Evaluating Colonoscopy Quality by Performing Provider Type.

BACKGROUND: Colorectal Cancer (CRC) is the third most diagnosed cancer and the second leading cause of cancer death in the United States. Colonoscopy is an essential tool for screening, used both as a primary approach and follow-up to an abnormal stool-based CRC screening result. Colonoscopy quality is often measured with four key indicators: bowel preparation, cecal intubation, mean withdrawal time, and adenoma detection. Colonoscopies are most often performed by gastroenterologists (GI), however, in rural and medically underserved areas non-GI providers often perform colonoscopies. This study aims to evaluate the quality and safety of screening colonoscopies performed by non-GI providers, comparing their outcomes to those of GI providers. METHODS: Descriptive statistics were used to characterize the study population. Results for quality indicators were stratified by provider type and compared. Statistical significance was determined using p < 0.05 as the threshold for all comparisons; all p-values were two-sided. RESULTS: No statistical difference was found when comparing performance by provider type. Median performance for gastroenterologists, general surgeons, and family medicine providers ranged form 98-100% for cecal intubation; 97.4-100% for bowel preparation; 57.4-88.9% for male adenoma detection rate; 47.7-62.13% for female adenoma detection rate; and 0:12:10-0:20:16 for mean withdrawal time. All provider types met and exceeded the goal metric for each of the quality indicators (p < 0.001). In this analysis, non-GI providers can be expected to perform colonoscopies with similar quality to GI providers based on performance outcomes for the key quality metrics.

Considering depression as a secondary outcome in the optimization of physical activity interventions for breast cancer survivors in the PACES trial: a factorial randomized controlled trial.

BACKGROUND: Depressive symptoms result in considerable burden for breast cancer survivors. Increased physical activity may reduce these burdens but existing evidence from physical activity interventions in equivocal. Furthermore, physical activity intervention strategies may differentially impact depressive symptoms, which should be considered in designing and optimizing behavioral interventions for breast cancer survivors. METHODS: The Physical Activity for Cancer Survivors (PACES) trial enrolled 336 participants breast cancer survivors, who were 3 months to 10 years post-treatment, and insufficiently active (< 150 min of moderate-to-vigorous physical activity per week). Participants were randomly assigned to a combination of 4 intervention strategies in a full-factorial design: 1) supervised exercise sessions, 2) facility access, 3) Active Living Every Day, and 4) Fitbit self-monitoring. Depressive symptoms were assessed at baseline, mid-intervention (3 months), and post-intervention (6 months) using the Quick Inventory for Depressive Symptoms. Change in depressive symptoms were analyzed using a linear mixed-effects model. RESULTS: Results from the linear mixed-effects model indicated that depressive symptoms decreased significantly across the entire study sample over the 6-month intervention (F = 4.09, p = 0.044). A significant ALED x time interaction indicated participants who received the ALED intervention experienced greater reductions in depressive symptoms (F = 5.29, p = 0.022). No other intervention strategy significantly impacted depressive symptoms. CONCLUSIONS: The ALED intervention consists of strategies (i.e., goal setting, social support) that may have a beneficial impact on depressive symptoms above and beyond the effect of increased physical activity. Our findings highlight the need to consider secondary outcomes when designing and optimizing physical activity interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03060941. Posted February 23, 2017.

Prevalence and correlates of false-positive results after 3-D screening mammography among uninsured women in a community outreach program.

False-positive results have been rarely investigated among uninsured minority women who undergo 3-D screening mammography. Here, we analyzed data from 21,022 women participating in the Breast Screening and Patient Navigation (BSPAN) program of North Texas with an aim to report prevalence and correlates of false-positive results after 3-D screening mammography, stratified by age. False-positives were defined as a negative diagnostic mammogram or a negative biopsy within 1 year of a positive screen. We used multivariable logistic regression to assess associations of demographic and clinical covariates and false positive results for age groups 40-49 and 50-64 years. Prevalence of false-positive results was 11.8% and 9.6% in the 40-49 and 50-64 age groups, respectively. Multivariable logistic regression demonstrated that, in the 40-49 age group, women who were non-menopausal, did not use hormone replacement therapy (HRT), and had self-reported prior mammograms had higher odds of false-positive results than those who were menopausal, used HRT and had no self-reported prior mammograms, respectively. In the 50-64 age group, women with a prior self-reported diagnostic mammogram had higher odds of false-positive results than those without a prior self-reported diagnostic mammogram. This study establishes contemporary evidence regarding prevalence and correlates of false-positive results after 3-D mammography in the unique BSPAN population, and demonstrate that use of 3-D mammography is not enough to reduce false-positive rates among uninsured women served through community outreach programs. Further research is needed to explore improved techniques to reduce false-positive rates, and ensure optimal use of scarce resources in outreach programs.

Implementation and Uptake of Rural Lung Cancer Screening.

OBJECTIVE: Given the higher rates of tobacco use along with increased mortality specific to lung cancer in rural settings, low-dose CT (LDCT)-based lung cancer screening could be particularly beneficial to such populations. However, limited radiology facilities and increased geographical distance, combined with lower income and education along with reduced patient engagement, present heightened barriers to screening initiation and adherence. METHODS: In collaboration with community leaders and stakeholders, we developed and implemented a community-based lung cancer screening program, including telephone-based navigation and tobacco cessation counseling support, serving 18 North Texas counties. Funding was available to support clinical services costs where needed. We collected data on LDCT referrals, orders, and completion. RESULTS: To raise awareness for lung cancer screening, we leveraged our established collaborative network of more than 700 community partners. In the first year of operation, 107 medical providers referred 570 patients for lung cancer screening, of whom 488 (86%) were eligible for LDCT. The most common reasons for ineligibility were age (43%) and insufficient tobacco history (20%). Of 381 ordered LDCTs, 334 (88%) were completed. Among screened patients, 61% were current smokers and 36% had insurance coverage for the procedure. The program cost per patient was $430. DISCUSSION: Implementation, uptake, and completion of LDCT-based lung cancer screening is feasible in rural settings. Community outreach, health promotion, and algorithm-based navigation may support such efforts. Given low lung cancer screening rates nationally and heightened lung cancer risk in rural populations, similar programs in other regions may be particularly impactful.

Long-term Mammography Adherence among Uninsured Women Enrolled in the Breast Screening and Patient Navigation (BSPAN) Program.

BACKGROUND: The Breast Screening and Patient Navigation (BSPAN) Program provides access to no-cost breast cancer screening services to uninsured women in North Texas. Using data from the longitudinal BSPAN program (2012-2019), we assessed prevalence and correlates of (i) baseline adherence and (ii) longitudinal adherence to screening mammograms. METHODS: Outcomes were baseline adherence (adherent if women received second mammogram 9-30 months after the index mammogram) and longitudinal adherence (assessed among baseline adherent women and defined as being adherent 39 months from the index mammogram). We used multivariable logistic regression and multivariable Cox proportional hazards model to assess associations of sociodemographic and clinical characteristics with baseline and longitudinal adherence, respectively. RESULTS: Of 19,292 women, only 5,382 (27.9%) were baseline adherent. Baseline adherence was more likely among women who were partnered, preferred speaking Spanish, had poor reading ability, had prior Papanicolaou (PAP) testing, and prior screening mammograms, compared with women who were non-partnered, preferred speaking English, had good reading ability, had no prior PAP testing, and no prior screening mammograms, respectively. Of those who were baseline adherent, 4,364 (81.1%) women demonstrated longitudinal adherence. Correlates of longitudinal adherence were similar to those from baseline adherence. CONCLUSIONS: A large proportion of baseline adherent women (>80%) achieved longitudinal adherence, which highlights the importance of concentrating resources during the second mammogram in the progression toward continued adherence. IMPACT: Results from our unique dataset provide realistic mammography adherence rates and may be generalizable to other areas introducing no-cost screening to low-income women, independent of any regular patient-centered medical home.

Innovative Cancer Survivorship Services for Rural and Underserved Communities.

