Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients
| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 2009 | ||||
| Last Updated Date | April 26, 2013 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed [ Time Frame: Survey perfomed at single point in time ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01031602 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients | ||||
| Official Title ICMJE | Assessment of the Prevalence of Sexual Dysfunction, Depression, and Anxiety in Underserved and Minority Patients With Gynecologic Cancers | ||||
| Brief Summary | Objectives:
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Gynecologic Cancer | ||||
| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 160 | ||||
| Estimated Completion Date | October 2014 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01031602 | ||||
| Other Study ID Numbers ICMJE | 2006-0436 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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