Debbie C. Bryant

Patient participation in cancer clinical trials: A pilot test of lay navigation

Background Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. Methods A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-min CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. Results During this 12-month pilot project, 85% (95% CI: 72%–93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%–98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. Conclusions In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

An Examination of Sociocultural Factors Associated With Mammography Screening Among Latina Immigrants

Introduction: The study hypothesized that sociocultural factors would be associated with breast cancer screening within the past 2 years among Latina immigrant women. Method: This study employed a survey design and included 82 Latina immigrant female participants 40 to 64 years of age for the analysis. Two multivariable binary logistic regression models were estimated, one for the sociocultural deterrents and the other for the symptomatic deterrents from the Cultural Cancer Screening Scale. Results: The results indicated two constructs of the Cultural Cancer Screening Scale, sociocultural deterrents (odds ratio = 2.00; 95% confidence interval = 1.04-3.86) and symptomatic deterrents (odds ratio = 1.65; 95% confidence interval = 1.08-2.54), were associated with screening in the past 2 years, when adjusting for sociodemographic and health-related characteristics. Conclusion: These findings provide evidence for the importance of sociocultural factors in Latina immigrant women’s timely mammography screening.

Acceptance of a community-based navigator program for cancer control among urban African Americans

Patient navigation is now a standard component of cancer care in many oncology facilities, but a fundamental question for navigator programs, especially in medically underserved populations, is whether or not individuals will use this service. In this study, we evaluated acceptance of a community-based navigator program for cancer control and identified factors having significant independent associations with navigation acceptance in an urban sample of African Americans. Participants were African American men and women ages 50-75 who were residents in an urban metropolitan city who were referred for navigation. Of 240 participants, 76% completed navigation. Age and perceived risk of developing cancer had a significant independent association with navigation acceptance. Participants who believed that they were at high risk for developing cancer had a lower likelihood of completing navigation compared with those who believed that they had a low risk for developing this disease. The likelihood of completing navigation increased with increases in age. None of the socioeconomic factors or health care variables had a significant association with navigation acceptance. There are few barriers to using community-based navigation for cancer control among urban African Americans. Continued efforts are needed to develop and implement community-based programs for cancer control that are easy to use and address the needs of medically underserved populations.

Beyond birds-and-bees: a qualitative content analysis of online HPV vaccination communication

ABSTRACT Background: South Carolina lags behind other states in the United States in HPV vaccination rates. This study investigated online HPV vaccination communication to provide insight to increase vaccine uptake through effective messaging. Method: A qualitative content analysis of publicly available documents in South Carolina between 1 June 2014 and 31 May 2015 was performed, including 83 website/blog posts, 211 tweets, 144 Facebook posts, and 31 articles in local and statewide newspapers. Diffusion of innovations theoretical framework and a constant comparative method were used to analyze data in HyperRESEARCH 3.7.2. Results: Current messaging in South Carolina emphasized the relative advantage of HPV vaccination as cancer prevention strategy. Two primary misconceptions about the HPV vaccination were identified: concerns about safety and that the vaccine could increase sexual activity among adolescents. The content analysis revealed that health care provider support is needed to normalize HPV vaccination as part of the routine immunization series. Observing messages from peers served as a vicarious trial experience of the vaccine for adolescents and young adults and showed gaps in vaccine uptake among males and lack of series completion among males and females. Conclusions: Future messaging should focus on compatibility with the target audience’s values by addressing misconceptions about the vaccine related to sexual activity and safety.

