Motivational Interviewing for Colonoscopy

NCT ID: NCT01877096

Last Updated: 2015-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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).

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Motivational Interviewing

Participants will undergo a brief (20-30 minutes) motivational interviewing session after their primary care appointment

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

A brief motivational interviewing session

Attention Control

Participants will undergo a brief (20-30 minutes) attention control session after their primary care appointment

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type 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.

Interventions

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Motivational Interviewing

A brief motivational interviewing session

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah J Miller, PsyD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 11-1377

Identifier Type: -

Identifier Source: org_study_id

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