Breast CancerNCT05496829
IMPACT Trial: Intervention to iMProve AdherenCe Equitably
A study testing Multicomponent Adherence Intervention in people with Breast Cancer, run by Columbia University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Multicomponent Adherence Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Dawn Hershman, MD, 212-305-1945, dlh23@columbia.edu
Dawn Hershman, MD
About this study
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).
- Conditions
- Breast Cancer
- Being tested
- Multicomponent Adherence Intervention, Usual Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Adherence InterventionBehavioural
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 CareOther
Receipt of usual care from providers
| Study group | Role | What they receive |
|---|---|---|
| Adherence Intervention | Experimental | Multicomponent Adherence Intervention Receives: Behavioral: Multicomponent Adherence Intervention |
| Usual Care | Other | Usual Care from treating providers Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Weeks
Secondary outcomes (15)
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.
Measured: 52 Weeks
Change in blood pressure at 24 weeks
To compare office blood pressure changes from baseline to 24 weeks
Measured: Baseline to 24 weeks
Change in blood pressure at 52 weeks
To compare office blood pressure changes from baseline to 52 weeks
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start2 Mar 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Dawn L. Hershman, Columbia University
- Investigators
- Dawn Hershman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496829
- Sponsor's protocol ID
- AAAT8817
- Other IDs
- 1P50MD017341
- Status last verified
- May 2026
- First submitted
- 17 Jun 2022
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sathe C, DeStephano D, Lee S, West H, Beauchemin M, Accordino M, Liyanage-Don N, Crew KD, Kukafka R, Harden E, Hershman DL, Kronish IM. Rationale and design of the IMProving Adherence to medications for breast Cancer and cardiovascular disease equiTably (IMPACT) randomized clinical trial. Contemp Clin Trials. 2025 Sep;156:108009. doi: 10.1016/j.cct.2025.108009. Epub 2025 Jul 11.
PubMed 40653311
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT Trial: Intervention to iMProve AdherenCe Equitably
- ClinicalTrials.gov ID
- NCT05496829
- Acronym / sponsor ID
- AAAT8817
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Aug 2022 (actual)
- 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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence Intervention | Experimental | Behavioral: Multicomponent Adherence InterventionMulticomponent Adherence Intervention |
| Usual Care | Other | Other: Usual CareUsual Care from treating providers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Multicomponent Adherence InterventionThe 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. | Behavioural | Adherence Intervention |
| Usual CareReceipt of usual care from providers | Other | Usual Care |
Primary outcome
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.
15 secondary outcomes
Number of Participants Adherent to ET and CVD Medication at 52 Weeks
Time frame: 52 Weeks
Change in blood pressure at 24 weeks
Time frame: Baseline to 24 weeks
Change in blood pressure at 52 weeks
Time frame: Baseline to 52 weeks
Change in low-density lipoprotein (LDL) cholesterol
Time frame: Baseline to 52 weeks
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks
Time frame: Baseline and 24 weeks
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks
Time frame: Baseline and 52 weeks
Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks
Time frame: Baseline and 24 weeks
Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks
Time frame: Baseline and 52 weeks
Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks
Time frame: Baseline and 24 weeks
Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks
Time frame: Baseline and 52 weeks
Change in Regimen Complexity
Time frame: Baseline and at 52 weeks
Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire
Time frame: at baseline
Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks
Time frame: 24 weeks
Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks
Time frame: 52 weeks
Impact of events using the Impact of Events Scale (IES)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40653311Sathe C, DeStephano D, Lee S, West H, Beauchemin M, Accordino M, Liyanage-Don N, Crew KD, Kukafka R, Harden E, Hershman DL, Kronish IM. Rationale and design of the IMProving Adherence to medications for breast Cancer and cardiovascular disease equiTably (IMPACT) randomized clinical trial. Contemp Clin Trials. 2025 Sep;156:108009. doi: 10.1016/j.cct.2025.108009. Epub 2025 Jul 11.
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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.
Dawn Hershman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Adherence Intervention in people with Breast Cancer, run by Columbia University at 1 site in United States.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Nurse Navigator (212-342-5162, cancerclinicaltrials@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05496829, which also lists 1 linked publication.
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 6 May 2026.