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

Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
• Intervention / Treatment: Behavioral: GOAL-AI; Behavioral: CST-AI

• Study Type: Interventional
• Enrollment (Estimated): 452
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Smrithi Divakaran, MBBS, MSPH; Phone Number: 919-681-7695; Email: smrithi.divakaran@duke.edu
• Study Contact Backup: Name: Michael W Willis, BA; Phone Number: 919-681-8437; Email: michael.w.willis@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GOAL-AI + CST-AI; Combination of clinic-level geriatric assessment and CBT-based coping skills training.	Behavioral: GOAL-AI; Clinic-level geriatric assessment and support program.; Behavioral: CST-AI; CBT-based coping skills training via telehealth.
Experimental: GOAL-AI alone; Clinic-level geriatric assessment and support only.	Behavioral: GOAL-AI; Clinic-level geriatric assessment and support program.
Experimental: CST-AI alone; CBT-based coping skills training only.	Behavioral: CST-AI; CBT-based coping skills training via telehealth.
No Intervention: Enhanced Usual Care; Standard care with educational materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form	The Brief Pain Inventory-Short Form (BPI-SF) will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). To calculate a pain severity score, the BPI-SF averages worst, least, average and current pain severity ratings on a 0 to 10 scale, with higher scores indicating more severe pain. To calculate a pain interference score, 7 items asking about interference from pain across different life domains will be averaged, with higher scores indicating higher pain interference.	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms	For the PROMIS® Anxiety and Depression 4-item Short Forms (4a, v1.0) items are summed to create a raw score from 4 to 20 that is converted to a T-score. Responses are on a 5-point scale from "never" (1) to "always" (5). Higher scores indicate higher emotional distress.	Baseline, 6 months, 12 months
Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form	For the PROMIS® Fatigue 6-item Short Form (6a, v1.0) items are summed to create a raw score that is converted to a T-score. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5). Sum scores may range from 6 to 30, with higher scores indicating higher fatigue.	Baseline, 6 months, 12 months
Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST)	The Five Times Sit to Stand Test (5xSST) assesses functional lower extremity strength, balance, risk of fall, functional decline, and frailty. The amount of time it takes a patient to sit and stand five times in succession with arms folded across their chest is averaged across three trials.	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rebecca Shelby, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Breast Neoplasms; Aromatase Inhibitors; Geriatric Oncology
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00118528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The following data will be preserved and shared: patient-reported data from study assessments, healthcare utilization data collected from the health record, AI adherence data collected via self-report and from the health record, physical function and geriatric assessment data collected by study staff in clinic and from the health record, and socio-demographic and medical data collected via patient report and health record.
• IPD Sharing Time Frame: Data will be shared either at the time of publication or at the end of the performance period, whichever comes first. All data deposited with the Duke Research Data Repository will be retained for a minimum of 25 years according to their stated Retention Policy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No