Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
|ClinicalTrials.gov Identifier: NCT01900418|
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : August 8, 2016
|Condition or disease||Intervention/treatment|
|Joint Pain Breast Cancer||Behavioral: Walk with Ease|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Factorial Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy|
|Study Start Date :||August 2013|
|Primary Completion Date :||October 2015|
|Study Completion Date :||June 2016|
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.
- Self-reported joint pain [ Time Frame: 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.
- Self-reported walking [ Time Frame: 6 weeks ]This will be measured by the number of days walked per week and the number of minutes per walk.
- Self-reported fatigue [ Time Frame: 6 weeks ]A valid and reliable Visual Analog Scale will be used to assess fatigue.
- Self-reported joint stiffness [ Time Frame: 6 week ]A valid and reliable Visual Analog Scale will be used to assess joint stiffness.
- Pain [ Time Frame: 6 weeks ]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.
- Lower extremity pain and function [ Time Frame: 6 weeks ]The Western Ontario McMaster Universities Arthritis Index will be used to assess hip and knee pain and function.
- Quality of life [ Time Frame: 6 weeks ]Functional Assessment of Cancer Therapy-General (FACT-G)
- Beliefs about engaging in exercise [ Time Frame: 6 weeks ]Expectations for Exercise (OEE) scale
- Self-efficacy to manage joint pain [ Time Frame: 6 weeks ]Arthritis Self-Efficacy Scale (ASE)
- Engagement in Physical Activity [ Time Frame: 6 weeks ]Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011
- Helplessness [ Time Frame: 6 weeks ]Rheumatology Attitudes Index (RAI)
- Adverse event [ Time Frame: 6 weeks ]Self-report of any adverse events will be used to monitor safety.
- Feasibility [ Time Frame: 6 weeks ]Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility.
- Tolerability [ Time Frame: 6 weeks ]Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900418
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Leigh F Callahan, PhD||University of North Carolina, Chapel Hill|