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Effectiveness of an mHealth Colorectal Cancer Screening Intervention (mCRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088333
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of North Carolina, Charlotte
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: mCRC intervention Behavioral: Healthy Lifestyles video Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention
Study Start Date : June 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mCRC intervention
intervention arm
Behavioral: mCRC 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

Placebo Comparator: Healthy lifestyles education
tablet-based patient education about healthy lifestyles
Behavioral: Healthy Lifestyles video
a brief video about healthy lifestyle habits displayed on a tablet device




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088333


Locations
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United States, North Carolina
Hillsdale Family Medicine
Advance, North Carolina, United States, 27006
Foothills Family Medicine
Mount Airy, North Carolina, United States, 27030
Wilkes Internal Medicine
Wilkesboro, North Carolina, United States, 28659
Downtown Health Plaza
Winston-Salem, North Carolina, United States, 27101
Peace Haven Family Medicine
Winston-Salem, North Carolina, United States, 27106
Reynolda Family Medicine
Winston-Salem, North Carolina, United States, 27106
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
University of North Carolina, Charlotte
Investigators
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Principal Investigator: David P Miller, MD, MS Wake Forest University Health Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02088333    
Other Study ID Numbers: CCCWFU 59A13
1R01CA178941 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
colorectal cancer screening
computer-assisted instruction
mHealth
text message
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases