Proactive Screening Outreach for Colorectal Cancer

(PROOF Trial)

Recruiting 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

3000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Proactive Screening Outreach for Colorectal Cancer?

Research shows that mailed outreach, which involves sending stool blood test kits to people's homes, significantly increases the completion of colorectal cancer screening compared to usual care. This approach has been shown to improve screening rates by 28% and is particularly effective when combined with patient navigation and educational materials. ^{1 2 3 4 5}

Is Proactive Screening Outreach for Colorectal Cancer safe for humans?

The research articles focus on patient-reported outcomes and adverse event reporting in cancer treatments, highlighting the importance of patient perspectives in safety data collection. While they do not specifically address the safety of Proactive Screening Outreach for Colorectal Cancer, they emphasize the value of patient-reported data in understanding treatment risks and benefits. ^{6 7 8 9 10}

How is the Proactive Screening Outreach treatment for colorectal cancer different from other treatments?

Proactive Screening Outreach is unique because it involves actively reaching out to individuals, often through mail or phone, to encourage them to complete colorectal cancer screening tests at home, such as fecal occult blood tests (FOBT). This approach contrasts with traditional methods that rely on patients visiting healthcare providers for screening, and it has been shown to significantly increase screening rates. ^{1 4 11 12 13}

What is the purpose of this trial?

The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population.

Research Team

Aasma Shaukat

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Using tailored telephone counseling to accelerate the adoption of colorectal cancer screening. [2007]

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

Six years of occult blood screening in an urban public hospital: concepts, methods, and reflections on approaches to reducing avoidable mortality among black Americans. [2022]

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

Mailed Outreach Is Superior to Usual Care Alone for Colorectal Cancer Screening in the USA: A Systematic Review and Meta-analysis. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic Review of Interventions to Increase Stool Blood Colorectal Cancer Screening in African Americans. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

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

The use of PRO in adverse event identification during cancer therapy - choosing the right questions to ask. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities? [2022]

10. United States 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. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Two-year follow-up of the effectiveness of a multifaceted intervention to improve adherence to annual colorectal cancer screening in community health centers. [2022]

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

Automated phone and mail population outreach to promote colorectal cancer screening. [2022]

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

Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. [2021]