mCRC: Effectiveness of an mHealth Colorectal Cancer Screening Intervention

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02088333
• Collaborator: National Cancer Institute (NCI) (NIH), University of North Carolina, Charlotte (Other)
• Enrollment: 450
• Locations: 6
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 75
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Completion of CRC Screening [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 [Day of enrollment]

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

2. Intention to receive CRC screening [Day of enrollment]

   Participant's stated intention to receive CRC screening

3. Self-efficacy [Day of enrollment]

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

4. Ability to make a screening decision [Day of enrollment]

5. CRC screening discussions [Up to 5 days]

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

6. Satisfaction with screening decision [Up to 5 days]

   Survey questions based on the Satisfaction with Decision Scale

7. CRC screening test order [24 weeks]

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

8. Cost of the mCRC intervention [24 weeks]

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

9. Usability of the mCRC system [Day of enrollment]

   Participant's rating of the usability of the mCRC system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillsdale Family Medicine	Advance	North Carolina	United States	27006
2	Foothills Family Medicine	Mount Airy	North Carolina	United States	27030
3	Wilkes Internal Medicine	Wilkesboro	North Carolina	United States	28659
4	Downtown Health Plaza	Winston-Salem	North Carolina	United States	27101
5	Peace Haven Family Medicine	Winston-Salem	North Carolina	United States	27106
6	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

• Principal Investigator: David P Miller, MD, MS, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02088333
• Other Study ID Numbers: IRB00023575; 1R01CA178941; CCCWFU 59A13
• First Posted: Mar 14, 2014
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• 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: Colorectal Neoplasms

Study Results

No Results Posted as of Feb 17, 2022