Abstract A72: Interim Recruitment Outcomes in an NCORP-Based Patient Navigation Trial for African Americans with Early Stage Lung Cancer

BACKGROUND: Enrollment of early stage lung cancer patients to randomized trials has historically been challenging. The STARS Trial enrolled 36 of 1,030 intended patients from 28 sites, while the ROSEL Trial recruited 22 of 960 intended patients from 10 sites. Unfortunately, evidence shows African Americans with early stage, NSCLC are significantly less likely than their European American counterparts to undergo resection and may also be less likely to participate in lung cancer trials as well. PURPOSE: The purpose of this research is to describe interim recruitment results from an NIMHD-funded, NCI NCORP-based patient navigation trial conducted with African Americans with early stage, probable/proven non-small cell lung cancer (NSCLC). DESIGN: The protocol-driven, barriers-focused patient navigation intervention is being conducted in the context of a two-arm cluster-randomized trial testing the effectiveness of the intervention in increasing rates of lung-directed curative-intent therapy (surgery and SBRT) in African Americans with Stage I-II NSCLC. The 2 study arms consist of the protocol-driven, intensive navigation intervention vs. usual care. The trial includes 24 study sites in 13 US states. Specific activities to enhance recruitment in the present trial include reaching out to referring physicians (e.g., primary care, pulmonologists, radiologists) to increase referrals of African American patients to the participating NCORP sites, and partnering with the leaders of community engagement activities at the sites to raise community-level awareness of the trial. RESULTS/CONCLUSIONS: To date, 64 African American patients have been recruited and the trial is now on target to meet its expected accrual goal of 200 patients. The majority of potential participants were ineligible due to receipt of surgical resection or radiation therapy prior to enrollment (32%), not having been told that they had probable/proven NSCLC prior to study contact (13%) or a previous history of lung cancer (13%). Only 9 potential participants have refused trial participation. The median age of the 64 participants is 64 years (range 37-86 years). Most are unmarried (64%) and have a high school diploma or less (72%). Only 13 of the participants (20%) have no comorbidities. The number of enrolled-to-date African American participants in this ongoing trial exceeds the total number of participants recruited to the STARS Trial or to the ROSEL Trial. Citation Format: Marvella E. Ford, Debbie C. Bryant, Kathleen B. Cartmell, Katherine Sterba, Dana R. Burshell, Elizabeth G. Hill, Allan De Toma, Kendrea D. Knight, Kathryn Weaver, Elizabeth Calhoun, Nestor F. Esnaola. Interim Recruitment Outcomes in an NCORP-Based Patient Navigation Trial for African Americans with Early Stage Lung Cancer. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr A72.

Abstract C45: A patient navigation model to increase rates of lung-directed therapy with curative intent (LDTCI) in African Americans with early stage non-small cell lung cancer (NSCLC)

Background: LDTCI (i.e., surgical resection or stereotactic body radiation therapy [SBRT] in patients who are not surgical candidates]) is the standard of care for patients with early stage NSCLC. Unfortunately, African Americans with early stage, NSCLC are significantly less likely than their European American counterparts to undergo resection. Purpose: This presentation will describe the design of an NIH/NIMHD-funded, NCORP-sponsored, cluster-randomized trial testing the effectiveness of a barriers-focused, protocol-driven patient navigation intervention on increasing rates of LDTCI in African Americans with early stage, probable/proven NSCLC. Design: The trial is currently being conducted at 13 study sites across the United States. The investigators developed an electronic, web-based version of the NIH/NCI Patient Navigation Barrier Checklist. Patient navigators at each intervention site use the electronic Checklist to identify patient barriers to care and guide their interactions with patients. The navigators then enter the data from these interactions into a secure, web-based electronic data management system. Results/Conclusions: Most of the African American patients at the study sites are ineligible for study participation due to advanced stage at diagnosis. Of the 2,529 patients who have been pre-screened for study eligibility to date, only 43 (1.7%) were determined to be African American with likely/proven stage I-II NSCLC. Of this number, 34 (79.1%) were consented for the study, and 29 are currently enrolled. During this presentation, the investigators will present de-identified case examples of barriers experienced by patients and the strategies used by the navigators to overcome these barriers. Plans are underway to add study sites to increase the denominator of potentially eligible participants. Citation Format: Nestor F. Esnaola, Debbie C. Bryant, Kathleen B. Cartmell, Elizabeth Calhoun, Katherine Sterba, Dana R. Burshell, Elizabeth G. Hill, Amy E. Wahlquist, Kendrea D. Knight, Marvella E. Ford. A patient navigation model to increase rates of lung-directed therapy with curative intent (LDTCI) in African Americans with early stage non-small cell lung cancer (NSCLC). [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr C45.

