Automated Reminders for Colorectal Cancer Screening

Not currently recruiting at 3 trial locations

Overseen By Annella Nelson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Louisiana State University Health Sciences Center Shreveport

Disqualifiers: Cancer history, Up-to-date CRC screening, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people maintain their colorectal cancer screening routines, especially in rural areas with limited resources. It compares two approaches: one provides educational materials only, while the other includes automated call or text reminders about screenings. Individuals who have visited a participating health clinic in the past year, speak English, and are not up-to-date with their colorectal cancer screenings may be suitable for this study. As an unphased trial, it offers a unique opportunity to contribute to improving cancer screening adherence in underserved communities.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the trial focuses on reminders for colorectal cancer screening.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on promoting colorectal cancer screening and does not mention medication changes.

What prior data suggests that these automated reminders are safe for promoting CRC screening?

Research shows that automated call or text reminders safely help people remember to complete colorectal cancer screenings. Although specific safety data for these reminders is lacking, they are widely used in healthcare. These reminders function like appointment notifications via text or call.

Studies have found that reminders, such as phone calls and letters, are common in healthcare and usually don't cause harm. Automated reminders serve as another tool to help people maintain their health routines. While live phone calls can sometimes be more effective, automated texts and calls remain helpful and safe.

No reports of negative side effects have emerged from using automated reminders for health screenings, suggesting that people generally handle them well. Prospective participants in studies using these reminders can feel confident in their safety, based on their current use in healthcare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to boost colorectal cancer (CRC) screening rates. Unlike traditional approaches that rely on patients remembering to schedule and attend screenings on their own, this trial uses automated reminders via calls and texts to nudge patients toward getting screened. By incorporating health literacy-appropriate educational materials and shared decision-making into the process, this approach aims to make the screening process easier and more accessible. This could lead to increased screening rates and earlier detection of CRC, potentially improving outcomes for many patients.

What evidence suggests that this trial's treatments could be effective for colorectal cancer screening?

Research has shown that automated calls and texts can increase participation in colorectal cancer screening. In this trial, participants in the PRIME CRC arm will receive these automated reminders to encourage screening. These reminders keep the screening on patients' minds, leading to higher screening rates. For example, automated calls are especially effective for older patients. Text message reminders also boost participation, though they might not be as effective if used alone. Overall, these strategies encourage more people to complete their screening tests, which is important for early detection of colorectal cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Connie L Arnold, PhD

Principal Investigator

LSU Health Sciences Center Shreveport

Are You a Good Fit for This Trial?

The PRIME-CRC Trial is for English-speaking individuals aged 45 to 75 who have visited participating rural health clinics in the past year. It's not for those up-to-date with CRC screening, very ill patients, or those with cognitive impairments, significant hearing or vision issues, a family history requiring different screening due to risk factors, or a history of cancer other than non-melanoma skin cancer.

Inclusion Criteria

English-speaking

Have been a patient at one of the participating FQHCs with at least one prior visit in the past 12 months

I am between 45 and 75 years old.

Exclusion Criteria

Have a documented or uncorrectable cognitive, hearing, or visual impairment

Are up-to-date with CRC screening according to USPSTF guidelines (FOBT in less than a year, sigmoidoscopy less than 5 years, or colonoscopy less than 10 years)

I am too sick to take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive patient-centered reminders and health literacy education to promote CRC screening adherence via colonoscopy or annual FIT

3 years

Frequent follow-up contact via automated call or SMS text

Follow-up

Participants are monitored for completion of CRC screening and adherence to screening guidelines

3 years

What Are the Treatments Tested in This Trial?

Interventions

• automated call reminders or automated texts
• health literacy appropriate education and demonstration
• shared decision making

Trial Overview

This trial tests an educational program designed to help people in rural areas stick with colorectal cancer (CRC) screenings over time. One group gets enhanced usual care; the other also receives automated calls or texts as reminders about test preparations and follow-ups.

How Is the Trial Designed?

Group I: Enhanced Usual Care Active Control 2 Interventions

Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will receive no reminder calls.

Group II: PRIME CRC Active Control 3 Interventions

Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will also receive automated reminder calls and texts for both screening options to encourage screening.

