Education + Patient Navigation for Cancer Screening

(NYC CONNECT Trial)

Recruiting at 1 trial location

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

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. 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 data supports the effectiveness of the treatment Education + Patient Navigation for Cancer Screening?

Research shows that patient navigation programs can improve cancer screening rates, especially in underserved populations, by helping individuals overcome barriers to receiving recommended care. These programs provide logistical and emotional support, which can lead to better health outcomes and increased patient satisfaction. ^{1 2 3 4 5}

Is patient navigation for cancer screening safe for humans?

The research does not specifically mention any safety concerns related to patient navigation for cancer screening, suggesting it is generally considered safe for humans. ^{1 3 4 5 6}

How is the Patient Navigation treatment for cancer screening different from other treatments?

Patient Navigation (PN) is unique because it focuses on guiding patients through the healthcare system to improve cancer screening, especially for underserved populations. Unlike traditional treatments that directly target cancer, PN helps eliminate barriers to accessing care, ensuring patients receive recommended screenings and follow-up care. ^{1 3 6 7 8}

What is the purpose of this trial?

NYC CONNECT will carry out a randomized controlled trial (RCT) which will assess the relative effectiveness of two evidence-based strategies to increase cancer screening rates for breast, cervical, and colorectal cancer. The RCT will compare the effectiveness of using a combination of 1) culturally and linguistically tailored cancer education materials and 2) community health workers (CHWs) to provide navigation services for cancer screening (the "patient navigation" \[PN\] arm) versus providing culturally and linguistically tailored cancer education only (the "less intensive" \[LI\] arm). The study population will include individuals who are due for breast, cervical, or colorectal cancer screening. All individuals recruited to the study will be provided navigation for unmet social determinants of health (SDH) needs.

Research Team

Chau Trinh, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

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

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)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England 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. [2022]

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

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

Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care. [2021]

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

Patient navigation for breast and colorectal cancer treatment: a randomized trial. [2021]

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

Patient Navigation in Cancer: The Business Case to Support Clinical Needs. [2022]

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

An Exploration of Patient Navigation and Community Health Worker Activities Across National Comprehensive Cancer Control Programs. [2020]

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

A national patient navigator training program. [2021]