Self-reported symptoms among cancer survivors in the Women's Health Initiative (WHI) Life and Longevity after Cancer (LILAC) cohort.

PURPOSE: Due to cancer survivors living longer and morbidity associated with cancer treatments, it is necessary to understand symptoms experienced by cancer survivors. This study will analyze the symptom burden among a large cohort of survivors across multiple cancer sites. METHODS: Data from the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study were used to examine the symptom burden of older cancer survivors. Poisson regression with robust standard errors was utilized to determine differences in symptoms by cancer site, treatment, and other covariates. RESULTS: The most frequently reported symptoms among cancer survivors were fatigue (15.8%) and feeling sad or depressed (14.1%). Multivariable analyses indicated that more symptoms were reported among survivors who were younger (p = 0.002), divorced or separated (p = 0.03), and had a combination of public and private insurance (p = 0.01). Survivors who received chemotherapy (p < 0.001), radiation (p = 0.01), or hormone therapy (p = 0.02) reported more symptoms than survivors who did not receive these treatments. Survivors diagnosed with cancer < 5 years ago reported fewer symptoms than longer-term survivors, particularly those diagnosed > 10 years ago (p = 0.02). CONCLUSIONS: Results indicate that common physical and psychological symptoms are reported across cancer types. Cancer survivors diagnosed with cancer 10 or more years ago reported more symptoms than those recently diagnosed. This suggests that symptoms may remain a problem for some survivors decades after their diagnosis. IMPLICATIONS FOR CANCER SURVIVORS: Future research should focus on implementing active surveillance of cancer survivors. Healthcare providers and those who care for cancer survivors should understand that the symptom burden associated with cancer may persist even decades following diagnosis.

Association of Lower Extremity Lymphedema With Physical Functioning and Activities of Daily Living Among Older Survivors of Colorectal, Endometrial, and Ovarian Cancer.

Importance: Lower extremity lymphedema (LEL) is associated with decreased physical functioning (PF) and activities of daily living (ADLs) limitations. However, the prevalence of LEL in older survivors of cancer is unknown. Objectives: To examine LEL among older female survivors of colorectal, endometrial, or ovarian cancer and investigate the association of LEL with PF and ADLs. Design, Setting, and Participants: This secondary analysis of the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study was conducted using data from postmenopausal women enrolled at 40 US centers. Participants were women who had a prior diagnosis of endometrial, colorectal, or ovarian cancer and who had completed the WHI LILAC baseline and year 1 follow-up questionnaires as of September 2017. Exposures: The 13-item Lower Extremity Lymphedema Screening Questionnaire in Women was used to determine LEL (ie, score ≥5). Main Outcomes and Measures: Validated surveys were used to assess PF and ADLs. Results: Among 900 older women diagnosed with endometrial, colorectal, or ovarian cancer, the mean (SD) age was 78.5 (5.9) years and the mean (range) time since cancer diagnosis was 8.75 (1.42-20.23) years. Overall, 292 women (32.4%) reported LEL, with the highest LEL prevalence among survivors of ovarian cancer (38 of 104 women [36.5%]), followed by survivors of endometrial cancer (122 of 375 women [32.5%]) and colorectal cancer (132 of 421 women [31.4%]). Compared with women without LEL, women with LEL had a PF score that was lower by a mean (SE) 16.8 (1.7) points (P < .001) and higher odds of needing help with ADLs (odds ratio [OR], 2.45; 95% CI, 1.64-3.67). In the association of LEL with PF, the mean (SE) decrease in PF score was greatest among survivors of colorectal cancer (-21.8 [2.6]) compared with survivors of endometrial cancer (-13.3 [2.7]) and ovarian cancer (-12.8 [5.2]). Additionally, among survivors of colorectal cancer, LEL was associated with increased odds of needing help with ADLs (OR, 3.59; 95% CI, 1.94-6.66), while there was no such association among survivors of endometrial cancer or ovarian cancer. However, there were no interaction associations between LEL and cancer type for either outcome. Additionally, the overall mean (SE) difference in PF between women with and without LEL was greater among those aged 80 years and older (-19.4 [2.6] points) vs those aged 65 to 79 years (-14.9 [2.2] points). However, among survivors of colorectal cancer, the mean (SE) difference in PF score was greater among women aged 65 to 79 years (-22.9 [3.7] points) vs those aged 80 years or older (-20.8 [3.7] points) (P for 3-way interaction = .03). Conclusions and Relevance: This study found that nearly one-third of older female survivors of colorectal, endometrial, or ovarian cancer experienced LEL and that LEL was associated with decreased PF and increased odds of needing help with ADLs. These findings suggest that clinicians may need to regularly assess LEL among older survivors of cancer and provide effective interventions to reduce LEL symptoms and improve PF for this population.

