PI-to-Oncologists briefing for clinical study (NCT00954564) patient recruitment
•Download as PPT, PDF•
1 like•293 views
Oncologist briefing given by Dr. Castel as Principal Investigator of the Breast Cancer Adjuvant Therapy prospective longitudinal study (NCT00954564) to communicate interim results and help oncologists identify and refer eligible breast cancer patients into the longitudinal cohort study. The goal of this presentation was to help achieve study enrollment targets.
Recommended
Recommended
More Related Content
What's hot
What's hot (19)
Similar to PI-to-Oncologists briefing for clinical study (NCT00954564) patient recruitment
Similar to PI-to-Oncologists briefing for clinical study (NCT00954564) patient recruitment (20)
Recently uploaded
Recently uploaded (20)
PI-to-Oncologists briefing for clinical study (NCT00954564) patient recruitment
- 1. Arthralgia in women with early-stage breast cancer taking aromatase inhibitors: Breast Cancer Adjuvant Therapy (BCAT) (BRE0939) Team-Oncologists Meeting Liana Castel, PhD, MSPH Tonya L. Brown, MBA Bradley Shields, BS Vanderbilt Institute for Medicine and Public Health Vanderbilt Epidemiology Center Monday March 18, 2013
- 2. 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.
- 3. 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
- 4. 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
- 6. Findings to date 52-week arthralgia trajectories and CIs (N=303)
- 9. Manuscript and grant submissions 1. MS: Descriptive epidemiology – preliminary findings 2. R01: Arthralgia, health outcomes, and adherence 3. MS: Validity and reliability of the Patient-Reported Arthralgia Inventory 4. MS: AI switching 5. MS: Arthralgia and HRQoL 6. MS: Arthralgia and AI adherence 7. MS: Adherence measurement methods validation
- 10. Funding • Vanderbilt Institute for Clinical and Translational Research • American Cancer Society • National Institutes of Health: Building Interdisciplinary Careers in Women’s Health Research
- 11. Clinic recruitment – Prescreening part 1: possible AI candidates – In-person clinic presence – Prescreening part 2: prescribed AI – Starpanel referrals: “BCAT-CastelLiana PhD”