Every Day Counts: A lifestyle program for women metastatic breast cancer

每一天都很重要：针对女性转移性乳腺癌的生活​​方式计划

• 批准号: 10554411
• 负责人: Patricia Maureen Sheean
• 金额: $ 63.51万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10554411
• 关键词: Address; Adherence; Adipose tissue; Adopted; Adverse event; African American; American Cancer Society; Behavior; Behavioral; Biological; Biological Markers; Body Composition; Cancer Survivor; Caring; Chronic Disease; Clinical; Communities; Consensus; Control Groups; Dimensions; Disease; Disease Management; Distress; Eating; Evidence based intervention; Exclusion; Exercise; Exhibits; Fatigue; Feedback; Goals; Guidelines; Habits; Incidence; Inflammation; Inflammatory; Insulin Resistance; Intervention; Intervention Trial; Lead; Learning; Life Style; Mediating; Menopausal Status; Metastatic breast cancer; Methodology; MicroRNAs; Mitochondria; Molecular; Obesity; Outcome; Participant; Pathway interactions; Patient Outcomes Assessments; Physical Function; Physical activity; Pilot Projects; Prognosis; Program Sustainability; Quality of life; Randomized; Recommendation; Research; Safety; Serum; Survivors; Symptoms; Testing; Thinness; Toxicity due to chemotherapy; Treatment-related toxicity; Tumor Promotion; Underserved Population; Update; Waiting Lists; Woman; Work; adipokines; attentional control; clinically significant; control trial; design; differential expression; efficacy evaluation; exercise intervention; experience; healthy lifestyle; improved; innovation; insulin sensitivity; interest; intervention effect; lifestyle intervention; multidisciplinary; novel; nutrition; physiologic model; pilot trial; post intervention; prognosis biomarker; prognostic; programs; recruit; reduce symptoms; survivorship; symptom management; targeted treatment; theories; treatment response; trend; tumor progression; young woman

The community of women with metastatic breast cancer (MBC) is growing due to greater disease incidence and treatment advances, with over 30% of women now surviving over 5 years (vs. just 4% in 2000). Managing symptoms to maintain the highest quality of life (QOL) is the major goal of care in the metastatic setting. Thus, research that addresses QOL, prognosis and survivorship in this burgeoning and underserved survivor group is critically needed. BC treatment is associated with adverse body composition changes, specifically gains in adipose tissue and reductions in strength and lean mass (LM). Excess adiposity contributes to inflammation and insulin-resistance, which are theorized to promote tumor progression and loss of LM. Low levels of LM are associated with chemotherapy toxicity, increased symptom burden and compromised survival in women with MBC. Lifestyle interventions with early stage BC survivors result in reduced symptoms, improved biomarkers of BC prognosis and enhanced quality of life (QOL). To date, women with MBC have been largely excluded from these trials. Our pilot work in women with MBC demonstrates they are interested, capable, adherent and benefit from participation in a lifestyle intervention. Our results show clinically meaningful improvements in QOL, increased physical activity and strength. We also find improved trends in biomarkers of prognosis, as well as mitochondrial function for women in the immediate intervention vs. control group. Further, our work shows that inflammation-associated microRNAs are differentially expressed following participation in our pilot trial, providing highly novel potential targets to explain mechanisms by which lifestyle interventions improve QOL for these women. We propose a randomized atttention control trial in women with MBC (n=176) to test the immediate and sustained effects of “Every Day Counts,” a 16-week lifestyle intervention based on current lifestyle recommendations for cancer survivors. This trial is adequately powered to examine changes in: 1) QOL - the primary determinant of care in the metastatic setting and (2) body composition, serum biomarkers of prognosis/survival, and pertinent patient reported outcomes. We will also explore mitochondrial function and novel microRNA signatures associated with inflammatory biomarkers and mitochondrial function. Every Day Counts incorporates critical feedback and experiences from our pilot study with women with MBC. Our robust, multidisciplinary study team applies an innovative, highly integrated physiologic model to examine the mechanistic effects of the intervention on decidedly relevant outcomes of interest. The present study challenges current clinical assumptions regarding the presumed ineffectiveness of lifestyle behaviors in the metastatic setting, providing evidence that may inform a paradigm shift expanding the application and relevance of the nutrition and physical activity guidelines to women with MBC. Importantly, this study will provide clinicians with updated evidence and strategies to help make every day count for women with MBC representing high impact for a currently underserved group of survivors.

由于疾病的发病率更大，乳腺癌转移性乳腺癌（MBC）的社区正在增长 和治疗的进展，超过30％的妇女现在存活了5年（在2000年仅4％）。管理 维持最高质量的症状（QOL）是转移环境中护理的主要目标。那， 在这个水伤和服务不足的幸存者组中涉及QOL，提示和生存的研究 非常需要。卑诗省治疗与身体不良成分的变化有关，特别是在 脂肪组织和强度和瘦质量（LM）的降低。过度肥胖会导致炎症 和胰岛素抵抗，理论上促进LM的肿瘤进展和丧失。低水平的LM是 与化学疗法毒性相关，症状增加以及妇女的生存率损害 MBC。 BC早期生存的生活方式干预措施导致症状减少，改善了生物标志物 BC预后和增强的生活质量（QOL）。迄今为止，有MBC的妇女在很大程度上被排除在外 这些试验。我们在MBC女性中的飞行员工作表明她们感兴趣，有能力，坚持和 受益于参加生活方式的干预措施。我们的结果表明临床上有意义的改善 生活质量，增强体育锻炼和力量。我们还发现预后生物标志物的趋势得到了改善，因为 以及直接干预与对照组中女性的线粒体功能。此外，我们的工作 表明参与我们的飞行员后，与炎症相关的microRNA的表达不同 试验，提供了高新颖的潜在目标来解释生活方式干预改善的机制 这些妇女的QoL。我们建议在MBC女性（n = 176）中进行一项随机进行控制试验以进行测试 “每天都很重要”的直接和持续影响，这是基于当前的16周生活方式干预 癌症存活的生活方式建议。该试验足以进行检查：1） QOL-在转移环境中的护理和（2）身体成分，血清生物标志物的主要确定 预后/生存和相关患者报告了预后。我们还将探索线粒体功能和 与炎性生物标志物和线粒体功能相关的新型microRNA特征。每天 计数结合了我们与MBC女性试点研究的重要反馈和经验。我们的健壮， 多学科研究团队采用创新的高度综合生理模型来检查 干预对明确相关结果的机械影响。本研究 挑战当前关于生活方式行为无效的临床假设 转移环境，提供证据，可以告知范式转移，以扩大申请，并 营养和体育活动指南与MBC女性的相关性。重要的是，这项研究将 为临床医生提供最新的证据和策略，以帮助MBC女性每天计算 代表当前服务不足的一组生存的影响。