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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272244
• Other study ID #: AD-1306-01882
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: March 31, 2017

Study information

• Verified date: August 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 31, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Decision Support & Navigation

• Standard

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Thomas Jefferson University	Fox Chase Cancer Center, Lehigh Valley Hospital, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 Months
Secondary	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.	6 months