Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

Tailored Navigation in CRC Screening

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: medical chart review; Other: survey administration; Procedure: fecal occult blood test; Procedure: screening colonoscopy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Recruiting
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Screening utilization over the 6-month observation period

Secondary Outcome Measures

Outcome Measure
Screening preference
Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening
Number and length of contacts with each participant and the type of communication during those contacts
Identification of predictors of CRC screening use and screening preference

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Ronald Myers, PhD, Jefferson Medical College of Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): December 1, 2010
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000584278; TJUH-2006-44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No