Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy (GOAL-AI)

Duke University

Status: Begins enrollment in 3 months

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

Treatments: Behavioral: CST-AI; Behavioral: GOAL-AI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07232056

Pro00118528

Details and patient eligibility

About

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.

Enrollment: 452 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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452 participants in 4 patient groups

GOAL-AI + CST-AI

Experimental group

Description:

Combination of clinic-level geriatric assessment and CBT-based coping skills training.

Treatment:

Behavioral: GOAL-AI

Behavioral: CST-AI

GOAL-AI alone

Experimental group

Description:

Clinic-level geriatric assessment and support only.

Treatment:

Behavioral: GOAL-AI

CST-AI alone

Experimental group

Description:

CBT-based coping skills training only.

Treatment:

Behavioral: CST-AI

Enhanced Usual Care

No Intervention group

Description:

Standard care with educational materials.