Post-Radiation Survey Data from Navigator-Assisted Hypofractionation (NAVAH) Phase I Trial

IF 2.3 4区医学 Q1 MEDICINE, GENERAL & INTERNAL

Journal of the National Medical Association Pub Date : 2025-09-01 DOI:10.1016/j.jnma.2025.08.076

Dante A. Sanders MS, Tamika K. Smith AAB, Ursula J. Burnette MA, Erica Fleming-Hall BS, Abizairie Sanchez-Feliciano BS, Maya J. Stephens MS, Louisa Onyewadume MD, MPH, Chesley W. Cheatham Med, MCHES, Daniel E. Spratt MD, Angela Y. Jia MD, PhD, Shearwood McClelland III MD

{"title":"Post-Radiation Survey Data from Navigator-Assisted Hypofractionation (NAVAH) Phase I Trial","authors":"Dante A. Sanders MS, Tamika K. Smith AAB, Ursula J. Burnette MA, Erica Fleming-Hall BS, Abizairie Sanchez-Feliciano BS, Maya J. Stephens MS, Louisa Onyewadume MD, MPH, Chesley W. Cheatham Med, MCHES, Daniel E. Spratt MD, Angela Y. Jia MD, PhD, Shearwood McClelland III MD","doi":"10.1016/j.jnma.2025.08.076","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Prostate cancer (PC) is the leading cause of malignancy-related death in men. Per the 2024 Ohio annual cancer report, stratification of PC patients by race reveals a greater than 80% increase in mortality of African-American versus White patients. An assessment of how social determinants of health (SDOH) impact disparities in cancer-related mortality contributed to the founding of the Navigator- Assisted Hypofractionation (NAVAH) program. The NAVAH program for PC takes an innovative patient navigation approach and culturally sensitive survey aiming to better identify SDOH faced by African-American patients receiving radiation therapy (RT) treatment. This is an early report of the post-RT data during piloting of the NAVAH PC program’s innovative survey as part of a Phase I clinical trial (ClinicalTrials.gov ID: NCT05978232).</div></div><div><h3>Methods</h3><div>Patients who met criteria of having histologically diagnosed PC, African-American race, and having consented to RT with their Radiation Oncologist, were recruited for trial enrollment. Surveys were administered prior to receipt of RT and at one-month following RT completion. Post-RT survey questions were divided into sections representative of the following categories: availability (coordinating care; overall quality of care), accessibility (transportation; distance to care), affordability (financial considerations; employment; level of education), accommodation (access to internet; navigating transportation; healthcare literacy), and acceptability (comfort and prejudice among interactions with the system). Responses to each question were systematically scored and tabulated into representative scores: outstanding, excellent, good, average, below average.</div></div><div><h3>Results</h3><div>Scores thus far reveal: good availability (37 responses), excellent accessibility (3 responses), below average affordability (6 responses), below average accommodation (18 responses), and average acceptability (9 responses). The presence of patient navigation was noted to be helpful and positively contribute to cancer care, and participation in a clinical trial was viewed positively, with comfort in clinical trial participation at the cancer center where RT was received.</div></div><div><h3>Conclusions</h3><div>These findings support the viability of the NAVAH program survey for use in African-American PC patient population after RT completion. Scoring indicates that PC patients having completed RT positively embrace the quality and accessibility of services with neutral attitude about hospital facilities and providers, but have concerns about service cost and assistance. Continuance of this Phase I study will better elucidate SDOH faced by this patient population and the potential impact of RT receipt on these outcomes.</div></div>","PeriodicalId":17369,"journal":{"name":"Journal of the National Medical Association","volume":"117 1","pages":"Page 40"},"PeriodicalIF":2.3000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the National Medical Association","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S002796842500272X","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Prostate cancer (PC) is the leading cause of malignancy-related death in men. Per the 2024 Ohio annual cancer report, stratification of PC patients by race reveals a greater than 80% increase in mortality of African-American versus White patients. An assessment of how social determinants of health (SDOH) impact disparities in cancer-related mortality contributed to the founding of the Navigator- Assisted Hypofractionation (NAVAH) program. The NAVAH program for PC takes an innovative patient navigation approach and culturally sensitive survey aiming to better identify SDOH faced by African-American patients receiving radiation therapy (RT) treatment. This is an early report of the post-RT data during piloting of the NAVAH PC program’s innovative survey as part of a Phase I clinical trial (ClinicalTrials.gov ID: NCT05978232).

