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Item A National Quality Improvement Study Identifying and Addressing Cancer Screening Deficits Due To the COVID-19 Pandemic(Wiley, 2022) Joung, Rachel Hae-Soo; Nelson, Heidi; Mullett, Timothy W.; Kurtzman, Scott H.; Shafir, Sarah; Harris, James B.; Yao, Katharine A.; Brajcich, Brian C.; Bilimoria, Karl Y.; Cance, William G.; Surgery, School of MedicineBackground: Cancer-related deaths over the next decade are expected to increase due to cancer screening deficits associated with the coronavirus disease 2019 (COVID-19) pandemic. Although national deficits have been quantified, a structured response to identifying and addressing local deficits has not been widely available. The objectives of this report are to share preliminary data on monthly screening deficits in breast, colorectal, lung, and cervical cancers across diverse settings and to provide online materials from a national quality improvement (QI) study to help other institutions to address local screening deficits. Methods: This prospective, national QI study on Return-to-Screening enrolled 748 accredited cancer programs in the United States from April through June 2021. Local prepandemic and pandemic monthly screening test volumes (MTVs) were used to calculate the relative percent change in MTV to describe the monthly screening gap. Results: The majority of facilities reported monthly screening deficits (colorectal cancer, 80.6% [n = 104/129]; cervical cancer, 69.0% [n = 20/29]; breast cancer, 55.3% [n = 241/436]; lung cancer, 44.6% [n = 98/220]). Overall, the median relative percent change in MTV ranged from -17.7% for colorectal cancer (interquartile range [IQR], -33.6% to -2.8%), -6.8% for cervical cancer (IQR, -29.4% to 1.7%), -1.6% for breast cancer (IQR, -9.6% to 7.0%), and 1.2% for lung cancer (IQR, -16.9% to 19.0%). Geographic differences were not observed. There were statistically significant differences in the percent change in MTV between institution types for colorectal cancer screening (P = .02). Conclusion: Cancer screening is still in need of urgent attention, and the screening resources made available online may help facilities to close critical gaps and address screenings missed in 2020. Lay summary: Question: How can the effects of the coronavirus disease 2019 pandemic on cancer screening be mitigated? Findings: When national resources were provided, including methods to calculate local screening deficits, 748 cancer programs promptly enrolled in a national Return-to-Screening study, and the majority identified local screening deficits, most notably in colorectal cancer. Using these results, 814 quality improvement projects were initiated with the potential to add 70,000 screening tests in 2021. Meaning: Cancer screening is still in need of urgent attention, and the online resources that we provide may help to close critical screening deficits.Item African American patients' intent to screen for colorectal cancer: Do cultural factors, health literacy, knowledge, age and gender matter?(Johns Hopkins University Press, 2016-02) Brittain, Kelly; Christy, Shannon M.; Rawl, Susan M.; Department of Psychology, School of ScienceAfrican Americans have higher colorectal cancer (CRC) mortality rates. Research suggests that CRC screening interventions targeting African Americans be based upon cultural dimensions. Secondary analysis of data from African-Americans who were not up-to-date with CRC screening (n=817) was conducted to examine: 1) relationships among cultural factors (i.e., provider trust, cancer fatalism, health temporal orientation (HTO)), health literacy, and CRC knowledge; 2) age and gender differences; and 3) relationships among the variables and CRC screening intention. Provider trust, fatalism, HTO, health literacy and CRC knowledge had significant relationships among study variables. The FOBT intention model explained 43% of the variance with age and gender being significant predictors. The colonoscopy intention model explained 41% of the variance with gender being a significant predictor. Results suggest that when developing CRC interventions for African Americans, addressing cultural factors remain important, but particular attention should be given to the age and gender of the patient.Item Algorithm Development and Early Performance Evaluation of a Next-Generation Multitarget Stool DNA Screening Test for Colorectal Cancer(Elsevier, 2024-05-17) Imperiale, Thomas F.; Gagrat, Zubin D.; Krockenberger, Martin; Porter, Kyle; Ziegler, Emily; Leduc, Christine M.; Matter, Michael B.; Olson, Marilyn C.; Limburg, Paul J.; Medicine, School of MedicineBackground and aims: The multitarget stool DNA (mt-sDNA) assay is a noninvasive average-risk colorectal cancer (CRC) screening test. A new biomarker panel was developed for a next-generation test to improve specificity while maintaining/increasing sensitivity. We aimed first to establish an algorithm and cutoff for the next-generation mt-sDNA test and then to validate it using archived samples from the pivotal DeeP-C study (NCT01397747) of the first-generation test. Methods: Algorithm development and cross-validation included 3011 samples from 2 specimen collection studies (NCT03821948 and NCT03789162). The algorithm and cutoff were locked before validation. Validation test set samples included 57 CRC, 583 advanced precancerous lesions (APLs), and 7022 samples negative for CRC or APLs from the DeeP-C study, which prospectively enrolled average-risk, asymptomatic adults aged 50-84 years before screening colonoscopy. Next-generation biomarkers included methylated DNA markers ceramide synthase 4 gene, leucine-rich repeat-containing protein 4 gene, serine/threonine-protein phosphatase 2A 56 kDa regulatory subunit gamma isoform gene, and zinc finger DHHC-type containing 1 gene (reference marker), and fecal hemoglobin. Primary validation end points were CRC sensitivity and specificity for the absence of advanced neoplasia. Secondary end points included APL sensitivity and specificity for non-neoplastic findings or negative colonoscopy. Results: Cross-validation and best-fit results from algorithm development closely matched, confirming algorithm reliability and reproducibility. For the test set, next-generation mt-sDNA test sensitivity was 93.0% (95% confidence interval [CI], 83.0%-98.1%) for CRC and 48.4% (95% CI, 44.2%-52.5%) for APLs. Specificity was 88.5% (95% CI, 87.7%-89.2%) for the absence of advanced neoplasia and 90.4% (95% CI, 89.5%-91.2%) for the combination of non-neoplastic findings or negative colonoscopy. Conclusion: Based on archived samples, the next-generation mt-sDNA test demonstrated promising CRC screening performance characteristics that will be further assessed in a prospective clinical validation study (BLUE-C; NCT04144738).Item Impact of the COVID-19 pandemic on adherence to diagnostic colonoscopy after a positive non-invasive screening test for colorectal cancer in two Indiana healthcare systems(Elsevier, 2024-11-26) Richter, Benjamin; Roth, Sarah M.; Golzarri-Arroyo, Lilian; Kumar, Vinod; Tuason, Rick; Imperiale, Thomas F.; Medicine, School of MedicineObjective: To describe trends in the use of non-invasive tests (NIST) and the interval between a positive NIST and diagnostic colonoscopy. Methods: Using a retrospective time-trend design, we examined medical records of patients within two large Indiana integrated healthcare systems who had a positive NIST between January 2019 and June 2021 and quantified the proportion of patients who had not completed colonoscopy within 60, 90, and 180 days to determine the interval between NIST result and diagnostic colonoscopy in days. Results: Of 1379 patients with positive NISTs, 930 (68 %) underwent diagnostic colonoscopy during the 30-month study timeframe. Median time to colonoscopy completion was significantly longer in 2020 compared to 2019 (50 vs. 37 days, p < 0.01) and 2021 (46 days, p = 0.06). The proportion of patients completing colonoscopy within 90 days of a positive FIT in 2019, 2020, and 2021 were 79 %, 83 %, and 72 %, respectively (p = 0.63), and were 86 %, 78 %, and 84 %, respectively, after positive FIT/DNA (p = 0.07). Median time to diagnostic colonoscopy completion was significantly longer in 2020, likely due to the COVID-19 pandemic. Conclusions: Studies of outcomes in those who declined or delayed colonoscopy in 2020 are needed to estimate the potential subsequent colorectal cancer disease burden.Item Layperson Views about the Design and Evaluation of Decision Aids: A Public Deliberation(Sage, 2021-07) Schwartz, Peter H.; O’Doherty, Kieran C.; Bentley, Colene; Schmidt, Karen K.; Burgess, Michael M.; Medicine, School of MedicinePurpose: We carried out the first public deliberation to elicit lay input regarding guidelines for the design and evaluation of decision aids, focusing on the example of colorectal ("colon") cancer screening. Methods: A random, demographically stratified sample of 28 laypeople convened for 4 days, during which they were informed about key issues regarding colon cancer, screening tests, risk communication, and decision aids. Participants then deliberated in small and large group sessions about the following: 1) What information should be included in all decision aids for colon screening? 2) What risk information should be in a decision aid and how should risk information be presented? 3) What makes a screening decision a good one (reasonable or legitimate)? 4) What makes a decision aid and the advice it provides trustworthy? With the help of a trained facilitator, the deliberants formulated recommendations, and a vote was held on each to identify support and alternative views. Results: Twenty-one recommendations ("deliberative conclusions") were strongly supported. Some conclusions matched current recommendations, such as that decision aids should be available for use with and without providers present (conclusions 1-4) and should support informed choice (conclusion 9). Some conclusions differed from current recommendations, at least in emphasis-for example, that decision aids should disclose cost of screening (conclusion 11) and should be kept simple and understandable (conclusion 14). Deliberants recommended that decision aids should disclose the baseline risk of getting colon cancer (conclusions 15, 17). Limitations: Single location and medical decision. Conclusions: Guidelines for design of decision aids should consider putting a greater focus on disclosing cost and keeping decision aids simple, and they possibly should recommend disclosing less extensive amounts of quantitative information than currently