Colorectal Cancer ScreeningNCT01141114
Study of Patient Navigation to Promote Colon Cancer Screening
A study testing Patient navigation in people with Colorectal Cancer Screening, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers. Read more about this study
- Who is it for?
- Ages 52 to 75 years
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Patient navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on HEDIS criteria.
Who cannot join
- Current cancer diagnosis, undergoing treatment (or treatment completed within the past year)
- Severe cardiac disease (high-risk CAD,9 valvular disease, NYHA Class III or IV CHF, EF < 35%)
- Severe COPD (FEV1< 1liter or on home oxygen)
- CVA with severe functional impairment (aphasia or hemiparesis)
- MS with severe functional impairment
- Renal failure with CrCl< 30 or on dialysis
Show all 17Show fewer
- Gastrointestinal symptoms (pain, bleeding, etc) within the past 6 months
- Chronic active liver disease or cirrhosis, with albumin < 3 or elevated INR
- Advanced HIV disease (CD4 count <200)
- Severe lupus (with cerebritis or renal failure as defined above)
- Severe complications of diabetes (blindness, amputations other than toes)
- Advanced Dementia
- Psychosis
- Paranoia
- Active substance abuse
- Schizophrenia
- Psychiatric hospitalization within the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
About this study
Official title: Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients
This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Patient navigation, Usual care
- Keywords
- community health centers, colorectal cancer screening, urban health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient navigationOther
Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Use of a Patient Navigator | Experimental | Not described Receives: Other: Patient navigation |
| Usual Care | Other | No Intervention - usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
completion of colorectal cancer screening
Measured: 1 year
Secondary outcomes (1)
Comparison of detection of polyps and cancers in intervention vs. control groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startSep 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Karen E Lasser, MD, MPH, Principal investigator, Cambridge Health Alliance/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141114
- Sponsor's protocol ID
- MRSGT-05-007-01-CPPB
- Status last verified
- Apr 2017
- First submitted
- 9 Jun 2010
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.
PubMed 18304342Lasser KE, Murillo J, Lisboa S, Casimir AN, Valley-Shah L, Emmons KM, Fletcher RH, Ayanian JZ. Colorectal cancer screening among ethnically diverse, low-income patients: a randomized controlled trial. Arch Intern Med. 2011 May 23;171(10):906-12. doi: 10.1001/archinternmed.2011.201.
PubMed 21606094
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients
- ClinicalTrials.gov ID
- NCT01141114
- Acronym / sponsor ID
- MRSGT-05-007-01-CPPB
- Conditions
- Colorectal Cancer Screening
- Keywords
- community health centers, colorectal cancer screening, urban health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Harvard Medical School (HMS and HSDM)
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Jun 2010 (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.
This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of a Patient Navigator | Experimental | Other: Patient navigation |
| Usual Care | Other | Other: Usual careNo Intervention - usual care |
Who may qualify
- Ages
- 52 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on HEDIS criteria.
Key exclusion criteria (17 listed)
- Current cancer diagnosis, undergoing treatment (or treatment completed within the past year)
- Severe cardiac disease (high-risk CAD,9 valvular disease, NYHA Class III or IV CHF, EF < 35%)
- Severe COPD (FEV1< 1liter or on home oxygen)
- CVA with severe functional impairment (aphasia or hemiparesis)
- MS with severe functional impairment
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 navigationLetter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators. | Other | Use of a Patient Navigator |
| Usual careUsual care | Other | Usual Care |
Primary outcome
completion of colorectal cancer screening
Time frame: 1 year
1 secondary outcome
Comparison of detection of polyps and cancers in intervention vs. control groups
Time frame: 1 year
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 18 Apr 2017.
- Background: PubMed 18304342Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.
- Derived from this study: PubMed 21606094Lasser KE, Murillo J, Lisboa S, Casimir AN, Valley-Shah L, Emmons KM, Fletcher RH, Ayanian JZ. Colorectal cancer screening among ethnically diverse, low-income patients: a randomized controlled trial. Arch Intern Med. 2011 May 23;171(10):906-12. doi: 10.1001/archinternmed.2011.201.
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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.
Karen E Lasser, MD, MPH principal investigator
Cambridge Health Alliance/Harvard Medical School
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 Screening, run by Cambridge Health Alliance 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 17 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 18 Apr 2017. 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?
completion of colorectal cancer screening (time frame: 1 year). 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 NCT01141114, which also lists 2 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 18 Apr 2017.