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


Phase 1
35 Years
90 Years
Open (Enrolling)
Female
Arthralgia, Breast Cancer

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Liana Castel, PhD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000650647

NCT ID:

NCT00954564

Start Date:

June 2009

Completion Date:

June 2017

Related Keywords:

  • Arthralgia
  • Breast Cancer
  • arthralgia
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Arthralgia
  • Breast Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838