Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors (AIMS)
December 15, 2015 updated by: HealthPartners Institute
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 Overview
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.
Study Type
Observational
Enrollment (Actual)
150
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
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Minnesota
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Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Center
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St. Louis Park, Minnesota, United States, 55426
- Park Nicollet Institute
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Post-menopausal breast cancer patients receiving aromatase inhibitors
Description
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.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast cancer patients on AIs
Breast cancer patients beginning Aromatase Inhibitor therapy
|
Observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identify a core set of instruments for measuring musculoskeletal symptoms
Time Frame: 09/2011
|
09/2011
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Model the time course and predictors of change in musculoskeletal symptoms
Time Frame: 09/2011
|
09/2011
|
|
Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment
Time Frame: 09/2011
|
09/2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen K Swenson, RN, PhD, HealthPartners Institute
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.
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
February 1, 2010
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
February 22, 2010
First Submitted That Met QC Criteria
February 23, 2010
First Posted (Estimate)
February 24, 2010
Study Record Updates
Last Update Posted (Estimate)
December 16, 2015
Last Update Submitted That Met QC Criteria
December 15, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03918-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.