The functional assessment of cancer-vulvar: Reliability and validity

Objectives. To assess the reliability and validity of the Functional Assessment of Cancer Therapy-Vulvar (FACT-V). Methods. Seventy-seven patients treated between January 1996 and January 2001 for cancer of the vulva completed the FACT-V, the Eastern Cooperative Oncology Group Performance Status Rating (ECOG-PSR) and the Hospital Anxiety and Depression Scale (HADS) once, 20 consecutive patients treated between February 2001 and October 2001 completed the questionnaires twice, once before surgery and at 2 months follow-up. The FACT-V scores were compared by patients' performance status, FIGO stage, recurrence, and age, and correlated to the HADS scores. Changes in the FACT-V from baseline to 2 months follow-up were evaluated to establish FACT-V's responsiveness to change. Results. The FACT-V's internal consistency was adequate (Chronbach's alpha range, 0.75 to 0.92). Patients with lower performance status, higher FIGO-stage or recurrent disease received lower FACT-V scores, indicating discriminant validity. The correlation between the FACT-V and the HADS were in the expected direction, indicating convergent and divergent validity. From pre- to post-surgery, scores in nine out of fifteen items of the vulvar cancer-specific subscale improved, while those of five items declined, indicating sensitivity of the vulvar cancer specific items to changes in patients' well-being. Conclusions. The newly developed FACT-V provides a reliable and valid assessment of the quality of life of women with vulvar cancer. It can be used as a short measure of quality of life within research studies, and to facilitate communication about quality of life issues in clinical practice.