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

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Center
      • St. Louis Park, Minnesota, United States, 55426
        • Park Nicollet Institute

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
Other: Other
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

HealthPartners Institute

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.

General Publications

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

Keywords

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.

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