Validation of Spanish-Language Surveys Utilized for the Navigator-Assisted Hypofractionation (NAVAH) Program to Aid Hispanic-American Breast Cancer Patients.

OBJECTIVES: Cancer accounts for 22% of all mortality and is the leading cause of death among Hispanic and/or Latinx patients in the United States. The disparities in access to radiation therapy (RT), mortality rates, and treatment outcomes among Hispanic-American breast cancer patients compared with other populations highlight the urgent need for targeted interventions. The Navigator-Assisted Hypofractionation (NAVAH) program, with its innovative patient navigation approach and culturally sensitive survey, aims to better identify the specific barriers faced by this population. This study is a report of the NAVAH program experience piloting a Spanish-language culturally sensitive survey in Hispanic-American volunteers. METHODS: Hispanic-American volunteers with fluency in Spanish were recruited to participate in survey conduction, identified from local networks. Survey information was assessed by topic category, and survey responses were amalgamated into a representative score for each category. Survey categories include acceptability (comfort and prejudice among interactions with the system), accessibility (transportation, distance to care, and health care literacy), accommodation (access to the internet, navigating transportation), affordability (financial considerations, employment, and level of education), and availability (access to a medical center, coordinating care, and overall quality of care). RESULTS: A total of 6 volunteers meeting inclusion criteria completed the survey; 4 in person and 2 by telephone. The median survey completion time was 12 minutes 38 seconds. Respondents noted satisfaction and trust in their interactions with medical providers; however, responses in the acceptability category highlighted a high perception of disparities in the medical system, including a high prevalence of racial and ethnic prejudice and a high prevalence of treatment differences between high-income and low-income patients in clinical settings. CONCLUSIONS: In the first Spanish-language survey of its kind, our findings indicate that this survey design is feasible in the Hispanic-American population. Implementation of this survey in breast cancer patients will provide more definitive and comprehensive answers regarding other categories in the survey, including financial challenges during treatment, access to accommodations, and perception of treatment during cancer care. The investigation involving patients actively receiving breast cancer RT is currently underway.

Patient Navigation in Cancer Treatment: A Systematic Review.

PURPOSE OF REVIEW: Patient navigation promotes access to timely treatment of chronic diseases by eliminating barriers to care. Patient navigation programs have been well-established in improving screening rates and diagnostic resolution. This systematic review aimed to characterize the multifaceted role of patient navigators within the realm of cancer treatment. RECENT FINDINGS: A comprehensive electronic literature review of PubMed and Embase databases was conducted to identify relevant studies investigating the role of patient navigators in cancer treatment from August 1, 2009 to March 27, 2023. Fifty-nine articles were included in this review. Amongst studies focused on cancer treatment initiation, 70% found a significant improvement in treatment initiation amongst patients who were enrolled in patient navigation programs, 71% of studies focused on treatment adherence demonstrated significant improvements in treatment adherence, 87% of studies investigating patient satisfaction showed significant benefits, and 81% of studies reported a positive impact of patient navigators on quality care indicators. Three palliative care studies found beneficial effects of patient navigation. Thirty-seven studies investigated disadvantaged populations, with 76% of them concluded that patient navigators made a positive impact during treatment. This systematic review provides compelling evidence supporting the value of patient navigation programs in cancer treatment. The findings suggest that patient navigation plays a crucial role in improving access to care and optimizing treatment outcomes, especially for disadvantaged cancer patients. Incorporating patient navigation into standard oncology practice can reduce disparities and improve the overall quality of cancer care.

Navigator utilization among African-American breast cancer patients at a Comprehensive Cancer Center.

Background: Patient navigation has been demonstrated to improve access to standard-of-care oncologic therapy. However, many patients - particularly those of African-American race - often do not have access to navigation upon receiving a diagnosis of cancer. As the most common cancer among African-American women is breast cancer, we sought to assess the rate of patient navigation among African-American breast cancer patients at our institution, which resides in a regional ZIP code comprised of 46% African-American residents. Materials and methods: African-American breast cancer patients who had been discussed at our weekly breast cancer multidisciplinary tumor board over a recent three-month period were assessed by a patient navigator representing the Navigator-Assisted Hypofractionation (NAVAH) program to determine their access to navigation in their cancer care. Responses were assessed from a breast cancer support group and culled to determine a baseline proportion of navigation utilization. Results: A total of 18 women of African-American race having been diagnosed with breast cancer were identified and assessed. Of these a total of 4 noted that they had received navigation, yielding a navigation utilization percentage of 22.2% among African-American breast cancer patients at our institution. Conclusion: The rate of navigation utilization among African-American breast cancer patients is poor. Despite our center residing in a region comprised of increased African-Americans, such predominance has not translated into optimizing navigation access for African-American breast cancer patients. This 22% rate of navigation utilization serves as a starting benchmark for initiatives such as the NAVAH program to provide tangible improvement in this patient population.

Navigator-assisted hypofractionation (NAVAH) to address radiation therapy access disparities facing African-Americans with breast cancer.

Background: African-Americans have the highest overall cancer death rate and shortest survival time of any racial or ethnic group in the United States. The most common cancer studied in African-American radiation therapy (RT) access disparities research is breast cancer. The goal of this study is to evaluate the impact of patient navigation on RT access for African-American breast cancer patients. Material and methods: This study is a prospective survey-based evaluation of the impact of patient navigation on access to hypofractionated RT and financial toxicity in African-American breast cancer patients. The impact of patient navigation on RT access will be collated and analyzed from survey results pre-RT versus post-RT as well as for patients with versus without receipt of patient navigation. The validated COST-Functional Assessment of Chronic Illness Therapy score will be used to compare hypofractionation versus standard fractionated RT financial toxicity for patients with early-stage breast cancer who have received lumpectomy. Conclusion: This is the first study to investigate the impact of patient navigation on reducing RT access disparities facing African-American breast cancer patients. The natural progression of this work will be to expand this model to include additional breast cancer populations most vulnerable to suffering RT access disparities (Native American, Hispanic American, Appalachian) within the United States.

