pi-to-oncologists briefing for clinical study (nct00954564) patient recruitment
TRANSCRIPT
Arthralgia in women with early-stage breast cancer taking aromatase inhibitors:
Breast Cancer Adjuvant Therapy (BCAT)(BRE0939) Team-Oncologists Meeting
Liana Castel, PhD, MSPHTonya L. Brown, MBA
Bradley Shields, BSVanderbilt Institute for Medicine and Public Health
Vanderbilt Epidemiology Center
Monday March 18, 2013
Aims of the prospective cohort
Among women with early breast cancer initiating adjuvant endocrine therapy with an aromatase inhibitor, and among postmenopausal women without breast cancer, to:
• AIM 1: Estimate arthralgia time-to-onset, prevalence, incidence, background rate, trajectories, and risk factors
• AIM 2: Measure the impact of arthralgia on health-related quality of life and medication adherence (adherence for AI pts only)
• SECONDARY AIM: Develop a roster of current physician-advised or prescribed treatments, as well as self-management techniques being used for AI-induced arthralgia (AI pts only), to further inform intervention development.
INDIVIDUAL LEVEL•Demographic•Clinical•Psychosociobehavioral(e.g., level of social support)
MEDICAL CARE LEVEL•Non-cancer treatments•Cancer treatments, including aromatase inhibitor (AI) therapy
RISK FACTORS
•Prevalence•Incidence•Time to onset•Severity•Trajectory•Background rate
ARTHRALGIA•Sleep •Depression•Physical function
HEALTH-RELATED QUALITY OF LIFE
ARTHRALGIA TREATMENTS
INDIVIDUAL LEVEL•Exercise•Self-care•Complementary medicine
MEDICAL CARE LEVEL•Evidence-based anticipatory guidance•Prescription medication•Over the counter medication•Non-pharmaceutical interventions
Recurrence rates/ disease-free survival
CLINICAL EFFECTIVENESS OF AROMATASE INHIBITORS
ADHERENCE
•AI adherence level(self-report)
•AI persistence at 1, 3, and 12 months(self-report)
•AI persistence(MEMS)
•Switch from AI to tamoxifen
Aim 1
Aim 3
Aim 2
INDIVIDUAL LEVEL•Demographic•Clinical•Psychosociobehavioral(e.g., level of social support)
MEDICAL CARE LEVEL•Non-cancer treatments•Cancer treatments, including aromatase inhibitor (AI) therapy
RISK FACTORS
•Prevalence•Incidence•Time to onset•Severity•Trajectory•Background rate
ARTHRALGIA•Sleep •Depression•Physical function
HEALTH-RELATED QUALITY OF LIFE
ARTHRALGIA TREATMENTS
INDIVIDUAL LEVEL•Exercise•Self-care•Complementary medicine
MEDICAL CARE LEVEL•Evidence-based anticipatory guidance•Prescription medication•Over the counter medication•Non-pharmaceutical interventions
Recurrence rates/ disease-free survival
CLINICAL EFFECTIVENESS OF AROMATASE INHIBITORS
ADHERENCE
•AI adherence level(self-report)
•AI persistence at 1, 3, and 12 months(self-report)
•AI persistence(MEMS)
•Switch from AI to tamoxifen
Aim 1
Aim 3
Aim 2
Conceptual model: arthralgia and other outcomes
Design and methods• Current sample size = 300 women
100 AI and 200 comparison group women • Multi-level identification and recruitment• 1 year of enrollment and 1 year per-participant follow up• 8 surveys (paper) per patient• Domains:
– Pain in joints, stiffness in joints, pain impact on activities– Quality of life (depression, sleep, physical function, symptoms)– Medications– Treatments– Nonpharmacologic pain management– Clinical and demographic characteristics– Exercise
Findings to date
52-week arthralgia trajectories and CIs (N=303)
Manuscript and grant submissions1. MS: Descriptive epidemiology – preliminary findings2. R01: Arthralgia, health outcomes, and adherence3. MS: Validity and reliability of the Patient-Reported Arthralgia
Inventory4. MS: AI switching5. MS: Arthralgia and HRQoL6. MS: Arthralgia and AI adherence7. MS: Adherence measurement methods validation
Funding
• Vanderbilt Institute for Clinical and Translational Research• American Cancer Society • National Institutes of Health: Building Interdisciplinary
Careers in Women’s Health Research
Clinic recruitment
– Prescreening part 1: possible AI candidates– In-person clinic presence– Prescreening part 2: prescribed AI– Starpanel referrals: “BCAT-CastelLiana PhD”
Feedback/discussion