The FACIT-AI, a new tool for assessing symptoms associated with malignant ascites.

Objective: The objectives of this study are to assess the clinical relevance and validity of the Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) in women with ovarian cancer and malignant ascites, and to modify the instrument guided by qualitative feedback from patients with recurrent malignant ascites.

Methods: Fourteen adult female patients with recurrent symptomatic malignant ascites were enrolled from three centers. All completed an open-ended symptom list to identify their primary concerns regarding their condition. They then completed a draft 10-item FACIT-AI questionnaire created from expert input. Eleven patients provided comments regarding the FACIT-AI questionnaire using a written feedback format. Three patients participated in a "think-aloud" cognitive debriefing interview to ensure patient comprehension of questionnaire items.

Results: Of the first 11 patients surveyed, 7 believed that the draft FACIT-AI contained all important symptoms associated with malignant ascites. Responses from the remaining 4 patients revealed three symptoms that 2 or more patients nominated for inclusion: urinary frequency, constipation and emotional distress. These items were added to the original FACIT-AI to produce a 13-item index of symptoms associated with malignant ascites.

Conclusions: The 13-item FACIT-AI has content validity among women with malignant ascites associated with ovarian cancer. It is available for use in clinical research or practice, with the expectation that more will be learned about its performance and interpretation over time.