Effectiveness of an mHealth Colorectal Cancer Screening Intervention

Colorectal Neoplasms Clinical Trial

— mCRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088333
• Other study ID #: IRB00023575
• Secondary ID: 1R01CA178941CCCW
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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
• Healthy Lifestyles video
a brief video about healthy lifestyle habits displayed on a tablet device

Locations

Country	Name	City	State
United States	Hillsdale Family Medicine	Advance	North Carolina
United States	Foothills Family Medicine	Mount Airy	North Carolina
United States	Wilkes Internal Medicine	Wilkesboro	North Carolina
United States	Downtown Health Plaza	Winston-Salem	North Carolina
United States	Peace Haven Family Medicine	Winston-Salem	North Carolina
United States	Reynolda Family Medicine	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI), University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CRC Screening Attitudes and Beliefs	A survey scale measuring the participant's attitudes and beliefs about CRC screening	Day of enrollment
Secondary	Intention to receive CRC screening	Participant's stated intention to receive CRC screening	Day of enrollment
Secondary	Self-efficacy	Participant's belief that they are capable of completing CRC screening	Day of enrollment
Secondary	Ability to make a screening decision		Day of enrollment
Secondary	CRC screening discussions	Participants' self-report of whether they discussed CRC screening with a medical provider	Up to 5 days
Secondary	Satisfaction with screening decision	Survey questions based on the Satisfaction with Decision Scale	Up to 5 days
Secondary	CRC screening test order	Whether or not a CRC screening test was ordered for the participant	24 weeks
Secondary	Cost of the mCRC intervention	Additional cost of the mCRC intervention as captured by additional time and technology costs	24 weeks
Secondary	Usability of the mCRC system	Participant's rating of the usability of the mCRC system	Day of enrollment