Motivational Interviewing for Colonoscopy

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).

Official Title
-----------------
Motivational Interviewing for Colonoscopy: A Feasibility and Pilot Study

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing
* Behavioral: Attention Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>Participants will undergo a brief (20-30 minutes) motivational interviewing session after their primary care appointment | Behavioral: Motivational Interviewing<br>* A brief motivational interviewing session<br>|
| Active Comparator: Attention Control<br>Participants will undergo a brief (20-30 minutes) attention control session after their primary care appointment | Behavioral: Attention Control<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motivational Interviewing, Screening Colonoscopy, Cancer Prevention