Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Conditions
Keywords
Breast Neoplasms, Geriatric Oncology, Aromatase Inhibitors
Brief 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.
Interventions
BEHAVIORALGOAL-AI
Clinic-level geriatric assessment and support program.
BEHAVIORALCST-AI
CBT-based coping skills training via telehealth.
Sponsors
Duke University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form | Baseline, 6 months, 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms | Baseline, 6 months, 12 months | For the PROMIS® Anxiety and Depression 4-item Short Forms (4a, v1.0) items are summed to create a raw score from 4 to 20 that is converted to a T-score. Responses are on a 5-point scale from "never" (1) to "always" (5). Higher scores indicate higher emotional distress. |
| Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form | Baseline, 6 months, 12 months | For the PROMIS® Fatigue 6-item Short Form (6a, v1.0) items are summed to create a raw score that is converted to a T-score. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5). Sum scores may range from 6 to 30, with higher scores indicating higher fatigue. |
| Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST) | Baseline, 6 months, 12 months | The Five Times Sit to Stand Test (5xSST) assesses functional lower extremity strength, balance, risk of fall, functional decline, and frailty. The amount of time it takes a patient to sit and stand five times in succession with arms folded across their chest is averaged across three trials. |
Contacts
CONTACTSmrithi Divakaran, MBBS, MSPH
CONTACTMichael W Willis, BA
PRINCIPAL_INVESTIGATORRebecca Shelby, PhD
Duke University
Outcome results
None listed