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

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要乳腺癌是50岁以下女性中最常见的癌症，最多占新的25％乳腺癌病例。乳腺癌诊断后的生存率提高已将注意力集中在关键上需要解决该疾病及其治疗对年轻女性长期结局的影响。这已成为越来越重要的癌症控制优先事项，包括关注的联邦立法女性的独特需求<45岁。研究始终表明年轻女性有更大的乳腺癌后的心理和身体发病率比老年妇女和年龄匹配的女性癌症病史，包括抑郁症和其他行为症状的水平升高（即疲劳，睡眠干扰，血管舒张症症状），会导致生活质量严重损害。行为增加症状已记录在该人群诊断后长达10年，这表明该影响如果没有干预，可能无法进行补救。年轻的乳腺癌幸存者有长期不利的风险影响，使其成为特别脆弱的人口，只有少数特定的干预措施测试。采用许多行为干预措施的主要障碍是缺乏转化研究实施策略，因此这些干预措施无法成为临床上的护理标准提供并报销。为了应对这一挑战，我们将进行III期，三组随机临床在三个地理分离的NCI指定的综合癌症中心的试验，随机分配360 治疗后的乳腺癌幸存者，两种有希望的干预措施之一（生存教育或正念意识实践），将每个实践与通常的护理/候补对照组进行比较。我们假设这一点这两个干预计划都将有效减少行为症状（抑郁 - 主要结果;在6个月后，与通常的护理/候补对照组相比，干预期。此外，我们将研究干预措施相对于对照组的疗效在炎症的循环和基因组标记中，假设正念干预将显着减少炎症的标记。最后，我们将探索干预组中干预功效的潜在主持人。