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Not Yet Recruiting
NCT07759947
Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
Conditions: Hormone Receptor Positive Breast Cancer
Sex: Female
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: Massachusetts General Hospital
Location: Moffitt Cancer Center Tampa Florida
Summary
The goal of this study is to demonstrate the efficacy of an evidence-based, small-group, telehealth intervention ('STRIDE') for improving patients' ability to cope with side effects from adjuvant endocrine therapy (AET) and adhere to AET medication regimens for patients with hormone-sensitive breast cancer.
Eligibility Criteria
Inclusion Criteria:
* Female ≥ 21 years old
* Diagnosis of early-stage (0-IIIb), hormone receptor positive (ER+/PR+) breast cancer
* Completed primary treatment (surgery, chemotherapy, and/or radiation)
* Within 3 to 12 months of starting oral adjuvant endocrine therapy (AET)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Ability to read and respond in English or Spanish
* Distress about AET ≥ 4 on a 0-10 scale
Exclusion Criteria:
* Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the treating oncologist
* Enrolled in a clinical trial for AET
Source: ClinicalTrials.gov (NCT07759947). StuddyBuddy aggregates publicly available trial information.