NCT07232056|Not Yet RecruitingDMC
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
GOAL-AI
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GOAL-AI
Sponsor study identifier
interventional
452
0 countries
N/A
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 14, 2025
Actual (reported)November 18, 2025
Actual (reported)October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Combination of clinic-level geriatric assessment and CBT-based coping skills training.
Clinic-level geriatric assessment and support only.
CBT-based coping skills training only.
Clinic-level geriatric assessment and support program.
CBT-based coping skills training via telehealth.
Rebecca Shelby, PhD
Duke University
First Submitted
November 14, 2025
First Posted
November 18, 2025
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2030
Standard care with educational materials.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 29, 2026
Record last verified: 2025-11
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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