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: 10366559
• 负责人: Patricia Maureen Sheean
• 金额: $ 68.21万
• 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/10366559
• 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; Disease; Disease Management; Distress; Eating; Evidence based intervention; Exercise; Exhibits; Fatigue; Feedback; Goals; Guidelines; Habits; Incidence; Inflammation; Inflammatory; Insulin Resistance; Intervention; Intervention Trial; Lead; 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; Underserved Population; Update; Waiting Lists; Woman; Work; adipokines; attentional control; base; clinically significant; control trial; 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; prognostic of survival; programs; recruit; reduce symptoms; survivorship; symptom management; targeted treatment; therapy design; 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.

由于更高的发病率，转移性乳腺癌(MBC)的女性社区正在增长 治疗也取得了进步，现在有超过30%的妇女存活5年以上(2000年时只有4%)。管理 保持最高生活质量(QOL)的症状是转移性环境下护理的主要目标。因此， 针对这一新兴和服务不足的幸存者群体的生活质量、预后和生存问题的研究 是非常需要的。BC治疗与身体成分的不良变化有关，特别是在 脂肪组织和强度和瘦体重(Lm)的减少。过度肥胖会导致炎症 和胰岛素抵抗，它们被认为促进了肿瘤的进展和LM的丧失。低水平的LM是 与化疗毒性、症状负担增加和生存受损有关的女性 MBC。对早期BC幸存者的生活方式干预导致症状减轻，生物标志物改善 BC预后和提高的生活质量(QOL)。到目前为止，患有MBC的女性基本上被排除在 这些审判。我们在患有MBC的妇女中的试点工作表明，她们有兴趣、有能力、有依从性和 从参与生活方式干预中受益。我们的结果显示，在临床上有意义的改善 生活质量，增加体力活动和力量。我们还发现了预后生物标志物的改善趋势，如 即刻干预组与对照组相比，线粒体功能也有显著差异。此外，我们的工作 显示炎症相关的microRNA在参与我们的试验后有不同的表达 试验，提供了非常新颖的潜在目标来解释生活方式干预改善的机制 这些女性的生活质量。我们建议对患有MBC的女性(n=176)进行随机注意力对照试验以进行测试。 “每一天都很重要”的直接和持续影响，这是一种基于当前生活方式的16周干预 癌症幸存者的生活方式建议。本试验有足够的能力检查以下方面的变化：1) 生活质量-转移性环境中护理的主要决定因素和(2)身体成分，血清生物标记物 预后/存活率，以及相关患者报告的结果。我们还将探索线粒体的功能和 与炎性生物标记物和线粒体功能相关的新的microRNA特征。每天 Counts结合了我们对患有MBC的女性进行的试点研究的批判性反馈和经验。我们健壮的， 多学科研究团队应用一种创新的高度集成的生理学模型来检查 干预对明确相关的利益结果的机械性影响。目前的研究 挑战目前的临床假设，即生活方式行为的推定无效 转移的环境，提供证据，可以提供扩展应用程序和 营养和体力活动指南对患有MBC的妇女的相关性。重要的是，这项研究将 为临床医生提供最新的证据和策略，帮助患有MBC的妇女过好每一天 对于目前服务不足的幸存者群体来说，这意味着很大的影响。