NCT00506376

Brief Summary

The primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. A secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

13.1 years

First QC Date

July 20, 2007

Last Update Submit

February 25, 2016

Conditions

Keywords

Cervical CancerHysterectomyInterview

Outcome Measures

Primary Outcomes (1)

  • Preference Assessment

    Baseline + Interview

Study Arms (1)

Surgical Treatment Preferences

Assessment of patient's feelings toward risks associated with surgical treatment of cervical cancer.

Behavioral: Interview

Interventions

InterviewBEHAVIORAL

Interview that will take about 20 minutes to complete.

Surgical Treatment Preferences

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants at high-risk for cervical cancer and those already diagnosed with cervical cancer.

You may qualify if:

  • Women who are at least 18 years of age.
  • Women who speak English
  • Women presenting to the Colposcopy Clinic in the Gynecologic Oncology Clinic at M.D. Anderson Cancer Center OR women with an established diagnosis of either Stage IA2 or IB1 cervix cancer treated with radical hysterectomy 3-24 months prior to presenting to the Gynecologic Oncology

You may not qualify if:

  • Women who are not 18 years of age.
  • Women who are non-English speakers.
  • Women with a diagnosis of any type of cancer other than cervical cancer.
  • Women who are currently pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Charlotte C. Sun, DrPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 25, 2007

Study Start

January 1, 2003

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations