PROMIS to explore Burden and Stress in Cancer Caregivers

这项纵向、自然历史研究的主要目的是检验在积极治疗期间收集基于网络的患者报告结果（PROs）的可行性。此外，我们将研究在积极治疗期间，癌症患者的无偿非正式照顾者的自我效能、相互关系、心理因素（压力、负担和孤独）、健康行为（健康促进生活方式档案- 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。本研究的主要目的是检验在无薪照顾者中收集基于网络的专业意见的可行性。需要129名受试者完成至少一个时间点的样本，以充分评估计划的主要分析和评估主要目标。招聘于2014年2月开始，目前仍在进行中。该研究于2013年9月16日获得IRB批准，招募于2014年2月开始；第一名受试者于2014年3月入组。目前共有57名受试者入组，完成时间点#1的受试者为51名，完成时间点#2的受试者为14名。共有22名受试者被从研究中剔除

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. Currently there are 57 subjects enrolled, with n=51 with time point #1 and n=14 with time point #2 completed. A total of 22 subjects have been removed from the study