Symptom Monitoring Using Patient-Report To Improve Medication Use

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Kathryn Ruddy, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Adjuvant endocrine therapy (AET) for breast cancer reduces mortality, but one-third to one-half of patients discontinue it early or are nonadherent. Read More on PubMed

Clinical Trials