Clinical trial · Observational
Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.
- 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)
RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors plan treatment and help patients live more comfortably. PURPOSE: This observational epidemiologic cohort is designed to study arthralgia, patient-reported outcomes, and medication adherence in postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aromatase inhibition therapy - OBSERVATIONAL ONLY | Other | — | UNRESOLVED |
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| medical chart review | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Arthralgia incidence, defined as proportion of the baseline population (those who have taken ≥ 9 doses of aromatase inhibitor [AI]) in which new or worsening joint pain or stiffness is observed at 1, 3, and 12 months after beginning AI therapy
- timeFrame
- 12 months
- measure
- Time to onset of arthralgia (continuous variable in weeks) among baseline population
- timeFrame
- 12 months
- measure
- Arthralgia point prevalence, defined as proportion of the baseline population with a score of ≥ 2 on any one dimension of the outcome measure at 1, 3, and 12 months after beginning AI therapy
- timeFrame
- 12 months
Secondary outcomes (2)
- measure
- Symptom trajectories over the course of treatment
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 90 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Planning to begin aromatase inhibitor (AI) therapy or taken fewer than 10 doses of adjuvant AI therapy * Hormone-receptor status not specified PATIENT CHARACTERISTICS: * Postmenopausal * ECOG performance status 0-1 * Able to understand and respond to questions in English * No condition that would impair the ability to provide informed consent * No other non-breast cancer condition PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 9 prior doses of AI
References
Publications (1)
- DERIVEDCastel LD, Hartmann KE, Mayer IA, Saville BR, Alvarez J, Boomershine CS, Abramson VG, Chakravarthy AB, Friedman DL, Cella DF. Time course of arthralgia among women initiating aromatase inhibitor therapy and a postmenopausal comparison group in a prospective cohort. Cancer. 2013 Jul 1;119(13):2375-82. doi: 10.1002/cncr.28016. Epub 2013 Apr 10. PMID 23575918