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?

Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

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 telehealth screening for colorectal cancer safe for humans?

The research articles do not provide specific safety data for telehealth screening solutions for colorectal cancer, but they focus on improving screening rates and follow-up procedures, which are generally considered safe practices. ^{1 2 3 4 5}

How is the Telehealth Screening Solutions for Colorectal Cancer treatment different from other treatments?

This treatment is unique because it combines telehealth methods like video text messaging and social needs navigation with mailed fecal immunochemical tests (FIT) and reminders to improve colorectal cancer screening adherence, especially in populations where screening is underused. It integrates multiple strategies to address both the logistical and social barriers to screening, which is not commonly seen in standard treatments. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment Telehealth Screening Solutions for Colorectal Cancer?

Research shows that patient navigation and mailed reminders can effectively increase adherence to colorectal cancer screening, especially in populations where screening is underused. These strategies help ensure that patients complete necessary follow-up procedures, like colonoscopies, after initial screenings. ^{1 4 5 8 9}

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

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]

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 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]

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]

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 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]

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]

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. United States 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. [2023]

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

What Multilevel Interventions Do We Need to Increase the Colorectal Cancer Screening Rate to 80%? [2022]

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

Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers. [2021]

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

Precision Patient Navigation to Improve Rates of Follow-up Colonoscopy, An Individual Randomized Effectiveness Trial. [2023]

5. United States 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. [2018]

6. United States 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. [2022]

7. United States 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. [2022]

8. United States 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. [2021]

9. 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]