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Study of Adherence to Colonoscopy in Women

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ClinicalTrials.gov Identifier: NCT00883545
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Colonoscopy Other: Woman endoscopist Other: Usual care

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: The Effect of a Woman Endoscopist on Adherence to Screening Colonoscopy in Women
Study Start Date : October 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Woman endoscopist Other: Woman endoscopist
This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.
Active Comparator: Usual care Other: Usual care
This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883545


Locations
United States, Colorado
University of Colorado Denver Health Sciences Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Thomas D Denberg, MD, PhD University of Colorado Denver Health Sciences Center
More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00883545     History of Changes
Obsolete Identifiers: NCT00903097
Other Study ID Numbers: 08-1045
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: September 2012

Keywords provided by University of Colorado, Denver:
Adherence to screening colonoscopy in women