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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Support & Navigation
Standard
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal Cancer, Cancer Screening, Decision Support, Navigation

Eligibility Criteria

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

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

Sites / Locations

  • Lehigh Valley Hospital
  • Fox Chase Cancer Center
  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Decision Support & Navigation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Screening Adherence
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

Change in Screening Decision Stage
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.
Test Specific Screening Adherence
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.
Screening Knowledge and Perceptions
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.

Full Information

First Posted
October 20, 2014
Last Updated
August 8, 2019
Sponsor
Thomas Jefferson University
Collaborators
Lehigh Valley Hospital, Fox Chase Cancer Center, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02272244
Brief Title
Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
Official Title
Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (undefined)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Lehigh Valley Hospital, Fox Chase Cancer Center, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, Cancer Screening, Decision Support, Navigation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Decision Support & Navigation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Decision Support & Navigation
Intervention Type
Behavioral
Intervention Name(s)
Standard
Primary Outcome Measure Information:
Title
Overall Screening Adherence
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Screening Decision Stage
Description
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.
Time Frame
6 months
Title
Test Specific Screening Adherence
Description
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.
Time Frame
12 Months
Title
Screening Knowledge and Perceptions
Description
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.
Time Frame
6 months

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald E Myers, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19012
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30333221
Citation
Myers RE, Stello B, Daskalakis C, Sifri R, Gonzalez ET, DiCarlo M, Johnson MB, Hegarty SE, Shaak K, Rivera A, Gordils-Molina L, Petrich A, Careyva B, de-Ortiz R, Diaz L. Decision Support and Navigation to Increase Colorectal Cancer Screening Among Hispanic Patients. Cancer Epidemiol Biomarkers Prev. 2019 Feb;28(2):384-391. doi: 10.1158/1055-9965.EPI-18-0260. Epub 2018 Oct 17.
Results Reference
derived

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

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