recommended.Item Masculinity Beliefs and Colorectal Cancer Screening in Male Veterans(American Psychological Association, 2017-10) Christy, Shannon M.; Mosher, Catherine E.; Rawl, Susan M.; Haggstrom, David A.; Psychology, School of ScienceAs the third most common cause of cancer death among United States men, colorectal cancer (CRC) represents a significant threat to men's health. Although adherence to CRC screening has the potential to reduce CRC mortality by approximately half, men's current rates of adherence fall below national screening objectives. In qualitative studies, men have reported forgoing screenings involving the rectum (e.g., colonoscopy) due to concern about breaching masculinity norms. However, the extent to which masculinity beliefs predict men's CRC screening adherence has yet to be examined. The current study tested the hypothesis that greater endorsement of masculinity beliefs (i.e., self-reliance, risk-taking, heterosexual self-presentation, and primacy of work) would be associated with a lower likelihood of adherence to CRC screening with any test and with colonoscopy specifically. Participants were 327 men aged 51-75 at average risk for CRC who were accessing primary care services at a Midwestern Veterans Affairs Medical Center. Contrary to hypotheses, masculinity beliefs did not predict CRC screening outcomes in hierarchical regression analyses that controlled for demographic predictors of screening. Although results are largely inconsistent with masculinity theory and prior qualitative findings, further research is needed to determine the degree to which findings generalize to other populations and settings.Item New Scoring Systems for Predicting Advanced Proximal Neoplasia in Asymptomatic Adults With or Without Knowing Distal Colorectal Findings: A Prospective, Cross-sectional Study(Wolters Kluwer, 2022) Imperiale, Thomas F.; Monahan, Patrick O.; Stump, Timothy E.; Ransohoff, David F.; Medicine, School of MedicineBackground: Models estimating risk for advanced proximal colorectal neoplasia (APN) may be used to select colorectal cancer (CRC) screening test, either prior to knowing distal colorectal findings or afterward. Current models have only fair discrimination and nearly all require knowing distal findings. Objective: Derive and test risk prediction models for APN with and without distal findings. Setting: Selected endoscopy centers within central Indiana, USA. Participants: Average-risk persons undergoing first-time screening colonoscopy. Interventions: Demographics, personal and family medical history, lifestyle factors and physical measures were linked to the most advanced finding in proximal and distal colorectal segments. For both models, logistic regression identified factors independently associated with APN on a derivation set. Based on equation coefficients, points were assigned to each factor, and risk for APN was examined for each score. Scores with comparable risks were collapsed into risk categories. Both models and their scoring systems were tested on the validation set. Main outcome: APN, defined as any adenoma or sessile serrated lesion ≥1 cm, one with villous histology or high-grade dysplasia, or CRC proximal to the descending colon. Results: Among 3025 subjects in the derivation set (mean age 57.3 ± 6.5 years; 52% women), APN prevalence was 4.5%; 2859 (94.5%) had complete data on risk factors. Independently associated with APN were age, sex, cigarette smoking, cohabitation status, metabolic syndrome, non-steroidal anti-inflammatory drug use and physical activity. This model (without distal findings) was well-calibrated (P = 0.62) and had good discrimination (c-statistic = 0.73). In low-, intermediate- and high-risk groups that comprised 21, 58 and 21% of the sample, respectively, APN risks were 1.47% (95% CI, 0.67-2.77%), 3.09% (CI, 2.31-4.04%) and 11.6% (CI, 9.10-14.4%), respectively (P < 0.0001), with no proximal CRCs in the low-risk group and 2 in the intermediate-risk group. When tested in the validation set of 1455, the model retained good metrics (calibration P = 0.85; c-statistic = 0.83), with APN risks in low- (22%), intermediate- (56%) and high-risk (22%) subgroups of 0.62% (CI, 0.08-2.23%) 2.20% (CI, 1.31-3.46%) and 13.0% (CI, 9.50-17.2%), respectively (P < 0.0001). There were no proximal CRCs in the low-risk group, and two in the intermediate-risk group. The model with distal findings performed comparably, with validation set metrics of 0.18 for calibration, 0.76 for discrimination and APN risk (% sample) in low-, intermediate-, and high-risk groups of 1.1 (69%), 8.3 (22%) and 22.3% (9%). Conclusion: These models stratify large proportions of average-risk persons into clinically meaningful risk groups, and could improve screening efficiency, particularly for noncolonoscopy-based programs.Item Patient Navigation Plus Tailored Digital Video Disc Increases Colorectal Cancer Screening Among Low-Income and Minority Patients Who Did Not Attend a Scheduled Screening Colonoscopy: A Randomized Trial(Oxford University Press, 2024) Rawl, Susan M.; Perkins, Susan M.; Tong, Yan; Katz, Mira L.; Carter-Bawa, Lisa; Imperiale, Thomas F.; Schwartz, Peter H.; Fatima, Hala; Krier, Connie; Tharp, Kevin; Shedd-Steele, Rivienne; Magnarella, Mark; Malloy, Caeli; Haunert, Laura; Gebregziabher, Netsanet; Paskett, Electra D.; Champion, Victoria; School of NursingBackground: Up to 50% of people scheduled for screening colonoscopy do not complete this test and no studies have focused on minority and low-income populations. Interventions are needed to improve colorectal cancer (CRC) screening knowledge, reduce barriers, and provide alternative screening options. Patient navigation (PN) and tailored interventions increase CRC screening uptake, however there is limited information comparing their effectiveness or the effect of combining them. Purpose: Compare the effectiveness of two interventions to increase CRC screening among minority and low-income individuals who did not attend their screening colonoscopy appointment-a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based PN compared to usual care. Methods: Patients (n = 371) aged 45-75 years at average risk for CRC who did not attend a screening colonoscopy appointment were enrolled and were randomized to: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. CRC screening outcomes were from electronic medical records at 12 months. Multivariable logistic regression analyses were used to study intervention effects. Results: Participants randomized to tailored DVD plus PN were four times more likely to complete CRC screening compared to usual care and almost two and a half times more likely than those who were sent the DVD alone. Conclusions: Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend their screening colonoscopy appointments and has potential for wide dissemination.Item Patients’ Willingness to Share Limited Endoscopic Resources: A Brief Report on the Results of a Large Regional Survey(Sage, 2021-09-28) Piper, Marc S.; Zikmund-Fisher, Brian J.; Maratt, Jennifer K.; Kurlander, Jacob; Metko, Valbona; Waljee, Akbar K.; Saini, Sameer D.; Medicine, School of MedicineBackground: In some health care systems, patients face long wait times for screening colonoscopy. We sought to assess whether patients at low risk for colorectal cancer (CRC) would be willing to delay their own colonoscopy so higher-risk peers could undergo colonoscopy sooner. Methods: We surveyed 1054 Veterans regarding their attitudes toward repeat colonoscopy and risk-based prioritization. We used multivariable regression to identify patient factors associated with willingness to delay screening for a higher-risk peer. Results: Despite a physician recommendation to stop screening, 29% of respondents reported being "not at all likely" to stop. However, 94% reported that they would be willing to delay their own colonoscopy for a higher-risk peer. Greater trust in physician and greater health literacy were positively associated with willingness to wait, while greater perceived threat of CRC and Black or Latino race/ethnicity were negatively associated with willingness to wait. Conclusion: Despite high enthusiasm for repeat screening, patients were willing to delay their own colonoscopy for higher-risk peers. Appealing to altruism could be effective when utilizing scarce resources.Item Process Evaluation of a Mailed Interactive Educational DVD in a Comparative Effectiveness Trial to Promote Colorectal Cancer Screening(Sage, 2022) Katz, Mira L.; Emerson, Brent; Champion, Victoria L.; Schwartz, Peter H.; Impleriale, Thomas F.; Fatima, Hala; Paskett, Electra D.; Perkins, Susan M.; Tong, Yan; Gebregziabher, Netsanet; Krier, Connie; Tharp, Kevin; Malloy, Caeli; Strom, Sylvia; Rawl, Susan M.; School of NursingA process evaluation was conducted as part of a comparative effectiveness trial of a mailed interactive educational DVD intervention to promote colorectal cancer screening among average-risk patients who did not attend a scheduled colonoscopy. Participants (n = 371) for the trial were randomized to (1) mailed DVD, (2) mailed DVD plus patient navigation, or (3) usual care. Participants (n = 243) randomized to the two DVD intervention arms were called 2 weeks after mailing materials to complete a process evaluation interview about the DVD (September 2017-February 2020). Forty-nine (20%) participants were not reached, and 194 (80%) participants watched the DVD and completed the interview. The process evaluation assessed whether (1) the DVD content was helpful, (2) any new information was learned by participants, (3) the appropriate amount of information was included in the DVD, (4) participants were engaged when watching the DVD, (5) the DVD content was relevant, (6) participants were satisfied with the DVD (7) participants would recommend the DVD to others, and (8) their opinion about colorectal cancer screening was changed by watching the DVD. Among participants who watched the DVD, 99% reported the screening information was very or somewhat helpful, 47% learned new information, 75% said the DVD included the right amount of information, they were engaged (M = 3.35 out of 4, SD = 0.49), 87% reported all or most information applied to them, they were satisfied (M = 3.42 out of 4, SD = 0.39) with DVD content, 99% would recommend the DVD to others, and 45% reported changing their opinion about screening. To understand the effects of interventions being tested in trials and to plan the dissemination of evidence-based interventions, process evaluation is critical to assess the dose received and acceptability of behavioral interventions.