NCT01039493

Brief Summary

The objective of this study is to establish patient preferences in regards to common complications of cervical cancer treatments, and to compare these preferences to those of medical providers who care for cervical cancer patients. These preferences will be determined via a interview using the Standard Gamble, which is a well-recognized method for establishing utilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

December 23, 2009

Last Update Submit

September 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Utilities of complications associated with cervical cancer treatment.

    At time of interview

Study Arms (2)

Patients

Providers

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patient Population: Patients ≥18 and \<61 years old who were diagnosed with early cervical cancer (stages I and II) at least 3 years prior to the interview. We cannot limit our population to stage IB2 patients and meet our accrual goals due to the rarity of the disease. Patients with stages I and II cervical cancer are included because they have the potential to be exposed to the same treatment complications as patients with stage IB2 disease. Patients of all health statuses will be accepted. Provider Population: Providers who care for patients with cervical cancer at the University of Wisconsin, including: gynecologic oncologists, radiation oncologists, physician's assistants and nurses. Providers must be ≥18 and \<61 years old in any health status.

You may qualify if:

  • A subject has to have been diagnosed with early cervical cancer (Stage I or II) within the last 3 years and/or take care of patients with cervical cancer and identify her or himself as one of the following: gynecologic oncologist, radiation oncologist, physician's assistant or nurse.
  • Subjects must be ≥18 and \<61 years old.

You may not qualify if:

  • Subjects who are unable to read and speak English proficiently will be excluded. Proficiency will be assessed by the investigator enrolling patients.
  • Subjects who do not have capacity to consent will not be included in this study.
  • Subjects may not be investigators on this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ellen M Hartenbach, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 25, 2009

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations