Oncologist-Assisted Home Exercise Program for Advanced Colon Cancer Patients

描述（由申请人提供）：几项随机对照试验已经证明，运动可以使癌症患者的身体机能和症状受益。然而，很少有研究纳入晚期疾病患者，随着更多治疗方法的开发，这些患者的疾病寿命更长。例如，随着最近开发出多种治疗转移性结直肠癌的新药，这些患者的总生存率几乎增加了两倍。运动可以帮助这些患者维持功能和控制症状，并在可以耐受和有效控制疾病的情况下促进他们的持续治疗。拟议研究的目的是评估在综合癌症中心和社区临床肿瘤学实践网络（CCOP）的背景下，家庭运动干预对转移性和/或复发性结肠癌患者身体机能的影响大小的可行性并进行初步估计。建议 R21 收集数据以帮助规划大规模干预试验。 R21 的具体目标涉及与计划更大规模试验相关的三个领域：(1) 效果大小：我们的目标是与注意力控制干预（放松训练）相比，评估运动干预对晚期结肠癌患者身体机能主要结果（自我报告和表现测试）和症状次要结果（疲劳、睡眠、疼痛、恶心、心理困扰）的效果大小； (2) 可行性：拟议的研究将评估研究的可行性，具体化为患者依从性、计划实施、污染（例如对照组的干预或运动程度）、患者满意度以及临床工作人员评定的实施复杂性。 (3)理论：探索基于社会认知理论的运动坚持预测模型。我们将评估这些变量测量的心理测量特征，并估计运动干预对假设的中介因素的影响，并探索模型变量和运动依从性之间的关联。这项研究将招募在过去 28 天内开始新的化疗方案的不可切除的 IV 期或复发性结肠癌（ECOG 表现状态 0-1）的患者。参与者将被随机分配到两组中的一组：（1）家庭锻炼，包括用于监测步行的计步器和用于功能性力量训练的阻力带； (2)使用膈式呼吸和引导想象的放松训练。放松训练臂被包括作为注意力控制，因为拟议研究的许多结果以及任何潜在的未来试验将依赖于自我报告。两个研究组都将收到来自MD安德森研究人员的印刷材料和电话咨询，以鼓励坚持这种行为，以及患者肿瘤科医生关于运动或放松训练重要性的一封信和简短建议。参与者在进入研究时和干预 16 周后将填写问卷。他们还将在基线和 16 周时在诊所接受简短的身体机能测试。公共健康相关性：本研究的目的是收集有关晚期结肠癌患者运动干预的有效性和可行性的初步信息。我们将评估与放松训练干预相比，患者接受电话咨询、肿瘤科医生建议、书面材料、DVD 说明、计步器和阻力带的运动干预是否可以改善患者的身体功能和症状。如果这种干预措施有效，可以通过肿瘤科医生办公室向患者提供，并可以帮助他们在治疗期间更长时间地保持日常生活活动和独立性。

DESCRIPTION (provided by applicant): Several randomized controlled trials have demonstrated that exercise can benefit cancer patients in terms of their physical functioning and symptoms. However, few studies have included patients with advanced disease, a group that is living longer with their disease as more treatments are developed. For example, with the recent development of multiple novel agents in the treatment of metastatic colorectal cancer, the overall survival of these patients has nearly tripled. Exercise may help these patients maintain function and manage symptoms, and facilitate their continuing therapy for as long as it is tolerated and effective in controlling disease. The goal of the proposed study is to assess the feasibility and develop preliminary estimates of effect size of a home- based exercise intervention on physical functioning of patients with metastatic and/or recurrent colon cancer in the setting of both a comprehensive cancer center and the community clinical oncology practice network (CCOP). This R21 is proposed to collect data to help plan for a large trial of the intervention. The specific aims of this R21 address three areas related to planning a larger trial: (1) Effect sizes: We aim to develop estimates of the effect size of the exercise intervention on the primary outcome of physical functioning (self-reported and performance tests) and the secondary outcomes of symptoms (fatigue, sleep, pain, nausea, psychological distress) of patients with advanced colon cancer, compared to an attention control intervention (relaxation training); (2) Feasibility: The proposed research will evaluate study feasibility, operationalized as patient adherence, program implementation, contamination (e.g., intervention given or extent of exercise in control group), patient satisfaction, and implementation complexity as rated by clinic staff. (3) Theory: To explore Social Cognitive Theory-based model of predictors of adherence to exercise. We will evaluate psychometric characteristics of the measures of these variables and estimate the effects of the exercise intervention on the hypothesized mediators, as well as explore associations between the model variables and exercise adherence. This study will recruit patients with unresectable stage IV or recurrent colon cancer (ECOG performance status 0-1) who have started a new chemotherapy regimen in the past 28 days. Participants will be randomized to one of two arms: (1) Home-based exercise including pedometers for monitoring walking and resistance bands for functional strength training; (2) Relaxation training using diaphragmatic breathing and guided visualization. The relaxation training arm is included as an attention control, since many of the outcomes for the proposed study, as well as any potential future trials, will rely on self-report. Both study arms will receive print materials and telephone counseling from M. D. Anderson study staff to encourage adherence to the behavior, as well as a letter and brief advice from the patient's oncologist about the importance of exercise or relaxation training. Participants will complete questionnaires when they enter the study and after 16 weeks of intervention. They also will undergo brief physical performance tests in the clinic at baseline and at 16 weeks. PUBLIC HEALTH RELEVANCE: The goal of this study is to gather preliminary information on the effectiveness and feasibility of an exercise intervention for patients with advanced colon cancer. We will assess whether an exercise intervention in which patients receive telephone counseling, advice from their oncologist, written materials, DVD instructions, and a pedometer and resistance bands improves the physical functioning and symptoms of patients, compared to a relaxation training intervention. If this intervention is effective, it could be provided to patients through their oncologist's office, and may help them maintain activities of daily living and independence for longer periods of time during treatment.