Geriatric oncology assessment to link with support for older women taking adjuvant aromatase inhibitor therapy

Older women (age 65 years or older) experience a high burden of breast cancer incidence and mortality along with complex health issues that impact symptom burden, health-related quality of life (HRQoL), and treatment outcomes. Adjuvant endocrine therapy with an aromatase inhibitor (AI) is a crucial component of treatment for older women with hormone receptor positive (HR+) breast cancer. The adverse effects of AI therapy lead to impaired functioning, reduced HRQoL, and treatment discontinuation among older women. AI-associated arthralgia is a major concern, with more than 70% of older women experiencing moderate to severe AI- associated arthralgia that significantly interferes with daily functioning. Adverse effects of AI therapy also exacerbate the impacts of geriatric specific issues (e.g., low functional status), which are prevalent among older women with breast cancer. When geriatric specific issues and the adverse effects of AI therapy go unaddressed, older women with breast cancer suffer from progressive disability, excess treatment toxicity, and avoidable mortality. The proposed hierarchical 2 x 2 factorial randomized controlled trial (RCT) will test the separate and combined benefits of two interventions that have strong foundations in rigorous prior research: a clinic and provider-level Geriatric Oncology Assessment to Link with Support for AI therapy (GOAL-AI) intervention and a patient-level CBT-based coping skills training intervention for older women taking AI therapy (CST-AI). Guided by the Expanded Chronic Care Model and recommendations for improving the care of older adults with cancer, the GOAL-AI intervention integrates geriatric oncology training, brief geriatric assessment, and geriatric assessment-guided recommendations and referral resources. The CST-AI intervention teaches patients skills for managing AI-associated arthralgia and other symptoms, and strategies for engaging in health care to address geriatric specific issues. We will randomize 16 oncology practice sites to GOAL-AI or enhanced usual care (EUC), stratifying by practice site location (i.e., urban vs. rural). Within each site, participants will be randomly assigned to the CST-AI intervention or EUC. Randomization will establish four groups: 1) GOAL-AI + CST-AI, 2) GOAL-AI alone, 3) CST-AI alone, and 4) EUC (i.e., no intervention control group). Participating patients will be 452 older women (age ≥ 65 years) who are within 12 months of initiating adjuvant AI therapy for HR+ non- metastatic breast cancer. Study outcomes will be assessed at baseline, 6, and 12 months. We propose the following aims: 1) examine whether GOAL-AI + CST-AI, GOAL-AI alone, or CST-AI alone improve pain severity and interference, geriatric and AI-associated symptom burden, and HRQoL compared to EUC; 2) evaluate whether GOAL-AI + CST-AI, GOAL-AI alone, or CST-AI alone improve patient activation and self-efficacy compared to EUC and whether these variables at least partially mediate changes in study outcomes; and 3) examine GOAL-AI and CST-AI implementation-related factors using quantitative and qualitative approaches. Project Number: 1R01CA309588-01 | Fiscal Year: 2026 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: REBECCA SHELBY (+1 co-PI) | Institution: DUKE UNIVERSITY, DURHAM, NC | Award Amount: $668,691 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZRG1 HSS-P (90)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11285670