Colorectal CancerPhase 1/2CRCNCT01289288
A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese
A Phase 1/2 study testing Mailed printed materials and in-office training in people with Colorectal Cancer, run by Georgetown University at 2 sites in United States.
Trial summary
The objective of this study is to test whether a culturally-tailored in-office based intervention have impact on increasing Chinese physician's recommendation of colorectal cancer (CRC) screening to their nonadherent Chinese patients. Special aims are to: 1. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Mailed printed materials and in-office training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Jul 2012
- Phase
- Phase 1/2
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Physicians
- are Chinese American,
- practice primary care,
- have a least 75 Chinese patients aged 50 and older in their practice,
- can communicate with patients in Chinese (Mandarin, Cantonese, etc.)
- For Patients
Show all 10Show fewer
- visiting the participating physician at least once in the past 2 years,
- are Chinese Americans,
- are 50 years and older,
- never had any CRC screening or are overdue for screening.
Who cannot join
- For Patients:
- have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative), and
- had updated CRC screening (FOBT within one year, colonoscopy within 10 years, sigmoidoscopy within 5 years and double-contrast barium enema within 5 years).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple University
Philadelphia, Pennsylvania, 19122
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
The objective of this study is to test whether a culturally-tailored in-office based intervention have impact on increasing Chinese physician's recommendation of colorectal cancer (CRC) screening to their nonadherent Chinese patients.
Special aims are to:
- Evaluate the efficacy of a culturally-tailored physician intervention on increasing non-adherent Chinese American's patients' CRC screening rate.
- Identify factors that mediate or moderate the intervention effects. For example, patients who hold an eastern cultural view or are less acculturated will be more likely to benefit from the intervention than patients who hold a western view or who are more acculturated.
Read the detailed description
This study is a randomized controlled trial aiming to test the effect of the culturally-tailored in-office based intervention on physicians. A total of 24 Chinese physicians in the Washington DC and Philadelphia areas and a total of 24 eligible Chinese patients from each physician will be recruited for this study. Physicians and their patients are randomized into two groups: A and B. Physician in the intervention group (A) will receive mailed printed materials including a CRC physician guide, patient brochure, flip chart and a poster and two sessions of in-office training aimed to reinforce learning of the topic covered by the mailed materials and provide physicians with hands-on experience in using communication skills with standardized patients. Physicians in the control group (B) will receive nothing until the end of the study. Patients will be followed 12-month later after their completion of the baseline survey and their self-reported CRC screening status will be verified by chart audit.
- Conditions
- Colorectal Cancer
- Being tested
- Mailed printed materials and in-office training
- Keywords
- colorectal cancer screening, Chinese Americans, patients nonadherent with CRC Screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed printed materials and in-office trainingBehavioural
- Mailed printed materials including CRC physician guide, patient brochure, flip chart and a poster
- Two sessions of in-office training with two standardized patients
| Study group | Role | What they receive |
|---|---|---|
| Mailed printed materials and in-office training | Experimental | Not described Receives: Behavioral: Mailed printed materials and in-office training |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of CRC screening
Nonadherent Chinese American patient's CRC screening rates.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJul 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Georgetown UniversityThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Judy Wang, Georgetown University
- Investigators
- Judy Wang, Ph.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289288
- Sponsor's protocol ID
- 2007-297
- Other IDs
- R01CA121023
- Acronym
- CRC
- Status last verified
- May 2013
- First submitted
- 2 Feb 2011
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liang W, Wang JH, Chen MY, Mandelblatt JS. Language use and the receipt of cancer screening recommendations by immigrant Chinese American women. J Womens Health (Larchmt). 2009 Feb;18(2):201-7. doi: 10.1089/jwh.2007.0709.
PubMed 19183091Wang JH, Liang W, Chen MY, Cullen J, Feng S, Yi B, Schwartz MD, Mandelblatt JS. The influence of culture and cancer worry on colon cancer screening among older Chinese-American women. Ethn Dis. 2006 Spring;16(2):404-11.
PubMed 17682242Huei-Yu Wang J, Ma GX, Liang W, Tan Y, Makambi KH, Dong R, Vernon SW, Tu SP, Mandelblatt JS. Physician Intervention and Chinese Americans' Colorectal Cancer Screening. Am J Health Behav. 2018 Jan 1;42(1):13-26. doi: 10.5993/AJHB.42.1.2.
PubMed 29320335Wang JH, Sheppard VB, Liang W, Ma GX, Maxwell AE. Recruiting Chinese Americans into cancer screening intervention trials: strategies and outcomes. Clin Trials. 2014 Apr;11(2):167-77. doi: 10.1177/1740774513518849. Epub 2014 Feb 24.
PubMed 24567288
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese
- ClinicalTrials.gov ID
- NCT01289288
- Acronym / sponsor ID
- CRC / 2007-297
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer screening, Chinese Americans, patients nonadherent with CRC Screening
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Temple University, National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Feb 2011 (estimated)
- 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 this study is to test whether a culturally-tailored in-office based intervention have impact on increasing Chinese physician's recommendation of colorectal cancer (CRC) screening to their nonadherent Chinese patients.
Special aims are to:
- Evaluate the efficacy of a culturally-tailored physician intervention on increasing non-adherent Chinese American's patients' CRC screening rate.
- Identify factors that mediate or moderate the intervention effects. For example, patients who hold an eastern cultural view or are less acculturated will be more likely to benefit from the intervention than patients who hold a western view or who are more acculturated.
Detailed description
This study is a randomized controlled trial aiming to test the effect of the culturally-tailored in-office based intervention on physicians. A total of 24 Chinese physicians in the Washington DC and Philadelphia areas and a total of 24 eligible Chinese patients from each physician will be recruited for this study. Physicians and their patients are randomized into two groups: A and B. Physician in the intervention group (A) will receive mailed printed materials including a CRC physician guide, patient brochure, flip chart and a poster and two sessions of in-office training aimed to reinforce learning of the topic covered by the mailed materials and provide physicians with hands-on experience in using communication skills with standardized patients. Physicians in the control group (B) will receive nothing until the end of the study. Patients will be followed 12-month later after their completion of the baseline survey and their self-reported CRC screening status will be verified by chart audit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mailed printed materials and in-office training | Experimental | Behavioral: Mailed printed materials and in-office training |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For Physicians
- are Chinese American,
- practice primary care,
- have a least 75 Chinese patients aged 50 and older in their practice,
- can communicate with patients in Chinese (Mandarin, Cantonese, etc.)
Key exclusion criteria (3 listed)
- have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative), and
- had updated CRC screening (FOBT within one year, colonoscopy within 10 years, sigmoidoscopy within 5 years and double-contrast barium enema within 5 years).
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 |
|---|---|---|
| Mailed printed materials and in-office training1. Mailed printed materials including CRC physician guide, patient brochure, flip chart and a poster 2. Two sessions of in-office training with two standardized patients | Behavioural | Mailed printed materials and in-office training |
Primary outcome
Receipt of CRC screening
Time frame: 12 months
Nonadherent Chinese American patient's CRC screening rates.
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 21 May 2013.
- Background: PubMed 19183091Liang W, Wang JH, Chen MY, Mandelblatt JS. Language use and the receipt of cancer screening recommendations by immigrant Chinese American women. J Womens Health (Larchmt). 2009 Feb;18(2):201-7. doi: 10.1089/jwh.2007.0709.
- Background: PubMed 17682242Wang JH, Liang W, Chen MY, Cullen J, Feng S, Yi B, Schwartz MD, Mandelblatt JS. The influence of culture and cancer worry on colon cancer screening among older Chinese-American women. Ethn Dis. 2006 Spring;16(2):404-11.
- Derived from this study: PubMed 29320335Huei-Yu Wang J, Ma GX, Liang W, Tan Y, Makambi KH, Dong R, Vernon SW, Tu SP, Mandelblatt JS. Physician Intervention and Chinese Americans' Colorectal Cancer Screening. Am J Health Behav. 2018 Jan 1;42(1):13-26. doi: 10.5993/AJHB.42.1.2.
- Derived from this study: PubMed 24567288Wang JH, Sheppard VB, Liang W, Ma GX, Maxwell AE. Recruiting Chinese Americans into cancer screening intervention trials: strategies and outcomes. Clin Trials. 2014 Apr;11(2):167-77. doi: 10.1177/1740774513518849. Epub 2014 Feb 24.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Judy Wang, Ph.D. principal investigator
Georgetown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mailed printed materials and in-office training in people with Colorectal Cancer, run by Georgetown University 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 10 inclusion and 3 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 21 May 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Receipt of CRC screening (time frame: 12 months). 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 NCT01289288, which also lists 4 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 21 May 2013.