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Completed

NCT Number: NCT01877096

Motivational Interviewing for Colonoscopy

The purpose of this study is to begin to examine the efficacy of a motivational interviewing intervention to increase African Americans' screening colonoscopy rates. The results from this pilot study will allow us to estimate the magnitude of the intervention and mediation effect sizes.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Screening colonoscopy can aid in the early detection and prevention of CRC. A motivational interviewing (MI) intervention holds strong promise to increase African Americans' screening colonoscopy adherence and, by doing so, decrease CRC disparities. There is a great need to conduct a randomized clinical trial (RCT) that tests the efficacy of an MI intervention to increase screening colonoscopy adherence in African Americans. The first critical and necessary step in this line of research is to pilot test such an RCT.

Objective/hypotheses: The primary objective of the proposed study is to conduct pilot testing for a future RCT which will formally test the effects of MI on screening colonoscopy adherence in African Americans. The results from this pilot study will directly inform the development of a future RCT.

Specific aims: 1) To estimate the magnitude of the MI intervention effect size; and 2) To estimate the magnitude of the mediation effect sizes (drawn from Self Determination Theory).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • self-identified as African American
  • aged 50 years or older
  • attended a non-acute visit with a primary care physician
  • received a primary care physician referral for a screening colonoscopy
  • deemed eligible for an open access screening colonoscopy
  • agreed to have a screening colonoscopy conducted at Mount Sinai
  • English speaking

Exclusion criteria

  • Personal history of CRC or chronic GI disorder

Treatment and study plan

Motivational Interviewing

Behavioral

A brief motivational interviewing session

Attention Control

Behavioral

Participants will be asked to discuss the sources (e.g., the Internet) in which they receive information about their health. This group is designed to control for potential beneficial effects of meeting with an interventionist.

Primary outcomes

  1. Screening colonoscopy completion

    Time frame: 6 months

    Medical chart review will be conducted 6 months after the primary care appointment in which the participants received a referral for a screening colonoscopy

Secondary outcomes

  1. Psychological mediators

    Time frame: 5 minutes before intervention

    Psychological mediators (drawn from Self Determination Theory) Participants will complete questionnaires immediately before and after the intervention/attention control session.

  2. Psychological mediators

    Time frame: 5 minutes after intervention

    Psychological mediators (drawn from Self Determination Theory) Participants will complete questionnaires immediately before and after the intervention/attention control session.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Motivational Interviewing for Colonoscopy: A Feasibility and Pilot Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2013
Registry last updated
Nov 4, 2015

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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