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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test a new smartphone-based program designed to help African American men get screened for colorectal cancer (CRC). The main question it aims to answer is: ° Are African American men who complete the smartphone-based program more likely to get screened for colorectal cancer than men who do not? Participants will: * Complete a baseline survey asking about their colorectal cancer screening history and their thoughts and beliefs about colorectal cancer and the medical system. * Be randomized to receive the new smartphone-based program or to receive text messages containing colorectal cancer education materials designed by the Centers for Disease Control (CDC). The new program sends text messages with information about colorectal cancer. Some of these text messages have links to videos that try to help men overcome anything that may stand in the way of getting screened. * Complete a follow-up survey 6 months after the baseline survey. This survey will ask the same questions as the baseline survey. * A medical records review will be conducted at 6 months to verify whether participants received a colorectal cancer screening test during the study period. Researchers will compare participants who receive the new smartphone-based program to participants who receive the CDC information. The goal is to see whether the smartphone-based program increasing screening more than standard educational materials available on the internet.

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 data supports the effectiveness of the CRC mHealth treatment for colorectal cancer screening?

Research shows that mobile health (mHealth) interventions can effectively increase colorectal cancer screening rates. Studies have found that strategies like mailed outreach and patient navigation, which can be part of mHealth interventions, significantly improve screening adherence, especially in low-income and diverse populations. ^{1 2 3 4 5}

Is the CRC mHealth intervention safe for humans?

The research articles reviewed do not provide specific safety data for the CRC mHealth intervention or related mobile health applications for colorectal cancer screening. ^{6 7 8 9 10}

How does the CRC mHealth treatment for colorectal cancer screening differ from other treatments?

The CRC mHealth treatment is unique because it likely involves using mobile health technology to promote colorectal cancer screening, making it more accessible and convenient for patients. This approach may differ from traditional methods by leveraging digital tools to increase screening rates and adherence. ^{6 7 11 12 13}

Research Team

Samantha L Leaf, Ph.D.

Principal Investigator

ISA Associates

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Computer-delivered tailored intervention improves colon cancer screening knowledge and health beliefs of African-Americans. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. [2021]

4. Thailand pubmed.ncbi.nlm.nih.gov

Mobile health interventions for improving colorectal cancer screening rates: A systematic review and meta-analysis. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Community-based colorectal cancer screening trials with multi-ethnic groups: a systematic review. [2021]

6. Ireland 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Colorectal Cancer Screening-Related Apps. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of chemopreventive agents on colorectal cancer incidence and mortality: systematic review and network meta-analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Colorectal cancer: a summary of the evidence for screening and prevention. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Patterns and predictors of adherence to colorectal cancer screening recommendations in Alberta's Tomorrow Project participants stratified by risk. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial. [2022]