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

This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01031602
First received: December 10, 2009
Last updated: April 26, 2013
Last verified: April 2013

December 10, 2009
April 26, 2013
October 2007
October 2014   (final data collection date for primary outcome measure)
Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed [ Time Frame: Survey perfomed at single point in time ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01031602 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients
Assessment of the Prevalence of Sexual Dysfunction, Depression, and Anxiety in Underserved and Minority Patients With Gynecologic Cancers

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Gynecologic Cancer
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
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.
Intervention: Behavioral: Surveys
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
October 2014
October 2014   (final data collection date for primary outcome measure)

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.

Female
Not Provided
Yes
Contact: Lois M. Ramondetta, MD 713-563-4586
United States
 
NCT01031602
2006-0436
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Study Chair: Lois M. Ramondetta, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP