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

远程医疗抵抗运动干预以保持老年乳腺癌患者的剂量强度和活力（THRIVE）

• 批准号: 10450916
• 负责人: Nathan A. Berger
• 金额: $ 36.86万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-11 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10450916
• 关键词: Adherence; Adjuvant Chemotherapy; Administrator; Age; Attenuated; Body Weight decreased; Breast Cancer Patient; Breast Cancer Treatment; Cancer Patient; Caring; Control Groups; Data; Diagnosis; Diet; Dietitian; Disease Outcome; Dose; Dose-Limiting; Effectiveness of Interventions; Elderly; Elements; Etiology; Evaluation; Exercise; Fatigue; General Population; Geriatric Assessment; Goals; Health education; Human Resources; Hybrids; Incidence; Inferior; Intake; Intervention; Mental Depression; Modeling; Nutrient; Older Population; Oncology; Outcome; Participant; Patient Outcomes Assessments; Patients; Persons; Physical Function; Play; Population; Proteins; Quality of life; Randomized; Randomized Controlled Trials; Recurrence; Risk; Role; SEER Program; Self-Help Devices; Severities; Sleep; Supplementation; Symptoms; Tablets; Therapeutic; Time; Toxic effect; Translations; Treatment Protocols; Treatment outcome; Treatment-related toxicity; Woman; aged; behavior change; breast cancer diagnosis; cancer therapy; chemotherapy; clinical practice; cost; disorder risk; exercise intervention; experience; falls; functional status; human old age (65+); implementation barriers; implementation intervention; improved; improved outcome; intervention cost; malignant breast neoplasm; member; mortality; muscle form; older women; predictive modeling; preservation; programs; protein intake; psychologic; psychosocial; resistance exercise; telehealth; treatment center; treatment planning; young woman

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.

项目摘要/摘要 2020年，超过276,480名妇女被诊断出患有乳腺癌，其中12万例发生 妇女65岁以上。鉴于美国人口的中位年龄增加，乳腺癌的数量 在未来几十年中，预计在老年妇女中被诊断为50％。老年乳腺癌的妇女 与年轻女性相比，经历较差的乳腺癌特异性结果，可能不足 扮演核心角色。研究表明，接受<85％接受的乳腺癌患者 剂量强度（RDI），一种将总剂量与计划的总剂量结合在一起的度量 治疗时间表，与妇女相比，疾病复发的风险增加了57％ 他们至少获得85％的RDI。只有50-76％的乳腺癌患者> 65例接受RDI> 85 这些患者的治疗毒性增加。降低与治疗相关的毒性以增强RDI为 对于不断增长的老年乳腺癌患者人群中疾病预后至关重要。 为此，预测严重的毒性的模型表明，许多潜在的可修改 因素（通常是老年评估的一部分评估），是趋化性的重要决定者， 包括功能，抑郁和跌落（或使用辅助设备）。运动具有重大的积极影响 在这些可修改因素中，在普通人群和癌症患者中。但是，关于 运动干预措施提高治疗耐受性并保留剂量强度的能力 癌症患者缺乏。我们提出了一项随机对照试验，以评估 多组分，混合远程医疗（TH）运动和蛋白质摄入支持（繁荣干预） 关于RDI，趋化性，功能状态，肌肉质量和患者的事件和严重程度 报告了270名乳腺癌患者≥65例接受NEO/辅助化疗的结果。 参与者将被随机地进行繁荣干预或健康教育和支持控制 团体。干预将通过混合模型进行，利用现有的乳腺癌重量 损失（BWEL）试用中心。在面对两个人的现场练习会议之后，我们将过渡到课程 在研究中提供了平板电脑，由认证的运动教练量身定制行为以支持 相对于症状烧伤的依从性。为了优化干预效果，参与者将经历 用注册营养师评估饮食充足性，重点是最佳的每日蛋白质摄入量。 如果需要，将提供每日1.2 gm/kg的摄入量，将提供补充。焦点合并 建立良好的呼叫中心（BWEL）的专业知识，提高了广泛实施的潜力 美国，包括癌症治疗中心，患者太少，无法证明必要的人员合理。该项目也是如此 旨在评估干预成本，以及实施此项的促进者和障碍 干预措施是在成功完成Thrive试验后将其转化为临床实践的目标。