NCT07232056

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

Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant Aromatase Inhibitor Therapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia

Interventions

Type	Name	Description
BEHAVIORAL	GOAL-AI	Clinic-level geriatric assessment and support program.
BEHAVIORAL	CST-AI	CBT-based coping skills training via telehealth.

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-11-30
• Completion: 2030-11-30
• First posted: 2025-11-18
• Last updated: 2025-11-18