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Behavioural Intervention

Mobile Health Support for Colorectal Cancer Screening (mPATH-Cloud Trial)

N/A

Waitlist Available

Led By Leah M Frerichs, PhD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 45-73 years at time of enrollment

At average risk for CRC (defined as no documented history of CRC, colonic adenomas, family history of CRC, or diagnosis of inflammatory bowel disease)

Must not have

Age younger than 45 years or older than 73 years at the time of enrollment

Not at average risk for CRC (defined as history with colorectal carcinoma, colonic adenomas, family history of colorectal carcinoma, or diagnosis of inflammatory bowel disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,1 year, 2 years, 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking at a new way to encourage people to get screened for colorectal cancer. They are comparing a mobile technology intervention called mPATH™-Cloud to the usual care given by a health

Who is the study for?

This trial is for individuals overdue for colorectal cancer screening as per USPSTF guidelines, served by a health center in North Carolina. Participants must be comfortable with mobile or mail communication and willing to potentially engage with an online decision aid.

What is being tested?

The study compares usual care (in-person recommendations and referrals) against a mobile health intervention where participants receive messages to use mPATH™-Cloud, helping them choose between FIT tests or colonoscopies for colorectal cancer screening.

What are the potential side effects?

There are no direct side effects from the interventions being tested since they involve receiving information and making decisions about CRC screening methods. However, the actual screening procedures like colonoscopy may have their own risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 73 years old.

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I am at average risk for colorectal cancer with no family history or personal diagnosis of related conditions.

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I have never been diagnosed with colorectal cancer or had my colon completely removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either under 45 or over 73 years old.

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I am at higher risk for colorectal cancer due to my medical or family history.

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I have had a recent colorectal cancer screening test.

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My medical records show a colorectal cancer diagnosis or that I've had my entire colon removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,1 year, 2 years, 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,1 year, 2 years, 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,1 year, 2 years, 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Colorectal cancer screening completion rate

Secondary study objectives

Colorectal cancer screening up-to-datedness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Trial Mailed FIT InterventionExperimental Treatment1 Intervention

Subjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™-Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT mailed to their home address.

Group II: Trial Usual CareActive Control1 Intervention

Subjects randomized to this arm receive usual care. Current usual care at the participating community health centers consists of a visit-based colorectal cancer screening recommendation and referral.

0 / 7Eligibility criteria met