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18 Years
Open (Enrolling)
Sexuality, Gynecologic Cancer

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Trial Information

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 880 people (considering 10% drop-out from 200 people in each group) gynecologic
cancer(ovary, cervix and endometrium) and healthy female. Total 910 patients.

Inclusion Criteria:

- Healthy women

- Female without invasive cancer at least 1 year.

- Cancer free as of the most recent linkage

- At least 18 years of age

- Able to speak and read Korean

- Sexual activity within 3months.

- Gynecologic cancer patient

- History of gynecological 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.

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:


Outcome Time Frame:

one year

Safety Issue:



Korea: Institutional Review Board

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Sexuality
  • Gynecologic Cancer