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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA178941 | U.S. NIH Grant/Contract | View source | |
| CCCWFU 59A13 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of North Carolina, Charlotte | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mCRC intervention | Experimental | intervention arm |
|
| Healthy lifestyles education | Placebo Comparator | tablet-based patient education about healthy lifestyles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CRC Screening Attitudes and Beliefs | A survey scale measuring the participant's attitudes and beliefs about CRC screening | Day of enrollment |
| Intention to receive CRC screening | Participant's stated intention to receive CRC screening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Miller, MD, MS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillsdale Family Medicine | Advance | North Carolina | 27006 | United States | ||
| Foothills Family Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29532054 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Healthy Lifestyles video | Behavioral | a brief video about healthy lifestyle habits displayed on a tablet device |
|
| Day of enrollment |
| Self-efficacy | Participant's belief that they are capable of completing CRC screening | Day of enrollment |
| Ability to make a screening decision | Day of enrollment |
| CRC screening discussions | Participants' self-report of whether they discussed CRC screening with a medical provider | Up to 5 days |
| Satisfaction with screening decision | Survey questions based on the Satisfaction with Decision Scale | Up to 5 days |
| CRC screening test order | Whether or not a CRC screening test was ordered for the participant | 24 weeks |
| Cost of the mCRC intervention | Additional cost of the mCRC intervention as captured by additional time and technology costs | 24 weeks |
| Usability of the mCRC system | Participant's rating of the usability of the mCRC system | Day of enrollment |
| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |