NCT00087360

Brief Summary

RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening. PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2003

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

4 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

November 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

3.5 years

First QC Date

July 8, 2004

Last Update Submit

July 10, 2013

Conditions

Colorectal Cancer

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Colorectal cancer (CRC) screening rates by chart review at 4 months

Secondary Outcomes (2)

  • Knowledge regarding CRC risk by questionnaires at 4 and 12 months

  • CRC risk perception by questionnaires at 4 and 12 months

Interventions

counseling interventionOTHER
physiologic testingOTHER
evaluation of cancer risk factorsPROCEDURE

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Healthy participants * Eligible for colorectal cancer screening * No personal or family history of colorectal cancer * No more than 1 first-degree relative who has had colorectal cancer * Part 1: * Has not undergone regular screening for colorectal cancer * Part 2: * Not currently undergoing regular colon cancer testing, including any of the following: * Fecal occult blood testing within the past year * Flexible sigmoidoscopy or colonoscopy within the past 5 years PATIENT CHARACTERISTICS: Age * 50 to 74 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No inflammatory bowel disease (part 1 only) * No concurrent health issues that would preclude study participation (part 1 only) * No history of cancer except basal cell or squamous cell skin cancer (part 2 only) * Able to speak and read English (part 2 only) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-0165, United States

Location

Related Publications (1)

  • Weinberg DS, Myers RE, Keenan E, Ruth K, Sifri R, Ziring B, Ross E, Manne SL. Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial. Ann Intern Med. 2014 Oct 21;161(8):537-45. doi: 10.7326/M14-0765.

    PMID: 25329201DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • David Weinberg, MD, MSC

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

November 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(4)