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NCT02057536 · ClinicalTrials.gov registry record · NA
The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.
A NA study, sponsored by Christiana Care Health Services.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT02057536 is a NA study that has completed, run by Christiana Care Health Services. The registered enrollment target is 30 participants.
The verdict
NCT02057536, a NA study, has completed, sponsored by Christiana Care Health Services.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compliance with the medication and ultimately clinical outcome. In this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. Patients will be divided into two cohorts. Group A will receive AI therapy with a directed exercise program. Group B will receive AI therapy without a directed exercise program. Data will be collected when both cohorts of patients enroll in the study, at the end of PT for Group A and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression scale, and pain level scale.
Interventions
- OTHER Observation
- OTHER Arm A Directed exercise program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02057536
The ClinicalTrials.gov registry entry for NCT02057536 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Christiana Care Health Services, which has 82 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Observation is the first listed.
NCT02057536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02057536 about?
NCT02057536 is a clinical study titled "The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.". The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compli...
What is the current status of trial NCT02057536?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2014-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02057536?
The interventions under investigation include: Observation (OTHER), Arm A Directed exercise program (OTHER).
Who is sponsoring clinical trial NCT02057536?
This trial is sponsored by Christiana Care Health Services, which has 82 total clinical trials registered on ClinicalTrials.gov.
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