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Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 InstituteSt Louis Park, Minnesota  55416
North Memorial Medical CenterMinneapolis, Minnesota  55422