- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00883545
Study of Adherence to Colonoscopy in Women
The Effect of a Woman Endoscopist on Adherence to Screening Colonoscopy in Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer (CRC) is the third leading cause of cancer death in women. Although there are a variety of options for colon cancer screening, colonoscopy is thought to be the best modality for women. Despite recommendations by multiple societies, adherence to CRC screening among women is suboptimal. One possible barrier to adherence may be the gender of the endoscopist. Recent studies have shown that a large proportion of surveyed women would prefer a woman endoscopist. These studies suggest that having the option of a woman endoscopist would increase adherence to colonoscopy; however, there is no published literature that addresses this question.
Hypothesis
Women who are offered screening colonoscopy will be more likely to schedule and complete this procedure if they are given the option of a woman endoscopist.
Specific Aims
Primary
- Determine whether the option of a woman endoscopist is associated with increased woman patient adherence to screening colonoscopy.
- Assess the proportion of women who request a woman endoscopist when this option is made available to them.
Secondary
* Identify socio-demographic predictors of (a) completing a screening colonoscopy and (b) requesting a woman endoscopist (e.g. race/ethnicity, age, health insurance, marital status).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Denver Health Sciences Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female gender
- Age between 50 and 70
- Receiving primary care at a University Medicine clinic
Exclusion Criteria:
- No visit to a University Medicine clinic in 18 months or more
- Deceased
- Pregnant
- Terminal or cancer diagnosis
- No longer receiving primary care at a University Medicine clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
|
This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.
|
Experimental: Woman endoscopist
|
This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine whether the option of a woman endoscopist is associated with increased woman patient willingness to schedule and complete screening colonoscopy.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identify socio-demographic predictors of (a) completing a screening colonoscopy and (b) requesting a woman endoscopist (e.g. race/ethnicity, age, health insurance, marital status).
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas D Denberg, MD, PhD, University of Colorado Denver Health Sciences Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 08-1045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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