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Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01039493
First received: December 23, 2009
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Utilities of complications associated with cervical cancer treatment. [ Time Frame: At time of interview ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Providers

  Eligibility

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039493

Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Ellen M Hartenbach, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Ellen Hartenbach, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT01039493     History of Changes
Other Study ID Numbers: M-2009-1240, OS09708
Study First Received: December 23, 2009
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 17, 2013