A pragmatic dietary intervention to improve bladder cancer survivorship

提高膀胱癌生存率的务实饮食干预

• 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
• 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

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 膀胱癌是国家中十大癌症之一，也是男性中第四个癌症 大多数（70-80％）在早期诊断出膀胱癌，而癌症仅限于 膀胱的上皮和椎板层，被称为非肌肉浸润性膀胱癌（NMIBC）。 NMIBC可以取消成功； 在类似阶段经历多次复发。 NMIBC患者的膀胱镜检查，构成膀胱癌的治疗。 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。 我们在体外，体内和流行病学研究中的发现支持饮食异硫氰酸酯（ITC） 针对膀胱癌的有效抗癌活性是源自植物化学物质的主要 十字花科蔬菜和饮食ITC的口服消费可以快速代谢，将 膀胱并集中在尿液中，使异常的膀胱上皮成为我们的最佳靶标 回顾性研究，高消耗原始的十字花科蔬菜量与膀胱减少有关 癌症特定的死亡率和整体死亡率。 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处合作，招募合格的患者及其临床护理护理护理护理 我们的集水区的提供者，患有高率癌症的高度癌症。 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 获得理想的尿液ITC水平，可对我们的社区有效。 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 系统的过程包括有关信息，讨论组和模拟干预提供的过程。 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个NMIBC幸存者中实施随机控制设计，是治疗组（n = 40）将 接受基于证据的电话干预以增加十字花科蔬菜和控制 组（n = 40）将根据NCI指南获得一般的水果和蔬菜进气口进气口。 结果将是十字花科蔬菜摄入和尿液ITC水平，次要结果将是基因 尿液上上皮细胞的表达变化是替代性效应。 目的：让参与我们干预障​​碍的患者的临床护理提供者和 通过进行20个半结构化的临床内部实施国际实施的促进者 采访。