Responding to healthcare distrust among underserved communities: Phase II.

OBJECTIVE: Medical distrust is both a psychosocial construct and an underappreciated individual social determinant of health with the potential to affect oncology care and clinical trial participation. A community-based participatory research effort, called the Forward Movement Project (FMP), identified multilevel factors affecting trust for healthcare and research in an underserved urban community. In FMP Phase II, we implemented a community-responsive approach to provide lay-oriented education and address misinformation, with the goal of beginning to remediate distrust for healthcare systems and biomedical research. METHODS: Community residents (N = 154 adults, 64% male, M = 61.5 years old, 53% annual income <$10,000, 83% African American/Black) engaged in participant-driven dialogues with oncology clinicians/clinical researchers and support services professionals. A program evaluation focused on trust for healthcare and biomedical research. RESULTS: Participants reported positive evaluations of both the program and the cancer center clinicians and staff, who were rated as trustworthy (80% strong agreement). However, trust for healthcare systems ("Strongly agree" = 58%) and medical researchers ("Strongly agree" = 50%) following the program was moderate. Over half of the sample (52%) strongly agreed they would participate in a clinical trial compared to before joining this study. CONCLUSION: Findings supported the user-generated program approach. The FMP is an example of a model for true community engaged research and has implications for rebuilding trust in healthcare and research.

Understanding Multilevel Factors Related to Urban Community Trust in Healthcare and Research.

BACKGROUND: Community and patient engagement in the healthcare system and biomedical research are prerequisites for eliminating health disparities. We conducted a "listening tour" to enhance our understanding of multilevel factors associated with community trust. METHODS: Using community-based participatory research (CBPR) methods, we conducted a phenomenological qualitative study. "Town-hall" style discussions were held at nine sites across an urban, Midwestern city. We recruited adults (N = 130) via community networks, social media, flyers, and word-of-mouth. Demographic assessments were self-administered and listening tour sessions were conducted by trained moderators. Themes were framed within the social ecological model (SEM; intrapersonal, interpersonal, institutional, community, and policy levels). RESULTS: Participants were mostly female (68%), African American (80%), had health coverage (97%) and were diagnosed with a chronic health condition (71%). The overarching theme was sociodemographic differences in distrust, such that African Americans and deaf/hearing impaired participants perceived disparities in healthcare, a lower quality of care, and skepticism about biomedical research, relative to Whites. CONCLUSIONS: The depth of distrust for healthcare providers, systems, and researchers in underserved communities remains strong and complex. Findings highlight the need to understand the lived experiences of community members, and how distrust is maintained. Multilevel interventions to increase trust and the accrual of underrepresented populations into clinical trials are needed.

Evaluating the Use of Plain Language in a Cancer Clinical Trial Website/App.

Medically complex titles and descriptions found on clinical trial websites and online applications present a barrier to comprehension for users from the general public. In this study, we examine the effectiveness of plain language trial descriptions for user comprehension of basic trial details. Two hundred seventeen volunteers recruited from patient waiting areas completed 441 user tests of ten plain language trial descriptions. The majority of volunteers adequately comprehended the cancer type and basic inclusion/exclusion criteria from plain language trial descriptions. Difficulty comprehending the treatment being studied was seen in seven of ten descriptions tested. Revision and retesting of the seven trial descriptions showed continued user challenges in comprehending the treatment being studied. Plain language clinical trial descriptions integrated into a website/app allowed users to understand basic inclusion/exclusion criteria. Despite plain language used, discerning the treatment being studied may be difficult for some users. Integration of plain language descriptions into clinical trial online applications can help users understand trial basics. Further research regarding effective use of plain language to communicate the treatment being studied is needed.

Consent form heterogeneity in cancer trials: the cooperative group and institutional review board gap.

BACKGROUND: Cooperative group (CG) provided consent forms (CGP-CFs) undergo re-review and revision by local institutional review boards (IRB) before institutional approval. We compared the relative readability and length of IRB-approved consent forms (IRB-CFs) used at seven academic institutions with their corresponding CGP-CFs. We also assessed the variability of these metrics across our institutions. METHODS: This study included 197 consent forms (CFs) from 56 CG trials that were open in at least two of the participating institutions. The Flesch Reading Ease Score (FRES), the Flesch-Kincaid Grade Level (FKGL), and document length were collected on all CFs. Unpaired t test was used to compare length and readability of CGP-CF with the IRB-CF. Analysis of variance and Bonferroni-Dunn tests were used to assess interinstitutional variability in readability for all IRB-CFs. All statistical tests were two-sided. RESULTS: IRB-CFs were statistically significantly longer than CGP-CFs (mean number of pages = 17 vs 13; P < .001). Mean FKGLs were higher (10.3 vs 9.4; P < .0001) and the mean FRESs were lower (53.1 vs 57.1; P < .0001) for IRB-CFs compared with CGP-CFs. Readability varied statistically significantly between institutions for all sections of the IRB-CF (P < .0001). Finalized IRB-CFs for identical clinical trials at different institutions demonstrated substantial heterogeneity of readability and length. CONCLUSIONS: As CFs progress from National Cancer Institute (NCI)-sponsored CGs to local IRBs, they seem to become longer and less readable. Interinstitutional heterogeneity in CF readability is substantial and widespread. More consistent adherence to CGP-CFs based on the newly revised NCI CF template with minimal modification by local IRBs should help simplify and standardize CFs used in cancer clinical trials.