Validation of Sexual Function Scale in Female Cancer

National Cancer Center (NCC)

Status: Unknown

Conditions: Sexuality; Healthy Women; Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01809405

NCCNCS-12-685

Details and patient eligibility

About

To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.

Full description

Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations.

The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 patients.

Enrollment: 1,130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy women

  • Female without history of cancer
  • Cancer free as of the most recent linkage
  • At least 18 years of age
  • Able to speak and read Korean
  • Sexual activity within 3months.

• Female cancer patient

  • History of gynecological or breast cancer
  • At least 18 years of age
  • Able to speak and read Korean
  • Sexual activity within 3months.

Exclusion criteria

• Women who are unable to complete the questionnaires.
• Refuse to participate in the survey.