Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00617071
First received: February 14, 2008
Last updated: December 17, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Other: medical chart review
Other: survey administration
Procedure: fecal occult blood test
Procedure: screening colonoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Health Services Research
Official Title: Tailored Navigation in CRC Screening

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Screening utilization over the 6-month observation period [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Screening preference [ Designated as safety issue: No ]
  • Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening [ Designated as safety issue: No ]
  • Number and length of contacts with each participant and the type of communication during those contacts [ Designated as safety issue: No ]
  • Identification of predictors of CRC screening use and screening preference [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: January 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617071

Locations
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer    215-955-6084      
Sponsors and Collaborators
Kimmel Cancer Center (KCC)
Investigators
Study Chair: Ronald Myers, PhD Jefferson Medical College of Thomas Jefferson University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00617071     History of Changes
Other Study ID Numbers: CDR0000584278, TJUH-2006-44
Study First Received: February 14, 2008
Last Updated: December 17, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014