Suspended

Validation of Sexual Function Scale in Female Cancer

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Behavior+1

+ Sexual Behavior

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2012
See protocol details

Summary

Principal SponsorNational Cancer Center, Korea
Study ContactSang-Yoon ParkMore contacts
Last updated: March 20, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorNational Cancer Center, Korea
Study ContactSang-Yoon ParkMore contacts
Last updated: March 20, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorSexual BehaviorNeoplasmsSexuality

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Cancer Center

Goyang-si, South KoreaOpen National Cancer Center in Google Maps
SuspendedOne Study Center