Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications
2 other identifiers
observational
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2010
Shorter than P25 for all trials
1 active site
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
CompletedFirst Posted
Study publicly available on registry
December 25, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedOctober 2, 2015
September 1, 2015
6 months
December 23, 2009
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen M Hartenbach, MD
University of Wisconsin, Madison
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