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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01031602
First received: December 10, 2009
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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.

Condition Intervention
Gynecologic Cancer
Behavioral: Surveys

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of the Prevalence of Sexual Dysfunction, Depression, and Anxiety in Underserved and Minority Patients With Gynecologic Cancers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed [ Time Frame: Survey perfomed at single point in time ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: October 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Psych Needs Assessment
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.
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.
Other Name: Questionnaire

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson (LBJ) General Hospital and able to read and write either English or Spanish.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031602

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Lyndon B. Johnson (LBJ) General Hosptial
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Lois M. Ramondetta, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01031602     History of Changes
Other Study ID Numbers: 2006-0436
Study First Received: December 10, 2009
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Gynecology
Sexual Dysfunction
Depression
Anxiety
Underserved
Minority
Psychological distress

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Sexual Dysfunctions, Psychological
Mental Disorders
Behavioral Symptoms
Mood Disorders
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on July 29, 2014