CRC mHealth for Colorectal Cancer Screening

Overseen By Douglas Billings, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: ISA Associates, Inc.

Disqualifiers: Colorectal cancer history

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone-based program called CRC mHealth, designed to encourage African American men to undergo colorectal cancer screening. The study compares this program to standard educational text messages from the CDC to determine which more effectively motivates men to complete screenings. Participants will take surveys and have their medical records checked to confirm screening completion. African American men who are not following current screening guidelines and have a mobile phone with internet access and texting can join. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance health outcomes in their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this smartphone-based program is safe for colorectal cancer screening?

Research has shown that digital health tools, such as the smartphone program in this study, are generally safe for users. These tools have increased colorectal cancer screening rates by sending helpful reminders and support messages. They operate by delivering text messages and videos to participants. No reports of negative effects from these programs exist. Users typically find them easy to use and not harmful. The primary goal is to encourage colorectal cancer screening, not to introduce new drugs or treatments. Although the program is new, it employs methods previously found safe and effective by many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CRC mHealth intervention because it leverages mobile health technology to boost colorectal cancer screening rates. Unlike traditional methods that rely on in-person visits or mailed reminders, this intervention uses digital platforms to engage participants directly on their smartphones. This approach is designed to make it more convenient and accessible for people to receive crucial information and reminders about screening, potentially increasing participation rates and catching cancer earlier when it's most treatable.

What evidence suggests that this smartphone-based program is effective for increasing colorectal cancer screening?

Research has shown that mobile health (mHealth) programs, like the CRC mHealth intervention tested in this trial, can significantly increase colorectal cancer screening rates. For example, one study found that these programs, which use text messages and videos, were 68.6% effective in encouraging screenings. Another study demonstrated that mHealth programs consistently led to higher participation in screenings. These programs help by clarifying the importance of screening and overcoming barriers that might prevent people from getting screened. Overall, mHealth programs have a strong record of improving screening rates. Participants in this trial will either receive the CRC mHealth intervention or be part of the control group receiving standard educational information about colorectal cancer and screening. ^{2 4 6 7 8}

Who Is on the Research Team?

Samantha L Leaf, Ph.D.

Principal Investigator

ISA Associates

Are You a Good Fit for This Trial?

This trial is for African American men who aren't up-to-date with colorectal cancer screenings, own a smartphone capable of texting and web access, and speak English. Men with a personal history of colorectal cancer cannot participate.

Inclusion Criteria

able to speak/understand English

not compliant with current United States Preventive Services Taskforce colorectal cancer screening recommendations

African American/Black

Exclusion Criteria

I have had colorectal cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey

Participants complete a baseline survey about their colorectal cancer screening history and beliefs

1 week

1 visit (virtual)

Intervention

Participants are randomized to receive either the smartphone-based program or CDC educational text messages

6 months

Ongoing virtual engagement

Follow-up

Participants complete a follow-up survey and medical records review is conducted to verify colorectal cancer screening

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Control
• CRC mHealth

Trial Overview

The study tests if an mHealth program on smartphones increases the rate at which African American men get screened for colorectal cancer compared to those who just receive standard CDC educational texts.

How Is the Trial Designed?

Group I: CRC mHealth intervention Experimental Treatment 1 Intervention

Experimental group participants will have access to the CRC mHealth intervention.

Group II: Control Education Active Control 1 Intervention

Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.

Who Is Running the Clinical Trial?

ISA Associates, Inc.

Lead Sponsor

Trials

6

Recruited

920+

Published Research Related to This Trial

A randomized controlled trial with 556 African-American patients showed that a computer-delivered tailored intervention significantly improved knowledge and health beliefs about colorectal cancer (CRC) screening compared to standard print materials.

Patients receiving the tailored intervention had notable increases in CRC knowledge, perceived risk, and understanding of the benefits of screening, indicating that such interventions can effectively encourage behavior change towards CRC screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-delivered tailored intervention improves colon cancer screening knowledge and health beliefs of African-Americans. Rawl, SM., Skinner, CS., Perkins, SM., et al.[2022]

Mailed outreach strategies, especially those including fecal immunohistochemical tests (FIT) or guaiac-based fecal occult blood tests (gFOBT), significantly increased colorectal cancer screening adherence in low-income populations, with relative risks of 2.20 and 4.34 respectively.

Patient navigation and non-individualized education also effectively improved screening rates, while individualized education and mailed outreach with incentives did not show significant benefits, highlighting the importance of intervention design in promoting screening adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to increase colorectal cancer screening adherence in low-income settings within the United States: A systematic review and meta-analysis. Rubin, L., Okitondo, C., Haines, L., et al.[2023]

A systematic review of ten randomized controlled trials involving adults due for colorectal cancer screening found that mobile health (mHealth) interventions significantly increased screening rates compared to usual care, with an adjusted odds ratio of 1.33.

The effectiveness of mHealth interventions was consistent across various methods, including automated phone education and text-message reminders, indicating that these digital tools can effectively promote colorectal cancer screening participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health interventions for improving colorectal cancer screening rates: A systematic review and meta-analysis. Elepaño, A., Fusingan, AS., Yasay, E., et al.[2022]

A review of 15 community-based randomized controlled trials found that 73% of interventions significantly increased colorectal cancer screening rates, particularly those using patient mailings and telephone outreach.

Tailoring information to patient preferences and considering community-level factors were key strategies that contributed to the success of these interventions in improving screening rates among multi-ethnic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based colorectal cancer screening trials with multi-ethnic groups: a systematic review. Morrow, JB., Dallo, FJ., Julka, M.[2021]

A network meta-analysis of 21 randomized controlled trials involving over 281,000 participants found that aspirin is the only chemopreventive agent effective in reducing long-term colorectal cancer (CRC) incidence and mortality, with protective effects observed at various doses.

Low-dose aspirin (75-325 mg/day) not only showed significant protective effects against CRC but also provided the highest net survival gain when considering risks of CRC mortality, cardiovascular disease, and gastrointestinal bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of chemopreventive agents on colorectal cancer incidence and mortality: systematic review and network meta-analysis. Veettil, SK., Jinatongthai, P., Nathisuwan, S., et al.[2022]

Mass screening for colorectal cancer in average-risk adults aged 50 and older is crucial, with fecal occult blood tests and flexible sigmoidoscopy being the most supported methods for effective screening.

While aspirin and certain anti-inflammatory drugs can reduce the risk of colorectal cancer, their use is limited by potential side effects like gastrointestinal bleeding, highlighting the need for careful consideration in prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer: a summary of the evidence for screening and prevention. Wilkins, T., Reynolds, PL.[2015]

In a study of 9,641 adults from Alberta's Tomorrow Project, only one-third of participants at average risk for colorectal cancer (CRC) were up-to-date with screening recommendations at baseline, indicating a significant gap in adherence to screening guidelines.

Higher-risk groups, particularly those with a family or personal history of bowel conditions, showed much better adherence to screening, with over 90% up-to-date, suggesting that targeted interventions may be needed to improve screening rates among average-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and predictors of adherence to colorectal cancer screening recommendations in Alberta's Tomorrow Project participants stratified by risk. Solbak, NM., Xu, JY., Vena, JE., et al.[2022]

A personally tailored interactive multimedia computer program (IMCP) significantly improved self-efficacy for colorectal cancer (CRC) screening and increased readiness for screening among 49 participants in a pilot trial.

Compared to a non-tailored control, the tailored IMCP showed promise in reducing perceived barriers to screening, suggesting that personalized approaches could enhance CRC screening uptake in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a tailored interactive multimedia computer program on determinants of colorectal cancer screening: a randomized controlled pilot study in physician offices. Jerant, A., Kravitz, RL., Rooney, M., et al.[2018]

Organized and population-based systems, such as mass mailing of fecal immunochemical tests (FITs), can effectively increase colorectal cancer screening rates in specific regions or health systems.

Patients can safely continue using aspirin, NSAIDs, anti-platelet agents, or anti-coagulants while collecting fecal samples for testing, which enhances convenience and reduces the risk of adverse cardiovascular events associated with stopping these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: It's time to make organized colorectal cancer screening convenient and easy for patients. Levin, TR.[2009]

A systematic review of 2,790 mobile health apps found 20 that could potentially improve colorectal cancer (CRC) screening uptake, but most were primarily informational and focused mainly on colonoscopies.

Despite the availability of these apps, there is a lack of empirical evidence on their effectiveness and usability, highlighting the need for future research to assess their content and impact on CRC screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Colorectal Cancer Screening-Related Apps. Jiang, Z., Hussain, A., Grell, J., et al.[2023]

A controlled trial involving 443 participants tested a combined intervention of a patient decision aid and practice-level support to increase colorectal cancer (CRC) screening rates, showing a modest increase in screening from 32.2% in usual care to 39% in the intervention group.

The intervention was particularly more effective for participants with higher incomes, suggesting that socioeconomic factors may influence the success of CRC screening interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Pignone, M., Winquist, A., Schild, LA., et al.[2021]

In a study involving 60,332 Vietnam-era veterans, various delivery methods for colorectal cancer screening (CRCS) interventions showed a combined increase in screening rates by 7% compared to controls, indicating that stepped interventions can be effective overall.

While individual interventions (like letters and phone calls) did not show statistically significant differences in CRCS rates, the cumulative effect of the interventions demonstrated a significant improvement in screening participation, highlighting the potential of multi-faceted approaches in increasing CRCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans. Vernon, SW., Del Junco, DJ., Coan, SP., et al.[2022]

The STOP CRC study is a large-scale trial involving 26 clinics aimed at improving colorectal cancer screening rates through an automated program that identifies eligible patients and mails them fecal immunochemical testing (FIT) kits.

If successful, this intervention could serve as a cost-effective and scalable model to increase screening rates, particularly in populations with historically low participation in colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial. Coronado, GD., Vollmer, WM., Petrik, A., et al.[2022]

Citations

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The effectiveness of mobile health intervention in colorectal ...

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Study Details | NCT06192862 | Effectiveness of Using ...

Despite the subsidy and promotion, the uptake rate of the population-based colorectal cancer screening was low. Only 275,000 (~10%) underwent FIT screening ...

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A Systematic Review and Meta-Analysis - PMC

This study showed that mHealth is associated with increased CRC screening participation regardless of the type of intervention used.

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jamanetwork.com/journals/jamanetworkopen/fullarticle/2831644

Mailed Outreach and Patient Navigation for Colorectal ...

A mailed FIT outreach and patient navigation program led to a significant 7.3–percentage point increase in colorectal cancer (CRC) screening over usual care.

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journals.plos.org

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Our findings show that digital tools can significantly improve screening rates, especially when paired with personal support such as patient navigators or ...

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Centralized Colorectal Cancer Screening Outreach in ...

The findings of this study suggest that centralized mailed fecal immunochemical testing outreach can substantially improve CRC screening in diverse patient ...