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Motivational Enhancement Therapy to Improve Adherence to Aromatase Inhibitors

NCT ID: NCT02883361

Last Updated: 2024-12-05

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

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-08-01

Brief Summary

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The proposed research is a randomized controlled investigation of the efficacy of motivational interviewing (MI) to improve adherence to aromatase inhibitors (AI) in a community sample of patients with poor adherence to AIs.

Detailed Description

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Background: The use of Aromatase Inhibitors (AIs) among breast cancer (BC) patients with hormone receptor-positive disease reduces recurrence by 41% and mortality by 31%. Despite the efficacy of AIs, one-quarter of BC survivors fail to take their AIs as prescribed during the first year with another one-fifth discontinuing later in treatment. There are a variety of reasons for non-adherence, including low motivation, poor patient-provider communication, low self-efficacy, low perceived risk, and the experience of side effects. One promising intervention for improving treatment adherence is motivational interviewing (MI), a broad set of patient-centered techniques designed to enhance motivation for behaviour change. Objectives: To conduct a parallel-group, double-blind, randomized controlled trial (RCT) to evaluate the efficacy of MI at improving 12-month adherence to AIs relative to attention control (AC). The primary outcome is medication adherence measured using pharmacy records and calculated by medication possession ratio (MPR). Secondary outcomes include self-reported adherence, motivation and self-efficacy. Methods: A community sample of BC survivors newly prescribed AIs will be recruited from a local cancer centre pharmacy for a 6-month medication adherence observation period. The investigators chose to recruit new AI users because a significant number (i.e., 20-35%) are expected to discontinue medication within 12-months. MPR will be calculated following the observation period and patients meeting inclusion criteria and deemed non-adherent (MPR \< 80%) will be enrolled in the trial, randomly assigned to MI or AC, and scheduled for a baseline appointment. Recruitment will continue until 128 (64 per group) non-adherent BC survivors are identified. Four MI or AC sessions will be delivered at 3-month intervals (0-,3-,6-,9-months), each lasting 30-45 minutes. A final assessment will occur at 12-months. Baseline and final assessments will be conducted by an assistant who is not affiliated with the trial. Given that the long-term adherence to AIs is poor, a lack of adherence leads to clinically meaningful increases in BC recurrence, morbidity and mortality, and there has been only one published intervention study related to AIs to date, our trial represents a top priority in the prevention and treatment of BC.

Conditions

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Breast Cancer Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Treatment

Receive 4 in-person motivational enhancement counseling sessions over the course of 12-months that specifically target medication adherence.

Group Type EXPERIMENTAL

Motivational enhancement therapy

Intervention Type BEHAVIORAL

Counseling meant to enhance motivation and decrease ambivalence about change, including asking open-ended questions, eliciting change-talk, and identifying discrepancies between current behaviour and valued behaviour

Control

Attend 4 in-person sessions to complete questionnaires and receive educational handouts.

Group Type PLACEBO_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

Having participants come into the lab and fill out questionnaires with a researcher in-person

Interventions

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Motivational enhancement therapy

Counseling meant to enhance motivation and decrease ambivalence about change, including asking open-ended questions, eliciting change-talk, and identifying discrepancies between current behaviour and valued behaviour

Intervention Type BEHAVIORAL

Attention Control

Having participants come into the lab and fill out questionnaires with a researcher in-person

Intervention Type BEHAVIORAL

Other Intervention Names

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Motivational interviewing

Eligibility Criteria

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Inclusion Criteria

* English-speaking women, prescribed their first aromatase inhibitor medication. Been identified as non-adherent following a 6-month observation run-in period (Phase 1).

Exclusion Criteria

* Unable to comply with protocols; diagnosis of cognitive impairment; severe psychopathology (e.g., schizophrenia); history of drug abuse; terminal condition with low likelihood of survival; living in a long-term care facility.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Tavis S. Campbell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Behavioural Medicine Laboratory

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB16-1463

Identifier Type: -

Identifier Source: org_study_id