In 2006, the Institute of Medicine recognized that cancer survivors faced complex physical and emotional health problems, often overlooked or inadequately managed. In Texas, access to programs specifically designed to address unique needs of cancer survivors is almost nonexistent for low-income uninsured or underinsured patients. In response to the unmet care needs of underserved cancer centers, Moncrief Cancer Institute, an affiliate of the National Cancer Institute-designated UT Southwestern Harold C. Simmons Comprehensive Cancer Center, established a community-based program using a survivorship care model similar to those offered in academic medical centers. Understanding that a one-size-fits-all approach could not successfully meet the needs across the service area, the cancer survivorship service line was mobilized to provide flexibility in delivery without sacrificing quality of care. The program continues to evolve, extending the foremost scientific information and resources into the communities it serves.

The effect of deadlines on cancer screening completion: a randomized controlled trial.

Cancer is the second leading cause of death in the United States. Although screening facilitates prevention and early detection and is one of the most effective approaches to reducing cancer mortality, participation is low-particularly among underserved populations. In a large, preregistered field experiment (n = 7711), we tested whether deadlines-both with and without monetary incentives tied to them-increase colorectal cancer (CRC) screening. We found that all screening invitations with an imposed deadline increased completion, ranging from 2.5% to 7.3% relative to control (ps < .004). Most importantly, individuals who received a short deadline with no incentive were as likely to complete screening (9.7%) as those whose invitation included a deadline coupled with either a small (9.1%) or large declining financial incentive (12.0%; ps = .57 and .04, respectively). These results suggest that merely imposing deadlines-especially short ones-can significantly increase CRC screening completion, and may also have implications for other forms of cancer screening.

Mailed fecal immunochemical test outreach for colorectal cancer screening: Summary of a Centers for Disease Control and Prevention-sponsored Summit.

Uptake of colorectal cancer screening remains suboptimal. Mailed fecal immunochemical testing (FIT) offers promise for increasing screening rates, but optimal strategies for implementation have not been well synthesized. In June 2019, the Centers for Disease Control and Prevention convened a meeting of subject matter experts and stakeholders to answer key questions regarding mailed FIT implementation in the United States. Points of agreement included: 1) primers, such as texts, telephone calls, and printed mailings before mailed FIT, appear to contribute to effectiveness; 2) invitation letters should be brief and easy to read, and the signatory should be tailored based on setting; 3) instructions for FIT completion should be simple and address challenges that may lead to failed laboratory processing, such as notation of collection date; 4) reminders delivered to initial noncompleters should be used to increase the FIT return rate; 5) data infrastructure should identify eligible patients and track each step in the outreach process, from primer delivery through abnormal FIT follow-up; 6) protocols and procedures such as navigation should be in place to promote colonoscopy after abnormal FIT; 7) a high-quality, 1-sample FIT should be used; 8) sustainability requires a program champion and organizational support for the work, including sufficient funding and external policies (such as quality reporting requirements) to drive commitment to program investment; and 9) the cost effectiveness of mailed FIT has been established. Participants concluded that mailed FIT is an effective and efficient strategy with great potential for increasing colorectal cancer screening in diverse health care settings if more widely implemented.

Lower Abnormal Fecal Immunochemical Test Cut-Off Values Improve Detection of Colorectal Cancer in System-Level Screens.

