Colorectal CancerNCT03481296
Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients
A study testing Culturally-Adapted Decision Support Navigation Intervention in people with Colorectal Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
The objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Culturally-Adapted Decision Support Navigation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening
Who cannot join
- Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Official title: Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients
The objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients.
Read the detailed description
This study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 Chinese and Korean American men and 200 Chinese and Korean American women aged 50 to 75 eligible for colorectal cancer screening. Participants are recruited from primary care physician clinics. The study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. Those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. Those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. Investigators in the study develop an individualized screening plan using a theory-based online Decision Counseling Program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. Using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. Additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.
- Conditions
- Colorectal Cancer
- Being tested
- Advanced Control, Culturally-Adapted Decision Support Navigation Intervention
- Keywords
- Colorectal Cancer Screening, Asian Americans, Patient Navigation, Decision Counseling Program
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced ControlBehavioural
Participants receive linguistically and culturally tailored information booklet on colorectal cancer and colorectal cancer screening, colonoscopy instructions, stool blood test kits and reminder by mail. Participants' height, weight, and waist/hip circumference, blood pressure, blood glucose, and cholesterol levels will be measured by trained research staff. Participants will also receive the result of body measurements right away as a free service.
Culturally-Adapted Decision Support Navigation InterventionBehavioural
Participants in this group receive everything that advanced control group receives. In addition to a set of standard materials, they receive culturally and linguistically adapted decision counseling from the patient navigator. The patient navigator develops an individualized colorectal cancer screening plan using a theory-based online Decision Counseling Program. After the Program is completed, the patient navigator develops individualized colorectal cancer screening plan and shares the information with participants and participants' primary care physicians. Then, primary care physicians encourage the colorectal cancer screening to participants.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Control | Active comparator | The advanced control group receives a set of standard materials regarding colorectal cancer screening. Receives: Behavioral: Advanced Control |
| Culturally Adapted Decision Support Navigation Intervention | Experimental | The culturally adapted decision support navigation intervention group receives everything advanced group receives as well as decision support and navigation contacts. Receives: Behavioral: Culturally-Adapted Decision Support Navigation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer screening adherence at 6 months by medical record review
Measure overall colorectal cancer screening adherence at 6 months by medical record review.
Measured: 6 months
Colorectal cancer screening adherence at 6 months by self-report
Measure overall colorectal cancer screening adherence at 6 months by self-report during 6-month survey (by phone).
Measured: 6 months
Overall colorectal cancer screening adherence at 12 months by medical record review
Measure overall colorectal cancer screening adherence at 12 months by medical record review.
Measured: 12 months
Overall colorectal cancer screening adherence at 12 months by self-report
Measure overall colorectal cancer screening adherence at 12 months by self-report (by phone interview).
Measured: 12 months
Colorectal cancer screening decision stage at baseline (Stool Blood Test)
Measure colorectal cancer screening decision stage for stool blood test at baseline.
Measured: Baseline
Colorectal cancer screening decision stage at 6-months (Stool Blood Test)
Measure colorectal cancer screening decision stage for stool blood test at 6 months.
Measured: 6 months
Change in colorectal cancer screening decision stage between baseline and 6 months (Stool Blood Test)
Measure change in colorectal cancer screening decision stage for stool blood test between baseline and 6 months.
Measured: Baseline and 6 months
Colorectal cancer screening decision stage at baseline (Colonoscopy)
Measure colorectal cancer screening decision stage for colonoscopy at baseline.
Measured: Baseline
Colorectal cancer screening decision stage at 6 months (Colonoscopy)
Measure colorectal cancer screening decision stage for colonoscopy at 6 months.
Measured: 6 months
Change in colorectal cancer screening decision stage between baseline and 6 months (Colonoscopy)
Measure change in colorectal cancer screening decision stage for colonoscopy between baseline and 6 months.
Measured: Baseline and 6 months
Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test)
Measure the fraction of participants who undergo a stool blood test at 6 months.
Measured: 6 months
Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)
Measure the fraction of participants who undergo a colonoscopy at 6 months.
Measured: 6 months
Colorectal cancer screening test-specific adherence at 12 months (Stool Blood Test)
Measure the fraction of participants who undergo a stool blood test at 12 months.
Measured: 12 months
Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy)
Measure the fraction of participants who undergo a colonoscopy at 12 months.
Measured: 12 months
Secondary outcomes (3)
Knowledge about colorectal cancer and colorectal cancer screening (Baseline)
Measure knowledge about colorectal cancer and colorectal cancer screening at baseline.
