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NCT Number: NCT05496829

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

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).

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Dawn Hershman, MD

CONTACT

[email protected]

212-305-1945

Dawn Hershman, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multicomponent Adherence Intervention

Behavioral

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.

Usual Care

Other

Receipt of usual care from providers

Primary outcomes

  1. Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks

    Time frame: 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.

Secondary outcomes

  1. Number of Participants Adherent to ET and CVD Medication at 52 Weeks

    Time frame: 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.

  2. Change in blood pressure at 24 weeks

    Time frame: Baseline to 24 weeks

    To compare office blood pressure changes from baseline to 24 weeks

  3. Change in blood pressure at 52 weeks

    Time frame: Baseline to 52 weeks

    To compare office blood pressure changes from baseline to 52 weeks

  4. Change in low-density lipoprotein (LDL) cholesterol

    Time frame: Baseline to 52 weeks

    To compare changes in low-density lipoprotein (LDL) cholesterol from baseline to 52 weeks.

  5. Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks

    Time frame: Baseline and 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.

  6. Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks

    Time frame: Baseline and 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.

  7. Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks

    Time frame: Baseline and 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.

  8. Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks

    Time frame: Baseline and 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.

  9. Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks

    Time frame: Baseline and 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.

  10. Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks

    Time frame: Baseline and 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.

  11. Change in Regimen Complexity

    Time frame: Baseline and at 52 weeks

    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.

  12. Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire

    Time frame: at baseline

    To evaluate reasons for medication nonadherence at baseline using the DOSE-Nonadherence reasons for nonadherence questionnaire

  13. Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks

    Time frame: 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.

  14. Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks

    Time frame: 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.

  15. Impact of events using the Impact of Events Scale (IES)

    Time frame: Baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Research Nurse Navigator

CONTACT

[email protected]

212-342-5162

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 11, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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