Clinical trial · Interventional
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant Aromatase Inhibitor Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CST-AI | Behavioral | — | UNRESOLVED |
| GOAL-AI | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- GOAL-AI + CST-AI
- description
- Combination of clinic-level geriatric assessment and CBT-based coping skills training.
- interventionNames
- Behavioral: GOAL-AI
- Behavioral: CST-AI
- type
- EXPERIMENTAL
- label
- GOAL-AI alone
- description
- Clinic-level geriatric assessment and support only.
- interventionNames
- Behavioral: GOAL-AI
- type
- EXPERIMENTAL
- label
- CST-AI alone
- description
- CBT-based coping skills training only.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available