Effectiveness of an mHealth Colorectal Cancer Screening Intervention

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Behavioral: mCRC intervention
* Behavioral: Healthy Lifestyles video


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mCRC intervention<br>intervention arm | Behavioral: mCRC intervention<br>* 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<br>|
| Placebo Comparator: Healthy lifestyles education<br>tablet-based patient education about healthy lifestyles | Behavioral: Healthy Lifestyles video<br>* a brief video about healthy lifestyle habits displayed on a tablet device<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer screening, computer-assisted instruction, mHealth, text message