PROMIS to explore Burden and Stress in Cancer Caregivers

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Abstract

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.