Clinical trial NCT00954564: Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
Official title: Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthralgia
Breast Cancer
Keywords: arthralgia
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: American Cancer Society, Inc.
First posted: 2009-08-07
Enrollment: 351
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with breast cancer initiating aromatase inhibitor therapy

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
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
timeFrame: 12 months
measure: Time to onset of arthralgia (continuous variable in weeks) among baseline population
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Symptom trajectories over the course of treatment
timeFrame: 12 months
measure: Patient well-being: sleep quality, mood, and physical function
timeFrame: 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Liana Castel, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.