TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder breast cancer patients (THRIVE)

项目概要/摘要 2020年，超过276，480名女性被诊断患有乳腺癌，其中120，000例发生在 65岁或以上的女性。考虑到美国人口年龄中位数的增加，乳腺癌的数量 预计在未来几十年内，老年妇女的诊断率将上升50%。乳腺癌的早期症状 与年轻女性相比，经历更差的乳腺癌特异性结局， 发挥核心作用。研究表明，接受<85%的乳腺癌患者， 剂量强度（RDI），一种将给予的总剂量与对计划剂量的依从性相结合的指标。 治疗方案，有57%的增加，在疾病复发的风险，在10年相比，妇女 至少有85%的RDI。只有50-76%的>65的乳腺癌患者接受RDI >85，主要是由于 这些患者的治疗毒性增加。降低治疗相关毒性以提高RDI是 对于改善日益增长的老年乳腺癌患者的疾病结局至关重要。 为此，预测严重化学毒性的模型表明，许多潜在的可改变的 因素（通常作为老年评估的一部分进行评估），是化学毒性的重要决定因素， 包括功能、抑郁和福尔斯（或使用辅助设备）。锻炼有显著的积极影响 在普通人群和癌症患者中，这些可变因素中的每一个。然而，数据显示， 运动干预改善老年乳腺癌患者治疗耐受性和保持剂量强度的能力 癌症患者缺乏。我们建议进行一项随机对照试验，以评估 多组分混合远程保健（TH）运动和蛋白质摄入支持（THRIVE干预） RDI、化疗毒性的发生率和严重程度、功能状态、肌肉质量和患者 报告了270例年龄≥ 65岁接受新/辅助化疗的乳腺癌患者的结局。 参与者将被随机分配到THRIVE干预组或健康教育和支持对照组 组干预将通过混合模式提供，利用现有的乳腺癌体重 损失（BWEL）试用呼叫中心。在2个现场练习课程之后，我们将过渡到TH课程 通过研究提供的平板电脑，由经过认证的运动教练提供，他们将根据需要改变行为， 坚持相对于症状负担。为了优化干预效果，参与者将接受TH 由注册营养师评估饮食充足性，重点是最佳每日蛋白质摄入量。蛋白 如果需要，将提供补充剂，以达到1.2 gm/kg的每日摄入量。TH重点巩固 在一个成熟的呼叫中心（BWEL）的专业知识，提高了在整个 美国，包括癌症治疗中心，病人太少，不需要必要的人员。该项目还 旨在评估干预成本，以及促进和实施这一TH的障碍 干预，以实现在成功完成THRIVE试验后转化为临床实践的目标。

Project Summary/Abstract More than 276,480 women were diagnosed with breast cancer in 2020, with 120,000 cases occurring in women 65 years or older. Given the increasing median age of the US population, the number of breast cancers diagnosed in older women is expected to rise by 50% in the coming decades. Older women with breast cancer experience worse breast cancer-specific outcomes as compared to younger women, under-treatment is likely to play a central role. Studies have demonstrated that breast cancer patients who receive <85% of received dose intensity (RDI), a metric that combines the total dose administered with adherence to the planned treatment schedule, have a 57% increase in the risk of disease recurrence at 10 years as compared to women who receive at least 85% RDI. Only 50-76% of breast cancer patients >65 receive an RDI >85, largely due to increased toxicity of therapy in these patients. Reducing treatment-related toxicity to enhance RDI is critical to improving disease outcomes among the growing population of older breast cancer patients. To this end, models predicting for severe chemotoxicity demonstrate that a number of potentially modifiable factors (commonly assessed as part of the geriatric assessment), are important determinants of chemotoxicity, including function, depression, and falls (or use of assistive devices). Exercise has a significant positive impact on each of these modifiable factors, in the general population and in cancer patients. However, data on the ability of exercise interventions to improve treatment tolerance and preserve dose intensity among older breast cancer patients are lacking. We propose a randomized controlled trial to assess the effects of a multicomponent, hybrid telehealth (TH) exercise and protein intake support (the THRIVE Intervention) on RDI, incidence and severity of chemotoxicities, functional status, muscle mass, and patient reported outcomes in 270 breast cancer patients age ≥ 65 receiving neo/adjuvant chemotherapy. Participants will be randomized to the THRIVE Intervention or to a Health Education and Support control group. The intervention will be delivered through a hybrid model, leveraging the existing Breast Cancer Weight Loss (BWEL) Trial call center. After 2 in-person, onsite exercise sessions, we will transition to TH sessions delivered on study provided tablets, by certified exercise coaches who will tailor behavior change to support adherence relative to symptom burden. To optimize intervention effectiveness, participants will undergo a TH evaluation of diet adequacy with a registered dietitian, focused on optimal daily protein intake. Protein supplementation will be provided if needed to achieve 1.2 gm/kg daily intake. The TH focus consolidates expertise at a well-established call center (BWEL), elevating the potential for broad implementation across the U.S., including cancer treatment centers with too few patients to justify necessary personnel. The project also seeks to evaluate intervention cost, as well as the facilitators and barriers to implementation of this TH intervention, toward the goal of translation to clinical practice upon successful completion of the THRIVE trial.