Developing a Patient Navigation Intervention to Improve Risk Management among Women at High Risk of Breast Cancer

制定患者导航干预措施以改善乳腺癌高危女性的风险管理

基本信息

批准号：
10593675
负责人：
Tasleem J Padamsee
金额：
$ 22.09万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-02-01 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10593675
关键词：
Acute Address Adopted Adoption Baseline Surveys Behavior Behavioral Belief Benchmarking Biometry Black race Breast Breast Cancer Prevention Breast Cancer Risk Factor Breast Magnetic Resonance Imaging Cancer Control Caring Communication Counseling Data Daughter Decision Making Diagnostic Dimensions Early Diagnosis Emotional Evidence based practice Face Family Funding Genetic Genetic Predisposition to Disease Goals Health Health Personnel Health Psychology Health Services Accessibility Hereditary Malignant Neoplasm High Risk Woman Information Management Inherited Intervention Intervention Trial Interview Knowledge Management Link Malignant Neoplasms Mammographic screening Mammography Medical Medical Genetics Methods Minority Women Mission Morbidity - disease rate Mothers National Comprehensive Cancer Network Operative Surgical Procedures Outcome Participant Pathway interactions Patient Representative Persons Pharmaceutical Preparations Population Heterogeneity Predisposition Preventive Process Provider Public Health Race Randomized Randomized, Controlled Trials Recommendation Recording of previous events Research Resolution Resources Risk Risk Management Risk Reduction Sampling Screening for cancer Services Shapes Sister Site Social Network Specialist Structure Surveys System Testing Woman black women cancer prevention cancer risk clinical care coping cost effective design evidence base experience feasibility testing gaps in access high risk high risk population improved individual patient innovation insight loved ones malignant breast neoplasm member mortality novel strategies patient navigation patient navigator population based prevent preventive intervention primary care provider programs randomized trial recruit screening screening program socioeconomics standard of care therapy design treatment arm

项目摘要

Project Summary/Abstract Women with a family history and/or genetic predisposition for breast cancer (BC) can face significantly elevated lifetime BC risk, but the cancer risk management options (i.e., surveillance routines, preventive surgeries, and medications) that are shown to reduce risk and enable early detection are used by only a small proportion of women for whom they are recommended. There is a critical need to develop evidence-based strategies to improve the standard of care for high-risk women. Population-based screening programs, usually facilitated through screening mammography services, offer significant promise of identifying most high-risk women. Effectively reducing BC morbidity and mortality, however, also requires additional steps to communicate personalized risk information and risk-management options; connect women with healthcare providers capable of explaining risk, its consequences, and risk-management options; support risk-related decision making; and facilitate risk-management decisions and behavior. Prior research has illuminated (a) a staged pathway along which high-risk women adopt risk-management behavior and (b) eight main facilitators (related to information, support, beliefs, access to care, and resolution of practical barriers) that help advance women along the risk-management adoption pathway (R-MAP). In addition, survey-based studies have demonstrated that the majority of high-risk women experience significant gaps in access to these facilitators, and that these gaps are particularly acute among Black women. The goal of the proposed study is to design, develop, and test a multi-dimensional patient navigation (PN) intervention to advance high-risk women along the risk-management adoption pathway by addressing the eight main facilitators of risk-management behavior. Aim 1: Determine the specific information, types of support, barrier reductions, and provider referrals that would advance women at high risk of BC along the pathway toward risk-management adoption, using semi- structured interviews with high-risk Black and White women. Aim 2: Develop a multi-dimensional PN intervention to advance high-risk women along the risk-management adoption pathway, guided by data generated in Aim 1 and a panel composed of experts and patient representatives. Aim 3: Test the feasibility of the PN intervention and of recruiting to a participants to a randomized controlled trial of the intervention. Seventy-five participants identified after a screening mammogram as potentially at high BC risk will be randomized to PN-intervention or information-only conditions in a 2:1 ratio. Baseline surveys and final surveys after eight months will be used to assess the primary hypothesis that most intervention-arm participants will be satisfied with the PN intervention, and to check several other benchmarks of feasibility. We will also descriptively estimate progress along the R-MAP and other outcomes, to appropriately power a randomized controlled trial (RCT) to come. This research will set the stage for a full-scale RCT of this innovative intervention with racially and socioeconomically diverse populations, and ultimately contribute to cancer prevention and control among high-risk women.

项目概要/摘要有乳腺癌 (BC) 家族史和/或遗传易感性的女性可能面临显着的风险终生 BC 风险升高，但癌症风险管理选项（即常规监测、预防性预防）手术和药物）被证明可以降低风险并实现早期发现，但只有少数人使用被推荐的女性比例。迫切需要开发基于证据的提高高危妇女护理标准的战略。基于人群的筛查计划，通常通过筛查乳房X光检查服务促进，为识别最高风险提供了重要承诺女性。然而，有效降低 BC 发病率和死亡率还需要采取额外措施传达个性化风险信息和风险管理选项；将女性与医疗保健联系起来能够解释风险、其后果和风险管理选项的提供商；支持风险相关决策;并促进风险管理决策和行为。先前的研究已阐明 (a) 高风险妇女采取风险管理行为的阶段性途径以及 (b) 八个主要促进因素（与信息、支持、信仰、获得护理的机会以及解决实际障碍有关）有助于推进风险管理采用途径 (R-MAP) 中的女性。此外，基于调查的研究表明大多数高风险女性在获得这些促进者方面存在巨大差距，这些差距在黑人女性中尤为严重。拟议研究的目标是设计，开发并测试多维患者导航 (PN) 干预措施，以推动高危女性通过解决风险管理行为的八个主要促进因素来制定风险管理采用途径。目标 1：确定具体信息、支持类型、减少障碍和提供者推荐将推动患有 BC 高风险的女性沿着采用风险管理的道路前进，使用半对高风险黑人和白人女性进行结构化访谈。目标 2：开发多维 PN 以数据为指导，采取干预措施，推动高风险妇女走上风险管理采用之路目标 1 中产生一个由专家和患者代表组成的小组。目标 3：测试可行性 PN 干预并招募参与者参加干预的随机对照试验。筛查乳房 X 光检查后发现的 75 名参与者可能具有 BC 高风险，将接受以 2:1 的比例随机分配至 PN 干预或纯信息条件。基线调查和最终调查八个月后将用于评估主要假设，即大多数干预组参与者将对 PN 干预感到满意，并检查其他几个可行性基准。我们也会描述性地估计 R-MAP 的进展和其他结果，以适当地支持随机化对照试验（RCT）即将到来。这项研究将为这一创新的全面随机对照试验奠定基础对种族和社会经济多样化人群的干预，最终导致癌症高危妇女的预防和控制。