IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Study Overview
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Brief Summary
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To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR).

Official Title
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IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Multicomponent Adherence Intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women or men age >18 years Diagnosed with stage I-III breast cancer prescribed endocrine therapy Within 3-years of the end of early active treatment (e.g., surgery, chemotherapy not including human epidermal growth factor receptor 2 (HER2)-directed therapy, radiation) Patients must be prescribed at least 1 antihypertensive or statin medication for CVD prevention Self-report of at least some nonadherence ET or CVD medication on DOSE-Nonadherence Extent of Nonadherence questionnaire Exclusion Criteria: Evidence of breast cancer recurrence Non-English or Non-Spanish speaking Not cognitively able to complete study requirements Do not follow with either a primary care provider or cardiologist within the New York Presbyterian Health system's Epic EHR Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adherence Intervention<br>Multicomponent Adherence Intervention | Behavioral: Multicomponent Adherence Intervention<br>* The adherence intervention will be comprised of a participant preference approach in which all participants undergo a baseline pharmacist-led medication optimization session and are offered training in how to use the patient portal and freely-available smartphone reminder app.<br>|
| Other: Usual Care<br>Usual Care from treating providers | Other: Usual Care<br>* Receipt of usual care from providers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks | Adherence to ET and CVD medication is a composite of both medication refills at 24 weeks (proportion of days covered (PDC) ≥80%) and self-report of taking the medication (as per DOSE-Nonadherence questionnaire; 3-item questionnaire in which participants with perfect adherence on each item will be categorized as adherent). Participants will be categorized as adherent if they have medication available by pharmacy fills and report being adherent to taking their pills day-today via self report. | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Adherent to ET and CVD Medication at 52 Weeks | Adherence to ET and CVD medication is a composite of both medication refills at 52 weeks (proportion of days covered (PDC) ≥80%) and self-report of taking the medication (as per DOSE-Nonadherence questionnaire; 3-item questionnaire in which participants with perfect adherence on each item will be categorized as adherent). Participants will be categorized as adherent if they have medication available by pharmacy fills and report being adherent to taking their pills day-today via self report. | 52 Weeks | 
| Change in blood pressure at 24 weeks | To compare office blood pressure changes from baseline to 24 weeks | Baseline to 24 weeks | 
| Change in blood pressure at 52 weeks | To compare office blood pressure changes from baseline to 52 weeks | Baseline to 52 weeks | 
| Change in low-density lipoprotein (LDL) cholesterol | To compare changes in low-density lipoprotein (LDL) cholesterol from baseline to 52 weeks. | Baseline to 52 weeks | 
| Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks | To evaluate changes in healthcare related quality of life (HRQOL), measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at baseline and 24 weeks. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29 is a well-validated assessment tool that includes 29 questions evaluating 7 domains including physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference (which is often associated with ET adherence). Several of these measures have been important determinants of medication adherence and have the potential to moderate intervention effects. | Baseline and 24 weeks | 
| Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks | To evaluate changes in healthcare related quality of life (HRQOL), measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at baseline and 52 weeks. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29 is a well-validated assessment tool that includes 29 questions evaluating 7 domains including physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference (which is often associated with ET adherence). Several of these measures have been important determinants of medication adherence and have the potential to moderate intervention effects. | Baseline and 52 weeks | 
| Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks | To compare participants' satisfaction with their medication regimens as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM). The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess participants' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. | Baseline and 24 weeks | 
| Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks | To compare participants' satisfaction with their medication regimens, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM). The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess participants' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. | Baseline and 52 weeks | 
| Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks | To compare participants' self-efficacy with their medication regimens as measured by the Medical Adherence Self-Efficacy Scale (MASES) at baseline and 24 weeks. MASES is a 13-item form, 12 of the items ask about confidence in ability to make medication adherence part of daily routine. The total scale ranges from 1-4, and it is an average score of all 13 items. | Baseline and 24 weeks | 
| Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks | To compare participants' self-efficacy with their medication regimens as measured by the Medical Adherence Self-Efficacy Scale (MASES) at baseline and 52 weeks. MASES is a 13-item form, 12 of the items ask about confidence in ability to make medication adherence part of daily routine. The total scale ranges from 1-4, and it is an average score of all 13 items. | Baseline and 52 weeks | 
| Change in Regimen Complexity | To evaluate regimen complexity at baseline and at 52 weeks. This will be extracted through manual chart review from the EHR. The investigators will extract total number of prescription medications and frequency of dosing for CVD medications as ET is once daily. | Baseline and at 52 weeks | 
| Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire | To evaluate reasons for medication nonadherence at baseline using the DOSE-Nonadherence reasons for nonadherence questionnaire | at baseline | 
| Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks | To evaluate reasons for medication nonadherence at 24 weeks using the DOSE-Nonadherence reasons for nonadherence questionnaire. The DOSE-Nonadherence Reasons for Nonadherence questionnaire asks how much 21 reasons for nonadherence contribute to missing doses such as trouble affording medications, insufficient social support, complexity of regimen, and concerns about adverse effects. This will be used to assess the effect of the intervention on barriers to adherence. | 24 weeks | 
| Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks | To evaluate reasons for medication nonadherence at 52 weeks using the DOSE-Nonadherence reasons for nonadherence questionnaire. The DOSE-Nonadherence Reasons for Nonadherence questionnaire asks how much 21 reasons for nonadherence contribute to missing doses such as trouble affording medications, insufficient social support, complexity of regimen, and concerns about adverse effects. This will be used to assess the effect of the intervention on barriers to adherence. | 52 weeks | 
| Impact of events using the Impact of Events Scale (IES) | To evaluate the impact of events using the Impact of Events Scale (IES) to evaluate intrusive and avoidant thoughts about participant's underlying breast cancer diagnosis at baseline. IES is a 15-item scale which queries intrusive and avoidant thoughts about a distressing event (breast cancer) in the past 7 days (similar to post-traumatic stress disorder [PTSD] symptoms). Each item has a scoring range of 0 (not at all)-5(often). This scale has been associated with disparities in ET and CVD medication nonadherence | Baseline |