Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors

NCT00738998 | Terminated

• 1 other identifier: 2006-1038
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to learn more about what it is like for patients with breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. Researchers also want to learn more about which patients are most likely to have joint symptoms by looking at certain proteins from routine blood draw samples.

Conditions

Breast Cancer

Keywords

Breast Cancer; Aromatase Inhibitors; Symptom Assessment; Questionnaire; Survey; Phone Call; Arimidex; Anastrozole

Outcome Measures

Primary Outcomes (1)

• Incidence, onset and severity of arthralgia during anastrozole treatment

  3 Years

Study Arms (1)

Questionnaire and Telephone Assessments

EXPERIMENTAL

Breast cancer patients assigned to one or two groups: Group 1) enrolled at beginning of anastrozole treatment; or Group 2) if beginning third year of anastrozole treatment.

Behavioral: Questionnaire; Other: Phone Calls

Interventions

Questionnaire BEHAVIORAL

Questionnaires about pain and other symptoms, quality of life, and ability to work will be completed.

Also known as: Survey

Questionnaire and Telephone Assessments

Phone Calls OTHER

A telephone system will call every 2 weeks so that you can rate your symptoms and how they interfere with daily activities. Each call will take about 5 minutes.

Questionnaire and Telephone Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with early stage hormone receptor positive breast cancer who are at these 2 time points in their anastrozole treatment: 1) at the time period between two months prior or one month after beginning of their anastrozole treatment (Cohort 1); 2) patients within +/- 2 months of the beginning of the third year of anastrozole treatment (Cohort 2).
• Patients \>= 18 years old.

You may not qualify if:

• Patients with metastatic disease.
• Patients who cannot complete the assessment tools.
• Patients without telephone access.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Charles Cleeland, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 21, 2008
• Study Start: June 5, 2008
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

US (1)