Measured: Baseline
Knowledge about colorectal cancer and colorectal cancer screening (6 months)
Measure knowledge about colorectal cancer and colorectal cancer screening at 6 months.
Measured: 6 months
Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months
Measure change in knowledge score about colorectal cancer and colorectal cancer screening between baseline and 6 months.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start20 Aug 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Thomas Jefferson University, University of Maryland, College Park
- Responsible party
- Principal investigator, Sunmin Lee, University of California, Irvine
- Investigators
- Sunmin Lee, ScD, Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481296
- Sponsor's protocol ID
- R01MD012778 [2020-5953]
- Other IDs
- 1R01MD012778-01A1
- Status last verified
- Jun 2023
- First submitted
- 2 Mar 2018
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morey BN, Shi Y, Ryu S, Redline S, Kawachi I, Park HW, Lee S. Risk of sleep apnea associated with higher blood pressure among Chinese and Korean Americans. Ethn Health. 2024 Apr;29(3):295-308. doi: 10.1080/13557858.2024.2311417. Epub 2024 Feb 2.
PubMed 38303653Morey BN, Ryu S, Shi Y, Lee S. The Mediating Role of Sleep Disturbance on the Association Between Stress and Self-Rated Health Among Chinese and Korean Immigrant Americans. Prev Chronic Dis. 2023 Jan 26;20:E04. doi: 10.5888/pcd20.220241.
PubMed 36701271Lee S, Ryu S, Lee GE, Redline S, Morey BN. Risk of Sleep Apnea Is Associated with Abdominal Obesity Among Asian Americans: Comparing Waist-to-Hip Ratio and Body Mass Index. J Racial Ethn Health Disparities. 2024 Feb;11(1):157-167. doi: 10.1007/s40615-022-01507-z. Epub 2023 Jan 9.
PubMed 36622567Morey BN, Ryu S, Shi Y, Park HW, Lee S. Acculturation and Cardiometabolic Abnormalities Among Chinese and Korean Americans. J Racial Ethn Health Disparities. 2023 Aug;10(4):1605-1615. doi: 10.1007/s40615-022-01347-x. Epub 2022 Jun 15.
PubMed 35705844Lee S, Ryu S, Lee GE, Kawachi I, Morey BN, Slopen N. The association of acculturative stress with self-reported sleep disturbance and sleep duration among Asian Americans. Sleep. 2022 Apr 11;45(4):zsab298. doi: 10.1093/sleep/zsab298.
PubMed 34922392
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients
- ClinicalTrials.gov ID
- NCT03481296
- Acronym / sponsor ID
- R01MD012778 [2020-5953]
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Screening, Asian Americans, Patient Navigation, Decision Counseling Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Thomas Jefferson University, University of Maryland, College Park
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Mar 2018 (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 objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients.
Detailed description
This study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 Chinese and Korean American men and 200 Chinese and Korean American women aged 50 to 75 eligible for colorectal cancer screening. Participants are recruited from primary care physician clinics. The study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. Those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. Those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. Investigators in the study develop an individualized screening plan using a theory-based online Decision Counseling Program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. Using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. Additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Control | Active comparator | Behavioral: Advanced ControlThe advanced control group receives a set of standard materials regarding colorectal cancer screening. |
| Culturally Adapted Decision Support Navigation Intervention | Experimental | Behavioral: Culturally-Adapted Decision Support Navigation InterventionThe culturally adapted decision support navigation intervention group receives everything advanced group receives as well as decision support and navigation contacts. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening
Key exclusion criteria (1 listed)
- Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.
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 |
|---|---|---|
| Advanced ControlParticipants receive linguistically and culturally tailored information booklet on colorectal cancer and colorectal cancer screening, colonoscopy instructions, stool blood test kits and reminder by mail. Participants' height, weight, and waist/hip circumference, blood pressure, blood glucose, and cholesterol levels will be measured by trained research staff. Participants will also receive the result of body measurements right away as a free service. | Behavioural | Advanced Control |
| Culturally-Adapted Decision Support Navigation InterventionParticipants in this group receive everything that advanced control group receives. In addition to a set of standard materials, they receive culturally and linguistically adapted decision counseling from the patient navigator. The patient navigator develops an individualized colorectal cancer screening plan using a theory-based online Decision Counseling Program. After the Program is completed, the patient navigator develops individualized colorectal cancer screening plan and shares the information with participants and participants' primary care physicians. Then, primary care physicians encourage the colorectal cancer screening to participants. | Behavioural | Culturally Adapted Decision Support Navigation Intervention |
Primary outcome
Colorectal cancer screening adherence at 6 months by medical record review
Time frame: 6 months
Measure overall colorectal cancer screening adherence at 6 months by medical record review.
