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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking | Active Comparator | Walk with Ease |
|
| Wait list control | No Intervention | Wait list control receiving the active intervention 6 weeks later. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk with Ease | Behavioral | An evidence-based walking program |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported fatigue | A valid and reliable Visual Analog Scale will be used to assess fatigue. | 6 weeks |
| Self-reported joint stiffness | A valid and reliable Visual Analog Scale will be used to assess joint stiffness. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh F Callahan, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D016138 | Walking |
| C034430 | methyl hydroxyethyl cellulose |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 6 week |
| Pain | The Brief Pain Inventory Short Form will be used to assess pain. It is a valid and reliable instrument that has been used in other studies of breast cancer survivors. | 6 weeks |
| Lower extremity pain and function | The Western Ontario McMaster Universities Arthritis Index will be used to assess hip and knee pain and function. | 6 weeks |
| Quality of life | Functional Assessment of Cancer Therapy-General (FACT-G) | 6 weeks |
| Beliefs about engaging in exercise | Expectations for Exercise (OEE) scale | 6 weeks |
| Self-efficacy to manage joint pain | Arthritis Self-Efficacy Scale (ASE) | 6 weeks |
| Engagement in Physical Activity | Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011 | 6 weeks |
| Helplessness | Rheumatology Attitudes Index (RAI) | 6 weeks |
| Adverse event | Self-report of any adverse events will be used to monitor safety. | 6 weeks |
| Feasibility | Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility. | 6 weeks |
| Tolerability | Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability. | 6 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D015444 | Exercise |
| D009043 | Motor Activity |