Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors

描述(由研究人员提供)：虽然在降低癌症死亡率方面已经取得了相当大的进展，但这是以癌症幸存者所经历的副作用和晚期效应为代价的。更严重和令人痛苦的后遗症之一是化疗引起的心力衰竭。运动训练已被发现对患有心力衰竭的非癌症患者以及没有心力衰竭的癌症幸存者都有好处，但还没有在患有化疗导致心力衰竭的癌症幸存者身上进行测试。我们建议对主要由化疗引起的毒性引起的心力衰竭幸存者进行运动干预的可行性测试。此外，我们将调查生活方式干预对初级结果(心肺健康、心力衰竭症状、心力衰竭疾病进展)、次要结果(身体功能、角色功能、医疗利用)、对行为的坚持(运动、钠摄入量)和行为中介(运动自我效能、心理困扰)的影响。由于这是一项初步研究，数据将被用来开发效应大小和方差估计，以用于规划更大的随机试验。最后，我们将探索基于社会认知理论的坚持锻炼建议的预测因素，测试我们测量的心理测量学特征，并探索与我们的概念模型一致的相关性。参与者将从M.D.安德森心脏病诊所招募。基线评估将包括心脏生物标志物和超声心动图；心肺适能测试；症状、生活质量和行为决定因素问卷；以及体力活动评估。在基线之后，80名患者将被分配到接受16周心脏生活方式干预或常规护理的最小化。接受心脏干预的患者将在M.D.安德森的行为研究和治疗中心参加有监督和有监控的锻炼课程。他们的训练强度和持续时间将根据他们最初的健康测试、并存条件和运动中的症状进行个性化。目标是患者每周至少锻炼30分钟，每次锻炼3次，锻炼速度为60%-70%或心率储备。在为期16周的干预过程中，演习将从监视和监督进行到较少监督的演习。分析将包括从招募和保留率、参与者安全性、干预课程的依从性、研究人员之间的污染和参与者满意度等方面对可行性进行评估。我们还将制定影响大小的估计，以用于规划更大规模的研究。如果在这项初步研究中收集的数据表明，在这一人群中进行更大规模的运动干预随机研究是可行的，我们计划准备一份NIH拨款申请，为此类研究提供资金。公共卫生相关性：这项研究的长期目标是提供有关运动训练是否可以帮助患有心力衰竭的癌症幸存者减轻症状、改善功能并尽可能完全恢复正常日常活动的信息。如果有效，运动干预可以提供一种有用的管理工具，这种工具风险低，不干扰癌症治疗，并可能以多种方式使癌症幸存者受益，例如，改善生活质量，降低复发风险。此外，对心力衰竭的有效干预可能有助于幸存者耐受更高、更具治疗性的治疗剂量，或者使他们能够在复发时再次使用有效的心脏毒性药物进行治疗。

DESCRIPTION (provided by investigator): While considerable progress has been made in reducing cancer mortality, this has come at some cost in terms of side effects and late effects experienced by cancer survivors. One of the more serious and distressing late effects is chemotherapy-induced heart failure. Exercise training has been found to be beneficial for non-cancer patients with heart failure, as well as for cancer survivors without heart failure, but it has not been tested in cancer survivors with chemotherapy-induced heart failure. We propose to test the feasibility of an exercise intervention for survivors with heart failure due primarily to toxicity caused by chemotherapy. Additionally, we will investigate the effect of the lifestyle intervention on primary outcomes (cardiorespiratory fitness, heart failure symptoms, heart failure disease progression), secondary outcomes (physical functioning, role functioning, health care utilization), adherence to behaviors (exercise, sodium intake), and behavioral mediators (exercise self-efficacy, psychological distress). Because this is a pilot study, data will be used to develop effect size and variance estimates to be used in planning a larger randomized trial. Finally, we will explore Social Cognitive Theory-based predictors of adherence to exercise recommendations, testing the psychometric characteristics of our measures and exploring correlations consistent with our conceptual model. Participants will be recruited from the M. D. Anderson cardiology clinic. The baseline assessment will consist of cardiac biomarkers and echocardiogram; a cardiorespiratory fitness test; symptom, quality of life, and behavioral determinant questionnaires; and assessment of physical activity. After baseline, 80 patients will be assigned using minimization to receive either the 16 week Take Heart lifestyle intervention or usual care. Patients in the Take Heart intervention arm will attend supervised and monitored exercise sessions in M. D. Anderson's Behavioral Research and Treatment Center. The intensity and duration of their sessions will be individualized based on their initial fitness test, comorbid conditions, and symptoms during exercise. The goal will be for patients to work up to at least 30 minutes of exercise 3 times a week at 60-70 percent or heart rate reserve. The exercise will proceed from monitored and supervised to less supervised exercise over the course of the 16 week intervention. Analysis will include an evaluation of the feasibility in terms of recruitment and retention rates, participant safety, intervention session adherence, contamination between study arms, and participant satisfaction. We will also develop estimates of the effect sizes to use in planning larger studies. If the data collected in this pilot study indicates a larger randomized study of an exercise intervention would be feasible in this population, we plan to prepare an NIH grant application to provide funding for such a study. PUBLIC HEALTH RELEVANCE: The long term goal of this research is to provide information about whether exercise training can help cancer survivors with heart failure decrease their symptoms, improve functioning, and return as fully as possible to their normal daily activities. If effective, an exercise intervention could provide a useful management tool that is low risk, does not interfere with cancer treatment, and may benefit the cancer survivor in multiple ways, e.g., improved QOL, and the reduced risk of recurrence. Furthermore, an effective intervention for heart failure may help survivors tolerate higher, more therapeutic doses of treatment or enable them to be re-treated with effective but cardiotoxic drugs should they experience a recurrence.