Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy

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.

NCT Number	NCT07232056
Lead Sponsor	Duke University Collaborators: National Cancer Institute (NCI)
Conditions	Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Enrollment	452 participants
Start Date	2026-10-15
Primary Completion	2030-11-30 (estimated)
Study Completion	2030-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-29