Study design and methods for the using exercise to relieve joint pain and improve AI adherence in older breast cancer survivors (REJOIN) trial.

Study design and methods for the using exercise to relieve joint pain and improve AI adherence in older breast cancer survivors (REJOIN) trial.
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DOI:
10.1016/j.jgo.2021.05.011
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发表时间:
2021-09
影响因子:
3
通讯作者:
Schmitz KH
Schmitz KH
中科院分区:
医学3区
文献类型:
--
作者:
Bluethmann SM;Truica C;Klepin HD;Olsen N;Sciamanna C;Chinchilli VM;Schmitz KH

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芳香化酶抑制剂(AIs)被推荐用于患有激素敏感性疾病的绝经后乳腺癌幸存者(BCS)的生存治疗。AI的依从性欠佳,在老年乳腺癌幸存者中尤其如此。关节疼痛是一种常见的与AI相关的症状,且与AI依从性低有关。“利用运动缓解老年乳腺癌幸存者关节疼痛”(REJOIN)试验将评估一种自我管理干预措施(运动 + 教育)的效果,该措施旨在提高症状管理的知识和自我效能,减轻关节疼痛,并可能提高计划服用AIs的老年乳腺癌幸存者对AI的依从性。 这项随机对照试点试验将纳入年龄在65岁及以上、被诊断患有I - III期激素敏感性乳腺癌、已完成原发性癌症治疗且计划开始服用AIs的久坐不动的乳腺癌幸存者。我们将调整一个针对老年人的循证体育活动项目,该项目包括每两周一次的有监督的运动课程以及30分钟的教育课程。这个为期16周的干预项目包括:8周的有监督课程以及8周的自我指导的家庭课程,并伴有定期的电话指导。我们将进行老年医学评估以及运动、关节疼痛和AI依从性的测量(基线、4个月、6个月和12个月)。 REJOIN是首批专门针对老年乳腺癌幸存者的试验之一,它利用一种基于老年医学评估和运动生理学的自我管理干预措施来改善幸存者的健康状况。REJOIN试验可以为跨学科研究奠定基础,该研究弥合了健康老龄化过程中临床和公共卫生视角之间的差距,并有机会将临床干预措施转化为针对日益增长但服务不足的老年幸存者群体的非药物工具。 NCT03955627
Aromatase Inhibitors (AIs) are recommended for survival in post-menopausal breast cancer survivors (BCS) with hormone-sensitive disease. AI Adherence is suboptimal, especially in older BCS. Joint pain is a common AI-related symptom that is associated with low AI adherence. The Using Exercise to Relieve Joint Pain in Older Breast Cancer Survivors (REJOIN) Trial will evaluate the efficacy of a self-management intervention (exercise + education) to increase knowledge/self-efficacy for symptom management, reduce joint pain and potentially increase AI adherence in older BCS planning to take AIs. This randomized controlled pilot trial will include sedentary BCS, 65 years and older, diagnosed with stage I-III hormone-sensitive breast cancer, who have completed primary cancer treatment and are planning to initiate AIs. We will adapt an evidence-based physical activity program for older adults that includes bi-weekly, supervised exercise sessions plus 30 minutes of education. The 16-week intervention program includes: 8-weeks of supervised sessions plus 8-weeks of self-guided home sessions with periodic phone coaching. We will conduct geriatric assessments plus measurements of exercise, joint pain, and AI adherence (baseline, 4, 6 and 12 months). REJOIN is one of the first trials to exclusively target older BCS using a self-management intervention, informed by geriatric assessment and exercise physiology, to improve health outcomes in survivorship. The REJOIN trial could lay the foundation for transdisciplinary research that bridges the gap between clinical and public health perspectives in healthy aging, with the opportunity to translate clinical interventions into non-pharmacological tools for a growing, yet underserved population of older survivors. NCT03955627
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