BACKGROUND & AIMS: Noninvasive tests used in colorectal cancer screening, such as the fecal immunochemical test (FIT), are more acceptable but detect neoplasias with lower levels of sensitivity than colonoscopy. We investigated whether lowering the cut-off concentration of hemoglobin for designation as an abnormal FIT result increased the detection of advanced neoplasia in a mailed outreach program. METHODS: We performed a prospective study of 17,017 uninsured patients, age 50 to 64 years, who were not current with screening and enrolled in a safety-net system in Texas. We reduced the cut-off value for an abnormal FIT result from 20 or more to 10 or more µg hemoglobin/g feces a priori. All patients with abnormal FIT results were offered no-cost diagnostic colonoscopy. We compared proportions of patients with abnormal FIT results and neoplasia yield for standard vs lower cut-off values, as well as absolute hemoglobin concentration distribution among 5838 persons who completed the FIT. Our primary aim was to determine the effects of implementing a lower hemoglobin concentration cut-off value on colonoscopy demand and yield, specifically colorectal cancer (CRC) and advanced neoplasia detection, compared with the standard, higher, hemoglobin concentration cut-off value. RESULTS: The proportions of patients with abnormal FIT results were 12.3% at the 10 or more µg hemoglobin/g feces and 6.6% at the standard 20 or more µg hemoglobin/g feces cut-off value (P = .0013). Detection rates for the lower vs the standard threshold were 10.2% vs 12.7% for advanced neoplasia (P = .12) and 0.9% vs 1.2% for CRC (P = .718). The positive predictive values were 18.9% for the lower threshold vs 24.4% for the standard threshold for advanced neoplasia (P = .053), and 1.7% vs 2.4% for CRC (P = .659). The number needed to screen to detect 1 case with advanced neoplasia was 45 at the lower threshold compared with 58 at the standard threshold; the number needed to scope to detect 1 case with advanced neoplasia increased from 4 to 5. Most patients with CRC (72.7%) or advanced adenoma (67.3%) had hemoglobin concentrations of 20 or more µg/g feces. In the group with 10 to 19 µg hemoglobin/g feces, there were 3 patients with CRC (3 of 11; 27.3%) and 36 with advanced adenoma (36 of 110; 32.7%) who would not have been detected at the standard positive threshold (advanced neoplasia Pcomparison < .001). The proportion of patients found to have no neoplasia after an abnormal FIT result (false positives) was not significantly higher with the lower cut-off value (44.4%) than the standard cut-off value (39.1%) (P = .1103). CONCLUSIONS: In a prospective study of 17,017 uninsured patients, we found that reducing the abnormal FIT result cut-off value (to ≥10 µg hemoglobin/g feces) might increase detection of advanced neoplasia, but doubled the proportion of patients requiring a diagnostic colonoscopy. If colonoscopy capacity permits, health systems that use quantitative FITs should consider lowering the abnormal cut-off value to optimize CRC detection and prevention. (ClinicalTrials.gov no: NCT01946282.).

Financial Incentives to Promote Colorectal Cancer Screening: A Longitudinal Randomized Control Trial.

BACKGROUND: Financial incentives may improve health behaviors. We tested the impact of offering financial incentives for mailed fecal immunochemical test (FIT) completion annually for 3 years. METHODS: Patients, ages 50 to 64 years, not up-to-date with screening were randomized to receive either a mailed FIT outreach (n = 6,565), outreach plus $5 (n = 1,000), or $10 (n = 1,000) incentive for completion. Patients who completed the test were reinvited using the same incentive the following year, for 3 years. In year 4, patients who returned the kit in all preceding 3 years were reinvited without incentives. Primary outcome was FIT completion among patients offered any incentive versus outreach alone each year. Secondary outcomes were FIT completion for groups offered $5 versus outreach alone, $10 versus outreach alone, and $5 versus $10. RESULTS: Year 1 FIT completion was 36.9% with incentives versus 36.2% outreach alone (P = 0.59) and was not statistically different for $10 (34.6%; P = 0.31) or $5 (39.2%; P = 0.070) versus outreach alone. Year 2 completion was 61.6% with incentives versus 60.8% outreach alone (P = 0.75) and not statistically different for $10 or $5 versus outreach alone. Year 3 completion was 79.4% with incentives versus 74.8% outreach alone (P = 0.080), and was higher for $10 (82.4%) versus outreach alone (P = 0.033), but not for $5 versus outreach alone. Completion was similar across conditions in year 4 (no incentives). CONCLUSIONS: Offering small incentives did not increase FIT completion relative to standard outreach. IMPACT: This was the first longitudinal study testing the impact of repeated financial incentives, and their withdrawal, on FIT completion.

Effects of program scale-up on time to resolution for patients with abnormal screening mammography results.

