Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954564
• Other study ID #: CDR0000650647
• Secondary ID: UL1RR024975VU-VI
• Status: Completed
• Phase: N/A
• First received: August 6, 2009
• Last updated: March 30, 2017
• Start date: June 2009
• Est. completion date: May 2014

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• aromatase inhibition therapy - OBSERVATIONAL ONLY
Observational only - as prescribed
• medical chart review
Observational only
• questionnaire administration
Observational only

Procedure:
• assessment of therapy complications
Observational only

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	American Cancer Society, Inc., National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months
Primary	Time to onset of arthralgia (continuous variable in weeks) among baseline population		12 months
Primary	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		12 months
Secondary	Symptom trajectories over the course of treatment		12 months
Secondary	Patient well-being: sleep quality, mood, and physical function		12 months