Colorectal Cancer ScreeningNCT01569620
Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care
A study testing Best clinical practices plus culturally targeted print materials, Best clinical practices plus standard print materials and Best clinical practices alone in people with Colorectal Cancer Screening, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The proposed study seeks to investigate the impact of a culturally targeted print educational intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Best clinical practices plus culturally targeted print materials, Best clinical practices plus standard print materials and Best clinical practices alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2015
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified Hispanic
- Between the ages of 50 and 85
- Able to provide informed consent in either English or Spanish
- No participation in study Focus Groups by a family member or oneself
- Referred for a screening colonoscopy by a primary care physician at Mount Sinai
- At average risk for developing colorectal cancer
- Have no colonoscopy procedure within the last 5 years
- Have telephone service
Who cannot join
- Personal history of CRC
- Personal history of any chronic GI disorder (irritable bowel syndrome, colitis) and
- Family history of CRC (first degree relative of CRC)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Improving Colorectal Cancer (CRC) Screening for Diverse Hispanics in an Urban Primary Care Setting
The proposed study seeks to investigate the impact of a culturally targeted print educational intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics. If, as expected, the addition of culturally targeted materials to best clinical practices as compared to a) best clinical practices plus standard materials or b) best clinical practices alone leads to higher rates of CRC screening via colonoscopy then the culturally targeted print educational materials can be easily disseminated among this rapidly growing minority group who have low rates of CRC screening and whose disease is detected at later, less curable stages.
Read the detailed description
CRC is the 2nd leading cause of cancer death among Hispanic women and men. Hispanics are more likely to be diagnosed at more advanced disease stages compared to non-Hispanic whites and have a lower probability of survival. A key way to decrease mortality from CRC among Hispanics is to increase rates of CRC screening and thereby early detection of CRC. To address low screening rates, thereby increasing the prevention and early detection of CRC, the proposed research seeks to increase CRC colonoscopy screening among Hispanics. The primary aim is to investigate the impact of a culturally targeted print educational intervention designed to increase CRC screening via colonoscopy in a diverse group of Hispanics 50 years of age and older. Our long standing (since 1999) research platform has included significant community input through ongoing meetings with our Community Advisory Board (CAB) soliciting their viewpoints and concerns. In addition, we consult with key community members on an ongoing basis for additional input. A Randomized Clinical Trial (RCT) will be conducted with 400 Hispanics within the context of the best clinical practices currently provided at Mount Sinai. There are three study arms: 1) best clinical practices plus culturally relevant print materials, 2) best clinical practices plus standard print materials and 3) best clinical practices alone. These three arms will allow the investigation of the addition of print materials and the comparison of culturally relevant to standard print materials to assess the differential impact of each print format. This comparison controls for the possible benefit of adding standard print materials to best clinical practices and allows for investigation of the additional benefit of culturally targeted relevant materials over and above that of standard materials. Further, by including feedback from the community, we will be able to clearly understand the benefits of, and be able to disseminate culturally targeted materials among this rapidly growing minority group. If, as hypothesized, the addition of the culturally targeted print materials leads to higher rates of colonoscopy, they can then be easily disseminated among health care settings treating Hispanics.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Best clinical practices plus culturally targeted print materials, Best clinical practices plus standard print materials, Best clinical practices alone
- Keywords
- Colorectal Cancer Screening, CRC, Screening Colonoscopy, Hispanics, Latinos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best clinical practices plus culturally targeted print materialsBehavioural
This intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study.
Best clinical practices plus standard print materialsBehavioural
This intervention arm includes best clinical practices (or usual care at MSSM) and the standard CRC screening print materials developed by the Centers for Disease Control (CDC).
Best clinical practices aloneBehavioural
Also called Usual Care
This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
| Study group | Role | What they receive |
|---|---|---|
| Culturally targeted print materials | Active comparator | Best clinical practices plus culturally print materials Receives: Behavioral: Best clinical practices plus culturally targeted print materials |
| Standard print materials | Active comparator | Best clinical practices plus standard print materials Receives: Behavioral: Best clinical practices plus standard print materials |
| Best clinical practices alone | Active comparator | Best clinical practices alone: This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials. Receives: Behavioral: Best clinical practices alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of colonoscopy at 3 months, 6 months, and 12 months.
Comparison of physician recommended colonoscopy (post intervention) obtained at approximately 3 months and 6 months (via self report) and at 12 months (as per chart review), to that of colonoscopy obtained at baseline.
Measured: Baseline, at 3 months, at 6 months, and at 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 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Outcomes assessor
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Katherine DuHamel, PhD, Principal investigator, Memorial Sloan Kettering Cancer CenterLina Jandorf, MA, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569620
- Sponsor's protocol ID
- GCO 08-1159
- Status last verified
- Jan 2016
- First submitted
- 29 Mar 2012
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cotter G, DuHamel K, Schofield E, Jandorf L. Processes of Change for Colonoscopy: Limited Support for Use Among Navigated Latinos. J Racial Ethn Health Disparities. 2019 Apr;6(2):327-334. doi: 10.1007/s40615-018-0528-4. Epub 2018 Oct 9.
