Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
NCT ID: NCT07232056
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
452 participants
INTERVENTIONAL
2026-06-01
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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GOAL-AI + CST-AI
Combination of clinic-level geriatric assessment and CBT-based coping skills training.
GOAL-AI
Clinic-level geriatric assessment and support program.
CST-AI
CBT-based coping skills training via telehealth.
GOAL-AI alone
Clinic-level geriatric assessment and support only.
GOAL-AI
Clinic-level geriatric assessment and support program.
CST-AI alone
CBT-based coping skills training only.
CST-AI
CBT-based coping skills training via telehealth.
Enhanced Usual Care
Standard care with educational materials.
No interventions assigned to this group
Interventions
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GOAL-AI
Clinic-level geriatric assessment and support program.
CST-AI
CBT-based coping skills training via telehealth.
Eligibility Criteria
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Inclusion Criteria
* HR+ non-metastatic breast cancer
* Within 12 months of starting AI therapy
* English-speaking
* Able to provide consent
Exclusion Criteria
* Metastatic cancer
* Cognitive impairment preventing consent
* Receiving care at multiple participating sites
65 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Rebecca Shelby, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Central Contacts
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Other Identifiers
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Pro00118528
Identifier Type: -
Identifier Source: org_study_id
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