NCT01877096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

June 11, 2013

Last Update Submit

November 3, 2015

Conditions

Keywords

Motivational InterviewingScreening ColonoscopyCancer Prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Psychological mediators

    5 minutes before intervention

  • Psychological mediators

    5 minutes after intervention

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

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

Behavioral: Motivational Interviewing

Attention Control

ACTIVE COMPARATOR

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

Behavioral: Attention Control

Interventions

A brief motivational interviewing session

Motivational Interviewing

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.

Attention Control

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Personal history of CRC or chronic GI disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sarah J Miller, PsyD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 13, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations