NCT01526239

Brief Summary

Colorectal cancer is the third most common cancer diagnosed and third leading cause of cancer-related deaths in the United States for both men and women. The American Cancer Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been dropping as a result of screening and early detection of cancer. In 2007, ACS reported that early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could be prevented each year if eligible patients received screening when necessary. However, despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible US patients are currently being screened. Specific Aims The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening. The following three areas will be investigated during this research:

  1. 1.To determine whether a communication tool provided to patients will initiate a conversation with their primary care physicians about CRC screening, especially via colonoscopy.
  2. 2.To determine whether this tool will impact referral patterns for screening, especially, although not primarily, among poor and underserved populations.
  3. 3.To determine whether differences exist in regard to patient-physician communication patterns about screening among residents and faculties in the fields of internal medicine and family practice clinics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
Last Updated

February 3, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

January 3, 2012

Last Update Submit

February 2, 2012

Conditions

Keywords

Colorectal cancer screeningcolon cancer screeningcolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Communication with primary care physicians about CRC screening

    The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening.

    2 years

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention consisted of a pamphlet about the benefit of CRC-S, given to patients prior to their PCP visit and a reminder note about CRC screening to be given to their physician during the encounter.

Other: Colorectal cancer screening pamphlet

Control group

NO INTERVENTION

Control group will not receive the pamphlet regarding colorectal cancers.

Interventions

Colorectal cancer screening pamphlet

Intervention group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patient age older than 50, exception for African American age 45 and older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUHSC HSC, GI department

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2012

First Posted

February 3, 2012

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 3, 2012

Record last verified: 2012-01

Locations