Arthralgia, Breast Cancer
Conditions
Keywords
arthralgia, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief summary
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.
Detailed description
OBJECTIVES: Primary * Estimate the incidence, time to onset, prevalence, and clinical and demographic predictors of arthralgia in post-menopausal women with early-stage breast cancer receiving aromatase inhibitors (AI). * Chart the trajectory of arthralgia symptom severity over the course of AI treatment in these patients. Secondary * Measure the impact of arthralgia on sleep quality, depression, and physical function in these patients. * Develop a roster of current physician-advised or prescribed treatments, including self-management techniques being used for AI-induced arthralgia, for intervention development. OUTLINE: Patients complete questionnaires about joint pain and stiffness, sleep, depression, physical function, medications and treatment, exercise and social support, demographics, comorbidities, body mass index (BMI), and performance status at baseline and then periodically for approximately 1 year after beginning aromatase inhibitor (AI) therapy. Patient medical records are reviewed for comorbidities, BMI, use of prior hormone replacement therapy, vitamin D levels and deficiency, performance status, histological stage, prior treatment, and medications at baseline and then periodically for approximately 1 year after beginning AI therapy.
Interventions
OTHERaromatase inhibition therapy - OBSERVATIONAL ONLY
Observational only - as prescribed
OTHERmedical chart review
Observational only
OTHERquestionnaire administration
Observational only
PROCEDUREassessment of therapy complications
Observational only
Sponsors
National Center for Research Resources (NCRR)
American Cancer Society, Inc.
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 12 months |
| Time to onset of arthralgia (continuous variable in weeks) among baseline population | 12 months |
| 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 | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Symptom trajectories over the course of treatment | 12 months |
| Patient well-being: sleep quality, mood, and physical function | 12 months |
Countries
United States
Outcome results
None listed