Methods

Patients who met criteria of having histologically diagnosed PC, African-American race, and having consented to RT with their Radiation Oncologist, were recruited for trial enrollment. Surveys were administered prior to receipt of RT and at one-month following RT completion. Post-RT survey questions were divided into sections representative of the following categories: availability (coordinating care; overall quality of care), accessibility (transportation; distance to care), affordability (financial considerations; employment; level of education), accommodation (access to internet; navigating transportation; healthcare literacy), and acceptability (comfort and prejudice among interactions with the system). Responses to each question were systematically scored and tabulated into representative scores: outstanding, excellent, good, average, below average.

Results

Scores thus far reveal: good availability (37 responses), excellent accessibility (3 responses), below average affordability (6 responses), below average accommodation (18 responses), and average acceptability (9 responses). The presence of patient navigation was noted to be helpful and positively contribute to cancer care, and participation in a clinical trial was viewed positively, with comfort in clinical trial participation at the cancer center where RT was received.

Conclusions

These findings support the viability of the NAVAH program survey for use in African-American PC patient population after RT completion. Scoring indicates that PC patients having completed RT positively embrace the quality and accessibility of services with neutral attitude about hospital facilities and providers, but have concerns about service cost and assistance. Continuance of this Phase I study will better elucidate SDOH faced by this patient population and the potential impact of RT receipt on these outcomes.

查看原文本刊更多论文

来自导航辅助减分术（NAVAH）一期试验的辐射后调查数据

背景前列腺癌（PC）是男性恶性肿瘤相关死亡的主要原因。根据2024年俄亥俄州年度癌症报告，按种族分层的PC患者显示，非裔美国人的死亡率比白人患者高出80%以上。对健康的社会决定因素（SDOH）如何影响癌症相关死亡率差异的评估促成了导航辅助低分割（NAVAH）计划的建立。针对PC的NAVAH项目采用了一种创新的患者导航方法和文化敏感性调查，旨在更好地识别接受放射治疗（RT）的非裔美国患者所面临的SDOH。这是NAVAH PC项目作为I期临床试验（ClinicalTrials.gov ID: NCT05978232）一部分的创新性调查试点期间rt后数据的早期报告。方法招募符合组织学诊断PC标准的患者，非裔美国人种族，并同意与放射肿瘤学家进行放射治疗。在接受放疗前和放疗完成后一个月进行调查。rt后的调查问题被分成代表以下类别的部分：可用性（协调护理；整体护理质量），可及性（交通；到护理的距离），可负担性（财务考虑；就业；教育水平），住宿（访问互联网；导航交通；医疗素养）和可接受性（与系统互动中的舒适度和偏见）。对每个问题的回答都进行了系统评分，并将其制成代表性分数：优秀、优秀、良好、一般、低于平均水平。到目前为止，得分显示：良好的可用性（37份回复），良好的可及性（3份回复），低于平均水平的可负担性（6份回复），低于平均水平的住宿（18份回复），以及平均可接受性（9份回复）。患者导航的存在被认为是有帮助的，对癌症治疗有积极的贡献，参与临床试验是积极的，在接受放疗的癌症中心参与临床试验是舒适的。结论：这些发现支持NAVAH项目调查在非裔美国人PC患者完成RT后使用的可行性。评分表明，完成RT的PC患者对服务质量和可及性持积极态度，对医院设施和提供者持中立态度，但对服务成本和援助有顾虑。这项I期研究的继续将更好地阐明该患者群体面临的SDOH以及接受RT治疗对这些结果的潜在影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of the National Medical Association 医学-医学：内科

CiteScore

4.80

自引率

3.00%

发文量

139

审稿时长

98 days

期刊介绍： Journal of the National Medical Association, the official journal of the National Medical Association, is a peer-reviewed publication whose purpose is to address medical care disparities of persons of African descent. The Journal of the National Medical Association is focused on specialized clinical research activities related to the health problems of African Americans and other minority groups. Special emphasis is placed on the application of medical science to improve the healthcare of underserved populations both in the United States and abroad. The Journal has the following objectives: (1) to expand the base of original peer-reviewed literature and the quality of that research on the topic of minority health; (2) to provide greater dissemination of this research; (3) to offer appropriate and timely recognition of the significant contributions of physicians who serve these populations; and (4) to promote engagement by member and non-member physicians in the overall goals and objectives of the National Medical Association.