Study of Adherence to Colonoscopy in Women

Colonoscopy Clinical Trial

Official title:

The Effect of a Woman Endoscopist on Adherence to Screening Colonoscopy in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883545
• Other study ID #: 08-1045
• Status: Completed
• Phase: N/A
• First received: April 15, 2009
• Last updated: January 3, 2013
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether 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.

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).

Other known NCT identifiers

• NCT00903097

Recruitment information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Other:
• Woman endoscopist
This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.
• Usual care
This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.

Locations

Country	Name	City	State
United States	University of Colorado Denver Health Sciences Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether the option of a woman endoscopist is associated with increased woman patient willingness to schedule and complete screening colonoscopy.		6 months	No
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).		6 months	No