Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Not Applicable

Completed

• Conditions: Breast Cancer; Joint Pain
• Interventions: Behavioral: Walk with Ease

• Registration Number: NCT01900418
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-16
• Study Start: 2013-08
• Primary Completion: 2015-10
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Walking	Walk with Ease	Walk with Ease

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Self-reported walking	6 weeks	This will be measured by the number of days walked per week and the number of minutes per walk.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States