Body image, physical activity and psychological health in older female cancer survivors.

OBJECTIVES: To determine the association of physical activity and body image with psychological health outcomes and whether body image mediates the association of physical activity with psychological health among older female cancer survivors. MATERIALS AND METHODS: Data from the Women's Health Initiative (WHI) Life and Longevity after Cancer (LILAC) Study were used. Surveys assessed body image (appearance, attractiveness, scars), moderate-strenuous physical activity (min/week), and psychological health (depression, anxiety, distress). A mediation analysis was conducted to estimate the percentage of the total effect of physical activity on psychological health mediated by body image concerns. RESULTS: Among 4567 female cancer survivors aged 66-98 years, the average time since cancer diagnosis was 9.2 years. Approximately 50% reported no moderate-strenuous physical activity; 15% reported depressive symptoms, 6% reported anxiety, and 5% reported psychological distress; 3% had concerns with appearance, 20% had concerns with attractiveness, and 21% had concerns with scars. When unadjusted for body image concerns, every 30 min/week increase in physical activity was associated with lower risk of depressive symptoms (RR = 0.93, 95%CI: 0.90-0.96), anxiety (RR = 0.92, 95%CI: 0.87-0.97), and distress (RR = 0.92, 95%CI: 0.87-0.98). Body image concerns with appearance mediated 7%, 8.8%, and 14.5% of the association between physical activity and depressive symptoms, anxiety, and distress, respectively. CONCLUSION: Older female cancer survivors reported body image concerns, which were associated with both physical activity and psychological health. Our findings suggest that interventions designed to address body image concerns in older female cancer survivors could serve to improve the benefit of physical activity on psychological health.

A Multi-level Model to Understand Cervical Cancer Disparities in Appalachia.

The Appalachian region experiences higher incidence and mortality due to cervical cancer compared with other regions of the United States. The goal of the Ohio State University Center for Population Health and Health Disparities (CPHHD), called the Community Awareness Resources and Education (CARE) project, was to understand reasons for this disparity. The first wave (2003-2008) of funding included three projects focusing on the known risk factors for cervical cancer, lack of screening, smoking, and infection with human papillomavirus (HPV). On the basis of the results of these projects, the second wave (2011-2017) included four projects, designed to address a multi-level model of factors contributing to cervical disparities in Appalachia. The results of these projects were then used to refine a multi-level model that explains cervical cancer disparities in Appalachia. Future funded projects will take these multi-level explanations for cervical disparities and focus on implementation science strategies to reduce the burden of cervical cancer morbidity and mortality in Appalachia.See all articles in this Special Collection Honoring Paul F. Engstrom, MD, Champion of Cancer Prevention.

Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial.

BACKGROUND: First-degree relatives (FDR) of patients with colorectal cancer are at risk for colorectal cancer, but may not be up to date with colorectal cancer screening. We sought to determine whether a one-time recommendation about needing colorectal cancer screening using patient navigation (PN) was better than just receiving the recommendation only. METHODS: Participants were FDRs of patients with Lynch syndrome-negative colorectal cancer from participating Ohio hospitals. FDRs from 259 families were randomized to a website intervention (528 individuals), which included a survey and personal colorectal cancer screening recommendation, while those from 254 families were randomized to the website plus telephonic PN intervention (515 individuals). Primary outcome was adherence to the personal screening recommendation (to get screened or not to get screened) received from the website. Secondary outcomes examined who benefited from adding PN. RESULTS: At the end of the 14-month follow-up, 78.6% of participants were adherent to their recommendation for colorectal cancer screening with adherence similar between arms (P = 0.14). Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared with the website intervention (OR: 2.98; 95% confidence interval, 1.68-5.28). CONCLUSIONS: Addition of PN to a website intervention did not improve adherence to a colorectal cancer screening recommendation overall; however, the addition of PN was more effective in increasing adherence among FDRs who needed screening immediately. IMPACT: These findings provide important information as to when the additional costs of PN are needed to assure colorectal cancer screening among those at high risk for colorectal cancer.

