Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors (AIMS)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors|
- Identify a core set of instruments for measuring musculoskeletal symptoms [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
- Model the time course and predictors of change in musculoskeletal symptoms [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
- Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Breast cancer patients on AIs
Breast cancer patients beginning Aromatase Inhibitor therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074320
|United States, Minnesota|
|North Memorial Medical Center|
|Robbinsdale, Minnesota, United States, 55422|
|Park Nicollet Institute|
|St. Louis Park, Minnesota, United States, 55426|
|Principal Investigator:||Karen K Swenson, RN, PhD||Park Nicollet Institute|