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

NCT07232056

Not Yet RecruitingNA

Sponsor: Duke University

Conditions: Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia

Interventions: GOAL-AI, CST-AI

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.

Eligibility overview

Sex: FEMALE

Age: 65 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Female, age ≥65 years
* HR+ non-metastatic breast cancer
* Within 12 months of starting AI therapy
* English-speaking
* Able to provide consent

Exclusion Criteria:

* Age \<65 years
* Metastatic cancer
* Cognitive impairment preventing consent
* Receiving care at multiple participating sites