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

NCT07232056 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

GOAL-AI

Clinic-level geriatric assessment and support program.

BEHAVIORAL

CST-AI

CBT-based coping skills training via telehealth.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Rebecca Shelby, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2030-11-30
Completion
2030-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232056 on ClinicalTrials.gov