This trial is active, not recruiting.

Conditions joint pain, breast cancer
Treatment walk with ease
Sponsor University of North Carolina, Chapel Hill
Start date August 2013
End date October 2015
Trial size 78 participants
Trial identifier NCT01900418, 13-2321


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose health services research
(Active Comparator)
Walk with Ease
walk with ease
An evidence-based walking program
(No Intervention)
Wait list control receiving the active intervention 6 weeks later.

Primary Outcomes

Self-reported joint pain
time frame: 6 weeks

Secondary Outcomes

Self-reported walking
time frame: 6 weeks

Eligibility Criteria

Female participants from 21 years up to 99 years old.

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

Additional Information

Official title Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Principal investigator Leigh F Callahan, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.
Location data was received from the National Cancer Institute and was last updated in September 2016.