Breast Cancer, Joint Pain
Conditions
Keywords
breast cancer, aromatase inhibitors, physical activity, joint pain
Brief summary
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.
Interventions
BEHAVIORALWalk with Ease
An evidence-based walking program
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported joint pain | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported walking | 6 weeks | This will be measured by the number of days walked per week and the number of minutes per walk. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-reported joint stiffness | 6 week | A valid and reliable Visual Analog Scale will be used to assess joint stiffness. |
| Lower extremity pain and function | 6 weeks | The Western Ontario McMaster Universities Arthritis Index will be used to assess hip and knee pain and function. |
| Quality of life | 6 weeks | Functional Assessment of Cancer Therapy-General (FACT-G) |
| Beliefs about engaging in exercise | 6 weeks | Expectations for Exercise (OEE) scale |
| Self-efficacy to manage joint pain | 6 weeks | Arthritis Self-Efficacy Scale (ASE) |
| Pain | 6 weeks | 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. |
| Helplessness | 6 weeks | Rheumatology Attitudes Index (RAI) |
| Adverse event | 6 weeks | Self-report of any adverse events will be used to monitor safety. |
| Feasibility | 6 weeks | Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility. |
| Tolerability | 6 weeks | Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability. |
| Engagement in Physical Activity | 6 weeks | Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011 |
| Self-reported fatigue | 6 weeks | A valid and reliable Visual Analog Scale will be used to assess fatigue. |
Countries
United States
Outcome results
None listed