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: 10608200
• 负责人: Nathan A. Berger
• 金额: $ 119.26万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-19 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10608200
• 关键词: Adherence; Adjuvant Chemotherapy; Administrator; Age; Attenuated; Body Weight decreased; Breast Cancer Patient; Breast Cancer Treatment; Cancer Patient; Caring; Certification; Control Groups; Data; Diagnosis; Diet; Dietitian; Disease Outcome; Dose; Dose Limiting; Effectiveness of Interventions; Elderly; Elements; Etiology; Evaluation; Exercise; Fatigue; General Population; Geriatric Assessment; 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; Recurrent disease; Risk; Role; SEER Program; Self-Help Devices; Severities; Site; Sleep; Supplementation; Symptoms; Tablets; Therapeutic; Toxic effect; Treatment Protocols; Treatment outcome; Treatment-related toxicity; Woman; aged; behavior change; breast cancer diagnosis; cancer therapy; chemotherapy; clinical practice; cost; disorder risk; efficacy evaluation; 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; translational goal; 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 例病例发生在 2020 年。 鉴于美国人口中位年龄的增加，65 岁或以上的女性患乳腺癌的数量也随之增加。 未来几十年，诊断出患有乳腺癌的老年女性预计将增加 50%。 与年轻女性相比，乳腺癌特异性结果更差，治疗可能不足 研究表明，接受治疗的乳腺癌患者的比例<85%。 剂量强度 (RDI)，一种结合总剂量和遵守计划的指标 与女性相比，10 年后疾病复发的风险增加 57% 接受至少 85% RDI 的乳腺癌患者中，只有 50-76% >65 岁的患者接受 RDI >85，这主要是由于 减少治疗相关的毒性以增强 RDI 是这些患者治疗的毒性增加。 对于改善日益增长的老年乳腺癌患者的疾病结果至关重要。 为此，预测严重化学毒性的模型表明，许多潜在的可修改的 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、抑郁和跌倒（或使用辅助设备）具有显着的积极影响。 然而，关于普通人群和癌症患者中每一个可改变因素的数据。 运动干预提高老年乳房治疗耐受性并保持剂量强度的能力 我们建议进行一项随机对照试验来评估癌症患者的效果。 多成分、混合远程医疗 (TH) 运动和蛋白质摄入支持（THRIVE 干预） RDI、化学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 名年龄≥ 65 岁的乳腺癌患者接受新/辅助化疗的结果。 参与者将被随机分配接受 THRIVE 干预或健康教育和支持控制 该干预措施将通过混合模型实施，利用现有的乳腺癌权重。 损失 (BWEL) 试用呼叫中心 在 2 次现场现场练习课程后，我们将过渡到 TH 课程。 由经过认证的运动教练在研究提供的平板电脑上提供，他们将定制行为改变以支持 为了优化干预效果，参与者将接受 TH 治疗。 与注册营养师一起评估饮食是否充足，重点关注每日最佳蛋白质摄入量。 如果需要达到 1.2 克/公斤的每日摄入量，将提供补充剂。 完善的呼叫中心 (BWEL) 的专业知识，提升了在整个行业广泛实施的潜力 美国的癌症治疗中心患者数量太少，无法承担必要的人员配备。 旨在评估干预成本以及实施该 TH 的促进因素和障碍 干预，以实现在成功完成 THRIVE 试验后转化为临床实践的目标。