Impact of Web-Based Lifestyle Interventions on Prostate Cancer Prognosis

基于网络的生活方式干预对前列腺癌预后的影响

• 批准号: 9534558
• 负责人: Stacey Kenfield
• 金额: $ 67.2万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9534558
• 关键词: Address; Adjuvant Therapy; Affect; Biological; Biology; Biopsy; California; Cancer Biology; Cancer Etiology; Cancer Patient; Cancer Prognosis; Cessation of life; Clinical; Contralateral; DNA Repair; Data; Diagnosis; Diet; Dietary Factors; Disease; Enrollment; Evidence based intervention; Exercise; FDA approved; Goals; Growth Factor; Indolent; Inflammation; Internet; Intervention; Life Style; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Messenger RNA; Morbidity - disease rate; Neoplasm Metastasis; Normal tissue morphology; Online Systems; Operative Surgical Procedures; Outcome; Oxidative Stress; Pathway interactions; Patients; Pattern; Physical activity; Probability; Prognostic Marker; Prostate; Prostate Cancer therapy; Prostate-Specific Antigen; Prostatectomy; Prostatic Neoplasms; Radical Prostatectomy; Randomized; Randomized Controlled Trials; Recurrence; Reporting; Risk; San Francisco; Signal Pathway; Signal Transduction; Testing; Text Messaging; Time; Tissues; Tumor Biology; Tumor Tissue; United States; Universities; adipokines; angiogenesis; arm; base; cancer diagnosis; cancer recurrence; design; diet and exercise; evidence base; exercise intervention; experience; fitbit; follow up assessment; improved; innovation; insulin signaling; lifestyle factors; lifestyle intervention; mRNA Expression; men; mortality; multidisciplinary; novel; overtreatment; post intervention; pre-clinical; prevent; primary outcome; prognostic; programs; prostate cancer progression; prostate cancer risk; prostate surgery; public health priorities; tailored messaging; treatment arm; treatment as usual; tumor; tumor progression; urinary; usual care arm

PROJECT SUMMARY Prostate cancer is the most commonly diagnosed cancer among men in the United States (US), with more than 220,800 new diagnoses expected in 2015. While a large proportion of new cases appear to have clinically indolent tumors, prostate cancer remains the second-leading cause of cancer death among men in the US. Preventing progression of initially localized prostate cancers to lethal disease is a key priority. Evidence from our group and others suggests that lifestyle factors after prostate cancer diagnosis may prevent non-metastatic prostate cancer from becoming lethal disease. We recently developed an 11-factor score based on lifestyle practices after diagnosis that is strongly associated with reduced risk of prostate cancer death (unpublished). Men with 4-7 and 8-11 points (vs. 0-3) had a 48% (HR= 0.52, 95%CI=0.32, 0.84) and 75% (HR=0.25; 95% CI=0.09, 0.69) lower risk of prostate cancer death, respectively. Based on these compelling data, we developed a lifestyle program delivered via the Internet for prostate cancer patients, with the ultimate goal of improving clinical outcomes in men with prostate cancer by incorporating a lifestyle intervention as adjuvant therapy to standard prostate cancer management. In this proposal, we aim to address the critical question – does access to an Internet-based lifestyle program (designed to increase exercise +/- improve diet quality) impact prostate biology and reduce risk of prostate cancer progression? We propose to conduct a 2-year 3-arm (web-based intervention targeting exercise vs. web-based intervention targeting exercise + diet vs. usual care) randomized controlled trial among 150 prostate cancer patients opting for surgery at the University of California, San Francisco. Men will be enrolled eight weeks before radical prostatectomy and complete follow-up assessments 6 months, 1 year, and 2 years post-surgery. Men assigned to the intervention arms will receive a two-year web- based lifestyle program post-surgery and text messaging tailored to the intervention (i.e., exercise or exercise + diet) and Fitbits. We will examine the effect of exercise vs. exercise + diet vs. usual care on: 1) a validated, FDA- approved prognostic score, Decipher, measured in biopsy (pre-intervention) and prostatectomy (post-initial 8- week intervention period) tissue; 2) mRNA expression of cancer-related pathways in tumor and normal tissue from biopsy and prostatectomy; 3) detectable PSA post-surgery and risk of prostate cancer recurrence at 2- years after radical prostatectomy; and 4) sexual and urinary function at 6 months, 1 year, and 2 years post- surgery. This study will provide critical translational data on the effect of a sustainable Internet-based intervention on prostate tumor biology and clinical outcomes in men with prostate cancer. These data will support the use of lifestyle interventions as adjuvant therapy for prostate cancer. Strengths of this proposal include our novel, evidence-based, intervention; highly relevant preliminary data; innovative prognostic biomarker outcome; and experienced multi-disciplinary team with outstanding track record.

项目总结