PubMed 30302744
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Colorectal Cancer (CRC) Screening for Diverse Hispanics in an Urban Primary Care Setting
- ClinicalTrials.gov ID
- NCT01569620
- Acronym / sponsor ID
- GCO 08-1159
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal Cancer Screening, CRC, Screening Colonoscopy, Hispanics, Latinos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Apr 2012 (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 proposed study seeks to investigate the impact of a culturally targeted print educational intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics. If, as expected, the addition of culturally targeted materials to best clinical practices as compared to a) best clinical practices plus standard materials or b) best clinical practices alone leads to higher rates of CRC screening via colonoscopy then the culturally targeted print educational materials can be easily disseminated among this rapidly growing minority group who have low rates of CRC screening and whose disease is detected at later, less curable stages.
Detailed description
CRC is the 2nd leading cause of cancer death among Hispanic women and men. Hispanics are more likely to be diagnosed at more advanced disease stages compared to non-Hispanic whites and have a lower probability of survival. A key way to decrease mortality from CRC among Hispanics is to increase rates of CRC screening and thereby early detection of CRC. To address low screening rates, thereby increasing the prevention and early detection of CRC, the proposed research seeks to increase CRC colonoscopy screening among Hispanics. The primary aim is to investigate the impact of a culturally targeted print educational intervention designed to increase CRC screening via colonoscopy in a diverse group of Hispanics 50 years of age and older. Our long standing (since 1999) research platform has included significant community input through ongoing meetings with our Community Advisory Board (CAB) soliciting their viewpoints and concerns. In addition, we consult with key community members on an ongoing basis for additional input. A Randomized Clinical Trial (RCT) will be conducted with 400 Hispanics within the context of the best clinical practices currently provided at Mount Sinai. There are three study arms: 1) best clinical practices plus culturally relevant print materials, 2) best clinical practices plus standard print materials and 3) best clinical practices alone. These three arms will allow the investigation of the addition of print materials and the comparison of culturally relevant to standard print materials to assess the differential impact of each print format. This comparison controls for the possible benefit of adding standard print materials to best clinical practices and allows for investigation of the additional benefit of culturally targeted relevant materials over and above that of standard materials. Further, by including feedback from the community, we will be able to clearly understand the benefits of, and be able to disseminate culturally targeted materials among this rapidly growing minority group. If, as hypothesized, the addition of the culturally targeted print materials leads to higher rates of colonoscopy, they can then be easily disseminated among health care settings treating Hispanics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Culturally targeted print materials | Active comparator | Behavioral: Best clinical practices plus culturally targeted print materialsBest clinical practices plus culturally print materials |
| Standard print materials | Active comparator | Behavioral: Best clinical practices plus standard print materialsBest clinical practices plus standard print materials |
| Best clinical practices alone | Active comparator | Behavioral: Best clinical practices aloneBest clinical practices alone: This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-identified Hispanic
- Between the ages of 50 and 85
- Able to provide informed consent in either English or Spanish
- No participation in study Focus Groups by a family member or oneself
- Referred for a screening colonoscopy by a primary care physician at Mount Sinai
Key exclusion criteria (3 listed)
- Personal history of CRC
- Personal history of any chronic GI disorder (irritable bowel syndrome, colitis) and
- Family history of CRC (first degree relative of CRC)
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 |
|---|---|---|
| Best clinical practices plus culturally targeted print materialsThis intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study. | Behavioural | Culturally targeted print materials |
| Best clinical practices plus standard print materialsThis intervention arm includes best clinical practices (or usual care at MSSM) and the standard CRC screening print materials developed by the Centers for Disease Control (CDC). | Behavioural | Standard print materials |
| Best clinical practices aloneAlso: Usual CareThis intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials. | Behavioural | Best clinical practices alone |
Primary outcome
Change from baseline of colonoscopy at 3 months, 6 months, and 12 months.
Time frame: Baseline, at 3 months, at 6 months, and at 12 months
Comparison of physician recommended colonoscopy (post intervention) obtained at approximately 3 months and 6 months (via self report) and at 12 months (as per chart review), to that of colonoscopy obtained at baseline.
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 29 Jan 2016.
- Derived from this study: PubMed 30302744Cotter G, DuHamel K, Schofield E, Jandorf L. Processes of Change for Colonoscopy: Limited Support for Use Among Navigated Latinos. J Racial Ethn Health Disparities. 2019 Apr;6(2):327-334. doi: 10.1007/s40615-018-0528-4. Epub 2018 Oct 9.
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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.
Katherine DuHamel, PhD principal investigator
Memorial Sloan Kettering Cancer Center
Lina Jandorf, MA principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best clinical practices plus culturally targeted print materials, Best clinical practices plus standard print materials and Best clinical practices alone in people with Colorectal Cancer Screening, run by Icahn School of Medicine at Mount Sinai 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 8 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 29 Jan 2016. 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?
Change from baseline of colonoscopy at 3 months, 6 months, and 12 months. (time frame: Baseline, at 3 months, at 6 months, and at 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 NCT01569620, which also lists 1 linked publication.
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 Jan 2016.