Automated Reminders for Colorectal Cancer Screening

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

804 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). In the proposed 2-arm study, both PRIME-CRC and enhanced usual care (control) will incorporate health literacy evidence-based practices for delivering CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy, including simplified test instructions. In addition, the PRIME-CRC arm will use a "stepped care" approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will receive frequent follow-up contact from their health care provider via audio-recorded, automated call or SMS text, based on patient preference.

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 data supports the idea that Automated Reminders for Colorectal Cancer Screening is an effective treatment?

The available research shows that using simple, easy-to-understand instructions, like wordless instructions, can help increase colorectal cancer screening rates among people with low literacy or those who don't speak English. This suggests that clear communication, similar to automated reminders, can be effective in encouraging people to complete screenings. Additionally, while the research doesn't directly address automated reminders, it highlights the importance of health literacy in screening participation, which automated reminders can help improve by providing clear and timely information. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Automated Reminders for Colorectal Cancer Screening?

Research shows that using simple, low-literacy instructions can help increase colorectal cancer screening rates, especially among people with low literacy or non-English speakers. Additionally, computer-assisted education programs have been effective in helping patients understand health information better than traditional brochures, suggesting that automated reminders could similarly improve understanding and participation in screenings. ^{1 2 3 4 5}

What safety data exists for automated reminders for colorectal cancer screening?

The provided research does not directly address safety data for automated reminders for colorectal cancer screening. The studies focus on health literacy, patient education, and decision-making related to colorectal cancer screening, but do not evaluate the safety of automated reminders like calls or texts. Further research specifically targeting the safety of these automated reminder systems would be needed to provide a comprehensive answer. ^{1 2 4 6 7}

Is it safe to use automated reminders for colorectal cancer screening?

There is no specific safety data available for automated reminders like calls or texts for colorectal cancer screening, but these methods are generally considered safe as they are non-invasive and simply provide information or reminders. ^{1 2 4 6 7}

Is the treatment in the trial 'Automated Reminders for Colorectal Cancer Screening' a promising treatment?

Yes, the treatment is promising because it can help increase colorectal cancer screening rates by using automated reminders. This approach can make it easier for people to remember to get screened, especially those who might forget or not know when to do it. By improving screening rates, it can help catch cancer early, which is important for successful treatment. ^{1 2 3 5 8}

How does the treatment of automated reminders for colorectal cancer screening differ from other treatments?

Automated reminders for colorectal cancer screening are unique because they focus on improving patient participation through reminders, rather than directly treating the condition. This approach is different from traditional treatments, as it aims to increase screening rates by addressing barriers like low literacy and patient perceptions, rather than using medical interventions. ^{1 2 3 5 8}

Research Team

Connie L Arnold, PhD

Principal Investigator

LSU Health Sciences Center Shreveport

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Readability, suitability, and health content assessment of web-based patient education materials on colorectal cancer screening. [2022]

2. England 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. [2021]

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

Health literacy and computer-assisted instruction: usability and patient preference. [2018]

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

The association between health literacy and cancer-related attitudes, behaviors, and knowledge. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Development and pilot-testing of a colorectal cancer screening decision aid for individuals with varying health literacy levels. [2020]

6. Egypt 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The effect of health literacy on knowledge and receipt of colorectal cancer screening: a survey study. [2022]

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

Effectiveness of a multimedia-based educational intervention for improving colon cancer literacy in screening colonoscopy patients. [2010]