Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01900418|
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : August 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Joint Pain Breast Cancer||Behavioral: Walk with Ease||Not Applicable|
|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|
|Actual Primary Completion Date :||October 2015|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|