TeleHealth resistance exercise intervention to preserve dose intensity and vitality in elder breast Cancer patients (THRIVE 65)

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-09-12 DOI:10.1016/j.cct.2025.108074

Kathryn H. Schmitz , Nathan A. Berger , Cynthia Owusu , Cynthia A. Thomson , Vernon M. Chinchilli , Karen Basen-Engquist , William J. Evans , John J. Pink , Erica A. Schleicher , Chao Cao , Shawna E. Doerksen , Jenna D. Binder , Michele D. Sobolewski , Anna M. Tanasijevic , Kaedryn A. Diguglielmo , Truong L. Nguyen , Carissa A. Mills , Wendy Kemp , Jay B. Oppenheim , Jennifer A. Ligibel

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引用次数: 0

Abstract

Background

Older women with breast cancer are more likely than younger women to experience dose-limiting toxicities with chemotherapy. This leads to dose reduction, treatment discontinuation, and inferior treatment outcomes. Older women are also at higher risk of long-term detrimental impacts of treatment on quality of life and physical function.

Aim

The primary aim of the TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder breast cancer patients (THRIVE-65) trial is to assess the effects of an exercise and nutrition intervention on chemotherapy relative dose intensity among women aged ≥65 receiving chemotherapy for early-stage breast cancer.

Methods/Design

THRIVE-65 is a 2-arm parallel-group randomized controlled trial. The intervention includes two 30–45 min telehealth delivered resistance exercise sessions weekly, 90 min of unsupervised aerobic exercise weekly, and dietitian-guided high protein intake (1.2 g/kg/day)) delivered throughout the course of chemotherapy. The Health Education and Support control group receives a tablet with supportive care materials. Planned and observed chemotherapy dose and treatment schedule are recorded to assess relative dose intensity. Pre- and post- intervention assessments include patient reported outcomes, a geriatric assessment, dietary and physical activity measures, physical function and body composition.

Conclusions

The THRIVE-65 trial is poised to answer a crucial scientific question: Can exercise and nutrition support improve chemotherapy tolerance among older breast cancer patients? Study results will inform clinical practice related to exercise and nutrition support for this population.

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远程健康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 65）。

背景：老年女性乳腺癌患者比年轻女性更容易经历化疗的剂量限制性毒性。这导致剂量减少、停药和较差的治疗结果。老年妇女也面临着治疗对生活质量和身体功能产生长期不利影响的更高风险。目的：远程健康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-65）试验的主要目的是评估运动和营养干预对65岁以上接受早期乳腺癌化疗的妇女化疗相对剂量强度的影响。方法/设计：THRIVE-65是一项两组平行随机对照试验。干预包括每周两次30-45 分钟远程医疗提供的阻力运动，每周90 分钟无监督有氧运动，以及在整个化疗过程中提供营养师指导的高蛋白摄入（1.2 g/kg/天）。健康教育和支持控制组收到一个装有支持性护理材料的药片。记录计划和观察的化疗剂量和治疗计划，以评估相对剂量强度。干预前和干预后评估包括患者报告的结果、老年评估、饮食和身体活动测量、身体功能和身体组成。结论：THRIVE-65试验准备回答一个关键的科学问题：运动和营养支持能否改善老年乳腺癌患者的化疗耐受性？研究结果将为这一人群的运动和营养支持相关的临床实践提供信息。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.