ArthralgiaNCT00954564
Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
An observational study of Arthralgia and Breast Cancer, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthralgia, Breast Cancer
- What is being tested?
- aromatase inhibition therapy - OBSERVATIONAL ONLY, medical chart review and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 351 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.
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.
Read the detailed description
OBJECTIVES:
Primary
- Estimate the incidence, time to onset, prevalence, and clinical and demographic predictors of arthralgia in post-menopausal women with early-stage breast cancer receiving aromatase inhibitors (AI).
- Chart the trajectory of arthralgia symptom severity over the course of AI treatment in these patients.
Secondary
- Measure the impact of arthralgia on sleep quality, depression, and physical function in these patients.
- Develop a roster of current physician-advised or prescribed treatments, including self-management techniques being used for AI-induced arthralgia, for intervention development.
OUTLINE: Patients complete questionnaires about joint pain and stiffness, sleep, depression, physical function, medications and treatment, exercise and social support, demographics, comorbidities, body mass index (BMI), and performance status at baseline and then periodically for approximately 1 year after beginning aromatase inhibitor (AI) therapy.
Patient medical records are reviewed for comorbidities, BMI, use of prior hormone replacement therapy, vitamin D levels and deficiency, performance status, histological stage, prior treatment, and medications at baseline and then periodically for approximately 1 year after beginning AI therapy.
- Conditions
- Arthralgia, Breast Cancer
- Being tested
- aromatase inhibition therapy - OBSERVATIONAL ONLY, medical chart review, questionnaire administration, assessment of therapy complications
- Keywords
- arthralgia, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Arthralgia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatase inhibition therapy - OBSERVATIONAL ONLYOther
Observational only - as prescribed
medical chart reviewOther
Observational only
questionnaire administrationOther
Observational only
assessment of therapy complicationsProcedure or surgery
Observational only
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Time to onset of arthralgia (continuous variable in weeks) among baseline population
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Symptom trajectories over the course of treatment
Measured: 12 months
Patient well-being: sleep quality, mood, and physical function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Liana Castel, PhD, MSPH, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954564
- Sponsor's protocol ID
- CDR0000650647
- Other IDs
- UL1RR024975, VU-VICC-BRE-0939, 119475-MRSG-10-169-01-PCSM
- Status last verified
- Mar 2017
- First submitted
- 6 Aug 2009
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23575918
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.
- ClinicalTrials.gov ID
- NCT00954564
- Acronym / sponsor ID
- CDR0000650647
- Conditions
- Arthralgia, Breast Cancer
- Keywords
- arthralgia, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), American Cancer Society, Inc.
- Study start
- Jun 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Estimate the incidence, time to onset, prevalence, and clinical and demographic predictors of arthralgia in post-menopausal women with early-stage breast cancer receiving aromatase inhibitors (AI).
- Chart the trajectory of arthralgia symptom severity over the course of AI treatment in these patients.
Secondary
- Measure the impact of arthralgia on sleep quality, depression, and physical function in these patients.
- Develop a roster of current physician-advised or prescribed treatments, including self-management techniques being used for AI-induced arthralgia, for intervention development.
OUTLINE: Patients complete questionnaires about joint pain and stiffness, sleep, depression, physical function, medications and treatment, exercise and social support, demographics, comorbidities, body mass index (BMI), and performance status at baseline and then periodically for approximately 1 year after beginning aromatase inhibitor (AI) therapy.
Patient medical records are reviewed for comorbidities, BMI, use of prior hormone replacement therapy, vitamin D levels and deficiency, performance status, histological stage, prior treatment, and medications at baseline and then periodically for approximately 1 year after beginning AI therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with breast cancer initiating aromatase inhibitor therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatase inhibition therapy - OBSERVATIONAL ONLYObservational only - as prescribed | Other | – |
| medical chart reviewObservational only | Other | – |
| questionnaire administrationObservational only | Other | – |
| assessment of therapy complicationsObservational only | Procedure or surgery | – |
Primary outcome
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
Time frame: 12 months
Time to onset of arthralgia (continuous variable in weeks) among baseline population
Time frame: 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
Time frame: 12 months
2 secondary outcomes
Symptom trajectories over the course of treatment
Time frame: 12 months
Patient well-being: sleep quality, mood, and physical function
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 23575918Castel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liana Castel, PhD, MSPH principal investigator
Vanderbilt-Ingram Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthralgia and Breast Cancer, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.