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Completed

NCT Number: NCT02272244

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lehigh Valley Hospital, Allentown, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Support & Navigation

Behavioral

Standard

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Fox Chase Cancer Center
  • Lehigh Valley Hospital
  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2014
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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