Colorectal CancerNCT02392143
Promoting CRC Screening in an Urban Minority Population
A study testing Printed Education Material, Academic Detailing and Academic Detailing+Telephone Education in people with Colorectal Cancer, run by Teachers College, Columbia University.
Trial summary
The purpose of this study (Healthy Colon Project II) is to evaluate different educational approaches for increasing rates of colorectal cancer (CRC) screening in a hard-to-reach urban minority population with health insurance. 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?
- Printed Education Material, Academic Detailing and Academic Detailing+Telephone Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Sep 2014
- 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
- out of compliance with recommended CRC screening
- having a 'regular doctor' (for women, could be gynecologist)
- stated intention to remain in benefit fund for at least one year
- age 50 to 75
- reachable by telephone
- able to communicate in English
- ability to grant informed consent
Who cannot join
- colonoscopy in past 10 years
- flexible sigmoidoscopy, barium enema or CT colonography in past 5 years
- stool DNA in past 3 years
- 3 day FOBT or FIT within past year
- history of colorectal polyps, inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, ulcerative colitis, or current treatment for any type of cancer
About this study
Official title: Promoting CRC Screening in a Hard-To-Reach, Low-Income Minority Population
The purpose of this study (Healthy Colon Project II) is to evaluate different educational approaches for increasing rates of colorectal cancer (CRC) screening in a hard-to-reach urban minority population with health insurance.
Read the detailed description
This project is an extension of the investigators' earlier study (Healthy Colon Project I) in which the investigators demonstrated that telephone outreach to individuals had a significant effect on CRC screening in a hard-to-reach, working class, urban minority population (~27.0% screened who received telephone outreach vs. ~6.1% screened who received printed educational materials). Additional investigation suggested the possible benefits of intervening with primary care physicians (PCPs) regarding their CRC screening referral and follow-up practices.
In the current project, the investigators conducted a 3-group randomized trial. The aims are as follows: Aim 1: Evaluate the incremental effect of tailored telephone education (TTE), over and above the effect of academic detailing (AD), for increasing rates of CRC screening 12-months post-randomization; Aim 2: Evaluate the effect of academic detailing alone (AD) over minimal intervention (control group), for increasing rates of CRC screening 12-months post-randomization; Aim 3: Identify factors that mediate the effectiveness of the interventions; and Aim 4: Identify factors that moderate the effectiveness of the interventions among subgroups.
In one group, participants received printed education materials. In a second group, participants' PCPs received academic detailing (AD) to improve CRC screening referral and follow-up practices. And in a third group, PCPs received AD and participants received tailored telephone education (TTE). Participants were members of a union-based, self-administered and self-insured benefit fund in the NYC metropolitan area.
The educational intervention approaches were informed by the investigators' earlier study among this population, with the goal of helping participants to make an informed choice about screening. The CRC PEM described the importance of early detection and prevention, risk factors, and the importance of talking to the subject's doctor about CRC screening. The PEM highlighted colonoscopy as being the only test that can identify and prevent CRC and described how to prepare for a colonoscopy beginning seven days prior to the test. The PEM also described other CRC screening tests, including the FOBT, FIT, sigmoidoscopy, barium enema and virtual colonoscopy. Academic detailing (AD) involved an in-person visit from a member of the research team who attempted to communicate strategies for improving CRC screening uptake in the practice's patient panel. In cases where the PCP was unavailable, an office staff member was approached. A brief description of the RCT was followed by a semi-structured interview assessing usual practice regarding CRC screening referral and follow up. The direction of the discussion was guided by PCP responses. A variety of resources were provided: a binder with up-to-date scientific evidence about CRC screening recommendations and printed patient education materials, and order forms for refilling supplies. Specific directives were following up to make sure patients had made appointments with a gastroenterologist and offering 3-day FOBT. The detailer attempted to elicit a verbal commitment to do at least one new thing to strengthen the probability that patients would be screened. The TTE was based on the investigators' previously tested model and involved a semi-structured protocol in which the first goals were to build rapport and assess level of knowledge and readiness to be screened. In contrast to the earlier RCT, the current study's TTE clearly represented colonoscopy as the screening method of choice, while encouraging alternative screening methods as well. This emphasis was consistent with goals of the New York City Department of Health and Mental Hygiene and the American Cancer Society at the time of the study. Rapport established, the TTE dialogue focused on identifying and addressing barriers that might impede receipt of screening. Verbal commitments were elicited: to speak with the PCP and make an appointment for a colonoscopy, or request a home stool test, as appropriate. Follow up calls assessed progress towards achieving goals.
Three types of data were collected. Baseline survey data assessed eligibility and measured a variety of demographic and other variables. Implementation data monitored the extent to which the AD and TTE interventions had been conducted as planned. And outcome data (CRC screening one year post-randomization) was based on medical claims data.
- Conditions
- Colorectal Cancer
- Being tested
- Printed Education Material, Academic Detailing, Academic Detailing+Telephone Education
- Keywords
- colorectal cancer 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.
Printed Education MaterialOther
Also called Print education
The printed education material described the importance of early detection and prevention, risk factors, and the importance of talking to your doctor about CRC screening. The PEM highlighted colonoscopy as being the only test that can identify and prevent CRC and described how to prepare for a colonoscopy beginning seven days prior to the test [18]. The PEM also described other CRC screening tests, including the FOBT, FIT, sigmoidoscopy, barium enema and virtual colonoscopy.
Academic DetailingOther
Academic detailing (AD) involved an in-person visit from a member of the research team who attempted to communicate strategies for improving CRC screening uptake in the practice's patient panel. A brief description of the RCT was followed by a semi-structured interview assessing usual practice regarding CRC screening referral and follow up. The direction of the discussion was guided by PCP responses. A variety of resources were provided. Specific directives were following up to make sure patients had made appointments with a gastroenterologist and offering home stool tests. The detailer attempted to elicit a verbal commitment to do at least one new thing to strengthen the probability that patients would be screened.
Academic Detailing+Telephone EducationOther
Also called Academic Detailing+Tailored Telephone Education
PCPs received AD as described in the Academic Detailing arm. In addition, participants received tailored telephone education (TTE) which focused on identifying and addressing barriers that might impede screening. Verbal commitments were elicited to speak with their PCP and make an appointment for a colonoscopy, or request a home stool test, as appropriate. Follow-up calls assessed progress towards achieving goals.
| Study group | Role | What they receive |
|---|---|---|
| Printed Education Material | Active comparator | Participants received printed education materials (PEM) sent by first class mail. Receives: Other: Printed Education Material |
| Academic Detailing | Active comparator | Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices. Receives: Other: Academic Detailing |
| Academic Detailing+Telephone Education | Active comparator | Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices and participants received tailored telephone education (TTE). Receives: Other: Academic Detailing+Telephone Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening
defined as colonoscopy, flexibile sigmoidoscopy, barium enema, CT colonography or DNA stool test based on medical claims paid by benefit fund
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJan 2009
- Primary completionSep 2014
- Study completionSep 2014
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.
- 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
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, 1199SEIU Benefit and Pension Funds
- Responsible party
- Sponsor
- Investigators
- Charles E Basch, PhD, Principal investigator, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392143
- Sponsor's protocol ID
- 542376
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Basch CH, Basch CE, Zybert P, Wolf RL. Failure of Colonoscopy Knowledge to Predict Colonoscopy Uptake. J Community Health. 2016 Oct;41(5):1094-9. doi: 10.1007/s10900-016-0194-6.
PubMed 27098522Basch CH, Basch CE, Zybert P, Wolf RL. Fear as a Barrier to Asymptomatic Colonoscopy Screening in an Urban Minority Population with Health Insurance. J Community Health. 2016 Aug;41(4):818-24. doi: 10.1007/s10900-016-0159-9.
PubMed 26831486Wolf RL, Basch CE, Zybert P, Basch CH, Ullman R, Shmukler C, King F, Neugut AI. Patient Test Preference for Colorectal Cancer Screening and Screening Uptake in an Insured Urban Minority Population. J Community Health. 2016 Jun;41(3):502-8. doi: 10.1007/s10900-015-0123-0.
PubMed 26585609Basch CE, Zybert P, Wolf RL, Basch CH, Ullman R, Shmukler C, King F, Neugut AI, Shea S. A Randomized Trial to Compare Alternative Educational Interventions to Increase Colorectal Cancer Screening in a Hard-to-Reach Urban Minority Population with Health Insurance. J Community Health. 2015 Oct;40(5):975-83. doi: 10.1007/s10900-015-0021-5.