PURPOSE: Effects of geographic program expansion to rural areas on screening program outcomes are understudied. We sought to determine whether time-to-resolution (TTR) varied significantly by service delivery time period, location, and participant characteristics across 19 North Texas counties. METHODS: We calculated proportions undergoing diagnostic follow-up and resolved ≤ 60 days. We calculated median TTR for each time period and abnormal result BI-RADS 0, 4, 5. Cox proportional hazards regressions estimated time period and patient characteristic effects on TTR. Wilcoxon rank sum tests evaluated whether TTR differed between women who did or did not transfer between counties for services. RESULTS: TTR ranged from 14 to 17 days for BI-RADs 0, 4, and 5; 12.4% transferred to a different county, resulting in longer median TTR (26 vs. 16 days; p < .001). Of those completing follow-up, 92% were resolved ≤ 60 days (median 15 days). For BI-RAD 3, TTR was 208 days (including required 180 day waiting period). Follow-up was significantly lower for women with BI-RAD 3 (59% vs. 96%; p < .0001). CONCLUSION: Expansion maintained timely service delivery, increasing access to screening among rural, uninsured women. Policies adding a separate quality metric for BI-RAD 3 could encourage follow-up monitoring to address lower completion and longer TTR among women with this result.

The Promoting Activity in Cancer Survivors (PACES) trial: a multiphase optimization of strategy approach to increasing physical activity in breast cancer survivors.

BACKGROUND: Despite the significant, empirically supported benefits of physical activity, the majority of breast cancer survivors do not meet recommended guidelines for physical activity. A variety of effective strategies to increase physical activity in breast cancer survivors have been identified. However, it is unknown which of these strategies is most effective or how these strategies might be combined to optimize intervention effectiveness. METHODS: The proposed trial uses multiphase optimization strategy (MOST) to evaluate four evidence-based intervention strategies for increasing physical activity in breast cancer survivors. We will enroll 500 breast cancer survivors, age 18 and older, who are 3-months to 5 years post-treatment. Using a full-factorial design, participants will be randomized to receive a combination: 1) supervised exercise, 2) facility access, 3) self-monitoring, and 4) group-based active living counseling. The primary outcome, moderate-to-vigorous physical activity (MVPA) will be measured at baseline, 3 months, and 6 months using an Actigraph GT3X+. To evaluate intervention effects, a linear mixed-effects model will be conducted with MVPA as the outcome and with time (3 months and 6 months) as the within-subjects factor and intervention (i.e., supervised exercise, facility access, self-monitoring, and active living counseling) as the between subjects factor, along with all two-way interactions. DISCUSSION: The purpose of the PACES study is to evaluate multiple strategies for increasing physical activity in breast cancer survivors. Results of this study will provide in an optimized intervention for increasing physical activity in breast cancer survivors. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03060941 . Registered February 23, 2017.

Evaluation of effectiveness of survivorship programmes: how to measure success?

Although the number of cancer survivors has increased substantially in the past two decades, the evidence base regarding the effectiveness of cancer survivorship programmes is inadequate. Survivorship programmes tend to evaluate their effectiveness by assessing changes in patient-reported outcomes, symptoms and health status, knowledge, and receipt of cancer surveillance in programme participants. However, more comprehensive and high-quality evaluations of survivorship programmes are needed, including assessments using a broader set of measures. These expanded evaluations can include assessments of programme structure; long-term outcomes, such as survival, quality-adjusted life-years, and functional status; receipt of social support, nutritional, rehabilitative, and fertility preservation services; programme value, including costs and avoidance of inappropriate resource utilisation; and ability of programmes to increase access to needed survivorship care services and health equity. In this Series paper, we provide examples of assessment measures for currently used survivorship programmes, discuss the rationale for and potential benefits of expanded types of evaluation measures, and identify how these measures correspond to several evaluation frameworks. We conclude that use of a common, expanded set of measures to facilitate broad comparisons across survivorship programmes and thorough and systematic evaluations will help to identify the optimal programmes for individual survivors, improve outcomes, and prove the value of survivorship care.

County-level outcomes of a rural breast cancer screening outreach strategy: a decentralized hub-and-spoke model (BSPAN2).

