Colorectal CancerNCT00476970
Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations
A study testing Patient Navigation in people with Colorectal Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to implement and in a controlled randomised trial test a program to identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH Chelsea HC. Read more about this study
- Who is it for?
- Ages 52 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,223 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2008
- 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 52 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 52-79 years of age
- Have not had a colonoscopy within the last 10 years
- Have not had a sigmoidoscopy/barium enema within the past 5 years
- Have not had a home fecal occult blood testing within the past year.
Who cannot join
- Acutely ill
- Dementia
- Metastatic cancer
- Schizophrenia
- Any end stage disease
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Chelsea Health Center
Chelsea, Massachusetts, 02150
About this study
Official title: Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project
The goal of this study is to implement and in a controlled randomised trial test a program to identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH Chelsea HC.
Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities between patients with limited English proficiency and English speakers
Read the detailed description
We developed a training program for five health center interpreters fluent in eight different languages. Patients randomly assigned to the study intervention receive an introductory letter in their native language. During the initial contact the navigator educates patients about CRC screening and explores patients' barriers to CRC screening. Based on results from a qualitative study conducted at in 2006, we developed interventions to overcome individual barriers to CRC screening tailored to each individual patient. Specific interventions include elucidation of culturally-specific health beliefs; teaching about cancer risk, colonoscopy, and colon prep administration; and help with appointment-making and transport.
- Conditions
- Colorectal Cancer
- Being tested
- Patient Navigation
- Keywords
- Colorectal Cancer, Cancer Screening, Patient Navigation, Low English Proficiency
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Patient navigators will perform an initial interview with participants to identify and explore barriers, work with patients to overcome barriers, educate patients about CRC screening, motivate and coach patients, and schedule and accompany patients to colonoscopy testing
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation Intervention | Experimental | Participants randomized to this arm will receive language-concordant patient navigation in the form of an introductory letter with educational material followed by phone or in-person contact to provide individually tailored interventions. Receives: Behavioral: Patient Navigation |
| Usual Care | No intervention | Participants randomized to this arm will receive no additional navigation beyond the usual care for the duration of the 9-month intervention. Participants will be offered navigation services after the completion of the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening
Measured: 18 Months
Secondary outcomes (2)
Type of CRC Screening Test Performed in Study vs Control Groups
Measured: 18 Months
Number of Polyps and Cancers per 100 Patients in the Study vs Control Group
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionSep 2008
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 CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanja Percac-Lima, MD, Massachusetts General Hospital
- Investigators
- Sanja Percac-Lima, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476970
- Sponsor's protocol ID
- 2006P 002254
- Status last verified
- Sep 2016
- First submitted
- 21 May 2007
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, Richter JM, Atlas SJ. A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial. J Gen Intern Med. 2009 Feb;24(2):211-7. doi: 10.1007/s11606-008-0864-x.
PubMed 19067085
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project
- ClinicalTrials.gov ID
- NCT00476970
- Acronym / sponsor ID
- 2006P 002254
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Cancer Screening, Patient Navigation, Low English Proficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,223 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 May 2007 (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 goal of this study is to implement and in a controlled randomised trial test a program to identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH Chelsea HC.
Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities between patients with limited English proficiency and English speakers
Detailed description
We developed a training program for five health center interpreters fluent in eight different languages. Patients randomly assigned to the study intervention receive an introductory letter in their native language. During the initial contact the navigator educates patients about CRC screening and explores patients' barriers to CRC screening. Based on results from a qualitative study conducted at in 2006, we developed interventions to overcome individual barriers to CRC screening tailored to each individual patient. Specific interventions include elucidation of culturally-specific health beliefs; teaching about cancer risk, colonoscopy, and colon prep administration; and help with appointment-making and transport.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation Intervention | Experimental | Behavioral: Patient NavigationParticipants randomized to this arm will receive language-concordant patient navigation in the form of an introductory letter with educational material followed by phone or in-person contact to provide individually tailored interventions. |
| Usual Care | No intervention | –Participants randomized to this arm will receive no additional navigation beyond the usual care for the duration of the 9-month intervention. Participants will be offered navigation services after the completion of the intervention period. |
Who may qualify
- Ages
- 52 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 52-79 years of age
- Have not had a colonoscopy within the last 10 years
- Have not had a sigmoidoscopy/barium enema within the past 5 years
- Have not had a home fecal occult blood testing within the past year.
Key exclusion criteria (5 listed)
- Acutely ill
- Dementia
- Metastatic cancer
- Schizophrenia
- Any end stage disease
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 |
|---|---|---|
| Patient NavigationPatient navigators will perform an initial interview with participants to identify and explore barriers, work with patients to overcome barriers, educate patients about CRC screening, motivate and coach patients, and schedule and accompany patients to colonoscopy testing | Behavioural | Patient Navigation Intervention |
Primary outcome
Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening
Time frame: 18 Months
2 secondary outcomes
Type of CRC Screening Test Performed in Study vs Control Groups
Time frame: 18 Months
Number of Polyps and Cancers per 100 Patients in the Study vs Control Group
Time frame: 18 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 21 Sep 2016.
- Derived from this study: PubMed 19067085Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, Richter JM, Atlas SJ. A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial. J Gen Intern Med. 2009 Feb;24(2):211-7. doi: 10.1007/s11606-008-0864-x.
- 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.
Sanja Percac-Lima, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Colorectal Cancer, run by Massachusetts General Hospital 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 4 inclusion and 5 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 Sep 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?
Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening (time frame: 18 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 NCT00476970, 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 21 Sep 2016.