Study of Adherence to Colonoscopy in Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00883545
First received: April 15, 2009
Last updated: January 3, 2013
Last verified: September 2012
  Purpose

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 Intervention
Colonoscopy
Other: Woman endoscopist
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: The Effect of a Woman Endoscopist on Adherence to Screening Colonoscopy in Women

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 625
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00883545     History of Changes
Obsolete Identifiers: NCT00903097
Other Study ID Numbers: 08-1045
Study First Received: April 15, 2009
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014