A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

针对年轻乳腺癌幸存者行为症状的 III 期随机试验

• 批准号: 9315784
• 负责人: JULIENNE E BOWER
• 金额: $ 63.99万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-14 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9315784
• 关键词: Accounting; Acute; Address; Adoption; Aftercare; Age; Arousal; Attention; Awareness; Behavior Therapy; Behavioral; Behavioral Symptoms; Breast Cancer survivor; Cancer Control; Cancer Detection; Cancer Patient; Cancer Survivor; Cancer Survivorship; Characteristics; Clinical; Comprehensive Cancer Center; Control Groups; Diagnosis; Disease; Education; Educational process of instructing; Evaluation; Fatigue; Geography; Impairment; Inflammation; Inflammatory; Institution; Intervention; Life; Link; Literature; Long-Term Effects; Long-Term Survivors; Malignant Neoplasms; Menopausal Symptom; Mental Depression; Morbidity - disease rate; NCI-Designated Cancer Center; Outcome; Pharmacology; Phase; Population; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Reproducibility; Research; Risk; Sampling; Site; Sleep disturbances; Statutes and Laws; Survivors; Symptoms; Testing; Translating; Translational Research; Translations; Treatment Efficacy; Validation; Vasomotor; Vulnerable Populations; Woman; activity marker; base; breast cancer diagnosis; cancer care; cancer diagnosis; cancer therapy; care delivery; chemotherapy; circulating biomarkers; clinical care; depressive symptoms; design; efficacy testing; emotion regulation; experience; follow-up; genomic biomarker; group intervention; implementation research; improved; inflammatory marker; intervention effect; intervention program; malignant breast neoplasm; mindfulness; mindfulness intervention; mindfulness meditation; mortality; older women; post intervention; primary outcome; psychologic; psychosocial; public health relevance; randomized trial; secondary outcome; skills; standard of care; survivorship; treatment as usual; young woman

PROJECT SUMMARY Breast cancer is the most common cancer in women younger than 50 years, accounting for up to 25% of new breast cancer cases. Improved survival after a breast cancer diagnosis has focused attention on the critical need to address the impact of the disease and its treatments on long-term outcomes in younger women. This has become an increasingly important cancer control priority, including federal legislation focusing on the unique needs of women <45 years old. Studies have consistently shown that younger women have greater psychological and physical morbidity after breast cancer than older women and age-matched women with no cancer history, including elevated levels of depression and other behavioral symptoms (i.e., fatigue, sleep disturbance, vasomotor symptoms) that cause significant impairment in quality of life. Increased behavioral symptoms have been documented up to 10 years after diagnosis in this population, suggesting that effects may not remediate without intervention. Younger breast cancer survivors are at risk for adverse long-term effects, making them a particularly vulnerable population, for whom only a few specific interventions have been tested. A major barrier to adoption of many behavioral interventions is the lack of a translational research implementation strategy, and thus these interventions fail to become a standard of care that is clinically provided and reimbursed. To meet this challenge, we will conduct a phase III, three-group, randomized clinical trial at three geographically separated NCI-designated comprehensive cancer centers, randomly assigning 360 younger post-treatment breast cancer survivors, to one of two promising interventions (survivorship education or mindful awareness practices), comparing each to a usual care/waitlist control group. We hypothesize that both of the intervention programs will be effective in reducing behavioral symptoms (depression - primary outcome; fatigue, sleep disturbance, vasomotor symptoms-secondary outcomes) over a 6 month post- intervention period, in comparison to the usual care/waitlist control group. Additionally, we will examine the efficacy of the interventions relative to the control group on circulating and genomic markers of inflammation, hypothesizing that the mindfulness intervention will significantly reduce markers of inflammation. Finally, we will explore potential moderators of intervention efficacy in the intervention groups.

项目总结 乳腺癌是50岁以下女性最常见的癌症，占新发癌症的25%。 乳腺癌病例。乳腺癌诊断后存活率的提高将注意力集中在关键的 需要解决这种疾病及其治疗对年轻女性长期结局的影响。这 已成为日益重要的癌症控制优先事项，包括关注 45岁女性的独特需求。研究一直表明，年轻女性有更多的 乳腺癌后心理和生理方面的发病率高于老年妇女和年龄匹配的无乳腺癌妇女 癌症病史，包括抑郁水平升高和其他行为症状(如疲劳、睡眠 精神障碍、血管舒缩症状)，导致生活质量严重受损。增加了行为 在这一人群中，症状在确诊后长达10年的时间里被记录在案，这表明 不能在没有干预的情况下进行补救。年轻的乳腺癌幸存者面临长期不良反应的风险 影响，使他们成为特别脆弱的人群，对他们来说，只有几个具体的干预措施 测试过。采用许多行为干预的一个主要障碍是缺乏转化性研究 实施战略，因此这些干预措施未能成为临床护理的标准 已提供并已报销。为了迎接这一挑战，我们将进行第三阶段的三组随机临床试验。 在三个地理位置不同的NCI指定的综合癌症中心进行试验，随机分配360 年轻的乳腺癌治疗后幸存者接受两种有希望的干预措施之一(生存教育 或有意识的意识实践)，将每个人与通常的护理/等待名单控制组进行比较。我们假设 这两个干预方案都将有效地减少行为症状(抑郁症-主要 结果：疲劳、睡眠障碍、血管运动症状-继发性结果)超过6个月 干预期，与常规护理/等待名单对照组相比。此外，我们还将研究 与对照组相关的干预措施对循环和基因组炎症标志物的疗效， 假设正念干预将显著减少炎症的标志。最后，我们 将在干预组中探索干预效果的潜在调节因素。