[Development of a questionnaire to evaluate the impact of hot flashes in quality of life in patients with advanced prostate cancer. The ESCAPA study].
OBJECTIVE
Although the use of the androgen deprivation in advanced prostate cancer (APC) is extended, the impact of one of its frequent secondary effects, hot flashes, remains not deeply studied. Our aim is the design and validation of a specific questionnaire to evaluate the impact of hot flashes in APC patients with hormonal ablative treatment.


METHODS
Observational, prospective, multicenter study of 496 patients with APC, who were included in one of 2 groups -A (reliability): 56 patients without expected significative state changes; and B (sensitivity): 440 patients, who were either naïve or under changes in hormonal therapy because of intolerance or disease progression-, during 9 months. Hot Flashes Questionnaire (19 items) and the Rotterdam Symptoms Checklist (RSCL) were administered. Variables as disease stage, prostate-specific antigen and Karnofsky index were collected.


RESULTS
Response rate of questionnaire: 85.5%. Correlations observed between different items were high, ranging from 0.545 to 0.957. Effect size between initial visit and follow-up were 0.34, 0.41 and 0.53 at 3, 6 and 9 months. At 3 months, patients with progression showed a mean reduction (standard deviation) of hot flashes impact on daily life activities of 35.76 (37.05). Intern consistency, measured through Cronbach alpha, was of 0.98. Test-retest reliability, measured through intraclass correlation coefficient, resulted significative (0.84; 95% confidence interval, 0.69-0.91).


CONCLUSIONS
Hot Flashes Questionnaire presents good results in feasibility, validity, reliability and sensitivity to change. It's the first questionnaire in evaluating hot flashes impact on APC patients, showing good measure properties that make proper its use both for clinical practice and investigation.
Carballido
Joaquín
J
Servicio de Urología, Hospital Universitario Clínica Puerta de Hierro, Madrid, Spain.
Tisaire
José Luis
JL
Perulero
Núria
N
D000368:Aged; D000726:Androgen Antagonists / Q000009:adverse effects; D018450:Disease Progression; D019584:Hot Flashes / Q000139:chemically induced; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy; D011788:Quality of Life; D011795:Surveys and Questionnaires
D000726:Androgen Antagonists