Telehealth Screening Solutions for Colorectal Cancer

(PRIME Trial)

Overseen By Gloria Coronado, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Colorectal disease, Cancer, End-stage diseases, others

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

Compensation: Varies

Number of Visits: Unknown

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve colorectal cancer screening through telehealth solutions. It will test whether sending tailored video messages, mailing home screening kits (known as Fecal Immunochemical Test or FIT Kit), and offering help with social needs can boost screening rates compared to usual in-clinic visits. People who haven't had recent colorectal cancer screening, are aged 45-64, and are current patients of the clinic may be a good fit. Participants should also speak English or Spanish, have a mobile phone listed in their health record, and live in certain neighborhoods.

As an unphased trial, this study offers a unique opportunity to contribute to innovative screening methods that could benefit future patients.

Do I need to stop my current medications for this trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that sending video text messages and mailing fecal immunochemical tests (FIT) effectively encourage colorectal cancer screening. Studies have found that people generally receive this method well. It involves sending short videos and reminders, which are usually easy to manage. No major reports of negative effects have emerged from this approach.

Furthermore, using digital tools to guide patients through the screening process is considered safe and can increase screening completion rates. Overall, the methods tested in this trial, such as mailed FITs and video messaging, have been used safely in other contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these telehealth screening solutions for colorectal cancer because they aim to make screening more accessible and convenient, especially for those who might face barriers to traditional in-clinic methods. Unlike standard in-person screenings, this approach uses video text messages and mailed fecal immunochemical tests (FIT) to engage patients right at home. Additionally, it incorporates social needs navigation, which addresses non-medical barriers that might prevent someone from getting screened. This comprehensive, patient-centered strategy could increase screening rates and early detection, ultimately saving lives.

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

This trial will compare usual care with an intervention that includes video text messages, mailed FIT, and social needs navigation. Research has shown that mailing fecal immunochemical tests (FIT) and assisting patients with navigation significantly increases colorectal cancer (CRC) screening rates. Specifically, one study found a 7.3% increase in screening compared to regular care. Video text messages educate patients about preventive care, encouraging them to get screened. Text reminders, particularly those with videos, further enhance the likelihood of completing CRC screenings. Together, these methods provide a strong, evidence-based approach to increasing CRC screenings. ^{4 5 6 7 8}

Who Is on the Research Team?

Anne Escaron, PhD

Principal Investigator

AltaMed Health Services Corporation

Are You a Good Fit for This Trial?

This trial is for individuals aged 45-64 who are due for colorectal cancer screening, have visited the clinic in the past 6 months, speak English or Spanish, live in certain neighborhoods part of the study, and have a cell phone listed in their health records. Those with recent CRC screenings can't join.

Inclusion Criteria

Current patients (seen in the clinic in the last 6 months)

Resides in one of the neighborhoods included in the main trial

Cell phone listed in Electronic Health Record (EHR)

Exclusion Criteria

I have a history of colorectal disease such as ulcerative colitis or have had a colectomy.

Patients who decline research participation will be removed from the patient contact list

End-stage or life-threatening diseases

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive video text messages, mailed FIT kits, and patient navigation to improve CRC screening

6 months

Ongoing virtual interactions

Follow-up

Participants are monitored for completion of follow-up colonoscopy after abnormal FIT results

12 months

What Are the Treatments Tested in This Trial?

Interventions

• In-clinic CRC screening promotion
• Mailed FIT
• Reminders
• Social needs navigation
• Video text message

Trial Overview The trial tests a multi-level intervention to increase colorectal cancer screening rates. It includes promoting screenings at clinics, mailing fecal immunochemical test (FIT) kits to people's homes, sending reminders and video text messages about screening importance, and helping with social needs that may affect health care access.

How Is the Trial Designed?

Group I: Video text message, mailed FIT, and social needs navigation Experimental Treatment 3 Interventions

Tailored video text message, mailed FIT, and navigation to address patients' social needs.

Group II: Usual care Active Control 2 Interventions

Colorectal cancer (CRC) screening offers during in-person clinic visits.

In-clinic CRC screening promotion is already approved in United States, European Union for the following indications:

Approved in United States as CRC Screening Promotion for:

• Colorectal Cancer Screening

Approved in European Union as CRC Screening Intervention for:

• Colorectal Cancer Screening

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

AltaMed Health Services Corporation

Collaborator

Trials

11

Recruited

37,700+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

Published Research Related to This Trial

The PRECISE clinical trial aims to improve follow-up colonoscopy adherence among patients with positive fecal immunochemical tests (FIT) by using patient navigation, targeting those less likely to complete the procedure on their own.

This trial will assess the effectiveness and cost-effectiveness of patient navigation in increasing colonoscopy completion rates within one year, involving a diverse patient population, including 37% Latino individuals, to ensure broad applicability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers. Coronado, GD., Johnson, ES., Leo, MC., et al.[2021]

In a study involving 415 patients aged 50 to 75 with abnormal FIT results, patient navigation significantly improved follow-up colonoscopy completion rates, with 76% adherence in the navigation group compared to 65% in usual care.

