pi-to-oncologists briefing for clinical study (nct00954564) patient recruitment
TRANSCRIPT
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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
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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.
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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
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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
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Findings to date
52-week arthralgia trajectories and CIs (N=303)
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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
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Funding
• Vanderbilt Institute for Clinical and Translational Research• American Cancer Society • National Institutes of Health: Building Interdisciplinary
Careers in Women’s Health Research
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Clinic recruitment
– Prescreening part 1: possible AI candidates– In-person clinic presence– Prescreening part 2: prescribed AI– Starpanel referrals: “BCAT-CastelLiana PhD”
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Feedback/discussion