Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors
18 Years
N/A
Female
Breast Cancer
Trial Information
Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Identify a core set of instruments for measuring musculoskeletal symptoms
Outcome Time Frame:
09/2011
Safety Issue:
No
Principal Investigator
Karen K Swenson, RN, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Park Nicollet Institute
Authority:
United States: Institutional Review Board
Study ID:
03918-09
NCT ID:
NCT01074320
Start Date:
February 2010
Completion Date:
June 2012
Related Keywords:
- Breast Cancer
- breast cancer
- aromatase inhibitors
- musculoskeletal symptoms
- Breast Neoplasms
Name | Location |
|---|---|
| Park Nicollet Institute | St Louis Park, Minnesota 55416 |
| North Memorial Medical Center | Minneapolis, Minnesota 55422 |
