Motivational Interviewing for Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Motivational Interviewing for Colonoscopy: A Feasibility and Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877096
• Other study ID #: GCO 11-1377
• Status: Completed
• Phase: N/A
• First received: June 11, 2013
• Last updated: November 3, 2015
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Behavioral:
• Motivational Interviewing
A brief motivational interviewing session
• Attention Control
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening colonoscopy completion	Medical chart review will be conducted 6 months after the primary care appointment in which the participants received a referral for a screening colonoscopy	6 months	No
Secondary	Psychological mediators	Psychological mediators (drawn from Self Determination Theory) Participants will complete questionnaires immediately before and after the intervention/attention control session.	5 minutes before intervention	No
Secondary	Psychological mediators	Psychological mediators (drawn from Self Determination Theory) Participants will complete questionnaires immediately before and after the intervention/attention control session.	5 minutes after intervention	No