IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Breast Cancer Clinical Trial

Official title:

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496829
• Other study ID #: AAAT8817
• Secondary ID: 1P50MD017341
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: Research Nurse Navigator
• Phone: 212-342-5162
• Email: cancerclinicaltrials[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Multicomponent Adherence Intervention
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.

Other:
• Usual Care
Receipt of usual care from providers

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in blood pressure at 24 weeks	To compare office blood pressure changes from baseline to 24 weeks	Baseline to 24 weeks
Secondary	Change in blood pressure at 52 weeks	To compare office blood pressure changes from baseline to 52 weeks	Baseline to 52 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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