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

Completed

• Conditions: Gynecologic Cancer
• Interventions: Behavioral: Surveys

• Registration Number: NCT01031602
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-11
• Study First Posted: 2009-12-14
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-24
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psych Needs Assessment	Surveys	Female Sexual Function Index (FSFI), Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire given to underserved and minority women with a gynecologic cancer or premalignant condition.

Primary Outcome Measures

Name	Time	Method
Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed	Survey perfomed at single point in time

Trial Locations

Locations (2)

Lyndon B. Johnson (LBJ) General Hosptial; 🇺🇸 Houston, Texas, United States

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States