Spanish speaking; (3)self-identified as Latina, Black, or non-Latina White; and (4) no known increased risk for breast cancer. MAIN MEASURES: Main outcomes were participants' knowledge and perceptions of benefits and harms of screening mammography and their screening intentions. Focus groups were transcribed and analyzed using a qualitative descriptive approach. Quantitative data were summarized using descriptive statistics. KEY RESULTS: One hundred thirty-four women (n=52, 40-49 years; n=82, 50-75 years) participated in 28 focus groups. Participants were Latina (n=44); Black (n=51); and non-Latina White (n=39). Approximately one-quarter (n=32) had limited health literacy and almost one-fifth (n=23) had limited numeracy. In the context of differing national screening recommendations, participants questioned the motives of the recommendation-making agencies, including the role of costs and how costs were considered when making screening recommendations. Participants expressed concern that they were not represented (e.g., race/ethnicity) in the data informing the recommendations. Immediately following the focus groups, most participants expressed intention to screen within the upcoming year (pre n=100 vs. post n=107). CONCLUSIONS: Divergent breast cancer screening recommendations may lead to mistrust and paradoxically reinforce high overall enthusiasm for screening.

Management of Symptomatic Patients with Textured Implants.

SUMMARY: Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.

The impact of high-intensity interval exercise training on NK-cell function and circulating myokines for breast cancer prevention among women at high risk for breast cancer.

PURPOSE: Preclinical evidence suggests that natural killer cell (NK-cell) function and myokines facilitate the protective effects of exercise for breast cancer prevention. Since higher-intensity exercise acutely promotes greater mobilization and larger changes in NK-cell cytotoxicity than lower-intensity, high-intensity interval training (HIIT) might offer increased immune protection compared to moderate-intensity continuous-training (MICT). This study compared a 12-week HIIT program to a 12-week MICT program and usual care on changes in resting NK-cell function and circulating myokines among women at high risk for breast cancer. METHODS: Thirty-three women were randomized to HIIT, MICT, or usual care, for a supervised exercise intervention. Blood was collected at baseline and end-of-study. The cytotoxic activity of CD3-/CD56+ NK-cells against the K562 target cell line in vitro was determined by flow cytometry. Circulating myokines (IL-15, IL-6, irisin, OSM, osteonectin, IL-7) were assessed with luminex multiplex assays and ELISA. One-way ANOVA and paired sample t-tests assessed between- and within-group differences, respectively. Pearson correlation coefficients determined relationships between baseline fitness and change variables. RESULTS: Significant differences were not observed between groups for change in NK-cell function or circulating myokines (p > 0.05). Significant correlations were only observed for baseline peak aerobic capacity (ml/kg/min) and change in NK-cell-specific lysis (r = - 0.43, p = 0.02) and hemacytotoxicity for the total sample (r = - 0.46, p = 0.01). CONCLUSION: Our findings suggest that exercise intensity may not significantly impact change in resting NK-cell function and circulating myokines among women at high risk for breast cancer. Structured exercise training may have a larger impact on NK-cell function in those with lower levels of cardiorespiratory fitness. CLINICAL TRIAL REGISTRATION: NCT02923401; Registered on October 4, 2016.

A Randomized Phase IIb Study of Low-dose Tamoxifen in Chest-irradiated Cancer Survivors at Risk for Breast Cancer.

