ColonoscopyNCT00883545
Study of Adherence to Colonoscopy in Women
A study testing Woman endoscopist in people with Colonoscopy, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Woman endoscopist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Age between 50 and 70
- Receiving primary care at a University Medicine clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver Health Sciences Center
Aurora, Colorado, 80045
About this study
Official title: The Effect of a Woman Endoscopist on Adherence to Screening Colonoscopy in Women
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.
Read the 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
- Being tested
- Woman endoscopist, Usual care
- Keywords
- Adherence to screening colonoscopy in women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woman endoscopistOther
This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.
Usual careOther
This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.
| Study group | Role | What they receive |
|---|---|---|
| Woman endoscopist | Experimental | Not described Receives: Other: Woman endoscopist |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether the option of a woman endoscopist is associated with increased woman patient willingness to schedule and complete screening colonoscopy.
Measured: 6 months
Secondary outcomes (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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas D Denberg, MD, PhD, Principal investigator, University of Colorado Denver Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883545
- Sponsor's protocol ID
- 08-1045
- Status last verified
- Sep 2012
- First submitted
- 15 Apr 2009
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Woman Endoscopist on Adherence to Screening Colonoscopy in Women
- ClinicalTrials.gov ID
- NCT00883545
- Acronym / sponsor ID
- 08-1045
- Conditions
- Colonoscopy
- Keywords
- Adherence to screening colonoscopy in women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Woman endoscopist | Experimental | Other: Woman endoscopist |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female gender
- Age between 50 and 70
- Receiving primary care at a University Medicine clinic
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Woman endoscopistThis group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist. | Other | Woman endoscopist |
| Usual careThis group will receive an invitation to schedule a screening colonoscopy with any available endoscopist. | Other | Usual care |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D Denberg, MD, PhD principal investigator
University of Colorado Denver Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Woman endoscopist in people with Colonoscopy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.