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center Shreveport

Lead Sponsor

Trials

52

Recruited

19,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Low-literacy, wordless instructions for completing the fecal immunochemical test (FIT) were developed and tested, showing a preference among Spanish-speaking patients over traditional lengthy instructions.

The study suggests that these simplified instructions could improve colorectal cancer screening rates in low-literacy and non-English-speaking populations, highlighting the importance of accessible health communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of wordless instructions on how to complete a fecal immunochemical test: lessons from patient advisory council members of a federally qualified health center. Coronado, GD., Sanchez, J., Petrik, A., et al.[2021]

In a study involving 263 participants aged 50-74, over half had limited health literacy, yet most were able to complete computer-based educational programs on colorectal cancer screening without assistance, indicating the potential of such tools for patient education.

Participants reported learning more from the computer programs than from traditional brochures, suggesting that computer-assisted instruction could effectively enhance understanding, especially for those with varying literacy levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy and computer-assisted instruction: usability and patient preference. Duren-Winfield, V., Onsomu, EO., Case, DL., et al.[2018]

Most web-based patient education materials on colorectal cancer screening are written at a reading level above the recommended sixth-grade level, making them difficult for many patients to understand.

The materials often lack important health content, such as addressing specific risks for high-risk groups and common barriers to screening, which could hinder patient engagement and screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readability, suitability, and health content assessment of web-based patient education materials on colorectal cancer screening. Tian, C., Champlin, S., Mackert, M., et al.[2022]

In a study of 1013 insured adults aged 40-70, low health literacy was linked to negative attitudes towards healthcare, such as avoiding doctor's visits and having fatalistic views about cancer, which may hinder engagement in cancer prevention and screening activities.

Adults with low health literacy were less likely to be up to date on colorectal cancer screening, although this difference was not statistically significant, suggesting a potential barrier to effective cancer prevention in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between health literacy and cancer-related attitudes, behaviors, and knowledge. Morris, NS., Field, TS., Wagner, JL., et al.[2022]

A computer-based decision aid was developed and tested with 81 participants, showing it effectively improved knowledge about colorectal cancer screening and reduced decisional conflict for individuals with varying health literacy levels.

The decision aid was found to be acceptable and comprehensible, particularly benefiting those with low health literacy, although further enhancements are needed to improve usability for all users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot-testing of a colorectal cancer screening decision aid for individuals with varying health literacy levels. Woudstra, AJ., Smets, EMA., Dekker, E., et al.[2020]

A study of 73 colonoscopy patients revealed a significant knowledge gap regarding colon cancer concepts, with baseline literacy scores averaging only 53%.

After a multimedia educational intervention, participants' literacy scores improved dramatically to 88%, indicating that such educational strategies are effective and well-received by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multimedia-based educational intervention for improving colon cancer literacy in screening colonoscopy patients. Hassinger, JP., Holubar, SD., Pendlimari, R., et al.[2010]

Both individuals with low health literacy (HL) and those with adequate HL showed suboptimal informed decision-making regarding colorectal cancer (CRC) screening, with only 57% identified as informed decision-makers in the study of 141 participants.

Participants with low HL experienced significantly more decisional conflict compared to those with adequate HL, indicating a need for improved communication strategies to enhance understanding and participation in CRC screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and Informed Decision-Making about Population-Based Colorectal Cancer Screening Participation in Groups with Low and Adequate Health Literacy. Essink-Bot, ML., Dekker, E., Timmermans, DR., et al.[2022]

Patients aged 50 and older with limited health literacy were significantly less knowledgeable about colorectal cancer (CRC) screening tests, with only 50% able to name or describe a test compared to 96% of those with adequate literacy (p < 0.01).

Despite the knowledge gap, self-reported CRC screening rates were similar between patients with limited literacy (54%) and those with adequate literacy (58%), suggesting that low literacy may not directly affect the actual receipt of screening, but it does impact understanding of the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of health literacy on knowledge and receipt of colorectal cancer screening: a survey study. Miller, DP., Brownlee, CD., McCoy, TP., et al.[2022]

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