Clinical trial NCT01074320: Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors
Official title: Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
aromatase inhibitors
musculoskeletal symptoms
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal breast cancer patients receiving aromatase inhibitors

Brief summary: Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms are commonly reported with AI treatment,however, we do not have consistent methods to measure these symptoms prospectively. This gap in our knowledge inhibits the ability to test and develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate functional tests and standardized instruments for their ability to prospectively assess musculoskeletal symptoms in women being treated with AIs for breast cancer.

Detailed description: Specific Aims: 1) identify a core set of instruments for measuring musculoskeletal symptoms, 2) model the time course and predictors of change in musculoskeletal symptoms, 3) explore the effect of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment.

Methods: We will prospectively assess musculoskeletal symptoms due to treatment with aromatase inhibitors. Post-menopausal women beginning AI treatment for hormone responsive breast cancer will be invited to join this study.

Eligibility criteria: Inclusion Criteria:

* Women with stage I - IIIa invasive breast cancer,
* Hormone-receptor positive cancer (either ER+ or PR+ or both),
* Prescribed and have agreed to take exemestane, anastrazole or letrozole,
* Have completed initial treatment of surgery, RT, and/or chemotherapy,
* Are post-menopausal,
* No previous history of aromatase inhibitor therapy for invasive breast cancer,
* Have signed the consent form.

Exclusion Criteria:

* History of rheumatoid arthritis,
* Unable to read or understand English,
* History of psychiatric disability affecting informed consent or compliance with study procedures.

Primary outcomes:
measure: Identify a core set of instruments for measuring musculoskeletal symptoms
timeFrame: 09/2011
Secondary outcomes:
measure: Model the time course and predictors of change in musculoskeletal symptoms
timeFrame: 09/2011
measure: Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment
timeFrame: 09/2011
Other outcomes:
Locations:
city: Robbinsdale
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: St. Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Karen K Swenson, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swenson KK, Nissen MJ, Henly SJ, Maybon L, Pupkes J, Zwicky K, Tsai ML, Shapiro AC. Identification of tools to measure changes in musculoskeletal symptoms and physical functioning in women with breast cancer receiving aromatase inhibitors. Oncol Nurs Forum. 2013 Nov;40(6):549-57. doi: 10.1188/13.ONF.549-557.