Motivational enhancement therapy for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Behavioural Medicine Laboratory, Calgary, Canada
+1 More
Motivational enhancement therapy - Behavioral
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether motivational interviewing can improve adherence to aromatase inhibitors.

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Eligible Conditions

  • Breast Cancer
  • Adherence, Medication

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Motivational enhancement therapy will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Breast Cancer. Measurement will happen over the course of 12-months.

12-months
Medication adherence measured using medication possession ratio (MPR)
Motivation for medication adherence
Self Efficacy for Medication Adherence
Self-report medication adherence

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Atomoxetine
Gastrointestinal
47%
Headache
37%
Sinus/allergies/flu-like symptoms
37%
Dizziness/lightheaded
32%
Musculoskeletal
32%
Other
26%
Sexual dysfunction
26%
Hot/cold flashes
16%
Dry mouth
16%
Anxiety/depression
16%
Drowsiness
16%
Irritability
11%
Respiratory
0%
Increased urination
0%
Insomnia
0%
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00360269) in the Atomoxetine ARM group. Side effects include: Gastrointestinal with 47%, Headache with 37%, Sinus/allergies/flu-like symptoms with 37%, Dizziness/lightheaded with 32%, Musculoskeletal with 32%.

Trial Design

2 Treatment Groups

Control
Treatment
Placebo group

This trial requires 128 total participants across 2 different treatment groups

This trial involves 2 different treatments. Motivational Enhancement Therapy is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12-months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12-months for reporting.

Who is running the study

Principal Investigator
T. S. C.
Prof. Tavis S. Campbell, Professor
University of Calgary

Closest Location

Behavioural Medicine Laboratory - Calgary, Canada

Eligibility Criteria

This trial is for female patients aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
English-speaking women, prescribed their first aromatase inhibitor medication. Been identified as non-adherent following a 6-month observation run-in period (Phase 1).

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can adherence, medication be cured?

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It is difficult to imagine how a patient with schizophrenia can be cured of schizophrenia if they do not adhere to their treatment, if they discontinue their medication or if they do not take their medication regularly, especially if the medication they are taking is not working. The concept of a mental disease that is permanently cured, either biologically or psychologically, must be abandoned.

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What is adherence, medication?

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Achieving optimal disease management depends on the combined efforts of patients and healthcare providers to understand and adhere to treatment regimens. This article examines the patient and provider perspectives and emphasizes the role of the nursing staff in providing optimal adherence to illness management guidelines.

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What are common treatments for adherence, medication?

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Medication adherence is often an issue in the health care system, but little to no attention is given to it when treatment for HIV is provided.

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What are the signs of adherence, medication?

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Adherence to care can be measured as the number of missed appointments for each patient in a particular period of time. The more visits a patient has in a particular period, the worse his or she is at complying with treatment in that period. The average missing appointments are 2.0, with greater than four missed appointments in any given period being a reliable sign of poor adherence. Adherence, in part, is defined as the patients ability to take their medication, and to comply with doctor's instructions. The following will help you recognize whether or not your patient is taking their medication as instructed: Take one medication, no more than the allotted time, and no more than prescribed, for each medication.

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What causes adherence, medication?

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Factors which influence adherence may include social support, personality, mental health, and treatment efficacy. Additional research is needed to identify other variables which influence adherence.

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How many people get adherence, medication a year in the United States?

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The United States is now a global leader in improving medication adherence. The Veterans Administration emphasizes improving adherence and medication use for patients by enhancing patient education and providing information about medication side effects and potential side effects, providing telephone counseling to patients, and providing pharmaceutical assistance. Improving medication adherence may improve patient outcomes and lead to cost savings. Adherence to medication can be improved at the prescriber/health care team interface by providing appropriate education for both the physician and the patient. Adherence to other health-care interventions can also be improved.

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Does adherence, medication run in families?

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Patients with nonadherence are more likely to have a psychiatric diagnosis and medication treatment on their medication plan. However, they also tend to have a greater likelihood of a first psychiatric diagnosis and of adherence.

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How serious can adherence, medication be?

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Patients with poor adherence to medications have higher rates of cardiovascular events, whereas those with high adherence have lower event rates. Adherence is an important factor for optimizing cardiovascular outcome and preventing cardiovascular complications, a major component of cardiovascular disease prevention.

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What is the latest research for adherence, medication?

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People with multiple sclerosis are at risk of both nonadherence and medication-related problems. Increasingly, it seems, the problem is related directly to the severity of their condition. Adherence counseling must not only be tailored to the individual and their circumstances, but also integrate strategies targeted at achieving the desired behavior and reducing the risk of nonadherence. Strategies needed for optimal adherence to disease-modifying therapy are still poorly defined. Further evidence for strategies that optimize medication use for individuals with this chronic disease is desirable.

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Does motivational enhancement therapy improve quality of life for those with adherence, medication?

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QOL is a key outcome for patients with MMT. Data from a recent study suggest that MMT could serve as a useful tool to improve health-related QOL in this population.

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What does motivational enhancement therapy usually treat?

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Methadone maintenance patients do not have a stronger sense of motivation towards medication adherence. Nevertheless, patients in this group have improved motivation, and they can be treated for drug-related issues.

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What is motivational enhancement therapy?

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Treatment of chronic disease such as diabetes with MHT led to significant improvement in patients' health-related quality of life and adherence behaviors compared with standard care and motivational enhancement alone. More work needs to be done to determine causal explanations for these findings and also their ability to generalize to other chronic diseases, as well as to establish the most effective implementation methods for MHT and other behavioral interventions such as those used in MHT.

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