Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Joint Pain
• Intervention / Treatment: Behavioral: Walk with Ease

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Estimate): August 8, 2016
• Last Update Submitted That Met QC Criteria: August 5, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: joint pain; physical activity; aromatase inhibitors; breast cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: 13-2321