Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07232056). This is a study registration, not published results. Lead sponsor: Duke University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 452 participants (ESTIMATED). Conditions: Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia. Interventions: BEHAVIORAL: GOAL-AI; BEHAVIORAL: CST-AI. Primary outcome measures: Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form , Baseline, 6 months, 12 months. Brief summary: Older women (≥65 years) with HR+ non-metastatic breast cancer experience high symptom burden and reduced quality of life during aromatase inhibitor (AI) therapy. This hierarchical 2×2 factorial randomized controlled trial will test two interventions: (1) a clinic-level geriatric oncology assessment and support program (GOAL-AI) and (2) a patient-level CBT-based coping skills training (CST-AI). The study aims to improve pain, symptom burden, and health-related quality of life compared to enhanced usual care.