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Clinical Trials/NCT02088333
NCT02088333
Completed
N/A

A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention

Wake Forest University Health Sciences6 sites in 1 country450 target enrollmentJune 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Wake Forest University Health Sciences
Enrollment
450
Locations
6
Primary Endpoint
Completion of CRC Screening
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC) can increase the percentage of patients who receive colorectal cancer screening. The mCRC intervention will include a tablet-based patient education program, clinic protocols to facilitate the ordering of CRC screening tests, and electronic messaging with patients to promote screening. The investigators hypothesize that participants randomized to mCRC will be more likely to complete screening compared with those randomized to the control arm of the study. Additionally, the investigators hypothesize mCRC will increase several intermediate outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add little to the overall cost of screening.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
October 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English-speaking patients aged 50 - 74 years
  • Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit
  • Due for colorectal cancer screening

Exclusion Criteria

  • A personal history of CRC
  • Specific CRC risk factors, including: First degree relative with CRC; Personal history of adenomatous polyps; Recent blood in stools
  • Obvious physical or mental disability that would prevent participant from interacting with a tablet device.
  • Receipt of treatment for cancer (excluding non-melanoma skin cancers) within the last 6 months.

Outcomes

Primary Outcomes

Completion of CRC Screening

Time Frame: 24 weeks

Patient completion of a colorectal cancer screening test, such as the fecal occult blood test, a flexible sigmoidoscopy, or a colonoscopy.

Secondary Outcomes

  • Ability to make a screening decision(Day of enrollment)
  • Self-efficacy(Day of enrollment)
  • Cost of the mCRC intervention(24 weeks)
  • CRC Screening Attitudes and Beliefs(Day of enrollment)
  • Intention to receive CRC screening(Day of enrollment)
  • Satisfaction with screening decision(Up to 5 days)
  • CRC screening test order(24 weeks)
  • CRC screening discussions(Up to 5 days)
  • Usability of the mCRC system(Day of enrollment)

Study Sites (6)

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