Preserving Function in Rural Breast Cancer Patients Undergoing Chemotherapy

描述（由申请人提供）：乳腺癌患者经历与癌症和治疗副作用相关的功能限制。早期功能限制影响短期和长期生活质量，并可能导致长期并发症。生活在农村地区的病人面临的风险特别大，因为他们不容易获得服务。因此，早期干预对整体公众健康有影响。问题解决训练（PST）是一种标准化的手动驱动干预，可能非常适合帮助乳腺癌患者保持其有价值的活动并遵守推荐的症状管理方案（例如，物理治疗、有氧运动和放松/引导图像），以改善功能。从集中位置（如综合癌症中心）提供的基于电话的PST可以以具有成本效益的方式改善访问和结果。我们建议对30例接受辅助治疗的农村乳腺癌患者进行PST干预的可行性研究，这些患者被随机分配到PST或常规护理。干预组将连续六周接受每周一次的电话PST课程。这项R 03小额赠款申请的具体目的是：1）测试在临床试验中招募和保留新诊断的乳腺癌患者的可行性，以评估基于电话的PST。2)收集功能结局指标的初步数据，以确定效应量估计值，为全规模随机对照研究的功效分析提供信息。主要结局指标将是研究入组的接受率、两个干预组的保留率和PST干预的满意度。将在基线、基线后六周（PST干预结束）和3个月进行评估。这一系列调查的长期目标是开发实用的，广泛适用的康复护理模式，以保持功能和减少痛苦的癌症患者接受治疗。

DESCRIPTION (provided by applicant): Breast cancer patients experience functional limitations related to the cancer and treatment side effects. Early functional limitations affect short- and long-term quality of life, and may lead to long-term complications. Patients living in rural areas are at particular risk because they do not have easy access to services. Therefore, early intervention is indicated to have an impact on the overall public health. Problem solving training (PST) is a standardized manual driven intervention that may be ideally suited to assist breast cancer patients to preserve their valued activities and to comply with recommended symptom management regimens (e.g., physical therapy, aerobic exercise and relaxation/guided imagery) that improve function. Telephone-based PST provided from a centralized location (such as the comprehensive cancer center) may improve access and outcomes in a cost-effective manner. We propose to conduct a feasibility study of a PST intervention with 30 rural breast cancer patients undergoing adjuvant treatment randomly assigned to PST or to usual care. The intervention group will receive weekly phone-based PST sessions for six consecutive weeks. The specific aims of this R03 small grant application are to: 1) Test the feasibility of enrolling and retaining newly diagnosed breast cancer patients in a clinical trial to assess telephone-based PST. 2) Collect preliminary data on outcome measures of function to determine effect size estimates that will inform power analyses for a full scale randomized controlled study. Primary outcome measures will be acceptance rates for enrollment in the study, retention rates across both intervention arms, and satisfaction levels with the PST intervention. Assessments will be conducted at baseline, and at six weeks (end of PST intervention) and 3 months following baseline. The long-term goal of this line of investigation is to develop practical, widely applicable rehabilitation models of care to preserve function and decrease distress in cancer patients undergoing treatment.