title: The functional assessment of cancer-vulvar: reliability and validity.
abstract: OBJECTIVE
  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.
authors.affiliation: Centre for Public Health Research, Queensland University of Technology, Kelvin Grove, 4059 QLD, Australia. MJanda@qcfcancer.com.au
authors.forename: Monika
authors.initials: M
authors.lastname: Janda
authors.forename: Andreas
authors.initials: A
authors.lastname: Obermair
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Lewis C
authors.initials: LC
authors.lastname: Perrin
authors.forename: James L
authors.initials: JL
authors.lastname: Nicklin
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Ward
authors.forename: Alex J
authors.initials: AJ
authors.lastname: Crandon
authors.forename: Michael
authors.initials: M
authors.lastname: Trimmel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008875:Middle Aged; D011594:Psychometrics / Q000592:standards*; D015203:Reproducibility of Results; D014846:Vulvar Neoplasms / Q000523:psychology*