Clinical trial NCT00617071: Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants
Official title: Tailored Navigation in CRC Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-15
Enrollment: 900
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: Screening utilization over the 6-month observation period
Secondary outcomes:
measure: Screening preference
measure: Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening
measure: Number and length of contacts with each participant and the type of communication during those contacts
measure: Identification of predictors of CRC screening use and screening preference
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Jefferson Medical College of Thomas Jefferson University
name: Ronald Myers, PhD
role: STUDY_CHAIR
References: