Clinical trial NCT06765707: Symptom Monitoring Using Patient-Report to Improve Medication Use
Official title: Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Endocrine Therapy
Keywords: symptom management
symptom monitoring
pharmacist delivered intervention
oral endocrine therapy adherence
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-01-09
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multi-center, two-arm cross-over, randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* Cisgender women assigned female at birth
* Age 18 years or older
* Stage 1-3 hormone receptor-positive breast cancer

  1. Premenopausal patients being treated with GNRH agonist/antagonist to induce menopause are eligible
  2. Patients who received treatment with CDK 4/6 inhibitors are eligible
* Recommended to continue AET for ≥2 additional years after enrollment
* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Medication adherence
timeFrame: From baseline to 12 months
measure: Intervention durability on medication adherence
timeFrame: From 12 to 24 months
Secondary outcomes:
measure: Medication adherence
timeFrame: From baseline to 12 months
measure: Pain
timeFrame: From baseline to 24 months
measure: Fatigue
timeFrame: From baseline to 24 months
measure: Sleep
timeFrame: From baseline to 24 months
measure: Anxiety
timeFrame: From baseline to 24 months
measure: Depression
timeFrame: From baseline to 24 months
measure: Sexual function
timeFrame: From baseline to 24 months
measure: Physical functioning
timeFrame: From baseline to 24 months
measure: Social functioning
timeFrame: From baseline to 24 months
measure: Self-efficacy to manage medications
timeFrame: From baseline to 24 months
measure: Self-efficacy to manage symptoms
timeFrame: From baseline to 24 months
measure: Social support
timeFrame: From baseline to 24 months
measure: Team-patient communication quality
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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.