An Environmental Scan of Biopsychosocial and Clinical Variables in Cohort Studies of Cancer Survivors.

BACKGROUND: An inventory of cancer survivorship cohorts is necessary to identify important gaps in what is being studied among cancer survivors. METHODS: We conducted an environmental scan of cancer survivor cohorts to determine the scope and scale of information collected on demographic, biopsychosocial, and selected clinical variables from cancer survivors. Cohorts were eligible for inclusion in the environmental scan if the study was conducted in the United States, reported in English, and consisted of data collected from cancer survivors postdiagnosis and followed for at least 1 year. RESULTS: Out of the 131 cohorts identified, 62 were eligible. There were 23 cancer sites represented, and more than half of the studies included breast cancer survivors (n = 34). The next most commonly included cancers were leukemia (n = 22) and lymphoma (n = 23). The majority (n = 59) collected information on clinical characteristics and basic diagnostic information, patient demographic characteristics (n = 57), patient-reported symptoms (n = 44), lifestyle (n = 45), and psychologic characteristics (n = 42). Half collected biospecimens (n = 35) and biomarkers (n = 35); fewer collected CAM use (n = 19) and social characteristics (n = 27). CONCLUSIONS: Extensive data are available in cancer cohorts to study important questions relevant to cancer survivors. Cohorts should consider collecting information on social and environmental factors, as well as biospecimen collection and biomarker analyses, and should include survivors from cancer sites less likely to be studied. IMPACT: This information can assist researchers in understanding the types of information currently being gathered from cancer survivors for further analysis and identify areas where more research is needed.

The efficacy and cost-effectiveness of patient navigation programs across the cancer continuum: A systematic review.

Published studies regarding patient navigation (PN) and cancer were reviewed to assess quality, determine gaps, and identify avenues for future research. The PubMed and EMBASE databases were searched for studies investigating the efficacy and cost-effectiveness of PN across the cancer continuum. Each included article was scored independently by 2 separate reviewers with the Quality Assessment Tool for Quantitative Studies. The current review identified 113 published articles that assessed PN and cancer care, between August 1, 2010, and February 1, 2018, 14 of which reported on the cost-effectiveness of PN programs. Most publications focused on the effectiveness of PN in screening (50%) and diagnosis (27%) along the continuum of cancer care. Many described the effectiveness of PN for breast cancer (52%) or colorectal cancer outcomes (51%). Most studies reported favorable outcomes for PN programs, including increased uptake of and adherence to cancer screenings, timely diagnostic resolution and follow-up, higher completion rates for cancer therapy, and higher rates of attending medical appointments. Cost-effectiveness studies showed that PN programs yielded financial benefits. Quality assessment showed that 75 of the 113 included articles (65%) had 2 or more weak components. In conclusion, this review indicates numerous gaps within the PN and cancer literature where improvement is needed. For example, more research is needed at other points along the continuum of cancer care outside of screening and diagnosis. In addition, future research into the effectiveness of PN for understudied cancers outside of breast and colorectal cancer is necessary along with an assessment of cost-effectiveness and more rigorous reporting of study designs and results in published articles.

Correlates of Rural, Appalachian, and Community Identity in the CITIES Cohort.

PURPOSE: To determine correlates of rural, Appalachian, and community identity among a cohort of participants in the Community Initiative Towards Improving Equity and Health Status (CITIES) project. METHODS: Mixed linear and logistic regression effects models were utilized to determine correlates of 3 outcomes: 1) community identity, 2) rural identity, and 3) Appalachian identity among participants in the Ohio CITIES project. FINDINGS: Distinct demographic characteristics were found to be associated with each of the outcomes. For community identity, while no differences were found for rural or urban participants, those who were single or never married (P < .0001) as well as those who graduated from college (P = .0005) reported significantly lower community identity scores than married individuals with less than a college education. Those who resided in an Appalachian county reported higher community identity scores (P = .0009) than non-Appalachian residents. For rural identity, those who did not identify as Christian (P = .018) as well as those who identified as Democrat (P = .027) reported significantly lower rural identity scores than others. Lastly, for Appalachian identity, county-level percentage of families in poverty (P = .06), as well as gender (P = .05), were associated with self-reported Appalachian identity, but these effects were only marginally significant. CONCLUSIONS: Although community, rural, and Appalachian identity may be viewed as similar due to their measure of attachment to a place, results from this study suggest that there are distinct individual and area-level correlates associated with community, rural, and Appalachian identity.

