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

针对接受化疗的患有妇科癌症的老年女性进行量身定制的身体活动干预 (FIT4Treatment)

• 批准号: 10635366
• 负责人: Emma Barber
• 金额: $ 76.26万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10635366
• 关键词: Acceleration; Accelerometer; Address; Adherence; Adjuvant Chemotherapy; Age; Aging; Anxiety; Cancer Patient; Cancer Survivor; Caring; Clinical Trials; Clinical Trials Design; Disease; Disseminated Malignant Neoplasm; Dose; Elderly; Exercise; Fatigue; Goals; Health; Health Benefit; Health Care Visit; Health Technology; Health system; Histology; Impairment; Individual; Inferior; Intervention; Knowledge; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Measures; Mediator; Oncology; Outcome; Ovarian; Participant; Patient Outcomes Assessments; Patients; Performance; Persons; Physical Function; Physical activity; Population; Population Heterogeneity; Progression-Free Survivals; Provider; Quality of life; Randomized; Recommendation; Research; Research Design; Self Efficacy; Social support; Strenuous Exercise; Survivors; Symptoms; Testing; Time; Toxic effect; Toxicity due to chemotherapy; Treatment-related toxicity; United States; Woman; Work; age effect; cancer survival; cancer therapy; cancer type; cardiorespiratory fitness; cervical and uterine cancer; chemotherapy; design; evidence base; exercise intervention; experience; follow-up; frailty; functional decline; functional outcomes; health related quality of life; high risk population; improved; innovation; mHealth; mortality; multi-component intervention; multiphase optimization strategy; older patient; older women; randomized trial; remote delivery; sarcopenia; sedentary; success

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.

项目概要 老年妇科癌症患者就诊时已处于晚期，更具侵袭性 组织学检查，更常见的是需要辅助化疗，以及潜在的癌症。 导致加速衰老和毒性，使女性容易出现功能衰退、更加虚弱、 身体活动已被证明可以改善功能健康，改善与健康相关的生活质量。 生活质量、延缓衰老、降低衰弱和肌肉减少症的发生率。然而，允许存在局限性。 老年妇科癌症患者接受现有的身体活动干预措施，即许多人 亲自交付，并且没有考虑与化疗相关的症状的不同时间进程。 使用基于远程移动医疗 (mHealth) 技术的身体活动干预措施 研究表明，可以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 身体活动干预 (Fit4Treatment) 的哪些组成部分在 12 周内提供 12 周的随访对增加老年女性任何强度的体力活动都有意义 患有妇科癌症并接受化疗的参与者将被随机分配到一组。 零到四个不同的干预成分，使用全因子设计来估计每个成分的影响 Fit4Treatment 的组成部分包括 1) 症状负担定制目标设定。 2) 通过运动护理伙伴提供社会支持 3) 治疗肿瘤提供者的参与和 4) 辅导。 我们还将测试身体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） 最后，我们将检查两个中介因素（依从性、自我效能）和 Fit4Treatment 成分对健康的影响的调节因素（年龄、治疗剂量、癌症类型） 增加体力活动。 这项研究扩展了我们小组的稳健工作，检查了经过充分测试、患者主导、物理治疗的使用情况。 旨在改善癌症患者的健康和生存的活动干预措施，并且在使用有效的方法方面具有创新性 MOST研究设计，检查新的高危人群，并测试体力活动对衰老的影响 这项研究将有助于更好地理解如何有效地增加功能。 老年妇科癌症患者的体力活动是一个高需求且研究不足的人群。 最终，这些结果将改善老年癌症幸存者的健康、生活质量和生存率。