NCT00613873

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
611

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 15, 2009

Status Verified

January 1, 2009

Enrollment Period

5.5 years

First QC Date

January 31, 2008

Last Update Submit

January 14, 2009

Conditions

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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).

    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)

    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.

    conclusion of the study

Study Arms (1)

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.

Procedure: Colonoscopy and Questionnaire

Interventions

Pt is asked to complete attitude and belief questionnaire then have a Colonoscopy. Then within 6 weeks post colonoscopy a final telephone interview.

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Age \> or equal to 50
  • Availability by telephone

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Breast Examination Center of Harlem

New York, New York, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Interventions

ColonoscopySurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Moshe Shike, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

July 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 15, 2009

Record last verified: 2009-01

Locations