Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

March 30, 2017 updated by: Vanderbilt University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, United States, 37203
    - Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women with breast cancer initiating aromatase inhibitor therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	12 months
Time to onset of arthralgia (continuous variable in weeks) among baseline population Time Frame: 12 months	12 months
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	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom trajectories over the course of treatment Time Frame: 12 months	12 months
Patient well-being: sleep quality, mood, and physical function Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

American Cancer Society, Inc.

National Center for Research Resources (NCRR)

Investigators

Principal Investigator: Liana Castel, PhD, MSPH, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)