Abstract B27: Overweight/obesity and physical activity rates in an ethnically diverse sample of breast cancer survivors

Background: High body mass index (BMI) is linked to poorer survival after breast cancer diagnosis. Physical activity (PA) could moderate this association. Objectives/Hypothesis: Prevalence of high BMI (overweight/obesity) and level of PA were evaluated in a statewide sample of women within 18 months of breast cancer diagnosis. Methods: In an ongoing study, 73 women (35 EA and 38 AA) were identified through the SC Central Cancer Registry, and were interviewed to obtain their self-reported body weight, height, PA and other data. Results: Age: Age ranged from 26 to 90 years (mean 61 years, SD 13.0), with AAs 2.1 years younger than EAs (p=0.49). Education: 62% had more than a high school (HS) diploma (58% of AAs and 66% of EAs, p=0.49). BMI: 77% were overweight/obese; 42% of AAs and 31% of EAs were overweight, 45% of AAs and 34% of EAs were obese (p=0.03). PA: 23% reported no PA (29% of AAs and 17% of EAs, p=0.23). Only 38% met CDC PA guidelines of at least 150 min/week of moderate PA (29% of AAs and 47% of EAs; p=0.11). PA and BMI: PA HS education and meeting PA guidelines (p=0.15), or between >HS education and greater PA per week (p=0.57). Education and BMI: No significant association was seen (p=0.77). Conclusions: Prevalence of overweight/obesity was high, especially among AAs. Future Recommendations: It is imperative to identify strategies to reduce obesity/overweight in BRCA survivors. Citation Format: Joan E. Cunningham, Colleen E. Bauza, Erika T. Brown, Alberg J. Anthony, Emily Kistner-Griffin, Ida J. Spruill, Debbie C. Bryant, Nestor F. Esnaola, Melanie S. Jefferson, Keith Whitfield, Rita M. Kramer, Susan Bolick, Deborah Hurley, Catishia Mosley, Tonya R. Hazelton, Vivian J. Bea, Dana R. Burshell, Kendrea D. Knight, Marvella E. Ford. Overweight/obesity and physical activity rates in an ethnically diverse sample of breast cancer survivors. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr B27.

Abstract A64: Evaluating the feasibility of a cancer registry-based recruitment strategy to obtain saliva samples for genetic association analysis in an ethnically diverse sample of breast cancer survivors

