Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Vanderbilt University
Sponsor:
Collaborators:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Liana Castel, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00954564
First received: August 6, 2009
Last updated: June 11, 2013
Last verified: June 2013

August 6, 2009
June 11, 2013
June 2009
June 2014   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to onset of arthralgia (continuous variable in weeks) among baseline population [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Time to onset of arthralgia (continuous variable in weeks) among baseline population [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00954564 on ClinicalTrials.gov Archive Site
  • Symptom trajectories over the course of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient well-being: sleep quality, mood, and physical function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Symptom trajectories over the course of treatment [ Designated as safety issue: No ]
  • Patient well-being: sleep quality, mood, and physical function [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Postmenopausal women with breast cancer initiating aromatase inhibitor therapy

  • Arthralgia
  • Breast Cancer
  • Other: aromatase inhibition therapy - OBSERVATIONAL ONLY
    Observational only - as prescribed
  • Other: medical chart review
    Observational only
  • Other: questionnaire administration
    Observational only
  • Procedure: assessment of therapy complications
    Observational only
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
580
June 2017
June 2014   (final data collection date for primary outcome measure)

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
Female
35 Years to 90 Years
Yes
United States
 
NCT00954564
CDR0000650647, UL1RR024975, VU-VICC-BRE-0939, 119475-MRSG-10-169-01-PCSM
No
Liana Castel, Vanderbilt University
Vanderbilt University
  • National Center for Research Resources (NCRR)
  • American Cancer Society, Inc.
Principal Investigator: Liana Castel, PhD, MSPH Vanderbilt-Ingram Cancer Center
Vanderbilt University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP