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

NCT07232056 | Not Yet Recruiting DMC

• 1 other identifier: Pro00118528
• Study Type: interventional
• Target: 452
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Breast Neoplasms; Geriatric Oncology; Aromatase Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms

  Baseline, 6 months, 12 months

• Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form

  Baseline, 6 months, 12 months

• Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST)

  Baseline, 6 months, 12 months

Study Arms (4)

GOAL-AI + CST-AI

EXPERIMENTAL

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

Behavioral: GOAL-AI; Behavioral: CST-AI

GOAL-AI alone

EXPERIMENTAL

Clinic-level geriatric assessment and support only.

Behavioral: GOAL-AI

CST-AI alone

EXPERIMENTAL

CBT-based coping skills training only.

Behavioral: CST-AI

Enhanced Usual Care

NO INTERVENTION

Standard care with educational materials.

Interventions

GOAL-AI BEHAVIORAL

Clinic-level geriatric assessment and support program.

GOAL-AI + CST-AI; GOAL-AI alone

CST-AI BEHAVIORAL

CBT-based coping skills training via telehealth.

CST-AI alone; GOAL-AI + CST-AI

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rebecca Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smrithi Divakaran, MBBS, MSPH

CONTACT

919-681-7695; smrithi.divakaran@duke.edu

Michael W Willis, BA

CONTACT

919-681-8437; michael.w.willis@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: July 29, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.