Colorectal cancer screening adherence at 6 months by self-report
Time frame: 6 months
Measure overall colorectal cancer screening adherence at 6 months by self-report during 6-month survey (by phone).
Overall colorectal cancer screening adherence at 12 months by medical record review
Time frame: 12 months
Measure overall colorectal cancer screening adherence at 12 months by medical record review.
Overall colorectal cancer screening adherence at 12 months by self-report
Time frame: 12 months
Measure overall colorectal cancer screening adherence at 12 months by self-report (by phone interview).
Colorectal cancer screening decision stage at baseline (Stool Blood Test)
Time frame: Baseline
Measure colorectal cancer screening decision stage for stool blood test at baseline.
Colorectal cancer screening decision stage at 6-months (Stool Blood Test)
Time frame: 6 months
Measure colorectal cancer screening decision stage for stool blood test at 6 months.
Change in colorectal cancer screening decision stage between baseline and 6 months (Stool Blood Test)
Time frame: Baseline and 6 months
Measure change in colorectal cancer screening decision stage for stool blood test between baseline and 6 months.
Colorectal cancer screening decision stage at baseline (Colonoscopy)
Time frame: Baseline
Measure colorectal cancer screening decision stage for colonoscopy at baseline.
Colorectal cancer screening decision stage at 6 months (Colonoscopy)
Time frame: 6 months
Measure colorectal cancer screening decision stage for colonoscopy at 6 months.
Change in colorectal cancer screening decision stage between baseline and 6 months (Colonoscopy)
Time frame: Baseline and 6 months
Measure change in colorectal cancer screening decision stage for colonoscopy between baseline and 6 months.
Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test)
Time frame: 6 months
Measure the fraction of participants who undergo a stool blood test at 6 months.
Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)
Time frame: 6 months
Measure the fraction of participants who undergo a colonoscopy at 6 months.
Colorectal cancer screening test-specific adherence at 12 months (Stool Blood Test)
Time frame: 12 months
Measure the fraction of participants who undergo a stool blood test at 12 months.
Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy)
Time frame: 12 months
Measure the fraction of participants who undergo a colonoscopy at 12 months.
3 secondary outcomes
Knowledge about colorectal cancer and colorectal cancer screening (Baseline)
Time frame: Baseline
Knowledge about colorectal cancer and colorectal cancer screening (6 months)
Time frame: 6 months
Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 38303653Morey BN, Shi Y, Ryu S, Redline S, Kawachi I, Park HW, Lee S. Risk of sleep apnea associated with higher blood pressure among Chinese and Korean Americans. Ethn Health. 2024 Apr;29(3):295-308. doi: 10.1080/13557858.2024.2311417. Epub 2024 Feb 2.
- Derived from this study: PubMed 36701271Morey BN, Ryu S, Shi Y, Lee S. The Mediating Role of Sleep Disturbance on the Association Between Stress and Self-Rated Health Among Chinese and Korean Immigrant Americans. Prev Chronic Dis. 2023 Jan 26;20:E04. doi: 10.5888/pcd20.220241.
- Derived from this study: PubMed 36622567Lee S, Ryu S, Lee GE, Redline S, Morey BN. Risk of Sleep Apnea Is Associated with Abdominal Obesity Among Asian Americans: Comparing Waist-to-Hip Ratio and Body Mass Index. J Racial Ethn Health Disparities. 2024 Feb;11(1):157-167. doi: 10.1007/s40615-022-01507-z. Epub 2023 Jan 9.
- Derived from this study: PubMed 35705844Morey BN, Ryu S, Shi Y, Park HW, Lee S. Acculturation and Cardiometabolic Abnormalities Among Chinese and Korean Americans. J Racial Ethn Health Disparities. 2023 Aug;10(4):1605-1615. doi: 10.1007/s40615-022-01347-x. Epub 2022 Jun 15.
- Derived from this study: PubMed 34922392Lee S, Ryu S, Lee GE, Kawachi I, Morey BN, Slopen N. The association of acculturative stress with self-reported sleep disturbance and sleep duration among Asian Americans. Sleep. 2022 Apr 11;45(4):zsab298. doi: 10.1093/sleep/zsab298.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sunmin Lee, ScD principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally-Adapted Decision Support Navigation Intervention in people with Colorectal Cancer, run by University of California, Irvine 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 1 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: finished, as of the sponsor's last update on 3 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer screening adherence at 6 months by medical record review (time frame: 6 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481296, which also lists 5 linked publications.
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 3 Jul 2023.