Introduction: African American (AA) women are disproportionately impacted by breast cancer mortality; this disparity may be related to their higher burden of triple-negative breast cancer. Despite the disparity, AA women participate in breast cancer research at lower rates than European American (EA) women. We have analyzed interim recruitment outcomes in an ongoing feasibility study of 90 women in South Carolina (SC) with recently diagnosed breast cancer, in which we are investigating the prevalence of genetic (saliva) markers which may be associated with risk of triple-negative breast cancer. Methods: In this ongoing study, recruitment proceeds in two phases. In Phase 1, the SC Central Cancer Registry (SCCCR) identifies AA and EA patients through the registry. The SCCCR mails a letter to each identified patient9s physician to obtain passive consent from the physician. After attainment of passive consent, the SCCCR director mails an introductory study letter to each identified patient. Then an AA SCCCR interviewer calls each patient to obtain active consent prior to sharing the patient9s contact information with Medical University of SC (MUSC) study staff. In Phase 2, MUSC study staff send a recruitment letter to each patient after which an AA MUSC interviewer administers a telephone-based eligibility screener. Eligible patients are invited to the study and are asked to return a signed consent form and saliva sample in separate postage paid envelopes. To evaluate the effectiveness of our recruitment protocol, we are monitoring participation rates of women from each ethnic group. Results: From April 2012 through August 2013, the SCCCR identified 387 patients (Phase 1), of whom 172 opted in (44.4%) and were referred to MUSC for eligibility screening. One hundred and thirty-six women (79.1% of those referred) have completed screening interviews; 42 were ineligible due to stage of disease or ethnicity (30.9%) and 5 declined (3.7%). Of the 89 women eligible and willing to participate in the study, 78 (87.6%) have signed a consent form and thus far 66 of them (84.6%) have provided saliva samples. Overall, recruitment and retention rates are very similar for EAs and AAs. However, ethnic differences in refusal rates are apparent at different points in the recruitment process. In Phase 1, we found that AAs were more likely to opt out, not able to be contacted, or passively refuse during the SCCCR recruitment activities (55.4% AAs vs. 41.7% of EAs). In Phase 2, EAs were more likely to actively or passively refuse after agreeing to be contacted by MUSC staff (10.9% of AAs vs. 27.4% EAs). We are continuing to monitor this trend. Recruitment of AAs and EAs is nearly complete, with saliva samples collected thus far from 37 AA and 29 EA women. Conclusions: The study results demonstrate the success of our two-phase cancer registry-based method to identify and recruit participants. The strength of this strategy is shown by the similar numbers of AAs and EAs recruited to this genetic study. On a broader level, increasing numbers of women in the US are diagnosed annually with breast cancer. Therefore, it is critical to identify genetic markers for this disease and to develop effective recruitment strategies to enhance the diversity of participants in genetic research. Our study methods pave the way for future large-scale recruitment strategies. Citation Format: Marvella E. Ford, Dana Burshell, Rita M. Kramer, Anthony J. Alberg, Debbie C. Bryant, Colleen E. Bauza, Tonya R. Hazelton, Catishia Mosley, Susan Bolick, Deborah Hurley, Emily Kistner-Griffin, Joan E. Cunningham. Evaluating the feasibility of a cancer registry-based recruitment strategy to obtain saliva samples for genetic association analysis in an ethnically diverse sample of breast cancer survivors. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A64. doi:10.1158/1538-7755.DISP13-A64

Abstract B48: Design of a feasibility study of breast cancer candidate genes in three ethnic groups.

The purpose of this presentation is to highlight the design and preliminary recruitment outcomes of a translational feasibility study to investigate the impacts of selected genetic single nucleotide polymorphisms (SNPs) on ethnic disparities in breast cancer subtypes, defined by ER, PR, and Her2 expression, associated with higher breast cancer mortality rates. The study will investigate the frequencies of five SNPs in the 19p13 locus of BRCA1 and two SNPs on chr 5p12 in three ethnic groups: African Americans with Sea Island ancestry (SI; all four grandparents were born in SI geographic regions), African Americans without known Sea Island ancestry (AA; 0 grandparents were born in SI geographic regions), and European Americans (EA). The SI population is an AA subpopulation indigenous to the coastal southeast that has the lowest rates of European genetic admixture of AA tested.(1,2) Comparing risk alleles across these three ethnic groups provides a novel paradigm to assess the extent to which SI ancestry and social processes such as acculturation may be linked to breast cancer subtypes associated with poor prognosis. A protocol has been developed to identify, contact and recruit women recently diagnosed with breast cancer within each ethnic group. Breast cancer cases are initially ascertained through the South Carolina Central Cancer Registry (SCCCR). Recruitment methods encompass steps taken at the SCCCR that include passive consent from the physician of record to contact identified patients, followed by active consent from the identified patients prior to contact by study staff. An investigator-developed algorithm developed to determine SI ancestry of patients, based on geographic ancestry, is administered and eligible participants are asked to complete a telephone-administered survey and to provide a saliva sample for genetic analysis. Recruitment began in June 2012. To date, 23 participants have been recruited, of whom 6 are AA (26%) and 17 are EA (74%), with a mean age of 57.5 years (range =39-77 years). Recruitment will continue until 30 women in each ethnic group are enrolled (total 90 participants). The recruitment process is monitored using a CONSORT diagram. This work will ultimately identify loci for further investigation of breast cancer disparities in other groups and for future development of targeted clinical therapies. References: 1. Divers, J, Sale MM, Lu L, et al. The genetic architecture of lipoprotein subclasses in Gullah-speaking African American families enriched for Type 2 diabetes: the Sea Islands Genetic African American Registry (Project SuGAR). Journal of Lipid Research 2009;51:586-597. PubMed PMID: 9783527; PubMed Central PMCID: PMC2817588. 2. McLean DC, Jr., Spruill I, Argyropoulos G, et al. Mitochondrial DNA (mtDNA haplotypes reveal maternal population genetic affinities of Sea Island Gullah-speaking African Americans. American Journal of Physical Anthropology 2005;127:427-438. Citation Format: Marvella E. Ford, Joan E. Cunningham, Erika T. Brown, Ida J. Spruill, Anthony J. Alberg, Debbie C. Bryant, Karen D. Charles, Nestor F. Esnaola, Melanie S. Jefferson, Keith Whitfield, Rita M. Kramer, Susan Bolick, Deborah Hurley, Catishia Mosley, Tonya R. Hazelton, Vivian J. Bea, Dana R. Burshell, Shweta Singh, Emily Kistner-Griffin. Design of a feasibility study of breast cancer candidate genes in three ethnic groups. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr B48.

