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Completed

NCT Number: NCT00954564

Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

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.

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Key information

Age range

35 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aromatase inhibition therapy - OBSERVATIONAL ONLY

Other

Observational only - as prescribed

medical chart review

Other

Observational only

Questionnaire Administration

Other

Observational only

assessment of therapy complications

Procedure

Observational only

Primary outcomes

  1. 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

  2. Time to onset of arthralgia (continuous variable in weeks) among baseline population

    Time frame: 12 months

  3. 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

Secondary outcomes

  1. Symptom trajectories over the course of treatment

    Time frame: 12 months

  2. Patient well-being: sleep quality, mood, and physical function

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • American Cancer Society, Inc.
  • National Center for Research Resources (NCRR)

Registry information

Official study title

Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2009
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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