Motivational Enhancement Therapy to Improve Adherence to Aromatase Inhibitors

NCT02883361 | Withdrawn Phase 2

• 1 other identifier: REB16-1463
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Medication adherence measured using medication possession ratio (MPR)

  12-months

Secondary Outcomes (2)

• Motivation for medication adherence

  12-months

• Self-report medication adherence

  12-months

Other Outcomes (1)

• Self Efficacy for Medication Adherence

  12-months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: Motivational enhancement therapy

Control

PLACEBO COMPARATOR

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

Behavioral: Attention Control

Interventions

Motivational enhancement therapy 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

Also known as: Motivational interviewing

Treatment

Attention Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Behavioural Medicine Laboratory

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Medication Adherence

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: August 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CA (1)