NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation
ConditionCancer Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorNYU Langone Health
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Patient Navigation (PN) - More Intensive
BehavioralThe 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 Materials
BehavioralBoth PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
Patient Navigation (PN) - Less Intensive
BehavioralThe PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services.
Treatment groups
2,160 Participants
are divided into 2 treatment groupsGroup A: Patient Navigation (PN)Experimental treatment 2 interventions
Group B: Less Intensive (LI)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov