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Promoting CRC Screening in an Urban Minority Population

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Printed Education Material
Academic Detailing
Academic Detailing+Telephone Education
Sponsored by
Teachers College, Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring colorectal cancer screening

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Printed Education Material

    Academic Detailing

    Academic Detailing+Telephone Education

    Arm Description

    Participants received printed education materials (PEM) sent by first class mail.

    Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices.

    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).

    Outcomes

    Primary Outcome Measures

    Colorectal Cancer Screening
    defined as colonoscopy, flexibile sigmoidoscopy, barium enema, CT colonography or DNA stool test based on medical claims paid by benefit fund

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2015
    Last Updated
    March 17, 2015
    Sponsor
    Teachers College, Columbia University
    Collaborators
    Columbia University, 1199SEIU Benefit and Pension Funds
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02392143
    Brief Title
    Promoting CRC Screening in an Urban Minority Population
    Official Title
    Promoting CRC Screening in a Hard-To-Reach, Low-Income Minority Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Teachers College, Columbia University
    Collaborators
    Columbia University, 1199SEIU Benefit and Pension Funds

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    colorectal cancer screening

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    564 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Printed Education Material
    Arm Type
    Active Comparator
    Arm Description
    Participants received printed education materials (PEM) sent by first class mail.
    Arm Title
    Academic Detailing
    Arm Type
    Active Comparator
    Arm Description
    Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices.
    Arm Title
    Academic Detailing+Telephone Education
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Printed Education Material
    Other Intervention Name(s)
    Print education
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Academic Detailing
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Academic Detailing+Telephone Education
    Other Intervention Name(s)
    Academic Detailing+Tailored Telephone Education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Colorectal Cancer Screening
    Description
    defined as colonoscopy, flexibile sigmoidoscopy, barium enema, CT colonography or DNA stool test based on medical claims paid by benefit fund
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles E Basch, PhD
    Organizational Affiliation
    Teachers College, Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27098522
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    26831486
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    26585609
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    25850386
    Citation
    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.
    Results Reference
    derived

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    Promoting CRC Screening in an Urban Minority Population

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