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Completed

NCT Number: NCT02088333

Effectiveness of an mHealth Colorectal Cancer Screening Intervention

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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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hillsdale Family Medicine, Advance, North Carolina, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mCRC intervention

Behavioral

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

Healthy Lifestyles video

Behavioral

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

Primary outcomes

  1. 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

  1. CRC Screening Attitudes and Beliefs

    Time frame: Day of enrollment

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

  2. Intention to receive CRC screening

    Time frame: Day of enrollment

    Participant's stated intention to receive CRC screening

  3. Self-efficacy

    Time frame: Day of enrollment

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

  4. Ability to make a screening decision

    Time frame: Day of enrollment

  5. CRC screening discussions

    Time frame: Up to 5 days

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

  6. Satisfaction with screening decision

    Time frame: Up to 5 days

    Survey questions based on the Satisfaction with Decision Scale

  7. CRC screening test order

    Time frame: 24 weeks

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

  8. Cost of the mCRC intervention

    Time frame: 24 weeks

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

  9. Usability of the mCRC system

    Time frame: Day of enrollment

    Participant's rating of the usability of the mCRC system

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of North Carolina, Charlotte

Registry information

Official study title

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

Acronym: mCRC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2014
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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