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Clinical Trials/NCT01877096
NCT01877096CompletedNot Applicable

Motivational Interviewing for Colonoscopy: A Feasibility and Pilot Study

Icahn School of Medicine at Mount Sinai1 site in 1 country57 target enrollmentStarted: August 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
57
Locations
1
Primary Endpoint
Screening colonoscopy completion

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • Psychological mediators(5 minutes after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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