Cancer ScreeningNYC CONNECTNCT05742178
NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation
A study testing Patient Navigation (PN) - More Intensive, Educational Materials and Patient Navigation (PN) - Less Intensive in people with Cancer Screening, run by NYU Langone Health at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cancer Screening
- What is being tested?
- Patient Navigation (PN) - More Intensive, Educational Materials and Patient Navigation (PN) - Less Intensive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,160 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 21 and 75 years;
- Men between the ages of 45 and 75 years;
- Women (40-74 years) who have not had a mammogram in the past 12 months, a Pap smear in the last 3 years (21-64 years old) or HPV test in the last 5 years (30-64 years old), or women 45-75 years old who are not up-to-date on colorectal cancer screening (Fecal occult blood test (FOBT)/Fecal immunochemical test (FIT) past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
- Men not up-to-date on colorectal cancer screening (FOBT/FIT past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
- Must speak either English, Spanish, Haitian-Creole, French, or Chinese (Mandarin and Cantonese);
- Lives in East Flatbush (zip codes: 11236, 11203, 11212, 11226); Sunset Park (zip codes: 11215, 11220, 11232); Highbridge (zip code 10452, 10455, 10451); or Morrisania (zip codes: 10456, 10459)
Who cannot join
- Previous or current diagnosis of any cancer;
- Pregnancy (breast and cervical cancer only);
- Current participation in an existing cancer navigation program;
- Currently in hospice care;
- At least 66 years of age with advanced illness or frailty or who live in long-term institution for more than 90 days;
- Bilateral mastectomy or right and left unilateral mastectomy (breast cancer only);
- Hysterectomy with no residual cervix (cervical cancer only);
- Total colectomy (colorectal cancer only).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10461
Bruce Rapkin, 718-839-7453, bruce.rapkin@einsteinmed.org
About this study
Official title: NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation Randomized Controlled Trial (NYC CONNECT)
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.
- Conditions
- Cancer Screening
- Being tested
- Patient Navigation (PN) - More Intensive, Educational Materials, Patient Navigation (PN) - Less Intensive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation (PN) - More IntensiveBehavioural
The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for cancer screening status and social needs and provide navigational support to cancer screening and social services.
Educational MaterialsBehavioural
Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
Patient Navigation (PN) - Less IntensiveBehavioural
The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation (PN) | Experimental | 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. Receives: Behavioral: Patient Navigation (PN) - More Intensive; Behavioral: Educational Materials |
| Less Intensive (LI) | Active comparator | 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. Receives: Behavioral: Educational Materials; Behavioral: Patient Navigation (PN) - Less Intensive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment
Cancer screening defined as a breast, cervical, or colorectal cancer screening.
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start5 Jul 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Chau Trinh, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742178
- Sponsor's protocol ID
- 22-01516
- Acronym
- NYC CONNECT
- Status last verified
- Dec 2025
- First submitted
- 15 Feb 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Madison.LeCroy@nyulangone.org. Data will also be available for 5 years at a data repository, appropriately selected with the guidance of Nicole Contaxis, NYULH Data Catalog Coordinator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation Randomized Controlled Trial (NYC CONNECT)
- ClinicalTrials.gov ID
- NCT05742178
- Acronym / sponsor ID
- NYC CONNECT / 22-01516
- Conditions
- Cancer Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,160 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation (PN) | Experimental | Behavioral: Patient Navigation (PN) - More Intensive, Behavioral: Educational MaterialsParticipants 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. |
| Less Intensive (LI) | Active comparator | Behavioral: Educational Materials, Behavioral: Patient Navigation (PN) - Less IntensiveParticipants 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 may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women between the ages of 21 and 75 years;
- Men between the ages of 45 and 75 years;
- Women (40-74 years) who have not had a mammogram in the past 12 months, a Pap smear in the last 3 years (21-64 years old) or HPV test in the last 5 years (30-64 years old), or women 45-75 years old who are not up-to-date on colorectal cancer screening (Fecal occult blood test (FOBT)/Fecal immunochemical test (FIT) past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
- Men not up-to-date on colorectal cancer screening (FOBT/FIT past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
- Must speak either English, Spanish, Haitian-Creole, French, or Chinese (Mandarin and Cantonese);
Key exclusion criteria (8 listed)
- Previous or current diagnosis of any cancer;
- Pregnancy (breast and cervical cancer only);
- Current participation in an existing cancer navigation program;
- Currently in hospice care;
- At least 66 years of age with advanced illness or frailty or who live in long-term institution for more than 90 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigation (PN) - More IntensiveThe PN intervention will be administered by trained, bilingual CHWs: they will screen participants for cancer screening status and social needs and provide navigational support to cancer screening and social services. | Behavioural | Patient Navigation (PN) |
| Educational MaterialsBoth PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed. | Behavioural | Less Intensive (LI), Patient Navigation (PN) |
| Patient Navigation (PN) - Less IntensiveThe PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services. | Behavioural | Less Intensive (LI) |
Primary outcome
Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment
Time frame: Up to Month 6
Cancer screening defined as a breast, cervical, or colorectal cancer screening.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Madison.LeCroy@nyulangone.org. Data will also be available for 5 years at a data repository, appropriately selected with the guidance of Nicole Contaxis, NYULH Data Catalog Coordinator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chau Trinh, PhD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation (PN) - More Intensive, Educational Materials and Patient Navigation (PN) - Less Intensive in people with Cancer Screening, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chau Trinh-Shevrin, DrPH (646-501-3480, chau.trinh@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.