Study of Adherence to Colonoscopy in Women

NCT ID: NCT00883545

Last Updated: 2013-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 625 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-06-30

Brief 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.

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).

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Woman endoscopist

Group Type: EXPERIMENTAL

Woman endoscopist

Intervention Type: OTHER

This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.

Usual care

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.

Interventions

Woman endoscopist

This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.

Intervention Type: OTHER

Usual care

This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas D Denberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver Health Sciences Center

Locations

University of Colorado Denver Health Sciences Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

08-1045

Identifier Type: -

Identifier Source: org_study_id

NCT00903097

Identifier Type: -

Identifier Source: nct_alias