Clinical trial NCT02088333: Effectiveness of an mHealth Colorectal Cancer Screening Intervention
Official title: A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: colorectal cancer screening
computer-assisted instruction
mHealth
text message
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of North Carolina, Charlotte
First posted: 2014-03-14
Enrollment: 450
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Completion of CRC Screening
timeFrame: 24 weeks
Secondary outcomes:
measure: CRC Screening Attitudes and Beliefs
timeFrame: Day of enrollment
measure: Intention to receive CRC screening
timeFrame: Day of enrollment
measure: Self-efficacy
timeFrame: Day of enrollment
measure: Ability to make a screening decision
timeFrame: Day of enrollment
measure: CRC screening discussions
timeFrame: Up to 5 days
measure: Satisfaction with screening decision
timeFrame: Up to 5 days
measure: CRC screening test order
timeFrame: 24 weeks
measure: Cost of the mCRC intervention
timeFrame: 24 weeks
measure: Usability of the mCRC system
timeFrame: Day of enrollment
Other outcomes:
Locations:
city: Advance
country: United States
facility: Hillsdale Family Medicine
state: North Carolina
city: Mount Airy
country: United States
facility: Foothills Family Medicine
state: North Carolina
city: Wilkesboro
country: United States
facility: Wilkes Internal Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Downtown Health Plaza
state: North Carolina
city: Winston-Salem
country: United States
facility: Peace Haven Family Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Reynolda Family Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David P Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.