A randomized trial of lifestyle guidelines on breast cancer biomarkers and treatment adherence

许多健康组织发布饮食和身体活动指南，努力帮助成年人和癌症 幸存者在营养和体育活动方面作出知情选择。这些准则是基于 观察性证据表明，遵守指南可以提高乳腺癌的生存率。然而， 研究报告说，只有不到30%的乳腺癌幸存者遵循饮食和体育活动， 指南据我们所知，还没有试验在新诊断为乳腺癌的妇女中检查过， 采纳和实践关于坚持辅助治疗的饮食和体力活动指南， 癌症相关的生物标志物。我们建议检查，在250名新诊断为I-III期乳腺癌的妇女中， 没有实行饮食和生活方式指南的癌症患者，以及计划接受辅助治疗的癌症患者 化疗，1年饮食和身体活动指南干预与常规护理对 乳腺癌辅助治疗的依从性，包括化疗完成率和 内分泌治疗次要终点包括生物标志物、身体成分和生活质量的变化。 我们的应用是创新的，具有临床意义，因为我们建议在诊断后不久进行干预， 遵循饮食和身体活动指南的妇女的患病率很低，而且可能会恶化;检查 新的生物标志物和对辅助治疗的依从性;并使用翻译方法干预 乳房诊所，并通过电话，以促进最终传播和实施我们的 干预我们有强有力的初步数据显示，在招募乳腺癌患者方面， 癌症幸存者在治疗期间和治疗后接受随机生活方式干预， 干预措施。总之，如果我们发现我们的干预措施提高了乳腺癌治疗的依从性， 生物标志物和身体成分，那么我们的发现可能会导致乳腺癌护理的范式转变， 交付。

Many health organizations publish dietary and physical activity guidelines in an effort to help adults and cancer survivors make informed choices related to nutrition and physical activity. These guidelines are based on observational evidence showing that adhering to the guidelines improves breast cancer survival. Yet numerous studies have reported fewer than 30% breast cancer survivors follow the dietary and physical activity guidelines. To our knowledge, no trial has examined, in women newly diagnosed with breast cancer, the effect of adopting and practicing the dietary and physical activity guidelines on adherence to adjuvant treatments and cancer related biomarkers. We propose to examine, in 250 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on adherence to adjuvant breast cancer treatments including chemotherapy completion rates and adherence to endocrine therapy. Secondary endpoints include changes in biomarkers, body composition and quality of life. Our application is innovative and clinically meaningful as we propose to intervene soon after diagnosis when prevalence of women following the dietary and physical activity guidelines is low and likely to worsen; examine novel biomarkers and adherence to adjuvant treatments; and use a translational approach of intervening in the breast clinic and via telephone to facilitate in the eventual dissemination and implementation of our intervention. We have strong preliminary data showing a transdisciplinary team approach in recruiting breast cancer survivors into randomized lifestyle interventions during and after treatment with high adherence to the interventions. In summary, if we find our intervention improves adherence to breast cancer treatments, biomarkers and body composition, then our findings could cause a paradigm shift in how breast cancer care is delivered.