Study of Symptom Monitoring using Patient-Reported Outcomes to Optimize Medication Use (SyMPTOM)

Overview

About this study

The purpose of this study is to assess oral AET adherence post intervention and the durability of AET adherence 1 year post intervention.

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
    • 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
  • 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
  • Evidence that an oncology provider discontinued their AET
  • Pregnant or trying to get pregnant
  • Facility-administered medications (i.e., nursing home, home healthcare agency)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 09/26/2024. Questions regarding updates should be directed to the study team contact.

 

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.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available