Colorectal ScreeningNCT00613873
Use of Screening Colonoscopy Among Minority Women and Men
An observational study of Colorectal Screening, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
Colorectal cancer is a cancer in the colon or rectum. Routine screening can find it at an early stage, when it has a much higher chance of cure. Screening can also help to find polyps. These are mushroom shaped growths that could turn into cancer. A polyp can be removed before it turns into cancer. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Screening
- What is being tested?
- Colonoscopy and Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 611 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2003to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigators or research team at Memorial Sloan-Kettering Cancer Center(MSKCC). The study will be offered to all eligible women who come for breast or cervical cancer screening at The Breast Examination Center of Harlem during the study period
Who may be able to join
- Age > or equal to 50
- Availability by telephone
Who cannot join
- History of colorectal cancer screening (fecal occult blood testing annually for last 3 years; colonoscopy within the last 10 years)
- History of colorectal cancer
- Serious illness which precludes colonoscopy (severe heart disease; severe pulmonary disease; uncontrolled diabetes; uncontrolled hypertension; other medical contraindication)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Breast Examination Center of Harlem
New York, New York
About this study
Official title: A Model Program for Increasing Use of Screening Colonoscopy Among Minority Women and Men
Colorectal cancer is a cancer in the colon or rectum. Routine screening can find it at an early stage, when it has a much higher chance of cure. Screening can also help to find polyps. These are mushroom shaped growths that could turn into cancer. A polyp can be removed before it turns into cancer. Even though screening can save lives, not enough people in the country are having it. This is especially true in Harlem. Harlem has a higher rate of deaths from this cancer than other places in the U.S. because too many people do not get screened. By the time a person has symptoms, the cancer may be at a late stage, when it is much harder to cure.
We are doing this study to see if we can increase the number of people in Harlem who get screened. We plan to tell women about the screening when they have a mammogram or pap test. We will also ask them what they know and think about colorectal cancer. And, we will see if they get other members of their household to be screened.
- Conditions
- Colorectal Screening
- Being tested
- Colonoscopy and Questionnaire
- Keywords
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy and QuestionnaireProcedure or surgery
Pt is asked to complete attitude and belief questionnaire then have a Colonoscopy. Then within 6 weeks post colonoscopy a final telephone interview.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women participating in a community based mammography or cervical screening program will also participate in colonoscopy screening. Participation will be measured by stating an interest in colorectal cancer screening and then following through with colonoscopy screening. Furthermore we will assess whether those complying with colonoscopy will also recommend colonoscopy screening for their spouses or household members. Receives: Procedure: Colonoscopy and Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of using a community screening mammography center to recruit minority women form a low income community to undergo colorectal cancer screening (CRCS).
Measured: conclusion of the study
Secondary outcomes (2)
Identify individual level barriers (demographic, financial, and psychological) to CRCS among minority women who are already participating in screening for another cancer (breast or cervical)
Measured: conclusion of the study
Determine the feasibility of promoting CRCS among spouses (and other members of the household) of minority women who have undergone screening colonoscopy.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJul 2003
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal ScreeningStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- North General Hospital, New York, Ralph Lauren Center for Cancer Care and Prevention
- Investigators
- Moshe Shike, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613873
- Sponsor's protocol ID
- 03-066
- Status last verified
- Jan 2009
- First submitted
- 31 Jan 2008
- Last updated
- 15 Jan 2009
- Results posted
- No
Publications
Shike M, Schattner M, Genao A, Grant W, Burke M, Zauber A, Russo L, Cuyjet V. Expanding colorectal cancer screening among minority women. Cancer. 2011 Jan 1;117(1):70-6. doi: 10.1002/cncr.25566. Epub 2010 Oct 25.
PubMed 21170901
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model Program for Increasing Use of Screening Colonoscopy Among Minority Women and Men
- ClinicalTrials.gov ID
- NCT00613873
- Acronym / sponsor ID
- 03-066
- Conditions
- Colorectal Screening
- Keywords
- colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- North General Hospital, New York, Ralph Lauren Center for Cancer Care and Prevention
- Study start
- Jul 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Feb 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.
Colorectal cancer is a cancer in the colon or rectum. Routine screening can find it at an early stage, when it has a much higher chance of cure. Screening can also help to find polyps. These are mushroom shaped growths that could turn into cancer. A polyp can be removed before it turns into cancer. Even though screening can save lives, not enough people in the country are having it. This is especially true in Harlem. Harlem has a higher rate of deaths from this cancer than other places in the U.S. because too many people do not get screened. By the time a person has symptoms, the cancer may be at a late stage, when it is much harder to cure.
We are doing this study to see if we can increase the number of people in Harlem who get screened. We plan to tell women about the screening when they have a mammogram or pap test. We will also ask them what they know and think about colorectal cancer. And, we will see if they get other members of their household to be screened.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Colonoscopy and QuestionnaireWomen participating in a community based mammography or cervical screening program will also participate in colonoscopy screening. Participation will be measured by stating an interest in colorectal cancer screening and then following through with colonoscopy screening. Furthermore we will assess whether those complying with colonoscopy will also recommend colonoscopy screening for their spouses or household members. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigators or research team at Memorial Sloan-Kettering Cancer Center(MSKCC). The study will be offered to all eligible women who come for breast or cervical cancer screening at The Breast Examination Center of Harlem during the study period
Key inclusion criteria (2 listed)
- Age > or equal to 50
- Availability by telephone
Key exclusion criteria (3 listed)
- History of colorectal cancer screening (fecal occult blood testing annually for last 3 years; colonoscopy within the last 10 years)
- History of colorectal cancer
- Serious illness which precludes colonoscopy (severe heart disease; severe pulmonary disease; uncontrolled diabetes; uncontrolled hypertension; other medical contraindication)
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 |
|---|---|---|
| Colonoscopy and QuestionnairePt is asked to complete attitude and belief questionnaire then have a Colonoscopy. Then within 6 weeks post colonoscopy a final telephone interview. | Procedure or surgery | 1 |
Primary outcome
To determine the feasibility of using a community screening mammography center to recruit minority women form a low income community to undergo colorectal cancer screening (CRCS).
Time frame: conclusion of the study
2 secondary outcomes
Identify individual level barriers (demographic, financial, and psychological) to CRCS among minority women who are already participating in screening for another cancer (breast or cervical)
Time frame: conclusion of the study
Determine the feasibility of promoting CRCS among spouses (and other members of the household) of minority women who have undergone screening colonoscopy.
Time frame: conclusion of the study
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 15 Jan 2009.
- Derived from this study: PubMed 21170901Shike M, Schattner M, Genao A, Grant W, Burke M, Zauber A, Russo L, Cuyjet V. Expanding colorectal cancer screening among minority women. Cancer. 2011 Jan 1;117(1):70-6. doi: 10.1002/cncr.25566. Epub 2010 Oct 25.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Moshe Shike, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Screening, run by Memorial Sloan Kettering Cancer Center at 2 sites 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 15 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To determine the feasibility of using a community screening mammography center to recruit minority women form a low income community to undergo colorectal cancer screening (CRCS). (time frame: conclusion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00613873, which also lists 1 linked publication.
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 15 Jan 2009.