Abstract B92: Satisfaction with a breast cancer patient navigation program: Perspectives of patients, navigators, and clinical staff

Introduction: Patient navigation interventions are an emerging approach to reducing cancer disparities but few formal evaluations have been published. The purpose of this study was to evaluate perceptions of a breast cancer patient navigation program among patients, patient navigators (PNs), and breast cancer clinic staff members. Methods: Post-program interviews were conducted with 218 navigated patients. Individual semi-structured interviews were conducted with 5 PNs. Surveys were administered to 19 clinic staff. Results: Perceptions among Navigated Patients (n=218). Fifty-three percent of the surveyed patients were African American (n=116), 15.1% were Hispanic (n=33), 33.9% were married (n=74), 65.1% had ≤ a high school degree (n=142), and 75.2% had an annual income Perceptions among Navigators (n=5). Strengths of the program cited by the five navigators included: (a) the satisfaction that stems from helping patients receive needed health services; (b) recognition of the role of religious beliefs in the treatment decision-making of patients; (c) the need for navigators to be organized so they can effectively coordinate treatment among different clinicians for the patient; (d) using creative solutions to maintaining contact with navigated patients, such as pre-paid cell phones; and (e) meeting the challenges involved in working with patients with a wide variety of needs. Weaknesses of the program cited by the five navigators included: (a) difficulty in clarifying/distinguishing the roles of navigators and social workers; (b) language barriers with non-English speaking patients and the need to rely on hospital translation services, which often resulted in delayed provision of navigation services and slowed the clinic visit; and (c) the difficulty of presenting complex medical information in lay language to patients. Perceptions among Breast Cancer Clinic Staff Members (n=19). All respondents agreed/strongly agreed that navigators were knowledgeable, available when needed, and related well with navigated patients, breast clinicians and staff. Respondents agreed/strongly agreed that compared to patients who did not have a patient navigator, navigated patients were more prepared with requested documents needed for the clinic appointment (73.7%), missed fewer clinic appointments (76.5%), were more informed about their breast cancer treatment (89.5%), and received more timely breast cancer treatment (68.4%). Conclusions: We adopted a “triangulation” strategy to integrate perceptions of a patient navigation program through the eyes of patients, navigators, and breast cancer clinic staff members. The results show that the patient navigation program was favorably reviewed by these constituencies. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):B92.