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Effectiveness of an mHealth Colorectal Cancer Screening Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02088333
Acronym
mCRC
Enrollment
450
Registered
2014-03-14
Start date
2014-06-30
Completion date
2016-10-31
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

colorectal cancer screening, computer-assisted instruction, mHealth, text message

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.

Interventions

BEHAVIORALmCRC intervention

a multilevel intervention consisting of tablet-based patient education about CRC screening, post-visit patient electronic messaging, and clinic protocols to facilitate ordering of screening tests

BEHAVIORALHealthy Lifestyles video

a brief video about healthy lifestyle habits displayed on a tablet device

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of North Carolina, Charlotte
CollaboratorOTHER
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Completion of CRC Screening24 weeksPatient completion of a colorectal cancer screening test, such as the fecal occult blood test, a flexible sigmoidoscopy, or a colonoscopy.

Secondary

MeasureTime frameDescription
Intention to receive CRC screeningDay of enrollmentParticipant's stated intention to receive CRC screening
Self-efficacyDay of enrollmentParticipant's belief that they are capable of completing CRC screening
Ability to make a screening decisionDay of enrollment
CRC screening discussionsUp to 5 daysParticipants' self-report of whether they discussed CRC screening with a medical provider
CRC Screening Attitudes and BeliefsDay of enrollmentA survey scale measuring the participant's attitudes and beliefs about CRC screening
CRC screening test order24 weeksWhether or not a CRC screening test was ordered for the participant
Cost of the mCRC intervention24 weeksAdditional cost of the mCRC intervention as captured by additional time and technology costs
Usability of the mCRC systemDay of enrollmentParticipant's rating of the usability of the mCRC system
Satisfaction with screening decisionUp to 5 daysSurvey questions based on the Satisfaction with Decision Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026