AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT02392143
Study groupRoleWhat they receive
Printed Education MaterialActive comparatorParticipants received printed education materials (PEM) sent by first class mail.
Receives: Other: Printed Education Material
Academic DetailingActive comparatorParticipants' 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 EducationActive comparatorParticipants' 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.

  1. 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.

  1. First posted18 Mar 2015 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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)
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 27098522
  • Basch 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 26831486
  • Wolf 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 26585609
  • Basch 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

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.

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