Effectiveness of an mHealth Colorectal Cancer Screening Intervention (mCRC)

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

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Behavioral: mCRC intervention; Behavioral: Healthy Lifestyles video

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); University of North Carolina, Charlotte
• Investigators: Principal Investigator: David P Miller, MD, MS, Wake Forest University Health Sciences

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: mHealth; text message; colorectal cancer screening; computer-assisted instruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB00023575; 1R01CA178941 (U.S. NIH Grant/Contract); CCCWFU 59A13 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No