PURPOSE: Low-dose tamoxifen reduces breast cancer risk, but remains untested in chest-irradiated cancer survivors-a population with breast cancer risk comparable with BRCA mutation carriers. We hypothesized that low-dose tamoxifen would be safe and efficacious in reducing radiation-related breast cancer risk. PATIENTS AND METHODS: We conducted an investigator-initiated, randomized, phase IIb, double-blinded, placebo-controlled trial (FDA IND107367) between 2010 and 2016 at 15 U.S. sites. Eligibility included ≥12 Gy of chest radiation by age 40 years and age at enrollment ≥25 years. Patients were randomized 1:1 to low-dose tamoxifen (5 mg/day) or identical placebo tablets for 2 years. The primary endpoint was mammographic dense area at baseline, 1 and 2 years. IGF-1 plays a role in breast carcinogenesis; circulating IGF-1 and IGF-BP3 levels at baseline, 1 and 2 years served as secondary endpoints. RESULTS: Seventy-two participants (low-dose tamoxifen: n = 34, placebo: n = 38) enrolled at a median age of 43.8 years (35-49) were evaluable. They had received chest radiation at a median dose of 30.3 Gy. Compared with the placebo arm, the low-dose tamoxifen arm participants had significantly lower mammographic dense area (P = 0.02) and IGF1 levels (P < 0.0001), and higher IGFBP-3 levels (P = 0.02). There was no difference in toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and antithrombin III; urine N-telopeptide cross-links) between the treatment arms. We did not identify any grade 3-4 adverse events related to low-dose tamoxifen. CONCLUSIONS: In this randomized trial in chest-irradiated cancer survivors, we find that low-dose tamoxifen is effective in reducing established biomarkers of breast cancer risk and could serve as a risk-reduction strategy.

Biomarker Modulation Study of Celecoxib for Chemoprevention in Women at Increased Risk for Breast Cancer: A Phase II Pilot Study.

In preclinical studies, celecoxib has been associated with reduced risk of breast cancer. In this study, the aim was to assess the biomodulatory effect of celecoxib on blood and benign breast tissue biomarkers in women at increased risk for breast cancer. Women at increased risk for breast cancer [5-year Gail risk score of >1.67%, history of atypical hyperplasia, lobular carcinoma in situ, or previous estrogen receptor (ER)-negative breast cancer] were treated with celecoxib at 400 mg orally twice daily for 6 months. Participants underwent random periareolar fine needle aspiration and blood draw at baseline and at 6 months for analysis of biomarkers: serum levels of insulin-like growth factor 1 (IGF-1), IGF-binding protein 1 (IGFBP-1), and IGFBP-3; tissue expression of Ki-67 and ER; as well as cytology. Forty-nine patients were eligible for analysis. Median IGFBP-1 levels increased significantly from 6.05 ng/mL at baseline to 6.93 ng/mL at 6 months (P = 0.04), and median IGFBP-3 levels decreased significantly from 3,593 ng/mL to 3,420 ng/mL (P = 0.01). We also detected favorable changes in cytology of 52% of tested sites after 6 months of celecoxib therapy. No changes in tissue Ki-67 and ER expression levels were observed. No grade 3 or 4 toxicity was recorded. Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial. A phase IIb placebo-controlled study with celecoxib could be considered for women at increased risk for breast cancer.

The role of magnetic resonance imaging in patients with palpable breast abnormalities and negative mammographic and sonographic findings.

OBJECTIVE OR PURPOSE OF STUDY: The objective of this retrospective study was to determine the frequency of positive findings on breast magnetic resonance imaging (MRI) in patients with palpable breast abnormalities in the setting of negative mammographic and sonographic evaluations. MATERIALS, METHODS, AND PROCEDURES: Consecutive patients undergoing breast MRI for palpable abnormalities from January 1, 2005 to December 31, 2015 were identified for this retrospective study. Those with preceding imaging (mammograms or ultrasounds) demonstrating positive findings related to the palpable abnormalities were excluded. The location and the duration of the symptoms, the type and the location of the abnormal MRI findings, and their relationships to the symptoms were recorded. Clinical and imaging follow-up as well as the type and the resultant biopsies were recorded. Patients with less than two years of imaging or clinical follow-up were excluded from the study. RESULTS: 22 004 women presented with palpable abnormalities at one breast imaging center between January 1, 2005 and December 31, 2015. Nine thousand and three hundred and thirty-four patients had negative or benign findings on mammography, ultrasound, or mammography plus ultrasound. Thirty-one patients underwent MRI with the complaint of palpable abnormalities despite negative or benign mammographic and/or sonographic findings. Their age range was between 32 and 74 years, and their mean age was 49 years. Of those who had MRI, twenty-one patients had negative MRI findings. Six patients had negative concordant results for the palpable abnormalities and benign incidental findings. Three patients had benign concordant results for the palpable abnormalities, and one patient had incidental atypia. Twenty-eight patients had negative MRI results in the area of the palpable abnormality, and none of these patients underwent biopsy. Of the 31 cases, four patients (13%) underwent additional examinations (three second-look ultrasounds and one bone scan) after MRI. Five patients (16%) underwent MRI-guided biopsies, two patients (6%) underwent ultrasound-guided biopsies, and one patient (3%) had an excision. All biopsies showed benign results. The Gail risk score was calculated for 22 of them and the mean 5-year risk was 1.64 and the mean lifetime risk was 12.51. CONCLUSION: Breast MRI to evaluate palpable abnormalities after negative mammography and ultrasound results in a low yield for malignancy. The majority of patients (67.7%) had negative MRI examinations, and there were no malignancies detected. Our findings lead us to believe that there are no data to encourage the use of MRI in patients with palpable abnormalities and negative mammographic and/or ultrasound studies.

Using Continuous Glucose Monitoring to Motivate Physical Activity in Overweight and Obese Adults: A Pilot Study.

BACKGROUND: Regular physical activity (PA) is associated with a lower risk of several types of cancers. However, two-thirds of overweight/obese adults are not sufficiently active; this, in combination with the unfavorable effect of excess body weight, puts them at a greater risk for cancer. One reason that these individuals do not engage in enough PA may be their lack of motivation to change their current behavior due to the perception of putting in effort for possible future gain without obvious short-term benefits. There is a need for innovative ways to help individuals recognize the immediate health benefits of PA and thus increase their motivation. METHODS: This pilot intervention tested a PA education module that included a one-on-one counseling session highlighting the acute effects of PA on glucose patterns, followed by a 10-day self-monitoring period with a continuous glucose monitor (CGM) and a Fitbit tracker. Participants rated the acceptability of the education module on a 5-point Likert scale and completed surveys assessing stages of change for motivational readiness. RESULTS: Nineteen overweight/obese adults (84% female) completed the study. Participants gave high ratings to the counseling session for improving their PA-related knowledge (mean = 4.22), increasing motivation (mean = 4.29), and providing personally relevant information (mean = 4.35). The summary acceptability scores for the self-monitoring period were 4.46 for CGM and 4.51 for Fitbit. Participants reported a significant decrease in the precontemplation stage and an increase in the action stage (P < 0.05). CONCLUSIONS: CGM is a feasible tool for PA interventions. IMPACT: Information from CGM could be used as biological-based feedback to motivate PA.See all articles in this CEBP Focus section, "Modernizing Population Science."

Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial.

Importance: Lung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making. Objective: To examine the effect of a patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU) on decision-making outcomes among smokers. Design, Setting, and Participants: This randomized clinical trial was conducted using 13 state tobacco quitlines. Current and recent tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017. Data analysis was conducted between May 5, 2017, and September 30, 2018. Interventions: Participants were randomized to the PDA video Lung Cancer Screening: Is It Right for Me? (n = 259) or to EDU (n = 257). Main Outcomes and Measures: The primary outcomes were preparation for decision-making and decisional conflict measured at 1 week. Secondary outcomes included knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report. Results: Of 516 quit line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level. Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001). Feeling informed about their screening choice was reported by 117 of 234 participants (50.0%) using a PDA compared with 66 of 233 participants (28.3%) using EDU (OR, 2.56; 95% CI, 1.72-3.79; P < .001); 159 of 234 participants (68.0%) using a PDA compared with 110 of 232 (47.4%) participants using EDU reported being clear about their values related to the harms and benefits of screening (OR, 2.37; 95% CI, 1.60-3.51; P < .001). Participants using a PDA were more knowledgeable about lung cancer screening than participants using EDU at each follow-up assessment. Intentions to be screened and screening behaviors did not differ between groups. Conclusions and Relevance: In this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening. Many smokers eligible for lung cancer screening can be reached through tobacco quit lines. Trial Registration: ClinicalTrials.gov identifier: NCT02286713.

Reliability of self-reported smoking history and its implications for lung cancer screening.

