Motivational Interviewing for Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Attention Control; Behavioral: Motivational Interviewing

• Registration Number: NCT01877096
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-13
• Study Start: 2013-08
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control	Attention Control	Participants will undergo a brief (20-30 minutes) attention control session after their primary care appointment
Motivational Interviewing	Motivational Interviewing	Participants will undergo a brief (20-30 minutes) motivational interviewing session after their primary care appointment

Primary Outcome Measures

Name	Time	Method
Screening colonoscopy completion	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 Outcome Measures

Name	Time	Method
Psychological mediators	5 minutes after intervention	Psychological mediators (drawn from Self Determination Theory) Participants will complete questionnaires immediately before and after the intervention/attention control session.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States