PubMed 25850386
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting CRC Screening in a Hard-To-Reach, Low-Income Minority Population
- ClinicalTrials.gov ID
- NCT02392143
- Acronym / sponsor ID
- 542376
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Collaborators
- Columbia University, 1199SEIU Benefit and Pension Funds
- Study start
- Jan 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Mar 2015 (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 purpose of this study (Healthy Colon Project II) is to evaluate different educational approaches for increasing rates of colorectal cancer (CRC) screening in a hard-to-reach urban minority population with health insurance.
Detailed description
This project is an extension of the investigators' earlier study (Healthy Colon Project I) in which the investigators demonstrated that telephone outreach to individuals had a significant effect on CRC screening in a hard-to-reach, working class, urban minority population (~27.0% screened who received telephone outreach vs. ~6.1% screened who received printed educational materials). Additional investigation suggested the possible benefits of intervening with primary care physicians (PCPs) regarding their CRC screening referral and follow-up practices.
In the current project, the investigators conducted a 3-group randomized trial. The aims are as follows: Aim 1: Evaluate the incremental effect of tailored telephone education (TTE), over and above the effect of academic detailing (AD), for increasing rates of CRC screening 12-months post-randomization; Aim 2: Evaluate the effect of academic detailing alone (AD) over minimal intervention (control group), for increasing rates of CRC screening 12-months post-randomization; Aim 3: Identify factors that mediate the effectiveness of the interventions; and Aim 4: Identify factors that moderate the effectiveness of the interventions among subgroups.
In one group, participants received printed education materials. In a second group, participants' PCPs received academic detailing (AD) to improve CRC screening referral and follow-up practices. And in a third group, PCPs received AD and participants received tailored telephone education (TTE). Participants were members of a union-based, self-administered and self-insured benefit fund in the NYC metropolitan area.
The educational intervention approaches were informed by the investigators' earlier study among this population, with the goal of helping participants to make an informed choice about screening. The CRC PEM described the importance of early detection and prevention, risk factors, and the importance of talking to the subject's doctor about CRC screening. The PEM highlighted colonoscopy as being the only test that can identify and prevent CRC and described how to prepare for a colonoscopy beginning seven days prior to the test. The PEM also described other CRC screening tests, including the FOBT, FIT, sigmoidoscopy, barium enema and virtual colonoscopy. Academic detailing (AD) involved an in-person visit from a member of the research team who attempted to communicate strategies for improving CRC screening uptake in the practice's patient panel. In cases where the PCP was unavailable, an office staff member was approached. A brief description of the RCT was followed by a semi-structured interview assessing usual practice regarding CRC screening referral and follow up. The direction of the discussion was guided by PCP responses. A variety of resources were provided: a binder with up-to-date scientific evidence about CRC screening recommendations and printed patient education materials, and order forms for refilling supplies. Specific directives were following up to make sure patients had made appointments with a gastroenterologist and offering 3-day FOBT. The detailer attempted to elicit a verbal commitment to do at least one new thing to strengthen the probability that patients would be screened. The TTE was based on the investigators' previously tested model and involved a semi-structured protocol in which the first goals were to build rapport and assess level of knowledge and readiness to be screened. In contrast to the earlier RCT, the current study's TTE clearly represented colonoscopy as the screening method of choice, while encouraging alternative screening methods as well. This emphasis was consistent with goals of the New York City Department of Health and Mental Hygiene and the American Cancer Society at the time of the study. Rapport established, the TTE dialogue focused on identifying and addressing barriers that might impede receipt of screening. Verbal commitments were elicited: to speak with the PCP and make an appointment for a colonoscopy, or request a home stool test, as appropriate. Follow up calls assessed progress towards achieving goals.
