NCT01031602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

5.6 years

First QC Date

December 10, 2009

Last Update Submit

May 24, 2013

Conditions

Keywords

CancerGynecologySexual DysfunctionDepressionAnxietyUnderservedMinorityPsychological distress

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed

    Survey perfomed at single point in time

Study Arms (1)

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

Interventions

SurveysBEHAVIORAL

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.

Also known as: Questionnaire
Psych Needs Assessment

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- Women who are unable to complete the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon B. Johnson (LBJ) General Hosptial

Houston, Texas, 77030, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsSexual Dysfunction, PhysiologicalDepressionAnxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lois M. Ramondetta, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 14, 2009

Study Start

October 1, 2007

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations