Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Study Overview
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Brief Summary
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For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This proof-of-concept study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.

Official Title
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Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Conditions
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Joint Pain, Breast Cancer

Intervention / Treatment
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* Behavioral: Walk with Ease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks Experiencing more than mild joint pain/symptoms 21 or older have permission from physician to engage in moderate intensity physical activity Exclusion Criteria: Undergoing chemotherapy and/or radiation therapy at any time during the study period Scheduled for major surgery during the study period Presently engaged in high levels of physical activity on a daily basis Less than 21 years of age Unable to walk or engage in moderate intensity physical activity

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Walking<br>Walk with Ease | Behavioral: Walk with Ease<br>* An evidence-based walking program<br>|
| No Intervention: Wait list control<br>Wait list control receiving the active intervention 6 weeks later. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported joint pain | A valid and reliable 10cm Visual Analog Scale will be used to assess self-reported joint pain. This scale has been used in numerous trials. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported walking | This will be measured by the number of days walked per week and the number of minutes per walk. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, aromatase inhibitors, physical activity, joint pain