Effectiveness of an mHealth Colorectal Cancer Screening Intervention

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Behavioral: Healthy Lifestyles video; Behavioral: mCRC intervention

• Registration Number: NCT02088333
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Study Start: 2014-06
• Primary Completion: 2016-05
• Study Completion: 2016-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy lifestyles education	Healthy Lifestyles video	tablet-based patient education about healthy lifestyles
mCRC intervention	mCRC intervention	intervention arm

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (6)

Wilkes Internal Medicine; 🇺🇸 Wilkesboro, North Carolina, United States

Hillsdale Family Medicine; 🇺🇸 Advance, North Carolina, United States

Foothills Family Medicine; 🇺🇸 Mount Airy, 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, United States