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Breast Cancer Early Stage Breast Cancer (Stage 1-3)SyMPTOMNCT06765707

Symptom Monitoring Using Patient-Report to Improve Medication Use

A study testing Pharmacist delivered symptom monitoring and management in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Endocrine Therapy, run by Medical College of Wisconsin at 4 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is an intervention targeting patients at risk for non-adherence to endocrine therapy after primary treatments for hormone-positive breast cancer. In a randomized study, the study team will collect patient-reported symptoms monthly from participants through surveys. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pharmacist delivered symptom monitoring and management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
4 sitesUnited States
Study dates
23 Jun 2025to Aug 2029
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cisgender women assigned female at birth
  • Age 18 years or older
  • Stage 1-3 hormone receptor-positive breast cancer
  • Premenopausal patients being treated with GNRH agonist/antagonist to induce menopause are eligible
  • Patients who received treatment with CDK 4/6 inhibitors are eligible
  • Recommended to continue AET for ≥2 additional years after enrollment
Show all 9Show fewer
  • Low adherence defined as prescription fills with a proportion of days covered (PDC) of <80%, examined over all fills during the 2 years prior to date of eligibility review since the first AET prescription/data of AET start OR unable to calculate adherence
  • Verbal fluency in English or Spanish
  • Ability to understand informed consent and the willingness to sign it

Who cannot join

  • Unable to verbalize comprehension of study or impaired decision-making
  • Known distant metastatic disease
  • Not receiving breast cancer care or AET prescription from provider at participating site
  • Evidence that an oncology provider discontinued their AET
  • Pregnant or trying to get pregnant
  • Facility-administered medications (i.e., nursing home, home healthcare agency)

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States4 sites

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • University of Wisconsin--Madison

    Madison, Wisconsin, 53705

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 26509

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use

This is an intervention targeting patients at risk for non-adherence to endocrine therapy after primary treatments for hormone-positive breast cancer. In a randomized study, the study team will collect patient-reported symptoms monthly from participants through surveys. Pharmacists who specialize in cancer at the patients' hospital will give patients recommendations to help improve their symptoms and address other barriers so they can continue daily endocrine therapy medications.

Read the detailed description

This study will test whether oncology teams can adapt and combine models from intensive oncologic care and chronic noncancer care to support long-term oral oncologic medication adherence through better symptom monitoring and management. It will identify patients at risk of nonadherence through electronic health records and target them with a symptom monitoring and management intervention. The study will use patient-reported outcomes (PROs) to identify symptoms that may cause nonadherence and will involve clinical pharmacist-led follow-up.

Objectives:

  1. Assess the impact of the intervention on adherence to oral endocrine therapy.
  2. Evaluate the durability of adherence one-year post-intervention.
  3. Describe the impact on symptoms and explore mechanisms for adherence improvement.

Intervention:

During the intervention phase, patients will receive symptom monitoring and pharmacist-led management based on patient-reported outcomes (PROs).

Symptom Monitoring:

  1. Patients will report symptoms monthly for 12 months either online or via an interactive voice recording (IVR) system.
  2. Symptoms will be assessed using PROs focusing on issues like pain, hot flashes, anxiety, and more.
  3. Severe symptoms will trigger follow-up for management.

Symptom Management:

  1. After the initial symptom report, patients will have a face-to-face or virtual visit with a clinical pharmacist.
  2. The visit will be tailored based on patient preference and pharmacist judgment.
  3. Pharmacists will discuss symptom reports, provide management recommendations, and coordinate with oncologists for prescriptions if needed.
  4. All interactions will be documented in the electronic health record (EHR) for research analysis.

Control Phase:

Breast cancer patients on AET are typically seen every six months over a 5 to 10-year course, with more frequent visits if complications arise. Control group participants will continue to follow this schedule and receive an FDA document with tips for medication adherence.

Consent Process:

Informed consent will be obtained in person or remotely.

Being tested
Pharmacist delivered symptom monitoring and management
Keywords
symptom management, symptom monitoring, pharmacist delivered intervention, oral endocrine therapy adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist delivered symptom monitoring and managementBehavioural

    Patients in the intervention phase will receive PRO-based symptom monitoring once a month and pharmacist-led management for problematic symptoms based on routine clinical care recommendations.

Study groups in NCT06765707
Study groupRoleWhat they receive
Usual Care first, Then Symptom Monitoring and ManagementExperimentalPatients first receive care as usual which includes follow-up with their oncology team first 12 months of the study. Following data collection at 12 months they will then receive symptom monitoring and management for the second 12 months of the study.
Receives: Behavioral: Pharmacist delivered symptom monitoring and management
Symptom Monitoring and Management first, Then Usual CareExperimentalPatients first receive symptom monitoring and management for the first 12 months of the study. After data collection at 12 months they will then receive care as usual which includes follow-up with their oncology for the second 12 months of the study.
Receives: Behavioral: Pharmacist delivered symptom monitoring and management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication adherence

    Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap

    Measured: From baseline to 12 months

  2. Intervention durability on medication adherence

    Assess the durability of AET adherence 1 year post intervention on patients assigned to the intervention phase first. Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap

    Measured: From 12 to 24 months

Secondary outcomes (13)

  1. Medication adherence

    Medication adherence, based on prescription fill data (percent days covered, as used in screening)

    Measured: From baseline to 12 months

  2. Pain

    Patient-report collected via PROMIS Pain Interference measure

    Measured: From baseline to 24 months

  3. Fatigue

    Patient-report collected via PROMIS Fatigue measure

    Measured: From baseline to 24 months

  4. Sleep

    Patient-report collected via PROMIS Sleep-related Impairment measure

    Measured: From baseline to 24 months

  5. Anxiety

    Patient-report collected via PROMIS Anxiety measure

    Measured: From baseline to 24 months

  6. Depression

    Patient-report collected via PROMIS Depression measure

    Measured: From baseline to 24 months

  7. Sexual function

    Patient-report collected via PROMIS Sexual Function and Satisfaction measure

    Measured: From baseline to 24 months

  8. Physical functioning

    Patient-report collected via PROMIS Physical Functioning measure.

    Measured: From baseline to 24 months

  9. Social functioning

    Patient-report collected via PROMIS Ability to Participate in Social Roles and Activities measure

    Measured: From baseline to 24 months

  10. Self-efficacy to manage medications

    Patient-report collected via PROMIS Self-efficacy to Manage Medications measure

    Measured: From baseline to 24 months

  11. Self-efficacy to manage symptoms

    Patient-report collected via PROMIS Self-efficacy to Manage Symptoms measure

    Measured: From baseline to 24 months

  12. Social support

    Patient-reported collected via PROMIS Instrumental Support measure

    Measured: From baseline to 24 months

  13. Team-patient communication quality

    Team-patient communication quality collected using The Communication Assessment Tool

    Measured: From baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start23 Jun 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

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
Crossover
Model description
Multi-center, two-arm cross-over, randomized control trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06765707
Sponsor's protocol ID
PRO00051010
Other IDs
1R01CA285925-01A1
Acronym
SyMPTOM
Status last verified
Oct 2026
First submitted
27 Dec 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For patients who consent to sharing, the cleaned, de-identified, individual-participant level scientific data for all variables used in the analyses that address the specific aims will be shared, along with example transformations from initial raw data.

Publications

  • Neuner J, Weil E, Fergestrom N, Stolley M, Kamaraju S, Oxencis C, Winn A, Laud PW, Flynn KE. Feasibility of a pharmacist-led symptom monitoring and management intervention to improve breast cancer endocrine therapy adherence. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1321-1328.e3. doi: 10.1016/j.japh.2022.03.001. Epub 2022 Mar 5.

    PubMed 35393248

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist delivered symptom monitoring and management in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Endocrine Therapy, run by Medical College of Wisconsin at 4 sites 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 9 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

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 (time frame: From baseline to 12 months). The study lists 2 primary outcomes in all. 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 NCT06765707, 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 2 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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