Three types of data were collected. Baseline survey data assessed eligibility and measured a variety of demographic and other variables. Implementation data monitored the extent to which the AD and TTE interventions had been conducted as planned. And outcome data (CRC screening one year post-randomization) was based on medical claims data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Printed Education Material | Active comparator | Other: Printed Education MaterialParticipants received printed education materials (PEM) sent by first class mail. |
| Academic Detailing | Active comparator | Other: Academic DetailingParticipants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices. |
| Academic Detailing+Telephone Education | Active comparator | Other: Academic Detailing+Telephone EducationParticipants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices and participants received tailored telephone education (TTE). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- out of compliance with recommended CRC screening
- having a 'regular doctor' (for women, could be gynecologist)
- stated intention to remain in benefit fund for at least one year
- age 50 to 75
- reachable by telephone
Key exclusion criteria (5 listed)
- colonoscopy in past 10 years
- flexible sigmoidoscopy, barium enema or CT colonography in past 5 years
- stool DNA in past 3 years
- 3 day FOBT or FIT within past year
- history of colorectal polyps, inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, ulcerative colitis, or current treatment for any type of cancer
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 |
|---|---|---|
| Printed Education MaterialAlso: Print educationThe printed education material described the importance of early detection and prevention, risk factors, and the importance of talking to your doctor about CRC screening. The PEM highlighted colonoscopy as being the only test that can identify and prevent CRC and described how to prepare for a colonoscopy beginning seven days prior to the test [18]. The PEM also described other CRC screening tests, including the FOBT, FIT, sigmoidoscopy, barium enema and virtual colonoscopy. | Other | Printed Education Material |
| Academic DetailingAcademic detailing (AD) involved an in-person visit from a member of the research team who attempted to communicate strategies for improving CRC screening uptake in the practice's patient panel. A brief description of the RCT was followed by a semi-structured interview assessing usual practice regarding CRC screening referral and follow up. The direction of the discussion was guided by PCP responses. A variety of resources were provided. Specific directives were following up to make sure patients had made appointments with a gastroenterologist and offering home stool tests. The detailer attempted to elicit a verbal commitment to do at least one new thing to strengthen the probability that patients would be screened. | Other | Academic Detailing |
| Academic Detailing+Telephone EducationAlso: Academic Detailing+Tailored Telephone EducationPCPs received AD as described in the Academic Detailing arm. In addition, participants received tailored telephone education (TTE) which focused on identifying and addressing barriers that might impede screening. Verbal commitments were elicited to speak with their PCP and make an appointment for a colonoscopy, or request a home stool test, as appropriate. Follow-up calls assessed progress towards achieving goals. | Other | Academic Detailing+Telephone Education |
Primary outcome
Colorectal Cancer Screening
Time frame: one year
defined as colonoscopy, flexibile sigmoidoscopy, barium enema, CT colonography or DNA stool test based on medical claims paid by benefit fund
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 Mar 2015.
- Derived from this study: PubMed 27098522Basch CH, Basch CE, Zybert P, Wolf RL. Failure of Colonoscopy Knowledge to Predict Colonoscopy Uptake. J Community Health. 2016 Oct;41(5):1094-9. doi: 10.1007/s10900-016-0194-6.
- Derived from this study: PubMed 26831486Basch CH, Basch CE, Zybert P, Wolf RL. Fear as a Barrier to Asymptomatic Colonoscopy Screening in an Urban Minority Population with Health Insurance. J Community Health. 2016 Aug;41(4):818-24. doi: 10.1007/s10900-016-0159-9.
- Derived from this study: PubMed 26585609Wolf RL, Basch CE, Zybert P, Basch CH, Ullman R, Shmukler C, King F, Neugut AI. Patient Test Preference for Colorectal Cancer Screening and Screening Uptake in an Insured Urban Minority Population. J Community Health. 2016 Jun;41(3):502-8. doi: 10.1007/s10900-015-0123-0.
- Derived from this study: PubMed 25850386Basch CE, Zybert P, Wolf RL, Basch CH, Ullman R, Shmukler C, King F, Neugut AI, Shea S. A Randomized Trial to Compare Alternative Educational Interventions to Increase Colorectal Cancer Screening in a Hard-to-Reach Urban Minority Population with Health Insurance. J Community Health. 2015 Oct;40(5):975-83. doi: 10.1007/s10900-015-0021-5.
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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.
Charles E Basch, PhD principal investigator
Teachers College, Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Printed Education Material, Academic Detailing and Academic Detailing+Telephone Education in people with Colorectal Cancer, run by Teachers College, Columbia University.
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 7 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: one 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 NCT02392143, 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 18 Mar 2015.