A pragmatic dietary intervention to improve bladder cancer survivorship

提高膀胱癌生存率的务实饮食干预

基本信息

批准号：
10060213
负责人：
LI TANG
金额：
$ 44.02万
依托单位：
ROSWELL PARK CANCER INSTITUTE CORP
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10060213
关键词：
BCG Live Basic Science Behavior Therapy Behavioral Bladder Cancer Patient Cancer Survivor Cancer Survivorship Catchment Area Cauliflower Characteristics Clinic Clinical Management Cognitive Collaborations Communities Consumption Control Groups Cystoscopy Data Diagnosis Diet Dietary Intervention Dietary Isothiocyanate Disease Dose Eating Effectiveness of Interventions Enrollment Ensure Epidemiology Epithelial Epithelial Cells Epithelium Evidence based practice Feedback Gene Expression Goals Guidelines Healthcare Systems Hybrids In Vitro Incidence Intake Intervention Interview Isothiocyanates Lamina Propria Life Malignant Neoplasms Malignant neoplasm of urinary bladder Methods Muscle New York Oral Outcome Pathologic Patients Phytochemical Population Process Randomized Recurrence Research Retrospective Studies Risk Service delivery model Structure Survivors Telephone Testing Therapeutic Agents Translating Translational Research Transurethral Resection Urine Work anticancer activity base cancer recurrence cancer risk care providers clinical care clinical practice cost effective cruciferous vegetable epidemiology study evidence base experience fruits and vegetables high risk improved in vivo information gathering intravesical men mortality neoplasm registry non-muscle invasive bladder cancer novel pre-clinical primary outcome randomized controlled design recruit response secondary outcome side effect social therapy design treatment group tumor progression uptake urinary

项目摘要

PROJECT SUMMARY Bladder cancer is one of the top 10 cancers in the nation, and the 4th most common cancer in men. The majority (70-80%) of bladder cancer is diagnosed at an early stage, when the cancer is confined to the epithelial and lamina propria layer of the bladder and known as non-muscle invasive bladder cancer (NMIBC). NMIBC can be removed successfully; however, 50-80% of NMIBC recurs within 5 years, with some patients experiencing multiple recurrences at similar stages. Clinical management requires life-long surveillance by cystoscopy for NMIBC patients, amounting to bladder cancer being the most expensive cancer to treat. Novel and cost-effective intervention strategies to control NMIBC recurrence and progression are urgently needed. Our findings from in vitro, in vivo, and epidemiologic studies support that dietary isothiocyanates (ITCs) exert potent anti-cancer activities against bladder cancer. ITCs are a group of phytochemicals primarily derived from cruciferous vegetables and oral consumption of dietary ITCs can be rapidly metabolized, delivered to the bladder and concentrated in the urine, rendering the abnormal bladder epithelium the best target. In our retrospective study, high consumption of raw cruciferous vegetables was associated with reduced bladder cancer-specific mortality and overall mortality. We propose to translate our strong preclinical findings into a novel, dietary behavioral intervention to reduce bladder cancer recurrence and progression in NMIBC patients. We will partner with the New York State Cancer Registry to recruit eligible patients and their clinical care providers in our catchment area, which has a disproportionally high burden of bladder cancer. Specific Aim 1: Develop an evidence-based behavioral intervention to increase cruciferous vegetable intake, with the goal of attaining desirable urinary ITC levels effective for anti-cancer activities. We will work with our Community Advisory Board to adapt materials and methods from current evidence-based fruit and vegetable interventions and leverage our findings on ITC yield from cruciferous vegetables to develop our dietary intervention, using a systematic process consisting of information gathering, discussion groups, and mock intervention delivery. Specific Aim 2: Conduct a feasibility pilot of our dietary behavioral intervention through a hybrid I implementation randomized controlled design in 80 NMIBC survivors, where the treatment group (n=40) will receive an evidence-based telephone intervention to increase cruciferous vegetable intake and the control group (n=40) will receive a general fruit and vegetable intake intervention based on NCI guidelines. Primary outcomes will be cruciferous vegetable intake and urinary ITC levels, and the secondary outcome will be gene expression changes in urinary exfoliated epithelial cells as a surrogate for intermediate efficacy. Exploratory Aim: Engage the clinical care providers of patients enrolled in our intervention to ascertain the barriers and facilitators of intervention implementation within clinical practice through conducting 20 semi-structured interviews. The goal is to gain feedback and refine the intervention for “real-world' implementation.

项目摘要膀胱癌是美国十大癌症之一，也是男性第四大癌症。大多数（70-80％）的膀胱癌在早期被诊断为癌症，当时癌症仅限于膀胱的上皮和椎板层，被称为非肌肉浸润性膀胱癌（NMIBC）。可以成功删除NMIBC；但是，有5年的NMIBC在5年内出现，有些患者会出现在类似阶段经历多个回报。临床管理需要终身监视 NMIBC患者的膀胱镜检查，构成膀胱癌是最昂贵的癌症。小说迫切需要迫切需要控制NMIBC复发和进展的成本效益的干预策略。我们来自体外，体内和流行病学研究的发现支持饮食异硫氰酸盐（ITC）运动针对膀胱癌的潜在抗癌活性。 ITC是一组主要来自十字花科蔬菜和饮食中ITC的口服消费可以快速代谢，并递送给膀胱并集中在尿液中，使异常膀胱上皮成为最佳靶标。在我们的回顾性研究，原始十字花科蔬菜的高消耗与叶片减少有关癌症特异性死亡率和总体死亡率。我们建议将我们的强临床前发现转化为新颖的饮食行为干预，以减少NMIBC患者的膀胱癌复发和进展。我们将与纽约州癌症注册表合作，招募合格的患者及其临床护理我们的集水区的提供者，膀胱癌负担不成比例。具体目标1：制定基于证据的行为干预以增加十字花科蔬菜摄入量，目的是达到理想的尿液ITC水平有效，可有效。我们将与社区合作咨询委员会适应当前循证水果和蔬菜干预措施的材料和方法并利用我们从十字花科蔬菜中的ITC产量的发现来开发我们的饮食干预措施系统的过程包括信息收集，讨论组和模拟干预交付。具体目标2：通过混合I进行饮食行为干预的可行性试验在80 NMIBC表面上实施随机对照设计，其中治疗组（n = 40）将接受循证电话干预以增加十字花科蔬菜摄入量和控制组（n = 40）将根据NCI指南获得一般的水果和蔬菜摄入干预措施。基本的结果将是十字花科蔬菜摄入和尿路ITC水平，次要结果将是基因尿液去角质上皮细胞的表达变化是中等效率的替代物。探索性目的：与参加干预措施的患者的临床护理提供者联系，以确定障碍和通过进行20个半结构化的临床实践中干预实施的促进者访谈。目的是获得反馈并完善“现实世界实施”的干预措施。