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CompletedNCT02088333mCRCUpdated Feb 17, 2022

Effectiveness of an mHealth Colorectal Cancer Screening Intervention

An interventional study of mCRC intervention and Healthy Lifestyles video in Colorectal Neoplasms, sponsored by Wake Forest University Health Sciences. Completed at 6 sites in United States. Open to participants aged 50 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-17.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Neoplasms

Keywords

  • colorectal cancer screening
  • computer-assisted instruction
  • mHealth
  • text message
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In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 450 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    mCRC intervention

    intervention arm

    Behavioral: mCRC intervention

  • Placebo comparator
    Healthy lifestyles education

    tablet-based patient education about healthy lifestyles

    Behavioral: Healthy Lifestyles video

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

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What researchers measure

Primary outcomes

  1. Completion of CRC Screening

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

    Time frame: 24 weeks

Secondary outcomes

  1. CRC Screening Attitudes and Beliefs

    A survey scale measuring the participant's attitudes and beliefs about CRC screening

    Time frame: Day of enrollment

  2. Intention to receive CRC screening

    Participant's stated intention to receive CRC screening

    Time frame: Day of enrollment

  3. Self-efficacy

    Participant's belief that they are capable of completing CRC screening

    Time frame: Day of enrollment

  4. Ability to make a screening decision

    Time frame: Day of enrollment

  5. CRC screening discussions

    Participants' self-report of whether they discussed CRC screening with a medical provider

    Time frame: Up to 5 days

  6. Satisfaction with screening decision

    Survey questions based on the Satisfaction with Decision Scale

    Time frame: Up to 5 days

  7. CRC screening test order

    Whether or not a CRC screening test was ordered for the participant

    Time frame: 24 weeks

  8. Cost of the mCRC intervention

    Additional cost of the mCRC intervention as captured by additional time and technology costs

    Time frame: 24 weeks

  9. Usability of the mCRC system

    Participant's rating of the usability of the mCRC system

    Time frame: Day of enrollment

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Study locations

6 sites
  • Hillsdale Family Medicine
    Advance, North Carolina 27006, United States
  • Foothills Family Medicine
    Mount Airy, North Carolina 27030, United States
  • Wilkes Internal Medicine
    Wilkesboro, North Carolina 28659, United States
  • Downtown Health Plaza
    Winston-Salem, North Carolina 27101, United States
  • Peace Haven Family Medicine
    Winston-Salem, North Carolina 27106, United States
  • Reynolda Family Medicine
    Winston-Salem, North Carolina 27106, United States
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References and documents

Publications

  • Miller DP Jr, Denizard-Thompson N, Weaver KE, Case LD, Troyer JL, Spangler JG, Lawler D, Pignone MP. Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 17;168(8):550-557. doi: 10.7326/M17-2315. Epub 2018 Mar 13. PubMed 29532054 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02088333
Collaborators
National Cancer Institute (NCI), University of North Carolina, Charlotte
Responsible party
Sponsor
First posted
Mar 14, 2014
Start date
Jun 2014
Primary completion
May 2016
Completion
Oct 2016
Last update
Feb 17, 2022

Study contacts

David P Miller, MD, MS
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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