Rural mammography screening remains suboptimal despite reimbursement programs for uninsured women. Networks linking non-clinical community organizations and clinical providers may overcome limited delivery infrastructure in rural areas. Little is known about how networks expand their service area. To evaluate a hub-and-spoke model to expand mammography services to 17 rural counties by assessing county-level delivery and local stakeholder conduct of outreach activities. We conducted a mixed-method evaluation using EMR data, systematic site visits (73 interviews, 51 organizations), 92 patient surveys, and 30 patient interviews. A two-sample t test compared the weighted monthly average of women served between hub- and spoke-led counties; nonparametric trend test evaluated time trend over the study period; Pearson chi-square compared sociodemographic data between hub- and spoke-led counties. From 2013 to 2014, the program screened 4603 underinsured women. Counties where local "spoke" organizations led outreach activities achieved comparable screening rates to hub-led counties (9.2 and 8.7, respectively, p = 0.984) and did not vary over time (p = 0.866). Qualitative analyses revealed influence of program champions, participant language preference, and stakeholders' concerns about uncompensated care. A program that leverages local organizations' ability to identify and reach rural underserved populations is a feasible approach for expanding preventive services delivery.

Assessing local capacity to expand rural breast cancer screening and patient navigation: An iterative mixed-method tool.

BACKGROUND: Despite federal funding for breast cancer screening, fragmented infrastructure and limited organizational capacity hinder access to the full continuum of breast cancer screening and clinical follow-up procedures among rural-residing women. We proposed a regional hub-and-spoke model, partnering with local providers to expand access across North Texas. We describe development and application of an iterative, mixed-method tool to assess county capacity to conduct community outreach and/or patient navigation in a partnership model. METHODS: Our tool combined publicly-available quantitative data with qualitative assessments during site visits and semi-structured interviews. RESULTS: Application of our tool resulted in shifts in capacity designation in 10 of 17 county partners: 8 implemented local outreach with hub navigation; 9 relied on the hub for both outreach and navigation. Key factors influencing capacity: (1) formal linkages between partner organizations; (2) inter-organizational relationships; (3) existing clinical service protocols; (4) underserved populations. Qualitative data elucidate how our tool captured these capacity changes. CONCLUSIONS: Our capacity assessment tool enabled the hub to establish partnerships with county organizations by tailoring support to local capacity and needs. Absent a vertically integrated provider network for preventive services in these rural counties, our tool facilitated a virtually integrated regional network to extend access to breast cancer screening to underserved women.

Financial Incentives for Promoting Colorectal Cancer Screening: A Randomized, Comparative Effectiveness Trial.

OBJECTIVES: Offering financial incentives to promote or "nudge" participation in cancer screening programs, particularly among vulnerable populations who traditionally have lower rates of screening, has been suggested as a strategy to enhance screening uptake. However, effectiveness of such practices has not been established. Our aim was to determine whether offering small financial incentives would increase colorectal cancer (CRC) screening completion in a low-income, uninsured population. METHODS: We conducted a randomized, comparative effectiveness trial among primary care patients, aged 50-64 years, not up-to-date with CRC screening served by a large, safety net health system in Fort Worth, Texas. Patients were randomly assigned to mailed fecal immunochemical test (FIT) outreach (n=6,565), outreach plus a $5 incentive (n=1,000), or outreach plus a $10 incentive (n=1,000). Outreach included reminder phone calls and navigation to promote diagnostic colonoscopy completion for patients with abnormal FIT. Primary outcome was FIT completion within 1 year, assessed using an intent-to-screen analysis. RESULTS: FIT completion was 36.9% with vs. 36.2% without any financial incentive (P=0.60) and was also not statistically different for the $10 incentive (34.6%, P=0.32 vs. no incentive) or $5 incentive (39.2%, P=0.07 vs. no incentive) groups. Results did not differ substantially when stratified by age, sex, race/ethnicity, or neighborhood poverty rate. Median time to FIT return also did not differ across groups. CONCLUSIONS: Financial incentives, in the amount of $5 or $10 offered in exchange for responding to mailed invitation to complete FIT, do not impact CRC screening completion.