PROMIS to explore Burden and Stress in Cancer Caregivers

这项纵向自然史研究的主要目的是研究在积极治疗期间收集癌症患者无偿非正式护理人员随时间推移的基于网络的患者报告结果（PRO）的可行性。此外，我们将研究自我效能感，相互性，心理因素（压力，负担和孤独），健康行为（健康促进生活方式简介II（HPLP），吸烟，饮酒）和健康结果（睡眠，疲劳，焦虑，抑郁和认知功能）之间的相互关系在积极治疗期间癌症患者的无偿非正式照顾者。本研究的主要目的是探讨收集网络为基础的PRO随着时间的推移在无偿照顾者的可行性。需要完成至少一个时间点的129例受试者样本，以充分评价计划的主要分析和评价主要目的。2014年2月开始的招募目前仍在进行中，2013年9月16日获得IRB批准，2014年2月开始招募，2014年3月入组第1例受试者。自2014年3月以来，筛选了N=266例受试者参与研究。截至2015年9月，入组了115例受试者，其中n=106例完成了时间点1的研究，n=67例完成了时间点2的研究，n=40例完成了时间点3的研究，61例受试者退出了研究。

The primary purpose of this longitudinal, natural history study is to examine the feasibility of collecting web-based patient-reported outcomes (PROs) over time in unpaid informal caregivers of cancer patients during the active treatment period. Additionally, we will examine the interrelationships between self-efficacy, mutuality, psychological factors (stress, burden, and loneliness), health behaviors (Health Promoting Lifestyle Profile-II (HPLP), smoking, alcohol consumption), and health outcomes (sleep, fatigue, anxiety, depression, and cognitive function) in unpaid informal caregivers of cancer patients during the active treatment period. The primary objective of this study is to examine the feasibility of collecting web-basd PROs over time in unpaid caregivers. A sample of 129 subjects completing at least one time point is required to adequately evaluate for the planned primary analysis and evaluate the primary objectives. Recruitment began in February 2014 remains ongoing at this time.The study was approved by the IRB on September 16, 2013, recruitment began in February 2014; the 1st subject was enrolled in March 2014. Since March 2014, N=266 subjects have been screened for participation. As of September 2015, there are 115 subjects enrolled, with n=106 with time point #1 completed, n=67 with time point #2 completed, and n=40 with time point #3 completed, and 61 subjects have been removed from study participation.