Education + Patient Navigation for Cancer Screening

(NYC CONNECT Trial)

Recruiting at 2 trial locations

Overseen By Perla Chebli, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cancer, Pregnancy, Hospice, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

2160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to boost cancer screening rates for breast, cervical, and colorectal cancers. Researchers are testing whether combining community health worker support (Patient Navigation Services) with customized educational materials is more effective than providing education alone. The trial seeks men and women who are due for cancer screenings and speak English, Spanish, Haitian-Creole, French, or Chinese. Participants should live in certain neighborhoods in New York City and have no prior cancer diagnosis.

As an unphased trial, this study offers participants the chance to contribute to innovative strategies that could enhance cancer screening rates in their communities.

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 seems focused on cancer screening and education, so it's unlikely that your medications will be affected, but you should confirm with the trial organizers.

What prior data suggests that these strategies are safe for increasing cancer screening rates?

Research shows that patient navigation programs are generally safe and easy for people to use. These programs involve community health workers who guide patients through the healthcare system, especially for cancer screenings like breast, cervical, and colorectal cancer.

Studies have found that these programs help patients complete their screenings more quickly and effectively. One study showed that patient navigation services assist patients in overcoming obstacles to getting necessary screenings, such as scheduling, insurance, and other non-medical issues.

These programs have been successfully used in different healthcare systems, indicating their safety in similar settings. No reports of safety concerns or negative effects have been directly linked to patient navigation services, making them a dependable option for supporting patients in their healthcare journey. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how patient navigation (PN), both less intensive and more intensive, can enhance cancer screening outcomes. Unlike traditional methods that often rely heavily on patients navigating the healthcare system alone, these PN approaches provide personalized support through community health workers (CHWs). The more intensive PN includes additional guidance on social services and culturally tailored education, which could improve access and adherence to cancer screening, especially in underserved communities. This trial aims to find out whether such comprehensive support can lead to better screening rates and earlier detection, potentially transforming how preventative care is delivered.

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

Research has shown that community health workers can significantly increase breast, cervical, and colorectal cancer screening rates. In this trial, participants in the Patient Navigation (PN) arm will receive navigation for cancer screening from community health workers, a method proven to help patients overcome obstacles and complete screenings on time. Specifically, low-income minority patients experienced a better quality of life with assistance from community health workers. Participants in the Less Intensive (LI) arm will receive culturally relevant educational materials, which also encourage screening. Together, these strategies effectively raise cancer screening rates, making them promising methods for improving early cancer detection. ^{1 5 6 7 8}

Who Is on the Research Team?

Chau Trinh, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English, Spanish, Haitian-Creole, or Chinese Mandarin speakers in specific NYC areas who are due for breast, cervical, or colorectal cancer screenings. Women should be 21-75 years old and men 50-75. Exclusions include those with total colectomy, current cancer navigation program participants, hospice care patients, certain advanced illnesses or long-term institution residents over 66 years old.

Inclusion Criteria

I am a woman aged 50-74 without recent mammogram, Pap smear, HPV test, or colorectal screening.

Lives in East Flatbush (zip codes: 11236, 11203, 11212); Sunset Park (zip codes: 11215, 11220, 11232); Highbridge (zip code 10452); or Morrisania (zip codes: 10456, 10459)

I am a man who is not current with my colorectal cancer screenings.

Exclusion Criteria

I am currently receiving hospice care.

I have had my entire colon removed due to colorectal cancer.

Pregnancy (breast and cervical cancer only)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive culturally and linguistically tailored cancer education and navigation services for cancer screening

6 months

Surveys at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for cancer screening completion and social service needs

4 weeks

Optional Extension

Participants in the LI arm may opt to receive full navigational support provided to the PN arm

What Are the Treatments Tested in This Trial?

Interventions

• Educational Materials
• Patient Navigation (PN) - Less Intensive
• Patient Navigation (PN) - More Intensive

Trial Overview The study compares two methods to increase cancer screening rates: one uses tailored educational materials plus community health worker-led patient navigation (PN), while the other provides just the educational materials (less intensive). Participants will also receive help for unmet social needs.

How Is the Trial Designed?

Group I: Patient Navigation (PN) Experimental Treatment 2 Interventions

Participants randomized to the PN arm will receive community health worker (CHW)-administered PN for cancer screening + social service needs + culturally and linguistically tailored cancer education. All individuals will complete a survey at baseline, 3 months, and 6 months.

