Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Breast Cancer Clinical Trial

Official title:

Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900418
• Other study ID #: 13-2321
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: August 5, 2016
• Start date: August 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms
• Joint Pain

Intervention

Behavioral:
• Walk with Ease
An evidence-based walking program

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported fatigue	A valid and reliable Visual Analog Scale will be used to assess fatigue.	6 weeks	No
Other	Self-reported joint stiffness	A valid and reliable Visual Analog Scale will be used to assess joint stiffness.	6 week	No
Other	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	No
Other	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	No
Other	Quality of life	Functional Assessment of Cancer Therapy-General (FACT-G)	6 weeks	No
Other	Beliefs about engaging in exercise	Expectations for Exercise (OEE) scale	6 weeks	No
Other	Self-efficacy to manage joint pain	Arthritis Self-Efficacy Scale (ASE)	6 weeks	No
Other	Engagement in Physical Activity	Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011	6 weeks	No
Other	Helplessness	Rheumatology Attitudes Index (RAI)	6 weeks	No
Other	Adverse event	Self-report of any adverse events will be used to monitor safety.	6 weeks	Yes
Other	Feasibility	Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility.	6 weeks	No
Other	Tolerability	Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability.	6 weeks	No
Primary	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	No
Secondary	Self-reported walking	This will be measured by the number of days walked per week and the number of minutes per walk.	6 weeks	No