Colorectal Cancer ScreeningNCT07361614
Pilot Testing of a Colorectal Cancer Education Program
A study testing Educational Program in people with Colorectal Cancer Screening, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary objective of this study is to assess the feasibility, acceptability, and preliminary efficacy of a culturally and linguistically targeted, colorectal cancer (CRC) education program to improve CRC screening completion. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 31 Aug 2027
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-75 years
- Not guideline concordant (no stool testing for CRC within past 1 year)
- No colonoscopy in past 10 years; no sigmoidoscopy or CT colonography in past 5 years)
- Understands English or Chinese languages.
- Willing and able to consent to participate
Who cannot join
- 1) history of CRC or colectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
The primary objective of this study is to assess the feasibility, acceptability, and preliminary efficacy of a culturally and linguistically targeted, colorectal cancer (CRC) education program to improve CRC screening completion.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Educational Program
- Keywords
- CRC, Colorectal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ProgramBehavioural
Culturally and linguistically tailored program consisting of community health worker (CHW)-led education sessions followed by patient navigation (PN) services.
| Study group | Role | What they receive |
|---|---|---|
| Adults due for CRC screening who speak English or a Chinese language (Cantonese/Mandarin) | Experimental | Participants will receive one CRC educational session, which will take around 1-1.5 hours. Receives: Behavioral: Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening completion (yes/no)
Measured: Month 6
Secondary outcomes (4)
Change in Brief Illness Perception Questionnaire (IPQ-B) score
The IPQ-B is a 9-item questionnaire (validated in the Chinese population) that assesses CRC beliefs according to CRC beliefs according to SRM constructs (SRM) constructs. Each item is rated on a scale from 0 (strong disagree) to 10 (strongly agree). Total scores range from 0-90, with higher scores indicating a greater threat and worse perception of illness.
Measured: Baseline, Month 6
Change in Medicines Questionnaire (BMQ) score
The BMQ, validated in the Chinese population, adapted to assess concerns/necessity of CRC screening is a 5 items questionnaire. Items are assessed on a scale from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 5-25, with higher scores indicating positive beliefs about CRC screening.
Measured: Baseline, Month 6
Change in number of barriers to care
Participants re asked to select all that apply to barriers in care: Cost, Transportation, Lack of time, Fear of results, Embarrassment, Lack of trust in doctors, Language barriers, Other. Each item selected is counted, a decrease in the number of items selected indicates reduced barriers to care.
Measured: Baseline, Month 6
Change in trust in health/community health workers
Group-based medical mistrust scale consists of 2 statements of mistrust and 2 statements of trust. Each statement can be answered with 1) Strongly Disagree, 2) Disagree, 3) Neither Agree nor Disagree, 4) Agree, 5) Strongly Agree.
Measured: Baseline, 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 Jan 2026
- Study start5 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suzanne Vang, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361614
- Sponsor's protocol ID
- 25-01040
- Other IDs
- K01CA255411
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Apr 2026
- 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 will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to Suzanne.vang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of a Colorectal Cancer Education Program
- ClinicalTrials.gov ID
- NCT07361614
- Acronym / sponsor ID
- 25-01040
- Conditions
- Colorectal Cancer Screening
- Keywords
- CRC, Colorectal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
The primary objective of this study is to assess the feasibility, acceptability, and preliminary efficacy of a culturally and linguistically targeted, colorectal cancer (CRC) education program to improve CRC screening completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults due for CRC screening who speak English or a Chinese language (Cantonese/Mandarin) | Experimental | Behavioral: Educational ProgramParticipants will receive one CRC educational session, which will take around 1-1.5 hours. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 45-75 years
- Not guideline concordant (no stool testing for CRC within past 1 year)
- No colonoscopy in past 10 years; no sigmoidoscopy or CT colonography in past 5 years)
- Understands English or Chinese languages.
- Willing and able to consent to participate
Key exclusion criteria (1 listed)
- 1) history of CRC or colectomy
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 |
|---|---|---|
| Educational ProgramCulturally and linguistically tailored program consisting of community health worker (CHW)-led education sessions followed by patient navigation (PN) services. | Behavioural | Adults due for CRC screening who speak English or a Chinese language (Cantonese/Mandarin) |
Primary outcome
CRC screening completion (yes/no)
Time frame: Month 6
4 secondary outcomes
Change in Brief Illness Perception Questionnaire (IPQ-B) score
Time frame: Baseline, Month 6
Change in Medicines Questionnaire (BMQ) score
Time frame: Baseline, Month 6
Change in number of barriers to care
Time frame: Baseline, Month 6
Change in trust in health/community health workers
Time frame: Baseline, Month 6
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to Suzanne.vang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Suzanne Vang principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program in people with Colorectal Cancer Screening, run by NYU Langone Health at 1 site 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 5 inclusion and 1 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Angel Mui (646-501-3521, Angel.mui@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRC screening completion (yes/no) (time frame: 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 29 Apr 2026.