Group II: Less Intensive (LI) Active Control 2 Interventions

Participants randomized to LI arm will receive PN to social service needs + culturally and linguistically tailored cancer education materials. All individuals will complete a survey at baseline, 3 months, and 6 months. Once a participant randomized to the LI arm completes the 6-month survey, they will have the option to receive all navigational support provided by CHWs to individuals randomized to the PN arm.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

A randomized clinical trial involving 1612 patients showed that patient navigation (PN) significantly improved cancer screening rates for breast, cervical, and colorectal cancers, with completion rates of 10.2% in the PN group compared to 6.8% in the control group.

The PN intervention was particularly effective, leading to higher screening completion rates across all cancer types: breast (23.4% vs 16.6%), cervical (14.4% vs 8.6%), and colorectal (13.7% vs 7.0%), indicating that integrating PN into healthcare can enhance cancer screening in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. Percac-Lima, S., Ashburner, JM., Zai, AH., et al.[2022]

A standardized national training program for patient navigators (PNs) was successfully implemented, attended by 116 PNs from 85 cities, aimed at reducing cancer health disparities for medically underserved populations.

The training showed significant efficacy, with overall improvements in posttest scores compared to pretest scores, particularly among participants with higher education levels or more work experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. Calhoun, EA., Whitley, EM., Esparza, A., et al.[2021]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

A significant majority (82%) of NCCCP action plans included activities related to patient navigators (PNs) and community health workers (CHWs), indicating a strong commitment to addressing health disparities in cancer care.

PNs were more frequently mentioned in these plans (83%) compared to CHWs (58%), with a focus on screening and survivorship, highlighting the importance of these roles in improving cancer prevention and control efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploration of Patient Navigation and Community Health Worker Activities Across National Comprehensive Cancer Control Programs. Rohan, EA., McDougall, R., Townsend, JS.[2020]

In a study of 438 cancer patients, patient navigation (PN) did not significantly improve overall treatment completion time, satisfaction with care, or psychological distress compared to usual care.

However, socially disadvantaged patients who received PN reported higher satisfaction with their care, indicating that PN may be beneficial for specific groups, despite no overall benefits observed in the primary analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for breast and colorectal cancer treatment: a randomized trial. Fiscella, K., Whitley, E., Hendren, S., et al.[2021]

Patient navigation (PN) programs in cancer care have been shown to improve patient retention and physician loyalty, which can lead to increased revenue for cancer programs.

PN also helps reduce unnecessary healthcare resource use, such as emergency visits and hospitalizations, while alleviating burdens on oncology providers, potentially decreasing burnout and staff turnover.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation in Cancer: The Business Case to Support Clinical Needs. Kline, RM., Rocque, GB., Rohan, EA., et al.[2022]

In a study involving 3,189 patients (1,995 with breast abnormalities and 1,194 with cervical abnormalities), the presence of barriers significantly delayed the time to diagnostic resolution, with adjusted hazard ratios of 0.744 for breast and 0.792 for cervical participants, indicating that barriers negatively impact timely care.

Patient navigators played a crucial role in addressing these barriers by arranging appointments, making referrals, and providing education, suggesting that effective navigation can enhance access to cancer care and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care. Katz, ML., Young, GS., Reiter, PL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5586005/

Use of Community Health Workers and Patient Navigators ... Our findings support the effectiveness of CHW/PN programs to improve completion and timeliness of breast, cervical, and colorectal cancer screening in FQHCs.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01723

Community Health Worker Navigation for Patients With ... Low-income minority patients with cancer randomly assigned to a community health worker intervention had significantly improved health related quality of life ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7573022/

Effectiveness of Patient Navigation to Increase Cancer ... The goal of this study is to evaluate the effectiveness of patient navigation services in increasing colorectal, breast, and cervical cancer screening rates in ...

4. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-patient-navigation-services-to-increase-breast-cancer-screening.html

Breast Cancer Screening: Patient Navigation Patient navigation services provided through healthcare systems help patients overcome barriers to accessing breast cancer screening.

5. womenspreventivehealth.org womenspreventivehealth.org/wp-content/uploads/Patient-Navigation-Evidence-Review-Nov-25-2024.pdf

Patient Navigation Services for Breast and Cervical Cancer ... Screening rates are lower for women seen in Federally Qualified Health Centers (FQHC) compared with the general U.S. population based on data ...

6. prescancerpanel.cancer.gov prescancerpanel.cancer.gov/reports-meetings/enhancing-patient-navigation-2024/executive-summary

Executive Summary - Enhancing Patient Navigation with ... Patient navigation has been proven to reduce cancer disparities—a critical problem facing the National Cancer Program—by addressing individual ...

7. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-patient-navigation-services-to-increase-colorectal-cancer-screening.html

Colorectal Cancer Screening: Patient Navigation Patient navigation services provided through healthcare systems help patients overcome barriers to accessing colorectal cancer screening.

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is effective in improving participation in cancer screening and reducing the time from screening to diagnosis and from ...