Clinical guidelines endorse either a 30 or 20 pack-year smoking history threshold when determining eligibility for lung cancer screening (LCS). However, self-reported smoking history is subject to recall bias that can affect patient eligibility. We examined the reliability of smokers' self-reported tobacco use and its impact on eligibility for LCS. Current or former smokers aged 55-77 years completed questionnaires requesting demographic information and smoking history. Data were collected between December 2014 and September 2015. Total pack-year smoking history was calculated for each participant based on their responses at baseline and one month later. One hundred and two participants completed the study (mean age = 63.6 years). The intraclass correlation coefficient for the pack-year estimate was 0.93. For the 30 pack-year threshold, eight (7.8%) participants were eligible at one but not both assessment periods. For the 20 pack-year threshold, twelve participants (11.8%) were eligible at one but not both assessment periods. Inconsistent reporting was higher among current compared to former smokers. Smokers' self-reported tobacco use appears highly reliable over short time periods. Nevertheless, there is some inconsistent reporting. We recommend that clinicians carefully assess smoking history, probe patients' recall of duration and quantity of smoking, and collect tobacco use information at every encounter.

Does Animation Improve Comprehension of Risk Information in Patients with Low Health Literacy? A Randomized Trial.

Introduction. Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy. We tested the effect of presentation format on comprehension of colorectal cancer (CRC) screening probabilities to identify optimal risk communication strategies. Methods. Participants from a community foodbank and a cancer prevention center were randomized to 1 of 3 CRC screening risk presentations. The presentations used identical content but varied in format: 1) video with animated pictographs, 2) video with static pictographs, and 3) audiobooklet with static pictographs. Participants completed pre- and postpresentation surveys. The primary outcome was knowledge of probability/risk information regarding CRC screening, calculated as total, verbatim, and gist scores. Results. In total, 187 participants completed the study and were included in this analysis. Median age was 58 years (interquartile range [IQR]: 14 years), most participants were women (63%), and almost half had a high school education or less (46%). Approximately one-quarter had inadequate health literacy (Short Test of Functional Health Literacy in Adults marginal/inadequate: 28%; Brief Health Literacy Screener low: 18%), and about half had low numeracy (Subjective Numeracy Scale low: 54%; Graphical Literacy Measure low: 50%). We found no significant differences in total, verbatim, or gist knowledge across presentation formats (all P > 0.05). Discussion. Use of an animated pictograph to communicate risk does not appear to augment or impede knowledge of risk information. Regardless of health literacy level, difficulty understanding pictographs presenting numerical information persists. There may be a benefit to teaching or priming individuals on how to interpret numerical information presented in pictographs before communicating risk using visual methods. Trial Registry: NCT02151032.

High-Intensity Interval Training Is Feasible in Women at High Risk for Breast Cancer.

PURPOSE: This trial aimed to demonstrate the feasibility of high-intensity interval training (HIIT) in postmenopausal, overweight/obese women at high risk of invasive breast cancer and to explore HIIT on changes in cardiorespiratory fitness (CRF), body weight, and body mass index (BMI) compared with moderate-intensity continuous training (MICT) and usual care (UC). METHODS: Forty-four women were randomized to HIIT, MICT, or UC for a 12-wk, thrice weekly, supervised exercise intervention. HIIT included a 5-min warm-up at 50%-70% HRpeak, four cycles of 4 min at 90%-100% HRpeak, followed by 3 min at 50%-70% HRpeak. MICT consisted of 41 min at 60%-70% HRpeak. Feasibility was assessed by consent, adherence, compliance, and retention rates. CRF, body weight, and BMI were measured at baseline and end of study. Repeated-measures linear mixed models were used to assess within- and between-group differences. RESULTS: Average age was 63.9 ± 8.8 yr. BMI was 30.9 ± 5.7 kg·m. Participants completed 90% and 89% of HIIT and MICT workouts, respectively, with 100% compliance to the exercise prescriptions. No serious adverse events were reported. Compared with MICT and UC, HIIT exhibited improvements in change in treadmill time (101 s greater than MICT, and 125 s greater than UC, respectively, P < 0.001). Compared with UC, HIIT exhibited improvement in changes in absolute and relative V˙O2peak (a 0.15-L·min increase, P = 0.005, and a 2.3-mL·kg⋅min increase, P = 0.004). There were no significant differences between groups for body weight or BMI (P > 0.05). CONCLUSIONS: HIIT is feasible, safe, and seems to promote greater improvements in CRF compared with MICT and UC in women at high risk for breast cancer.