Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors

NCT01074320 | Completed

• 1 other identifier: 03918-09
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer; aromatase inhibitors; musculoskeletal symptoms

Outcome Measures

Primary Outcomes (1)

• Identify a core set of instruments for measuring musculoskeletal symptoms

  09/2011

Secondary Outcomes (2)

• Model the time course and predictors of change in musculoskeletal symptoms

  09/2011

• Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment

  09/2011

Study Arms (1)

Breast cancer patients on AIs

Breast cancer patients beginning Aromatase Inhibitor therapy

Other: Other

Interventions

Other OTHER

Observational study

Breast cancer patients on AIs

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-menopausal breast cancer patients receiving aromatase inhibitors

You may qualify if:

• 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.

You may not qualify if:

• History of rheumatoid arthritis,
• Unable to read or understand English,
• History of psychiatric disability affecting informed consent or compliance with study procedures.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (2)

North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

Park Nicollet Institute

Saint Louis Park, Minnesota, 55426, United States

Location

Related Publications (1)

• Swenson KK, Nissen MJ, Henly SJ, Maybon L, Pupkes J, Zwicky K, Tsai ML, Shapiro AC. Identification of tools to measure changes in musculoskeletal symptoms and physical functioning in women with breast cancer receiving aromatase inhibitors. Oncol Nurs Forum. 2013 Nov;40(6):549-57. doi: 10.1188/13.ONF.549-557.

  PMID: 24161633 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Karen K Swenson, RN, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-08

Locations

US (2)