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Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01900418
First Posted: July 16, 2013
Last Update Posted: August 8, 2016
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.
Information provided by (Responsible Party):
Leigh F Callahan, PhD, University of North Carolina, Chapel Hill
  Purpose
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.

Condition Intervention
Joint Pain Breast Cancer Behavioral: Walk with Ease

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Resource links provided by NLM:


Further study details as provided by Leigh F Callahan, PhD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 78
Study Start Date: August 2013
Study Completion Date: June 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Leigh F Callahan, PhD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Leigh F Callahan, PhD, Mary Link Briggs Distinguished Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01900418     History of Changes
Other Study ID Numbers: 13-2321
First Submitted: July 11, 2013
First Posted: July 16, 2013
Last Update Posted: August 8, 2016
Last Verified: August 2016

Keywords provided by Leigh F Callahan, PhD, University of North Carolina, Chapel Hill:
breast cancer
aromatase inhibitors
physical activity
joint pain

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Arthralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs