Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

Colorectal Cancer Clinical Trial

Official title:

Tailored Navigation in CRC Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00617071
• Other study ID #: CDR0000584278
• Secondary ID: TJUH-2006-44
• Status: Recruiting
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: December 17, 2013
• Start date: January 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Developing a personalized screening plan may be more effective than usual care in increasing the number of healthy participants who regularly undergo screening for colorectal cancer.

PURPOSE: This randomized phase III trial is studying personalized screening plans to see how well they work compared with usual care in increasing colorectal cancer screening in healthy participants.

Description:

OBJECTIVES:

• To compare the impact of tailored intervention vs standard intervention vs usual care on patient utilization of colorectal cancer (CRC) screening.

• To compare the impact of these interventions on CRC screening preference.

• To compare the impact of these interventions on patient perceptions about CRC screening.

OUTLINE: This is a multicenter study. Participants are stratified by practice and study wave and blocking. Participants are randomized to 1 of 3 arms.

• Arm I (usual care): Participants receive usual care in accordance with their normal patterns of interaction with study practices.

• Arm II (standard intervention [SI]): A generic screening invitation letter, a colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT) cards, and instructions for arranging a colonoscopy screening appointment are mailed to participants on day 15. On day 45, a reminder letter is mailed to participants who have not completed SBT or undergone a screening colonoscopy.

• Arm III (tailored navigation intervention [TNI]): A test-specific screening invitation letter, a CRC screening informational booklet, and additional test-specific materials (i.e., instructions for arranging a colonoscopy screening appointment or SBT cards) are mailed to participants on day 15. On day 30, a patient navigator contacts participants by telephone who have not completed SBT or undergone a screening colonoscopy. The patient navigator re-assesses screening test-specific decision stage; addresses CRC screening barriers; develops a personalized CRC screening plan to move the participant towards screening use (i.e., explains the steps in completing the SBT or scheduling a colonoscopy appointment); and facilitates screening plan implementation. On day 45, a reminder letter is mailed to participants who were contacted by the navigator.

Participants in all arms complete a survey at baseline and then at 6 months. Medical records for each participant are reviewed at 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

DISEASE CHARACTERISTICS:

• Meets the following criteria:

• No personal history of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease

• No family history of colorectal cancer (CRC) diagnosed before the age of 60

• Visited one of the six community-based primary care practices that are part of the Christiana Care Health System (CCHS) in Delaware within the past 2 years

• Not up-to-date with CRC screening, according to the United States Preventive Services Task Force guidelines

PATIENT CHARACTERISTICS:

• Must have a complete address and telephone number

• Able to communicate in English

• No psychosis or severe dementia

PRIOR CONCURRENT THERAPY:

• No prior participation in the developmental study CA10241

Study Design

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• medical chart review

• survey administration

Procedure:
• fecal occult blood test

• screening colonoscopy

Locations

Country	Name	City	State
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Kimmel Cancer Center (KCC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening utilization over the 6-month observation period			No
Secondary	Screening preference			No
Secondary	Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening			No
Secondary	Number and length of contacts with each participant and the type of communication during those contacts			No
Secondary	Identification of predictors of CRC screening use and screening preference			No