Prospective evaluation of the reliability, validity, and minimally important difference of the functional assessment of cancer therapy‐gastric (FACT‐Ga) quality‐of‐life instrument

Abstract

BACKGROUND:Recently, the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) was developed to measure the quality of life (QoL) of patients with gastric cancer. This newly developed instrument has not yet been validated. METHODS: Eighty-two patients with gastric adenocarcinoma completed questionnaires at baseline. The FACTGa scores were measured as a function of disease stage and performance status, and they were correlated with the Medical Outcomes Study 36-item short-form health survey (SF-36), the Beck Depression Inventory-II, the MarlowCrowne Social Desirability Scale, the Paulhus Deception Scale, and the State-Trait Anxiety Inventory. Patients received a second questionnaire 2 weeks after baseline to evaluate test-retest reliability and again at 3 months to evaluate the sensitivity of the FACT-Ga to changes in performance status and to estimate the minimally important differences in scores that represented meaningful change. RESULTS: The internal and test-retest reliability of the FACT-Ga instrument was adequate. With the exception of the social well being subscale, all FACT-Ga scores were correlated as hypothesized with other measures. Relevant components of the FACT-Ga were sensitive to changes in performance status. CONCLUSIONS: The current results indicated that the FACT-Ga provides a valid and reliable measurement of QoL in patients with gastric adenocarcinoma. It is a useful instrument for QoL assessment in clinical trials, and it also may be useful for the detection of significant changes in the QoL of individual patients.

Clinical and psychometric validation of the quality of life assessment system for advanced gastric cancer based on traditional Chinese medicine

“…To assess experts' perceptions of the importance of each potential item, the item pool was also administered to 50 clinical experts with a rating questionnaire that provided 5 responses, ranging from "not important" (1) to "extremely important". (5) An openended response item was also included so that experts could add issues that were not included on the original list. The potential number of questions was 34 after distilling (T14, T25-27, T29-31, T42 were deleted).…”

“…Clinical researchers are choosing measures of QOL as primary and secondary outcomes in clinical trials. Measurement of QOL has developed over the past decade and there are several questionnaires designed for patients with gastric cancer, such as the Functional Assessment of Cancer Therapy-Gastric Cancer (FACT-Ga), (5) and European Organization for Research and Treatment of Cancer (EORTC) QLQ-STO52 (The QLQ-STO 22 in conjunction with the QLQ-C30, the questionnaire module to assess health-related QOL in gastric cancer). (6)(7)(8) Although some studies have yielded useful clinical data, none of these questionnaires have been sufficiently powered to detect clinically significant QOL differences between groups of patients undergoing traditional Chinese medicine (TCM) therapy.…”

Phase I study of neoadjuvant chemotherapy with S-1 and oxaliplatin for locally advanced gastric cancer (Neo G-SOX PI)

“…10 We planned to assess quality of life (QoL) every 3 weeks from the date of the first administration of neoadjuvant chemotherapy (baseline) to the date of operation, and then after operation every 3 months from the date of the first administration of the adjuvant chemotherapy for 1 year. Assessment was done using the Japanese version of the Functional Assessment of Cancer Therapy-Gastric instrument (FACT-Ga) 11 and Functional Assessment of Cancer Therapy-Gynaecologic Oncology Group-Neurotoxicity (FACT-GOG-Ntx). 12 The FACT-Ga is a 46-item questionnaire that measures both general health-related quality of life (HRQOL) (FACT-G) and additional HRQOL specifically related to the gastric cancer subscale.…”

Effective palliation and quality of life outcomes in studies of surgery for advanced, non-curative gastric cancer: a systematic review

“…Valid and reliable methods of assessing QOL specific to the gastric cancer population have progressed slowly. In the past 10 years, tools developed include the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire STO22 (EORTC QOL-SO22) (stomach cancer-specific instrument for clinical trials published in 2001) and the Functional Assessment of Cancer Therapy-Gastric Quality of Life Instrument (FACgc) (validated in 2010) [23,24]. The Dysfunction after Upper Gastrointestinal Surgery for Cancer (DAUG S32), developed to assess QOL after cancer-related surgery, has also been validated and applies to the gastric cancer population [25].…”