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Behavioral Intervention
Motivational enhancement therapy for Breast Cancer (MI for AIs Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English-speaking women, prescribed their first aromatase inhibitor medication. Been identified as non-adherent following a 6-month observation run-in period (Phase 1).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
MI for AIs Trial Summary
This trial will test whether motivational interviewing can improve adherence to aromatase inhibitors in a community sample of patients.
Eligible Conditions
- Breast Cancer
- Medication Adherence
MI for AIs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMI for AIs Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Medication adherence measured using medication possession ratio (MPR)
Secondary outcome measures
Motivation for medication adherence
Self-report medication adherence
Other outcome measures
Self Efficacy for Medication Adherence
Side effects data
From 2008 Phase 2 trial • 38 Patients • NCT0036026947%
Gastrointestinal
37%
Headache
37%
Sinus/allergies/flu-like symptoms
32%
Dizziness/lightheaded
32%
Musculoskeletal
26%
Sexual dysfunction
26%
Other
16%
Hot/cold flashes
16%
Dry mouth
16%
Drowsiness
16%
Anxiety/depression
11%
Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atomoxetine
Placebo
MI for AIs Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Receive 4 in-person motivational enhancement counseling sessions over the course of 12-months that specifically target medication adherence.
Group II: ControlPlacebo Group1 Intervention
Attend 4 in-person sessions to complete questionnaires and receive educational handouts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational enhancement therapy
2008
Completed Phase 2
~730
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,606 Total Patients Enrolled
5 Trials studying Breast Cancer
2,104 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being actively sought for this experiment?
"The clinical trial indicated on clinicaltrials.gov is not actively recruiting patients at this time. The trial was initially posted on 2020-10-01 and was last updated on 2019-05-24. There are currently 1510 other clinical trials seeking patients."
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