The Functional Assessment of Cancer-Vulva: Reliability and Validity

Abstract

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, twenty consecutive patients treated between February 2001 and October 2001 completed the questionnaires twice, once before surgery and at two 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 two-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 0.87). 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.