Development of cervical cancer patient reported clinical outcome assessment scale (CC-PRO137): A dedicated tool for multidimensional evaluation of treatment outcomes.

Abstract

5537 Background: Worldwide, cervical cancer ranks fourth among female malignant tumors in terms of both incidence and mortality. In addition, there is an increasing trend of cervical cancer incidence among younger women. Since the uterus is located at the center of vascular-neural traffic of the pelvic floor, cervical cancer surgery may damage the function of multiple systems such as urinary, digestive, neurological, endocrine, and pelvic floor muscles, and further lead to short- and long-term effects in the psychological domain including sexual status, anxiety, and depression. Therefore, we developed the current scale, Cervical Cancer Patient Reported Clinical Outcome Assessment Scale (CC-PRO137), aimed to construct a functional patient self-report system scale to conveniently and accurately quantify the quality of life of cervical cancer patients from multiple dimensions. Methods: Items included in the scale were proposed by gynecologic oncologist, and were evaluated and modified by experts in various specialties. This scale (CC-PRO137) includes 3 domains and 13 modules, including physiological systems, psychological related symptoms, social life status. A total of 304 participants were tested within 6 and 12 months postoperatively. Subgroup analyses were carried out for different time period, stages, surgical methods and adjuvant treatment plans. Results: The reliability analysis showed that the Cronbach's α in each module of the physiological domain was between 0.602-0.929, the composite reliability was between 0.226-0.946, and the test-retest reliability was between 0.660-0.829; the Cronbach’s α of the psychological domain were between 0.700-0.940, the composite reliability was between 0.584-0.950, and the test-retest reliability was between 0.697-0.807; the Cronbach’s α of the social domain was between 0.836-0.861, the composite reliability was between 0.777-0.886, the test-retest reliability was between 0.732-0.792, and the reliability of each module was optimal. The content validity adopted the expert judgment. Convergent validity (CV) analysis showed that the average variance extraction of each module in the physiological domain was between 0.382-0.706, in the psychological domain was between 0.433-0.801, and in the social domain was 0.440-0.616. The convergent validity of each module was acceptable. Conclusions: Our results showed the effectiveness of CC-PRO137 as a comprehensive assessment tool for cervical cancer patients' quality of life, suggesting that the scale can accurately measure subtle changes postoperatively. CC-PRO137 can be a useful tool to quantitatively assess cervical cancer patients.