The CITIES Project: Understanding the Health of Underrepresented Populations in Ohio.

BACKGROUND: Ohio, the catchment area of The Ohio State University Comprehensive Cancer Center (OSUCCC), includes diverse populations with different cancer profiles. As part of the National Cancer Institute (NCI)-funded initiative to conduct population health assessments in cancer center catchment areas, the OSUCCC surveyed residents, focusing on factors contributing to cancer disparities in Ohio populations. METHODS: Two sampling strategies were used: (i) probability sampling of mailing lists and (ii) convenience sampling at community events, coupled with phone/in-person/web surveys. Survey items were chosen along multilevel framework constructs, used in concert with other funded NCI-Designated Cancer Centers. Multivariable logistic regression models investigated predictors associated with health behaviors, cancer beliefs, knowledge, and screening. RESULTS: The sample of 1,005 respondents were white (46.6%), African American (24.7%), Hispanic (13.7%), Somali (7.6%), and Asian (7.5%). A total of 216 respondents were Appalachian. Variations in cancer attitudes, knowledge, and behaviors were noted by racial/ethnic and geographic group. Multivariable models identified individuals with less financial security as less likely to exercise or be within guidelines for screening, but more likely to smoke and have a poor diet. At the community-level, measures of poverty were highest in Appalachia, whereas children in female-headed households were greater in urban minority areas. CONCLUSIONS: This population health assessment reinforced the diversity of the OSUCCC catchment area. These populations are ripe for implementation science strategies, focusing in communities and clinics that serve vulnerable populations. IMPACT: Understanding attitudes, knowledge, and behaviors of this population can assist tailoring outreach and research strategies to lessen the cancer burden.

Predictors of Colorectal Cancer Screening in Two Underserved U.S. Populations: A Parallel Analysis.

BACKGROUND: Despite declining colorectal cancer (CRC) incidence and mortality rates in the U.S., significant geographic and racial disparities in CRC death rates remain. Differences in guideline-concordant CRC screening rates may explain some of these disparities. We aim to assess individual and neighborhood-level predictors of guideline-concordant CRC screening within two cohorts of individuals located within CRC mortality geographic hotspot regions in the U.S. METHODS: A total of 36,901 participants from the Southern Community Cohort Study and 4,491 participants from the Ohio Appalachia CRC screening study were included in this study. Self-reported date of last CRC screening was used to determine if the participant was within guidelines for screening. Logistic regression models were utilized to determine the association of individual-level predictors, neighborhood deprivation, and residence in hotspot regions on the odds of being within guidelines for CRC screening. RESULTS: Lower household income, lack of health insurance, and being a smoker were each associated with lower odds of being within guidelines for CRC screening in both cohorts. Area-level associations were less evident, although up to 15% lower guideline adherence was associated with residence in neighborhoods of greater deprivation and in the Lower Mississippi Delta, one of the identified CRC mortality hotspots. CONCLUSION: These results reveal the adverse effects of lower area-level and individual socioeconomic status on adherence to CRC guideline screening.

Fear of recurrence among older breast, ovarian, endometrial, and colorectal cancer survivors: Findings from the WHI LILAC study.

OBJECTIVE: To examine the prevalence of and factors associated with fear of recurrence (FCR) following treatment for breast, ovarian, endometrial, and colorectal cancer among older women. METHODS: Participants were enrolled in the Women's Health Initiative Life and Longevity After Cancer study. Descriptive statistics and multivariate logistic regression models were used to assess the association of demographic, clinical, and quality of life variables with survivors' FCR, dichotomized as <14 (low) or ≥14 (high) using the Cancer Worry Scale. RESULTS: Out of the 4259 participants, 3124 (73.3%) were diagnosed with breast cancer, 559 (13.1%) with colorectal cancer, 493 (11.6%) with endometrial cancer, and 83 (2%) with ovarian cancer. There were no significant differences in FCR by cancer type (P = .75), with a mean scale score of 10.8 ± 2.87 for all participants combined. Approximately 16% (n = 679) were in the high FCR group. Multivariable analyses indicated that being younger at diagnosis, reporting a symptom score of ≥8, receipt of chemotherapy, and lower self-rated health were significantly associated with high FCR. Women who were widowed or never married were less likely to report high FCR. CONCLUSIONS: Fear of recurrence was experienced by a small but important proportion of older, long-term cancer survivors and is associated with multiple demographic and clinical variables. These results will better inform researchers and clinicians regarding the individuals who are at risk of FCR.

The Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) Study: Description and Baseline Characteristics of Participants.

Background: The Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study offers an important opportunity to advance cancer research by extending the original WHI studies to examine survivorship in women diagnosed with cancer during their participation in WHI.Methods: The goals of LILAC are to (i) obtain cancer treatment information and long-term cancer outcomes for women diagnosed with one of eight selected cancers (breast, endometrial, ovarian, lung, and colorectal cancers, and melanoma, lymphoma, and leukemia); (ii) augment the existing WHI biorepository with fixed tumor tissue from the solid tumor sites for cancers diagnosed since 2002; and (iii) develop, refine, and validate methods to use administrative data to capture treatment and recurrence data. Methods for accomplishing these goals are described, as are results from the initial LILAC participant survey.Results: A total of 9,934 WHI participants living with cancer were eligible for LILAC participation, of which 78% (N = 7,760) agreed to participate. Among the three most prevalent cancer types, 54% are breast cancer survivors, 11% are melanoma survivors, and 10% are survivors of colorectal cancer.Conclusions: In addition to describing this resource, we present pertinent lessons that may assist other investigators interested in embedding survivorship research into existing large epidemiologic cohorts.Impact: The LILAC resource offers a valuable opportunity for researchers to study cancer survivorship and issues pertinent to cancer survivors in future studies. Cancer Epidemiol Biomarkers Prev; 27(2); 125-37. ©2017 AACR.

Belief About Mandatory School Vaccinations and Vaccination Refusal Among Ohio Appalachian Parents: Do Demographic and Religious Factors, General Health, and Political Affiliation Play a Role?

PURPOSE: To examine how demographic, general health, religious, and political characteristics influenced beliefs about mandatory school vaccinations and history of vaccination refusal for children among Ohio Appalachian parents. METHODS: In 2013 and 2014, baseline data were obtained from parents (n = 337) of girls aged 9-17 from 12 counties in rural Ohio Appalachia enrolled in the Community Awareness, Resources and Education (CARE II) Project. Multivariate logistic regression models were used to identify correlates of parental beliefs about mandatory school vaccinations and history of refusing a doctor-recommended vaccine for their child(ren). RESULTS: About 47% of parents agreed that parents should have the right to refuse mandatory school vaccinations for their child(ren). Participants who reported their political affiliation as Republican (OR = 2.45, 95% CI: 1.28-4.66) or Independent (OR = 3.31, 95% CI: 1.70-6.44) were more likely to agree that parents should have the right to refuse school-mandated vaccinations than parents who reported their political affiliation as Democrat. Approximately 39% of parents reported ever refusing a vaccine for their child(ren). Participants who were female (OR = 3.90, 95% CI: 1.04-14.58) and believed that parents should have the right to refuse mandatory school vaccinations (OR = 3.27, 95% CI: 1.90-5.62) were more likely to report ever refusing a vaccine for their child(ren). CONCLUSION: The study findings provide information to better understand factors related to vaccination refusal among parents in Appalachia Ohio that can be used to design interventions to improve vaccination uptake.

Association between prediagnostic glucose, triglycerides, cholesterol and meningioma, and reverse causality.

BACKGROUND: Although meningioma is a benign tumour, it may cause significant morbidity. Obesity and diabetes are positively associated with meningioma. To evaluate the potential effects of obesity-related prediagnostic glucose, triglycerides and cholesterol on meningioma and of prediagnostic meningioma on these biomarkers, we conducted a cohort study. METHODS: We identified 41 355 individuals in the Apolipoprotein MOrtality RISk cohort with values for these biomarkers within 15 years before meningioma diagnosis, death, migration or the end of follow-up. We then estimated hazard ratios (HRs) and their interactions with time and age using Cox regression. RESULTS: Meningioma was diagnosed in 181 women and 115 men whose median follow-up time was 7 years. Fasting serum glucose level was inversely related to meningioma among women (Ptrend=0.0006) but not men (Ptrend=0.24). Prediagnostic diabetes was inversely related to meningioma in both sexes combined (HR=0.45, 95% confidence interval (CI) 0.29-0.71), as was serum cholesterol within the year before diagnosis (HR=0.50, 95% CI 0.34-0.72). CONCLUSIONS: Paradoxically, hyperglycaemia is inversely associated with meningioma in women. This finding does not necessarily negate the positive role of obesity or diabetes in meningioma development; rather, it may indicate that their effects depend on the stage of development. Furthermore, the prediagnostic tumour may reduce serum cholesterol levels.

Results of a Multilevel Intervention Trial to Increase Human Papillomavirus (HPV) Vaccine Uptake among Adolescent Girls.

BACKGROUND: Uptake of the human papillomavirus (HPV) vaccine is low in Appalachian Ohio and areas with high cervical cancer rates. METHODS: We conducted a group-randomized trial among 12 counties in Appalachian Ohio randomized to receive either an HPV vaccine (intervention counties) or influenza vaccine (comparison counties) multilevel intervention (MLI). Parents (n = 337) who had a daughter aged 9 to 17 years who had not received the HPV vaccine were recruited from commercial lists. Clinics (N = 24) and 119 providers from these clinics were also recruited. The primary outcome was medical record-confirmed receipt of the first shot of the HPV vaccine 3 months after receiving the intervention among daughters of parents enrolled in the study. Secondary outcomes included receipt of the first HPV vaccine shot by 6 months and changes in provider knowledge. RESULTS: According to medical records, 10 (7.7%) daughters of intervention participants received the first shot of the HPV vaccine within 3 months of being sent the intervention materials compared with 4 (3.2%) daughters of comparison group participants (P = 0.061). By 6 months, 17 (13.1%) daughters of intervention participants received the first HPV vaccine shot compared with eight (6.5%) daughters of comparison group participants (P = 0.002). Provider knowledge about HPV increased (P < 0.001, from baseline to after education). CONCLUSIONS: The MLI increased uptake of the HPV vaccine among girls aged 9 to 17 years; however, uptake was low. IMPACT: To improve HPV vaccine uptake, attention to additional levels of influence (e.g., policy, community) and more elements within levels (e.g., reminders, automated prompts) may be needed. Cancer Epidemiol Biomarkers Prev; 25(4); 593-602. ©2016 AACR SEE ALL ARTICLES IN THIS CEBP FOCUS SECTION, "MULTILEVEL APPROACHES TO ADDRESSING CANCER HEALTH DISPARITIES".

Impact of Patient Navigation Interventions on Timely Diagnostic Follow Up for Abnormal Cervical Screening.

OBJECTIVE: As part of the Patient Navigation Research Program, we examined the effect of patient navigation versus usual care on timely diagnostic follow-up, defined as clinical management for women with cervical abnormalities within accepted time frames. METHODS: Participants from four Patient Navigation Research Program centers were divided into low- and high-risk abnormality groups and analyzed separately. Low-risk participants (n = 2088) were those who enrolled with an initial Pap test finding of atypical squamous cells of undetermined significance (ASCUS) with a positive high-risk human papillomavirus (HPV) serotype, atypical glandular cells, or low-grade squamous intraepithelial lesion (LGSIL). High-risk participants were those with an initial finding of high-grade squamous intraepithelial lesion (HGSIL) (n = 229). A dichotomous outcome of timely diagnostic follow-up within 180 days was used for the low-risk abnormality group and timely diagnostic follow-up within 60 days for the high-risk group, consistent with treatment guidelines. A logistic mixed-effects regression model was used to evaluate the intervention effect using a random effect for study arm within an institution. A backward selection process was used for multivariable model building, considering the impact of each predictor on the intervention effect. RESULTS: Low-risk women in the patient navigation arm showed an improvement in the odds of timely diagnostic follow-up across all racial groups, but statistically significant effects were only observed in non-English-speaking Hispanics (OR 5.88, 95% CI 2.81-12.29). No effect was observed among high-risk women. CONCLUSION: These results suggest that patient navigation can improve timely diagnostic follow-up among women with low-risk cervical abnormalities, particularly in non-English-speaking Hispanic women.