Joint Pain | Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Joint Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Walk with EaseAn evidence-based walking program
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
WalkingWalk with Ease
Wait list controlWait list control receiving the active intervention 6 weeks later.
Start Date: August 2013
Completed Date: June 2016
Primary Outcome: Self-reported joint pain
Secondary Outcome: Self-reported walking
Study sponsors, principal investigator, and references
Principal Investigator: Leigh F Callahan, PhD
Lead Sponsor: University of North Carolina, Chapel Hill