Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients
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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 |
- Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed [ Time Frame: Survey perfomed at single point in time ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (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 |
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.
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| Contact: Lois M. Ramondetta, MD | 713-563-4586 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Lyndon B. Johnson (LBJ) General Hosptial | Completed |
| Houston, Texas, United States, 77030 | |
| 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: | April 26, 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 May 22, 2013