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

描述（由研究者提供）：虽然在降低癌症死亡率方面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后期影响为代价的。其中一个更严重和令人痛苦的后期效应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有益，但尚未在患有化疗引起的心力衰竭的癌症幸存者中进行过测试。我们建议测试运动干预对主要由化疗毒性引起的心力衰竭幸存者的可行性。此外，我们将调查生活方式干预对主要结局（心肺功能、心力衰竭症状、心力衰竭疾病进展）、次要结局（身体功能、角色功能、医疗保健利用）、行为依从性（运动、钠摄入量）和行为介质（运动自我效能感、心理困扰）的影响。由于这是一项初步研究，数据将用于制定效应大小和方差估计，以用于计划更大的随机试验。最后，我们将探索基于社会认知理论的运动建议依从性预测因素，测试我们测量的心理测量特征，并探索与我们的概念模型一致的相关性。参与者将从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；心肺适能试验；症状、生活质量和行为决定因素问卷；以及身体活动的评估。基线后，80名患者将使用最小化方法接受16周的Take Heart生活方式干预或常规护理。Take Heart干预组的患者将在md安德森行为研究和治疗中心参加有监督和监控的锻炼课程。他们的训练强度和持续时间将根据他们最初的体能测试、合并症和运动期间的症状进行个性化。目标是让患者每周锻炼3次，每次至少30分钟，心率保持在60- 70%。在为期16周的干预过程中，锻炼将从监控和监督到较少监督的锻炼。分析将包括在招募和保留率、受试者安全性、干预疗程依从性、研究组间污染和受试者满意度方面的可行性评估。我们还将对效应量进行估计，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，为这样的研究提供资金。公共卫生相关性：这项研究的长期目标是提供关于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低风险管理工具，不干扰癌症治疗，并可能在多个方面使癌症幸存者受益，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以帮助幸存者忍受更高、更有治疗作用的治疗剂量，或者使他们能够在复发时使用有效但对心脏有毒性的药物进行再治疗。

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.