Proactive Screening Outreach for Colorectal Cancer

(PROOF Trial)

Enrolling by invitation at 1 trial location

Overseen By Aasma Shaukat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Colorectal cancer, Inflammatory bowel disease, 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?

The trial aims to improve colorectal cancer screening rates in Brooklyn by mailing Fecal Immunochemical Tests (FIT), which are easy-to-use tests that can detect signs of colorectal cancer. This proactive screening outreach compares the effectiveness of this approach to standard care, where screenings occur during regular doctor visits. The trial targets individuals aged 45-75 who receive medical care at specific clinics in Brooklyn and are due or overdue for colorectal cancer screenings. As an unphased trial, it offers participants the opportunity to contribute to innovative screening methods that could enhance early detection and prevention strategies.

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 prior data suggests that this proactive screening outreach is safe?

Research has shown that the fecal immunochemical test (FIT), sent to homes for colorectal cancer screening, is safe to use. The US Preventive Services Task Force recommends this test. It is a simple at-home test that checks for blood in stool. No major safety concerns have been reported with FIT use. Most people find it easy to use because it doesn't involve invasive procedures. Mailing the FIT has effectively increased screening rates without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Proactive Screening Outreach approach for colorectal cancer because it aims to increase early detection through a novel method. Unlike the standard practice, which relies on opportunistic screening during doctor visits, this method proactively mails Fecal Immunochemical Tests (FIT) directly to participants. This approach could significantly boost screening rates by making it easier and more convenient for people to get tested. By catching colorectal cancer earlier, the hope is to improve outcomes and save lives.

What evidence suggests that proactive screening outreach is effective for boosting colorectal cancer screening rates?

Research has shown that mailing Fecal Immunochemical Tests (FIT) can significantly increase colorectal cancer screening rates. In this trial, participants in the Proactive Screening Outreach arm will receive mailed FITs to encourage screening. One study found a 7.3% rise in screening rates compared to regular methods. Another study demonstrated that using electronic health records to manage these mailings improved test completion and overall screening rates. Mailed FIT programs have also successfully boosted screening in low-income communities. These findings suggest that proactive outreach effectively encourages more people to get screened for colorectal cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Aasma Shaukat

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for men and women aged 45-75 who are patients or providers at specific clinics in Brooklyn, NY. They must be due or overdue for colorectal cancer screening and have had a medical visit within the past year. Primary caregivers at these clinics can also participate.

Inclusion Criteria

Patients with a medical visit of any type at clinic in the past year

Providers who provide care to CRC screen-eligible patients

Patients receiving medical care at NYULH Flatbush FHC and CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites

Exclusion Criteria

Patients in hospice care

Patients with no address or phone number on file

Providers: No longer employed at an included clinic site

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Proactive Outreach

Participants receive proactive outreach of mailed Fecal Immunochemical Tests (FIT) to screen for colorectal cancer

8 weeks

Follow-up

Participants are monitored for completion of FIT and any subsequent actions required

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Proactive Screening Outreach

Trial Overview The study aims to increase colorectal cancer screening rates among underserved communities by sending out Fecal Immunochemical Tests (FIT) proactively through mail, with strategies tailored to meet the population's needs.

How Is the Trial Designed?

Group I: Proactive Screening Outreach Experimental Treatment 1 Intervention

Participants assigned to the interventional arm will receive proactive outreach of mailed Fecal Immunochemical Tests (FIT) to screen for colorectal cancer.

Group II: Standard of Care Active Control 1 Intervention

Participants assigned to the standard of care group will receive usual care (i.e., opportunistic screening for colorectal cancer).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

The implementation of the PRO-CTCAE for patient-reported outcomes in a multicenter trial for rectal cancer showed high compliance rates, with 92% of expected assessments completed, indicating that patients can effectively report their symptoms from home.

Centralized backup calls significantly improved data capture, demonstrating that this method can enhance the feasibility of collecting patient-reported outcomes in clinical research with minimal administrative burden on site staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048. Basch, E., Dueck, AC., Rogak, LJ., et al.[2019]

The outreach program significantly increased colorectal cancer screening rates, with 45% of unscreened members completing screening after receiving an interactive voice response call and mailed fecal immunochemical test (FIT), resulting in a hazard ratio of 4.08 for screening completion.

The program was particularly effective for individuals without recent primary or specialty care visits, highlighting the need for targeted strategies to improve screening rates among underrepresented groups, such as African Americans and Hispanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated phone and mail population outreach to promote colorectal cancer screening. Kempe, KL., Shetterly, SM., France, EK., et al.[2022]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

A systematic method was developed to create a Patient Reported Outcome (PRO) questionnaire specifically for monitoring adverse events in metastatic prostate cancer patients undergoing treatment, based on data from multiple sources including FDA and EMA summaries, clinical trials, and patient interviews.

The resulting questionnaire, which includes 25 symptoms and 46 questions, was found to be useful and acceptable by patients, indicating its potential effectiveness in capturing adverse event information during oncologic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of PRO in adverse event identification during cancer therapy - choosing the right questions to ask. Nissen, A., Bager, L., Pappot, H.[2019]

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]

Patient forums can significantly enhance pharmacovigilance by providing real-time, uncensored reports of adverse drug events (ADEs) for rare cancers, as demonstrated in a case study on Gastrointestinal Stromal Tumor patients.

Using machine learning algorithms, the study identified that certain side effects, like cognitive impairment and alopecia from avapritinib, were reported at different rates compared to clinical trials, highlighting the potential of patient forums to uncover long-term and novel ADEs not previously documented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers. Dirkson, A., Verberne, S., Kraaij, W., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11915063/

Mailed Outreach and Patient Navigation for Colorectal Cancer ... 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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S155171442500309X

A randomized clinical trial of multi-level intervention to ... The primary outcome is CRC screening completion (FIT or colonoscopy) within six months. Secondary outcomes include colonoscopy follow-up after a ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2695511

Effectiveness of a Mailed Colorectal Cancer Screening ... An EHR-embedded mailed FIT outreach intervention significantly improved rates of FIT completion and rates of any colorectal cancer screening.

4. research.kpchr.org research.kpchr.org/mailed-fit/Publications

Mailed FIT Outreach for Colorectal Cancer Screening Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial. Cancer ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35369

A pragmatic randomized trial of mailed fecal immunochemical ... A regional mailed FIT intervention was effective for increasing CRC screening rates across CHC systems serving diverse, low-income populations.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7523556/

Mailed Fecal Immunochemical Test Outreach for Colorectal ... The fecal immunochemical test (FIT) is an at-home test for blood in the stool recommended by the US Preventive Services Task Force and others to be utilized ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1542356521007539

Increased Colorectal Cancer Screening Sustained with ... Reports of mailed fecal immunochemical test (FIT) outreach effectiveness over time are minimal. We aimed to better evaluate a mailed FIT program with ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2652650

Effect of Colonoscopy Outreach vs Fecal Immunochemical ... Importance Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer ( ...

9. oncologynurseadvisor.com oncologynurseadvisor.com/news/colorectal-cancer-default-mailed-fit-kits-effective-screening-outreach/

Default Mailed FIT Kits Is Most Effective Colorectal Cancer ... Usual care default mailed fecal immunochemical test (FIT) outreach was the most effective strategy to promote colorectal cancer screening to ...