Colorectal CancerNCT01877096
Motivational Interviewing for Colonoscopy
A study testing Motivational Interviewing in people with Colorectal Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Personal history of CRC or chronic GI disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Motivational Interviewing for Colonoscopy: A Feasibility and Pilot Study
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.
Read the 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).
- Conditions
- Colorectal Cancer
- Being tested
- Motivational Interviewing, Attention Control
- Keywords
- Motivational Interviewing, Screening Colonoscopy, Cancer Prevention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
A brief motivational interviewing session
Attention ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Participants will undergo a brief (20-30 minutes) motivational interviewing session after their primary care appointment Receives: Behavioral: Motivational Interviewing |
| Attention Control | Active comparator | Participants will undergo a brief (20-30 minutes) attention control session after their primary care appointment Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Psychological mediators
Psychological mediators (drawn from Self Determination Theory) Participants will complete questionnaires immediately before and after the intervention/attention control session.
Measured: 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.
Measured: 5 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Sarah J Miller, PsyD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877096
- Sponsor's protocol ID
- GCO 11-1377
- Status last verified
- Nov 2015
- First submitted
- 11 Jun 2013
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing for Colonoscopy: A Feasibility and Pilot Study
- ClinicalTrials.gov ID
- NCT01877096
- Acronym / sponsor ID
- GCO 11-1377
- Conditions
- Colorectal Cancer
- Keywords
- Motivational Interviewing, Screening Colonoscopy, Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingParticipants will undergo a brief (20-30 minutes) motivational interviewing session after their primary care appointment |
| Attention Control | Active comparator | Behavioral: Attention ControlParticipants will undergo a brief (20-30 minutes) attention control session after their primary care appointment |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Personal history of CRC or chronic GI disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingA brief motivational interviewing session | Behavioural | Motivational Interviewing |
| Attention ControlParticipants 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. | Behavioural | Attention Control |
Primary outcome
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
2 secondary outcomes
Psychological mediators
Time frame: 5 minutes before intervention
Psychological mediators
Time frame: 5 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah J Miller, PsyD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Colorectal Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening colonoscopy completion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.