Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GOAL-AI, CST-AI.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia. Basic parameters: from 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant Aromatase Inhibitor Therapy
Overview
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.
Interventions
- Behavioral GOAL-AI
Clinic-level geriatric assessment and support program. - Behavioral CST-AI
CBT-based coping skills training via telehealth.
Primary outcome measures
- Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (3)
- Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms [Time frame: Baseline, 6 months, 12 months]
- Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form [Time frame: Baseline, 6 months, 12 months]
- Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST) [Time frame: Baseline, 6 months, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07232056 · Pro00118528