Validation of FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort: a Gynecologic Oncology Group study

Objective. To evaluate the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort (FACT/GOG-AD) subscale for assessing abdominal discomfort in patients undergoing treatment for ovarian cancer. Methods. A four-item questionnaire was developed for use in Gynecologic Oncology Group (GOG) protocol 172. It was administered to patients with advanced ovarian cancer treated on this protocol with intravenous (IV) cisplatin/paclitaxel or a combination of intravenous and intraperitoneal (IP) cisplatin/paclitaxel (IV/IP) prior to randomization, before cycle 4, 3-6 weeks after cycle 6, and 12 months after cycle 6. The subscale was evaluated in patients receiving IV/IP therapy for internal consistency, concurrent validity, sensitivity to treatment differences, and responsiveness to abdominal discomfort grading. Results. Internal consistency coefficients were 0.83 and 0.87 at baseline and pre-cycle 4 assessments, respectively; the average inter-item correlation was 0.61 at the pre-cycle 4 assessment. Item correlation with other scales ranged from 0.00-0.44. This subscale was able to distinguish those graded to have physician-rated abdominal pain compared to those without clinician-reported discomfort. Conclusion. The four-item AD subscale reliably and validly assesses ovarian cancer-specific abdominal discomfort, and captures abdominal symptom responses to IV and IVAP cisplatin/paclitaxel treatments. (C) 2008 Elsevier Inc. All rights reserved.