Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients

Gynecologic Cancer Clinical Trial

Official title:

Assessment of the Prevalence of Sexual Dysfunction, Depression, and Anxiety in Underserved and Minority Patients With Gynecologic Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031602
• Other study ID #: 2006-0436
• Status: Completed
• Phase: N/A
• First received: December 10, 2009
• Last updated: May 24, 2013
• Start date: October 2007
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Objectives:

• Assess the prevalence and severity of depression and anxiety in underserved and minority women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital.

• Assess the prevalence and severity of sexual dysfunction in this patient population.

Description:

The instruments used in this study will be completed at one timepoint, by those women who choose to participate, anonymously. The questionnaires will be preceded with a statement informing the patient that by completing the study questionnaires she is consenting to study participation. No patient names or medical record numbers will be documented.

When a patient checks in for her clinic appointment, she will receive a packet of study materials consisting of a cover letter describing the study objectives, the Female Sexual Function Index, the Hospital Anxiety and Depression Scale, and a demographic questionnaire. The tools used in this study will be available in both English and Spanish.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson General Hospital. The women must be able to read and write either English or Spanish.

Exclusion Criteria:

• Women who are unable to complete the questionnaires.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Behavioral:
• Surveys
Surveys -- Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire completed at time of clinic appointment, taking about 20 minutes.

Locations

Country	Name	City	State
United States	Lyndon B. Johnson (LBJ) General Hosptial	Houston	Texas
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed		Survey perfomed at single point in time	No

External Links

•   UT MD Anderson Cancer Center website