Colon CancerNCT00723996
Preventive Health Behavior in Women
An observational study of Colon Cancer, run by University of Michigan at 1 site in United States.
Trial summary
The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Behavioral Study in Women
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Sep 2016
- Phase
- Observational
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are scheduled for a screening mammogram at a University Medical Center who are between 50 and 75 years old will recruited.
Who may be able to join
- Women between the ages of 50 and 75 years old.
- Scheduled for a screening mammogram.
Who cannot join
- CRC screening current (FOBT within preceding 12 months, FS within 5 years, or colonoscopy within 10 years).
- Family history of CRC in a first-degree relative.
- Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography.
Read the detailed description
The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography and to develop an innovative approach for reducing barriers colorectal cancer screening in women, using screening mammography, an existing non-colon cancer related screening test that has widespread public acceptance, as a "teachable moment." Although screening for colorectal cancer (CRC) has been shown to decrease the incidence of CRC and CRC associated mortality, adherence to screening guidelines from the American Cancer Society and the American Gastroenterological Association remains poor.1-5 Barriers to adherence are not fully defined, but may include poor understanding of the relative benefits and risks of CRC screening, absence of physician recommendation, lack of insurance coverage for screening procedures, and poor patient acceptance of screening procedures. A potential challenge in increasing patient knowledge may be the milieu in which the educational intervention is administered. This study will be the first prospective study to evaluate the effectiveness of an educational intervention designed to increase CRC screening administered at a cancer screening visit unrelated to CRC.
- Conditions
- Colon Cancer
- Being tested
- Behavioral Study in Women
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Study in WomenBehavioural
A Randomized study to assess the knowledge of womens health related issues
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Women receiving a CRC-related questionnaire and a CRC educational video. Receives: Behavioral: Behavioral Study in Women | |
| Group 2 | Women who receive only a CRC-related questionnaire. | |
| Group 3 | Women who receive neither questionnaire nor educational video. Receives: Behavioral: Behavioral Study in Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be determined through review of medical records or a telephone follow-up 6 months after enrollment
Measured: At 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startSep 2003
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Carlos M.D., University of Michigan
- Investigators
- Ruth Carlos, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723996
- Sponsor's protocol ID
- HUM00048680
- Status last verified
- Dec 2016
- First submitted
- 24 Jul 2008
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Health Behavior in Women
- ClinicalTrials.gov ID
- NCT00723996
- Acronym / sponsor ID
- HUM00048680
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Jul 2008 (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 overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography.
Detailed description
The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography and to develop an innovative approach for reducing barriers colorectal cancer screening in women, using screening mammography, an existing non-colon cancer related screening test that has widespread public acceptance, as a "teachable moment." Although screening for colorectal cancer (CRC) has been shown to decrease the incidence of CRC and CRC associated mortality, adherence to screening guidelines from the American Cancer Society and the American Gastroenterological Association remains poor.1-5 Barriers to adherence are not fully defined, but may include poor understanding of the relative benefits and risks of CRC screening, absence of physician recommendation, lack of insurance coverage for screening procedures, and poor patient acceptance of screening procedures. A potential challenge in increasing patient knowledge may be the milieu in which the educational intervention is administered. This study will be the first prospective study to evaluate the effectiveness of an educational intervention designed to increase CRC screening administered at a cancer screening visit unrelated to CRC.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Behavioral Study in WomenWomen receiving a CRC-related questionnaire and a CRC educational video. |
| Group 2 | – | –Women who receive only a CRC-related questionnaire. |
| Group 3 | – | Behavioral: Behavioral Study in WomenWomen who receive neither questionnaire nor educational video. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are scheduled for a screening mammogram at a University Medical Center who are between 50 and 75 years old will recruited.
Key inclusion criteria (2 listed)
- Women between the ages of 50 and 75 years old.
- Scheduled for a screening mammogram.
Key exclusion criteria (3 listed)
- CRC screening current (FOBT within preceding 12 months, FS within 5 years, or colonoscopy within 10 years).
- Family history of CRC in a first-degree relative.
- Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease
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 |
|---|---|---|
| Behavioral Study in WomenA Randomized study to assess the knowledge of womens health related issues | Behavioural | Group 1, Group 3 |
Primary outcome
The primary outcome will be determined through review of medical records or a telephone follow-up 6 months after enrollment
Time frame: At 6 month intervals
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 16 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Ruth Carlos, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by University of Michigan 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 2 inclusion and 3 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 16 Dec 2016. 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?
The primary outcome will be determined through review of medical records or a telephone follow-up 6 months after enrollment (time frame: At 6 month intervals). 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 16 Dec 2016.