PATIENT-TAILORED PHYSICAL ACTIVITY INTERVENTION AMONG OLDER WOMEN WITH GYNECOLOGIC CANCERS UNDERGOING CHEMOTHERAPY (FIT4TREATMENT)

项目总结 老年妇科癌症患者表现为晚期，更具侵袭性 组织学和更常见的需要辅助性化疗。这种化疗，以及潜在的癌症， 导致加速衰老和毒性，使妇女容易出现功能衰退，增加虚弱， 与健康相关的生活质量下降。体力活动已被证明可以改善机能健康，改善 生活质量，延缓衰老，降低虚弱和骨质疏松症的比率。但是，在允许 老年妇科癌症患者获得现有的体力活动干预，即许多是 亲自投药，并不考虑与化疗有关的症状的不同时间进程。这个 使用基于远程传送的移动健康(MHealth)技术的体力活动干预 研究表明，增加不同人群的体力活动，包括转移性癌症患者和老年人 成年人。 本研究的目的是使用多阶段优化策略(MOST)临床试验设计来确定 MHealth体力活动干预(Fit4Treatment)的哪些组成部分在12周内交付 12周的随访对老年女性增加任何强度的体力活动都有意义 接受化疗的妇科癌症患者。参与者将被随机分配到以下组合 零到四个不同的干预成分，使用完全析因设计来估计每个因素的影响 成分在增加的步骤上。Fit4Treatment组件包括1)症状负担定制目标设置 2)通过运动护理伙伴提供的社会支持3)治疗肿瘤提供者的参与和4)辅导。 我们还将测试体力活动的变化如何改善患者报告的结果(身体功能、疲劳、 焦虑、生活质量)、衰老结果(虚弱、功能表现)和癌症结果(化疗 延迟、无进展生存)。最后，我们将检查两个中介变量(坚持性、自我效能)和 调节因子(年龄、治疗剂量、癌症类型)对Fit4治疗成分的影响 增加体力活动。 这项研究扩展了我们小组对使用经过良好测试的、由患者主导的体检的可靠工作 活动干预改善癌症患者的健康和生存，并在创新中使用了一种高效 大多数研究设计，检查新的高危人群，并测试体育活动对衰老的影响 和功能结果。这项研究将有助于更好地理解如何有效地提高 老年妇科癌症患者的体力活动，这是一个需求很高但研究不足的人群。 最终，这些结果将改善老年癌症幸存者的健康、生活质量和存活率。

PROJECT SUMMARY Older patients with gynecologic cancers have increased advanced stage at presentation, more aggressive histology and more commonly require adjuvant chemotherapy. This chemotherapy, as well as underlying cancer, cause accelerated aging and toxicity, leaving women vulnerable to functional decline, increased frailty, decreased health related quality of life. Physical activity has been shown to improve functional health, improve quality of life, slow aging, and decrease rates of frailty and sarcopenia. However, limitations exist in allowing older gynecologic cancer patients to access existing physical activity interventions, namely that many are delivered in person and do not account for the varied time course of symptoms related to chemotherapy. The use of remotely delivered mobile health (mHealth) technology-based physical activity interventions has been shown to increase physical activity in diverse populations including patients with metastatic cancer and older adults. The objective of this study is to use a multi-phase optimization strategy (MOST) clinical trial design to determine which components of an mHealth physical activity intervention (Fit4Treatment) delivered over 12 weeks with a 12 week follow-up meaningfully contribute to increasing physical activity of any intensity among older women with gynecologic cancer receiving chemotherapy. Participants will be randomly assigned to a combination of zero to four different intervention components using a full factorial design to estimate the effects of each component on increasing steps. The Fit4Treatment components include 1) symptom burden tailored goal setting 2) social support through an exercise care partner 3) treating oncology provider engagement and 4) coaching. We will also test how changes in physical activity improve patient-reported outcomes (physical function, fatigue, anxiety, quality of life), aging outcomes (frailty, functional performance) and cancer outcomes (chemotherapy delays, progression free survival). Finally, we will examine both mediators (adherence, self-efficacy) and moderators (age, treatment dose, cancer type) of the effects of the components of the Fit4Treatment on increasing physical activity. This research expands upon the robust work of our group examining the use of well-tested, patient-led, physical activity interventions to improve cancer patients’ health and survival, and is innovative in the use of an efficient MOST study design, examining a new high-risk population, and testing the effects of physical activity on aging and functional outcomes. This study will lead to an improved understanding of how to effectively increase physical activity among older patients with gynecologic cancers, a high-need and understudied population. Ultimately, these results will improve the health, quality of life and survival of older cancer survivors.