NCT00954564

Brief Summary

RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors plan treatment and help patients live more comfortably. PURPOSE: This observational epidemiologic cohort is designed to study arthralgia, patient-reported outcomes, and medication adherence in postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

4.9 years

First QC Date

August 6, 2009

Last Update Submit

March 30, 2017

Conditions

ArthralgiaBreast Cancer

Keywords

arthralgiastage I breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (3)

  • Arthralgia incidence, defined as proportion of the baseline population (those who have taken ≥ 9 doses of aromatase inhibitor [AI]) in which new or worsening joint pain or stiffness is observed at 1, 3, and 12 months after beginning AI therapy

    12 months

  • Time to onset of arthralgia (continuous variable in weeks) among baseline population

    12 months

  • Arthralgia point prevalence, defined as proportion of the baseline population with a score of ≥ 2 on any one dimension of the outcome measure at 1, 3, and 12 months after beginning AI therapy

    12 months

Secondary Outcomes (2)

  • Symptom trajectories over the course of treatment

    12 months

  • Patient well-being: sleep quality, mood, and physical function

    12 months

Interventions

aromatase inhibition therapy - OBSERVATIONAL ONLYOTHER

Observational only - as prescribed

medical chart reviewOTHER

Observational only

questionnaire administrationOTHER

Observational only

assessment of therapy complicationsPROCEDURE

Observational only

Eligibility Criteria

Age35 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal women with breast cancer initiating aromatase inhibitor therapy

DISEASE CHARACTERISTICS: * Planning to begin aromatase inhibitor (AI) therapy or taken fewer than 10 doses of adjuvant AI therapy * Hormone-receptor status not specified PATIENT CHARACTERISTICS: * Postmenopausal * ECOG performance status 0-1 * Able to understand and respond to questions in English * No condition that would impair the ability to provide informed consent * No other non-breast cancer condition PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 9 prior doses of AI

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

  • Castel LD, Hartmann KE, Mayer IA, Saville BR, Alvarez J, Boomershine CS, Abramson VG, Chakravarthy AB, Friedman DL, Cella DF. Time course of arthralgia among women initiating aromatase inhibitor therapy and a postmenopausal comparison group in a prospective cohort. Cancer. 2013 Jul 1;119(13):2375-82. doi: 10.1002/cncr.28016. Epub 2013 Apr 10.

    PMID: 23575918DERIVED

MeSH Terms

Conditions

ArthralgiaBreast Neoplasms

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Liana Castel, PhD, MSPH

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 7, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(2)