Breast CancerPhase 2/3MI for AIsNCT02883361
Motivational Enhancement Therapy to Improve Adherence to Aromatase Inhibitors
A Phase 2/3 study testing Motivational enhancement therapy in people with Breast Cancer and Medication Adherence, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Medication Adherence
- What is being tested?
- Motivational enhancement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 1 Aug 2020
- Phase
- Phase 2/3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking women, prescribed their first aromatase inhibitor medication. Been identified as non-adherent following a 6-month observation run-in period (Phase 1).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Breast Cancer, Medication Adherence
- Being tested
- Motivational enhancement therapy, Attention Control
- Medical subject headings
- Breast Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational enhancement therapyBehavioural
Also called Motivational interviewing
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
Attention ControlBehavioural
Having participants come into the lab and fill out questionnaires with a researcher in-person
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Receive 4 in-person motivational enhancement counseling sessions over the course of 12-months that specifically target medication adherence. Receives: Behavioral: Motivational enhancement therapy |
| Control | Placebo comparator | Attend 4 in-person sessions to complete questionnaires and receive educational handouts. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence measured using medication possession ratio (MPR)
Measured: 12-months
Secondary outcomes (2)
Motivation for medication adherence
Change in motivation measured using the Treatment Self Regulation Questionnaire
Measured: 12-months
Self-report medication adherence
Change in self-report medication adherence
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start1 Aug 2020
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Why it stopped: Our team decided to conduct more preliminary work on understanding AI adherence to support the optimal development of a randomized controlled trial before proceeding with the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tavis S. Campbell, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883361
- Sponsor's protocol ID
- REB16-1463
- Acronym
- MI for AIs
- Status last verified
- Dec 2024
- First submitted
- 25 Aug 2016
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Enhancement Therapy to Improve Adherence to Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT02883361
- Acronym / sponsor ID
- MI for AIs / REB16-1463
- Conditions
- Breast Cancer, Medication Adherence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Our team decided to conduct more preliminary work on understanding AI adherence to support the optimal development of a randomized controlled trial before proceeding with the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 30 Aug 2016 (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 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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Motivational enhancement therapyReceive 4 in-person motivational enhancement counseling sessions over the course of 12-months that specifically target medication adherence. |
| Control | Placebo comparator | Behavioral: Attention ControlAttend 4 in-person sessions to complete questionnaires and receive educational handouts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking women, prescribed their first aromatase inhibitor medication. Been identified as non-adherent following a 6-month observation run-in period (Phase 1).
Key exclusion criteria (1 listed)
- 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.
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 enhancement therapyAlso: Motivational interviewingCounseling 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 | Behavioural | Treatment |
| Attention ControlHaving participants come into the lab and fill out questionnaires with a researcher in-person | Behavioural | Control |
Primary outcome
Medication adherence measured using medication possession ratio (MPR)
Time frame: 12-months
2 secondary outcomes
Motivation for medication adherence
Time frame: 12-months
Self-report medication adherence
Time frame: 12-months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Motivational enhancement therapy in people with Breast Cancer and Medication Adherence, run by University of Calgary at 1 site in Canada.
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 1 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: withdrawn, as of the sponsor's last update on 5 Dec 2024. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Medication adherence measured using medication possession ratio (MPR) (time frame: 12-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 5 Dec 2024.