The use of a predictive risk model to identify patients less likely to complete colonoscopy allowed targeted navigation, demonstrating a promising strategy to enhance adherence to colorectal cancer screening protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Patient Navigation to Improve Rates of Follow-up Colonoscopy, An Individual Randomized Effectiveness Trial. Coronado, GD., Rawlings, AM., Petrik, AF., et al.[2023]

Colorectal cancer screening significantly reduces mortality, yet adherence rates are low, falling short of the National Colorectal Cancer Roundtable's goal of 80%.

Various interventions, such as outreach programs, navigation assistance, patient and provider education, reminders, and financial incentives, have been shown to effectively increase screening uptake, with offering a choice of screening strategies leading to higher adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Multilevel Interventions Do We Need to Increase the Colorectal Cancer Screening Rate to 80%? Inadomi, JM., Issaka, RB., Green, BB.[2022]

The combination of a colorectal cancer (CRC) screening decision aid and patient navigation significantly increased screening completion rates among vulnerable populations, with 68% of participants completing screening compared to only 27% in the usual care group.

This intervention was particularly effective for women, who showed a 50 percentage point increase in screening rates, highlighting the potential of tailored approaches to improve health outcomes in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial. Reuland, DS., Brenner, AT., Hoffman, R., et al.[2022]

A study involving 35,000 unscreened North Carolina Medicaid enrollees found that sending mailed reminders along with fecal immunochemical testing (FIT) kits significantly increased colorectal cancer screening rates, with 23.2% participation compared to 15.8% for reminders alone.

The reminder + FIT intervention was not only more effective but also cost-saving from the Medicaid/state perspective, demonstrating that this approach can efficiently enhance screening completion for colorectal cancer in underutilized populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cost-effectiveness of mailed fecal immunochemical testing (FIT)-based interventions for increasing colorectal cancer screening in the Medicaid population. Wheeler, SB., O'Leary, MC., Rhode, J., et al.[2023]

In a study of 500 participants, sending reminders via WhatsApp significantly improved adherence to colorectal cancer screening using the fecal immunochemical test (FIT), with pick-up rates increasing from 59.3% to 80.3% and return rates from 57.3% to 79.9%.

After a crossover intervention, the WhatsApp reminder group maintained higher adherence rates, demonstrating that mobile messaging can effectively enhance participation in FIT screening programs over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile messenger-initiated reminders improve longitudinal adherence in a community-based, opportunistic colorectal cancer screening program: A single-blind, crossover randomized controlled study. Lam, TYT., Wu, PI., Tang, RSY., et al.[2021]

The patient navigation program in France significantly increased colorectal cancer screening participation by 3.3%, with a notable effect among affluent individuals (+4.1%) compared to deprived individuals (+2.6%).

While the program was more effective for affluent participants, it highlighted increased social inequalities in screening adherence when applied broadly; thus, it is recommended to focus navigation efforts on deprived populations, even though this approach may incur higher costs per additional individual screened.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. De Mil, R., Guillaume, E., Guittet, L., et al.[2018]

A quality improvement project in West Texas showed that reminder methods, such as letters and phone calls, significantly increased the return rate of fecal immunochemical tests (FIT) for colorectal cancer screening from 61.52% to 71.85%.

While the project aimed for a 25% increase in return rates, it achieved a statistically significant increase of approximately 16.79%, with higher return rates observed among Black and Hispanic participants, indicating the effectiveness of targeted reminders in improving screening participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Fecal Immunochemical Test Return Rates by Implementing Effective "Reminder to Complete Kit" Communication With Participants: A Quality Improvement Study. Prakash, S., Merza, N., Hosseini, O., 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41042066/

Comparative Effectiveness of Text + Video vs Text Alone to ... Screening for CRC can be accomplished by mailed fecal immunochemical testing (FIT) outreach. Text-based mailed FIT outreach reminders have been ...

2. thepermanentejournal.org thepermanentejournal.org/doi/10.7812/TPP/25.069

Comparative Effectiveness of Text + Video vs Text Alone to ... Screening for CRC can be accomplished by mailed fecal immunochemical testing (FIT) outreach. Text-based mailed FIT outreach reminders have been ...

3. researchgate.net researchgate.net/publication/371164208_Video_text_messaging_is_needed_to_deliver_patient_education_about_preventive_care_in_the_United_States

(PDF) Video text messaging is needed to deliver patient ... Background Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131942/

Using Text Messages and Fotonovelas to Increase Return ... Texting using NLU and fotonovela is valuable in increasing CRC screening as observed by the FIT return rate for patients in the intervention group.

5. jamanetwork.com 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.

6. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000258

Video text messaging is needed to deliver patient education ... The program sends short (<1 min) animated videos for both English- and Spanish-speakers about the importance of colorectal cancer (CRC) ...

7. aacrjournals.org aacrjournals.org/cebp/article/33/4/525/742065/The-Reach-of-Calls-and-Text-Messages-for-Mailed

The Reach of Calls and Text Messages for Mailed FIT ... Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening participation. We assessed the reach and effectiveness of adding ...

8. formative.jmir.org formative.jmir.org/2024/1/e53224

The Development of a Digital Patient Navigation Tool to ... Recent studies support the efficacy of digital patient navigation, especially SMS text message navigation, to improve CRC screening uptake [20- ...