FACT-Gastric: A new international measure of QOL in gastric cancer

8123 Background: A disease-specific subscale for gastric cancer was developed for the FACIT Measurement System. We developed it concurrently in North America and Asia to ensure its suitability outside of the US. Methods: The FACT-Ga subscale underwent a standard development process: item generation (17 pts and 12 experts), scale construction, initial validation (30 pts) and scale refinement. The item generation phase yielded 65 candidate items, which were reduced to 36 after a rigorous qualitative data review. Next, 13 experts from the US, Canada, and Japan rated the items on relevance and importance. Results led to removal of 10 items rated below an accepted median rating. The 26-item FACT-Ga was translated into Japanese using the FACIT translation methodology, followed by validation in Japan and Canada. Results: The Japanese (n=20) and Canadian (n=10) scale construction participants had mean ages of 57 and 66 years, respectively. All Japanese patients were diagnosed with gastric cancer: 70% were on treatment, and 65% were ECOG 0 or 1. The Canadian sample included 30% diagnosed with cancer of the gastric cardia, 70% with gastric cancer: 10% were on treatment, and 80% were ECOG 0 or 1. Patients completed the FACT-Ga and an Item Rating Survey to evaluate relevance and importance of each item. Interviews were also conducted to elicit feedback on appropriateness of item wording and content. The FACT-Ga performed well in this initial evaluation, with high reliability in both patient groups. Cronbach's alpha for the combined sample was .90 (.87 JPN and .94 ENG). Patients in both groups who had undergone total gastrectomy found it difficult to answer items containing the word “stomach” or related to nausea and vomiting, leading to their eventual removal. Seven items were removed from the scale for redundancy. This resulted in a 19-item questionnaire (Cronbach's alpha=.84 JPN;.93 ENG). Conclusions: The FACT-Ga in English and Japanese shows acceptable initial psychometric characteristics and performs well with patient groups in diverse countries, providing evidence of conceptual equivalence in both languages. It is suitable for use in research studies and clinical trials in English and Japanese. No significant financial relationships to disclose.