Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Leigh F Callahan, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01900418
First received: July 11, 2013
Last updated: September 10, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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 University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Self-reported joint pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A valid and reliable Visual Analog Scale will be used to assess fatigue.

  • Self-reported joint stiffness [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    A valid and reliable Visual Analog Scale will be used to assess joint stiffness.

  • Pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy-General (FACT-G)

  • Beliefs about engaging in exercise [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Expectations for Exercise (OEE) scale

  • Self-efficacy to manage joint pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Arthritis Self-Efficacy Scale (ASE)

  • Engagement in Physical Activity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011

  • Helplessness [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Rheumatology Attitudes Index (RAI)

  • Adverse event [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Self-report of any adverse events will be used to monitor safety.

  • Feasibility [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility.

  • Tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability.


Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900418

Contacts
Contact: Leigh F Callahan, PhD 919-966-0564 leigh_callahan@med.unc.edu
Contact: Kirsten A Nyrop, PhD 919-962-5139 kirsten_nyrop@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
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

No publications provided

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
Study First Received: July 11, 2013
Last Updated: September 10, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Breast Diseases
Skin Diseases
Arthralgia
Breast Neoplasms
Pain
Signs and Symptoms
Neoplasms by Site
Neoplasms
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014