Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
NCT ID: NCT00954564
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
351 participants
OBSERVATIONAL
2009-06-30
2014-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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aromatase inhibition therapy - OBSERVATIONAL ONLY
Observational only - as prescribed
medical chart review
Observational only
questionnaire administration
Observational only
assessment of therapy complications
Observational only
Eligibility Criteria
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Inclusion Criteria
* 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
35 Years
90 Years
FEMALE
Yes
Sponsors
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National Center for Research Resources (NCRR)
NIH
American Cancer Society, Inc.
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Liana Castel, PhD, MSPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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References
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Castel 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.
Other Identifiers
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VU-VICC-BRE-0939
Identifier Type: OTHER
Identifier Source: secondary_id
119475-MRSG-10-169-01-PCSM
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDR0000650647
Identifier Type: -
Identifier Source: org_study_id
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