Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants
Recruitment status was Recruiting
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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 |
- Screening utilization over the 6-month observation period [ Designated as safety issue: No ]
- 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) |
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 |
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| 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 | |
| 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: | October 6, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
colon cancer rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013