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Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272244
Recruitment Status : Completed
First Posted : October 22, 2014
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborators:
Lehigh Valley Hospital
Fox Chase Cancer Center
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Decision Support & Navigation Behavioral: Standard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
Study Start Date : October 1, 2014
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : March 31, 2017

Arm Intervention/treatment
Active Comparator: Standard
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
Behavioral: Standard
Experimental: Decision Support & Navigation
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Behavioral: Decision Support & Navigation



Primary Outcome Measures :
  1. Overall Screening Adherence [ Time Frame: 12 months ]
    The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.


Secondary Outcome Measures :
  1. Change in Screening Decision Stage [ Time Frame: 6 months ]
    At baseline and endpoint (6-month) survey, participants were asked about their decision stage regarding CRC screening. Possible decision stages are, ranked from lowest to highest stage: Decided not to do, Not considering, Haven't decided, Decided to Do and Done, with "Done" only possible at endpoint.

  2. Test Specific Screening Adherence [ Time Frame: 12 Months ]
    Test adherence (SBT or endoscopy) will be assessed using 6-month survey and 12-month medical records data. The two study groups will be compared in terms of the fraction of participants who have a screening test within 12 months.

  3. Screening Knowledge and Perceptions [ Time Frame: 6 months ]
    Knowledge and perceptions (Preventive Health Model scales) about CRC and screening will be assessed in a 6-month survey. Knowledge was measured by a set of 10 true-false statements about CRC and CRC screening. Knowledge was scored as the number of items correct with a possible range of 0 to 10. Perceptions about CRC and screening were measured using a 20-item scale based on the Preventive Health Model. Items were measured on a 5 point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. The total score and subscale scores were computed by taking the mean of component items resulting in scores that could range from 1 to 5, with higher scores indicating more favorable attitudes towards the CRC screening preventive health behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female
  • Self-identifies as being Hispanic or Latino
  • 50 to 75 years of age

Exclusion Criteria:

  • Previous diagnosis of CRC
  • Up to date with CRC screening guidelines.
  • Personal history of inflammatory bowel disease
  • Personal history of polyps
  • Family history of CRC diagnosed before the age of 60 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272244


Locations
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United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19012
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Lehigh Valley Hospital
Fox Chase Cancer Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Ronald E Myers, PhD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02272244    
Other Study ID Numbers: AD-1306-01882
First Posted: October 22, 2014    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
Colorectal Cancer
Cancer Screening
Decision Support
Navigation
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases